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Sample records for medication safety 2002-2008

  1. Medication safety in acute care in Australia: where are we now? Part 2: a review of strategies and activities for improving medication safety 2002-2008

    PubMed Central

    Semple, Susan J; Roughead, Elizabeth E

    2009-01-01

    Background This paper presents Part 2 of a literature review examining medication safety in the Australian acute care setting. This review was undertaken for the Australian Commission on Safety and Quality in Health Care, updating the 2002 national report on medication safety. Part 2 of the review examined the Australian evidence base for approaches to build safer medication systems in acute care. Methods A literature search was conducted to identify Australian studies and programs published from 2002 to 2008 which examined strategies and activities for improving medication safety in acute care. Results and conclusion Since 2002 there has been significant progress in strategies to improve prescription writing in hospitals with the introduction of a National Inpatient Medication Chart. There are also systems in place to ensure a nationally coordinated approach to the ongoing optimisation of the chart. Progress has been made with Australian research examining the implementation of computerised prescribing systems with clinical decision support. These studies have highlighted barriers and facilitators to the introduction of such systems that can inform wider implementation. However, Australian studies assessing outcomes of this strategy on medication incidents or patient outcomes are still lacking. In studies assessing education for reducing medication errors, academic detailing has been demonstrated to reduce errors in prescriptions for Schedule 8 medicines and a program was shown to be effective in reducing error prone prescribing abbreviations. Published studies continue to support the role of clinical pharmacist services in improving medication safety. Studies on strategies to improve communication between different care settings, such as liaison pharmacist services, have focussed on implementation issues now that funding is available for community-based services. Double checking versus single-checking by nurses and patient self-administration in hospital has been

  2. Medical Device Safety

    MedlinePlus

    ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Medical Devices Home Medical Devices Medical Device Safety Medical Device Safety Share Tweet Linkedin Pin it More sharing ...

  3. Medical Oxygen Safety

    MedlinePlus

    ... to the air a patient uses to breathe. Fire needs oxygen to burn. If a fire should start in an oxygen-enriched area, the ... Homes where medical oxygen is used need specific fire safety rules to keep people safe from fire ...

  4. Medical Device Safety

    MedlinePlus

    A medical device is any product used to diagnose, cure, or treat a condition, or to prevent disease. They range ... may need one in a hospital. To use medical devices safely Know how your device works. Keep instructions ...

  5. Medical Device Safety

    MedlinePlus

    A medical device is any product used to diagnose, cure, or treat a condition, or to prevent disease. They ... may need one in a hospital. To use medical devices safely Know how your device works. Keep ...

  6. Medical Oxygen Safety

    MedlinePlus

    ... near the oxygen. Post No Smoking and No Open Flames signs in and outside the home to remind people not to smoke. Your Source for SAFETY Information NFPA Public Education Division • 1 Batterymarch Park, Quincy, MA 02169 Name ...

  7. Medication safety: Filling your prescription

    MedlinePlus

    ... org/medication-safety-articles/item/387-is-ordering-medicines-online-safe-for. January 1, 2010. Accessed April 9, 2014. FamilyDoctor.org. How to Get the Most From Your Medicine. http://familydoctor.org/familydoctor/en/drugs-procedures-devices/ ...

  8. Optimizing medication safety in the home.

    PubMed

    LeBlanc, Raeanne Genevieve; Choi, Jeungok

    2015-06-01

    Medication safety among community-dwelling older adults in the United States is an ongoing health issue impacting health outcomes, chronic disease management, and aging in place at home. This article describes a medication safety improvement project that aimed to: (1) Increase the ability of participants to manage medications, (2) Identify and make necessary medication changes, (3) Create an accurate up-to-date medication list to be available in the home, and (4) Provide communication between the primary care provider, participant, and case manager. An in-home medication assessment was completed for 25 participants using an evidence-based medication management software system. This process was used to review medications; identify medication-related problems; create a shared medication list; and convey this information to the primary care provider, case manager, and client while addressing needed medication changes. Educational interventions on management and understanding of medications were provided to participants to emphasize the correct use of medications and use of a personal medication record. Outcome improvements included provision of an accurate medication list, early identification of medication-related problems, identification of drug duplication, and identification of medication self-management challenges that can be useful for optimizing medication safety-related home healthcare and inform future interventions. PMID:26034822

  9. Primary hyperparathyroidism and the road to surgery: appraisal of the proceedings of the four international workshops (1990, 2002, 2008, 2014) on primary hyperparathyroidism.

    PubMed

    Sklavenitis-Pistofidis, Romanos; Papaioannou, Ourania; Kotsa, Kalliopi

    2015-01-01

    Although surgery is unambiguously recommended for symptomatic primary hyperparathyroidism (PHPT) patients, management options for asymptomatic patients have varied between surgery, medications and follow-up. To deal with this issue, four International Workshops have taken place, in 1990, 2002, 2008 and 2014, during which a team of experts drew up criteria to stratify asymptomatic patients as surgery-eligible and surgery-ineligible. The efficacy of the criteria have however been questioned over the years and the majority of patients, both eligible and ineligible, may eventually have undergone surgery. Nevertheless, the criteria are still in use today and they clearly mirror the course of change in the treatment of PHPT patients. PMID:26158652

  10. Four Medication Safety Tips for Older Adults

    MedlinePlus

    ... Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products For Consumers Home For Consumers Consumer Updates Four Medication Safety Tips for Older Adults Share Tweet Linkedin Pin ...

  11. The Emergency Medical Services Safety Champions

    PubMed Central

    Patterson, P. Daniel; Anderson, Michelle S.; Zionts, Nancy D.; Paris, Paul M.

    2014-01-01

    The overarching mission of prehospital Emergency Medical Services (EMS) is to deliver life-saving care for people when their needs are greatest. Fulfilling this mission is challenged by threats to patient and provider safety. The EMS setting is high-risk because care is delivered rapidly in the out-of-hospital setting where patient-benefiting resources are limited. There is growing evidence that safety culture varies widely across EMS agencies. A poor safety culture may manifest as error in medication, back injuries, and other poor outcomes for patient and provider. Recently, federal and national leaders of EMS (i.e., the National Highway Traffic Safety Administration) have made improving EMS safety culture a national priority. Unfortunately, there are few initiatives that can help local EMS leaders achieve that priority. We describe the successful EMS Champs Fellowship program supported by the Jewish Healthcare Foundation (JHF) designed to train EMS leaders to improve safety for patients and providers. PMID:23150883

  12. Conditions for PMC formation in 2002-2008 estimated from TIMED/SABER measurements

    NASA Astrophysics Data System (ADS)

    Feofilov, Artem; Goldberg, Richard A.; Kutepov, Alexander; Pesnell, William

    In this work, mesospheric temperature, pressure, and water vapor concentration measured by the Sounding of the Atmosphere using Broadband Emission Radiometry (SABER) instrument on board the Thermosphere Ionosphere Mesosphere Energetics and Dynamics (TIMED) satel-lite are used to estimate the probability of the polar mesospheric ice clouds (PMC) formation for the summer periods of 2002-2008. We show the zonal averages of the PMC probability distri-butions and estimated PMC heights for both hemispheres and compare them to ground-based and satellite observations.

  13. [Information safety test of digital medical device].

    PubMed

    Liu, Jiong

    2014-07-01

    According to the background of the age of big data, the medical devices are informatized, we analyze the safety and efficiency for the information and data of digital medical devices or medical systems, also discussed some test methods. Lack of a suitable standard system of digital medical devices is a big problem both for domain standard and international standard. GB25000.51 is too ambiguous and free for testing, also not very operational. So this paper suggested some test advices and some prospective method. These test methods are helpful for finding the problem and performing the standards. What's more, these methods are famous in the world and used widely in the 3C region but just start in the medical region, which can promote the development of the medical devices. PMID:25330611

  14. Creating an organizational culture for medication safety.

    PubMed

    Dennison, Robin Donohoe

    2005-03-01

    Medication errors are costly from human, economic, and societal perspectives. All patients are vulnerable to the detrimental effects of these errors. Recommendations regarding the problem of medication errors include: Prevention of error by learning from the nonpunitive reporting of errors and near misses; Evaluation of the system for potential causes of error through failure mode and effects analysis and encouragement of a questioning attitude; Elimination of system problems that increase the risk of error; Recognition that humans are fallible and that error will occur even in a perfect system; Minimization of the consequences of errors when they do occur. An important goal for healthcare organizations should be to create a culture that accepts the imperfection of human performance and solicits the assistance of team members in the development of safeguards for error prevention. Proposed interventions to prevent medication errors can be described by the PATIENT SAFE taxonomy, which includes: Patient participation; Adherence to established policy and procedures; Technology use; Information accessibility; Education regarding medication safety; Nonpunitive approach to reporting of errors and near misses; Teamwork, communication, and collaboration; Staffing: adequate number and staffing mix; Administration support for the clinical goal of patient safety; Failure mode and effects analysis with team member involvement; Environment and equipment to support patient safety PMID:15733943

  15. Research on patient safety: falls and medications.

    PubMed

    Boddice, Sandra Dawn; Kogan, Polina

    2009-10-01

    Below you will find summaries of published research describing investigations into patient safety issues related to falls and medications. The first summary provides details on the incidence of falls associated with the use of walkers and canes. This is followed by a summary of a fall-prevention intervention study that evaluated the effectiveness of widespread dissemination of evidence-based strategies in a community in Connecticut. The third write up provides information on three classes of medications that are associated with a significant number of emergency room visits. The last summary describes a pharmacist-managed medication reconciliation intervention pilot program. For additional details about the study findings and interventions, we encourage readers to review the original articles. PMID:19820661

  16. Chemical Composition of Atmospheric Aerosol in Asian Dust Events Measured at Whistler Peak 2002-2008

    NASA Astrophysics Data System (ADS)

    MacDonald, A.; Leaitch, R.; Dabek, E.; Toom-Sauntry, D.; Celo, V.

    2009-12-01

    Measurements of atmospheric aerosols have been made at the Peak of Whistler Mountain on Canada’s West coast since March 2002. Particles were collected on filter packs with a 2.5 micron size cut on a 24 or 48 hour schedule and analyzed for inorganic species. Particle size distributions from 10 nm to 10 microns were measured with a combination of an optical particle counter and a differential mobility analyzer. Dust events from spring 2002-2008 are identified both from the particle physical measurements and by using calcium as an indicator for soil dust. With few exceptions, higher sulphate was found in these dust events implying a coincident transport of pollution with the dust. During the spring 2006 INTX-B campaign, particles were also sampled using MOUDI impactors and size-segregated samples were analyzed both for standard inorganics by ion chromatography and for an elemental analysis by ICP-MS. A substantial fine mode was found during the Asian dust events with the sulphate confirmed in both the submicron and the supermicron aerosol. Although coarse mode sulphate was associated with calcium, it was independent of calcium in the fine mode. The fine and coarse fractions of elements such as lead, associated with anthropogenic pollution, and of iron, mostly associated with soil dust in this case, suggst dust scavenging of anthropogenic particles.

  17. Safety of Topical Dermatologic Medications in Pregnancy.

    PubMed

    Patel, Viral M; Schwartz, Robert A; Lambert, W Clark

    2016-07-01

    Dermatologic drugs should be employed with caution in women of childbearing age who are pregnant or considering pregnancy. Topical drugs have little systemic absorption. Therefore, they are deemed safer than oral or parenteral agents and less likely to harm the fetus. However, their safety profile must be assessed cautiously, as there is limited available data. In this article, we aggregate human and animal studies and provide recommendations on using topical dermatologic medications in pregnancy.

    J Drugs Dermatol. 2016;15(7):830-834. PMID:27391632

  18. Implementation of a comprehensive MR safety course for medical students.

    PubMed

    Sammet, Steffen; Sammet, Christina L

    2015-12-01

    This review article proposes the design of an educational magnetic resonance (MR) safety course for instructing medical students about basic MR and patient-related safety. The MR safety course material can be implemented as a traditional didactic or interactive lecture in combination with hands-on safety demonstrations. The goal of the course is to ensure that medical students receive a basic understanding of MR principles and safety considerations. This course will prepare medical students for patient screening and safety consultations when ordering MR studies. A multiple-choice exam can be used to document the proficiency in MR safety of the medical students. The course can be used by various medical school programs and may help to ensure consistent quality of teaching materials and MR safety standards. PMID:26172156

  19. Highway Safety Program Manual: Volume 11: Emergency Medical Services.

    ERIC Educational Resources Information Center

    National Highway Traffic Safety Administration (DOT), Washington, DC.

    Volume 11 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) concentrates on emergency medical services. The purpose of the program, Federal authority in the area of medical services, and policies related to an emergency medical services (EMS) program are…

  20. Nursing Strategies to Increase Medication Safety in Inpatient Settings.

    PubMed

    Bravo, Katherine; Cochran, Gary; Barrett, Ryan

    2016-01-01

    Using data obtained through 2 multidisciplinary studies focused on medication safety effectiveness, this article provides nursing recommendations to decrease medication delivery errors. Strategies to minimize and address interruptions/distractions are proposed for the 3 most problematic time frames in which medication errors typically arise: medication acquisition, transportation, and bedside delivery. With planned interventions such as programmed scripts and hospital-based protocols to manage interruptions and distractions, patient safety can be maintained in the inpatient setting. PMID:26945258

  1. Cultivating a Culture of Medication Safety in Prelicensure Nursing Students.

    PubMed

    Bush, Peggy A; Hueckel, Rémi M; Robinson, Dana; Seelinger, Terry A; Molloy, Margory A

    2015-01-01

    Safety education in nursing has traditionally focused at the level of individual nurse-patient interactions. Students and novice clinicians lack clinical experience to create context and understand the complexity of the health care system and safety science. Using the Quality and Safety Education for Nurses quality and safety competency as a framework, the objective of this education project was to design comprehensive, engaging, learner-centered, online modules that increase knowledge, skills, and attitudes about medication safety. PMID:25719569

  2. NCCN's Commitment to Medication Safety: The Vincristine Initiative.

    PubMed

    Sugalski, Jessica; Stewart, F Marc; Carlson, Robert W

    2016-08-01

    The mission of NCCN is to improve the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Improving medication safety is an important aspect of fulfilling this mission. In September 2014, the NCCN Best Practices Committee began a medication safety initiative to improve the safe use of vincristine. This article describes and discusses this initiative. PMID:27496111

  3. The Environmental Context of Patient Safety and Medical Errors

    ERIC Educational Resources Information Center

    Wholey, Douglas; Moscovice, Ira; Hietpas, Terry; Holtzman, Jeremy

    2004-01-01

    The environmental context of patient safety and medical errors was explored with specific interest in rural settings. Special attention was paid to unique features of rural health care organizations and their environment that relate to the patient safety issue and medical errors (including the distribution of patients, types of adverse events…

  4. An intravenous medication safety system: preventing high-risk medication errors at the point of care.

    PubMed

    Hatcher, Irene; Sullivan, Mark; Hutchinson, James; Thurman, Susan; Gaffney, F Andrew

    2004-10-01

    Improving medication safety at the point of care--particularly for high-risk drugs--is a major concern of nursing administrators. The medication errors most likely to cause harm are administration errors related to infusion of high-risk medications. An intravenous medication safety system is designed to prevent high-risk infusion medication errors and to capture continuous quality improvement data for best practice improvement. Initial testing with 50 systems in 2 units at Vanderbilt University Medical Center revealed that, even in the presence of a fully mature computerized prescriber order-entry system, the new safety system averted 99 potential infusion errors in 8 months. PMID:15577664

  5. Medication Safety Systems and the Important Role of Pharmacists.

    PubMed

    Mansur, Jeannell M

    2016-03-01

    Preventable medication-related adverse events continue to occur in the healthcare setting. While the Institute of Medicine's To Err is Human, published in 2000, highlighted the prevalence of medical and medication-related errors in patient morbidity and mortality, there has not been significant documented progress in addressing system contributors to medication errors. The lack of progress may be related to the myriad of pharmaceutical options now available and the nuances of optimizing drug therapy to achieve desired outcomes and prevent undesirable outcomes. However, on a broader scale, there may be opportunities to focus on the design and performance of the many processes that are part of the medication system. Errors may occur in the storage, prescribing, transcription, preparation and dispensing, or administration and monitoring of medications. Each of these nodes of the medication system, with its many components, is prone to failure, resulting in harm to patients. The pharmacist is uniquely trained to be able to impact medication safety at the individual patient level through medication management skills that are part of the clinical pharmacist's role, but also to analyze the performance of medication processes and to lead redesign efforts to mitigate drug-related outcomes that may cause harm. One population that can benefit from a focus on medication safety through clinical pharmacy services and medication safety programs is the elderly, who are at risk for adverse drug events due to their many co-morbidities and the number of medications often used. This article describes the medication safety systems and provides a blueprint for creating a foundation for medication safety programs within healthcare organizations. The specific role of pharmacists and clinical pharmacy services in medication safety is also discussed here and in other articles in this Theme Issue. PMID:26932714

  6. The quality/safety medical index: implementation and analysis.

    PubMed

    Reiner, Bruce I

    2015-02-01

    Medical analytics relating to quality and safety measures have become particularly timely and of high importance in contemporary medical practice. In medical imaging, the dynamic relationship between medical imaging quality and radiation safety creates challenges in quantifying quality or safety independently. By creating a standardized measurement which simultaneously accounts for quality and safety measures (i.e., quality safety index), one can in theory create a standardized method for combined quality and safety analysis, which in turn can be analyzed in the context of individual patient, exam, and clinical profiles. The derived index measures can be entered into a centralized database, which in turn can be used for comparative performance of individual and institutional service providers. In addition, data analytics can be used to create customizable educational resources for providers and patients, clinical decision support tools, technology performance analysis, and clinical/economic outcomes research. PMID:25416467

  7. RFID authentication protocol to enhance patient medication safety.

    PubMed

    Kaul, Sonam Devgan; Awasthi, Amit K

    2013-12-01

    Medication errors can cause substantial harm to patients. Automated patient medication system with RFID technology is purposely used to reduce the medication error, to improve the patient safety, to provide personalized patient medication and identification and also to provide counterfeit protection to the patients. In order to enhance medication safety for patients we propose a new dynamic ID based lightweight RFID authentication protocol. Due to low storage capacity and limited computational and communicational capacity of tags, only pseudo random number generator function, one way hash function and bitwise Xor operation are used in our authentication protocol. The proposed protocol is practical, secure and efficient for health care domain. PMID:24122350

  8. Patient Safety in Medical Education: Students’ Perceptions, Knowledge and Attitudes

    PubMed Central

    Nabilou, Bahram; Feizi, Aram; Seyedin, Hesam

    2015-01-01

    Patient safety is a new and challenging discipline in the Iranian health care industry. Among the challenges for patient safety improvement, education of medical and paramedical students is intimidating. The present study was designed to assess students’ perceptions of patient safety, and their knowledge and attitudes to patient safety education. This cross-sectional analytical study was conducted in 2012 at Urmia University of Medical Sciences, West Azerbaijan province, Iran. 134 students studying medicine, nursing, and midwifery were recruited through census for the study. A questionnaire was used for collecting data, which were then analyzed through SPSS statistical software (version 16.0), using Chi-square test, Spearman correlation coefficient, F and LSD tests. A total of 121 questionnaires were completed, and 50% of the students demonstrated good knowledge about patient safety. The relationships between students’ attitudes to patient safety and years of study, sex and course were significant (0.003, 0.001 and 0.017, respectively). F and LSD tests indicated that regarding the difference between the mean scores of perceptions of patient safety and attitudes to patient safety education, there was a significant difference among medical and nursing/midwifery students. Little knowledge of students regarding patient safety indicates the inefficiency of informal education to fill the gap; therefore, it is recommended to consider patient safety in the curriculums of all medical and paramedical sciences and formulate better policies for patient safety. PMID:26322897

  9. Medication Safety During Pregnancy: Improving Evidence-Based Practice.

    PubMed

    Sinclair, Susan M; Miller, Richard K; Chambers, Christina; Cooper, Elizabeth M

    2016-01-01

    Nearly 90% of women in the United States have taken medications during pregnancy. Medication exposures during pregnancy can result in adverse pregnancy and neonatal outcomes including birth defects, fetal loss, intrauterine growth restriction, prematurity, and longer-term neurodevelopmental outcomes. Advising pregnant women about the safety of medication use during pregnancy is complicated by a lack of data necessary to engage the woman in an informed discussion. Routinely, health care providers turn to the package insert, yet this information can be incomplete and can be based entirely on animal studies. Often, adequate safety data are not available. In a busy clinical setting, health care providers need to be able to quickly locate the most up-to-date information in order to counsel pregnant women concerned about medication exposure. Deciding where to locate the best available information is difficult, particularly when the needed information does not exist. Pregnancy registries are initiated to obtain more data about the safety of specific medication exposures during pregnancy; however, these studies are slow to produce meaningful information, and when they do, the information may not be readily available in a published form. Health care providers have valuable data in their everyday practice that can expand the knowledge base about medication safety during pregnancy. This review aims to discuss the limitations of the package insert regarding medication safety during pregnancy, highlight additional resources available to health care providers to inform practice, and communicate the importance of pregnancy registries for expanding knowledge about medication safety during pregnancy. PMID:26771055

  10. Software development for safety-critical medical applications

    NASA Technical Reports Server (NTRS)

    Knight, John C.

    1992-01-01

    There are many computer-based medical applications in which safety and not reliability is the overriding concern. Reduced, altered, or no functionality of such systems is acceptable as long as no harm is done. A precise, formal definition of what software safety means is essential, however, before any attempt can be made to achieve it. Without this definition, it is not possible to determine whether a specific software entity is safe. A set of definitions pertaining to software safety will be presented and a case study involving an experimental medical device will be described. Some new techniques aimed at improving software safety will also be discussed.

  11. Using Contemporary Leadership Skills in Medication Safety Programs.

    PubMed

    Hertig, John B; Hultgren, Kyle E; Weber, Robert J

    2016-04-01

    The discipline of studying medication errors and implementing medication safety programs in hospitals dates to the 1970s. These initial programs to prevent errors focused only on pharmacy operation changes - and not the broad medication use system. In the late 1990s, research showed that faulty systems, and not faulty people, are responsible for errors and require a multidisciplinary approach. The 2013 ASHP Statement on the Role of the Medication Safety Leader recommended that medication safety leaders be integrated team members rather than a single point of contact. Successful medication safety programs must employ a new approach - one that embraces the skills of all health care team members and positions many leaders to improve safety. This approach requires a new set of leadership skills based on contemporary management principles, including followership, team-building, tracking and assessing progress, storytelling and communication, and cultivating innovation, all of which promote transformational change. The application of these skills in developing or changing a medication safety program is reviewed in this article. PMID:27303083

  12. [New initiatives to improve medication safety in hospitals].

    PubMed

    Otero López, María José

    2004-01-01

    Medication errors constitute a significant public health problem and are recognised as such nowadays among healthcare professionals, societies, authorities and international organizations. This has led to seeking and implementing effective practices focused on improving medication use safety. This article briefly describes some of the most recent initiatives promoted to prevent medication errors in the hospital setting. These safety improvement initiatives are based upon progressively developing an institutional culture of safety and on establishing practices designed to reduce errors or detect them in time, thus avoiding adverse effects to patients. Among these recent initiatives are the safety practices approved by the National Quality Forum, and the National Patient Safety Goals that the Joint Commission on Healthcare Accreditation has required since 2003. Also mentioned are several strategies that have been offered to facilitate the application of these practices, among which are the Pathways to Medication Safely, the development of collaborative projects among hospitals and organizations of experts, and the inclusion of a medication safety specialist in hospitals as a support figure overseeing the application of safety measures. Finally, the challenges inherent in putting these preventive measures into real patient's care are discussed. The barriers confronting this step must obviously be faced if improvements in patient safety are truly to be achieved. PMID:15293954

  13. [Medical safety in infectious disease--chairmen's introductory remarks].

    PubMed

    Shimetani, Naoto; Miida, Takashi

    2012-10-01

    "The National Joint Action of Risk Management" was started in May 2008. The Japanese Society of Laboratory Medicine took this opportunity to set up a Medical Safety Committee as a participant in this Action. The Society holds symposia concerning medical safety to educate the Society members. Nosocomial infections are medical accidents. Whereas community-acquired infections are likely to develop depending on a balance between pathogens and hosts, nosocomial infections are implicated with medical practices, so they develop depending on the interrelationship among pathogens, hosts, and medical practices. Medical practices are mostly indispensable for providing medical services; therefore, activities against nosocomial infections are critical for establishing medical safety, freedom from anxiety, and reliability. Hence, this symposium deals with five themes: Countermeasures against and the management of needle-stick and cut accidents, collaboration between the infection control team (ICT) and the bacteriology laboratory, information transmission from the clinical laboratory department to physicians engaged in infectious disease treatment, utilization of laboratory data for infection control, and medical safety against tuberculosis infection. PMID:23323465

  14. A proposed approach for safety management in medical software design.

    PubMed

    Rafeh, Reza

    2013-02-01

    Safe behavior of modern medical systems is the most important issue in this industry. Software has to follow safety instructions to keep the system away from any error situation. This paper proposes a new approach for safety management which can be used in different phases of software development before implementation and disposal phase. In the proposed approach safety begins from requirements as the infrastructure of design and continues through other phases of software production. PMID:23321965

  15. Applying airline safety practices to medication administration.

    PubMed

    Pape, Theresa M

    2003-04-01

    Medication administration errors (MAE) continue as major problems for health care institutions, nurses, and patients. However, MAEs are often the result of system failures leading to patient injury, increased hospital costs, and blaming. Costs include those related to increased hospital length of stay and legal expenses. Contributing factors include distractions, lack of focus, poor communication, and failure to follow standard protocols during medication administration. PMID:12736927

  16. The ethics and safety of medical student global health electives

    PubMed Central

    Dell, Evelyn M.; Varpio, Lara; Petrosoniak, Andrew; Gajaria, Amy

    2014-01-01

    Objectives To explore and characterize the ethical and safety challenges of global health experiences as they affect medical students in order to better prepare trainees to face them. Methods Semi-structured interviews were conducted with 23 Canadian medical trainees who had participated in global health experiences during medical school. Convenience and snowball sampling were utilized. Using Moustakas’s transcendental phenomenological approach, participant descriptions of ethical dilemmas and patient/trainee safety problems were analyzed. This generated an aggregate that illustrates the essential meanings of global health experience ethical and safety issues faced. Results We interviewed 23 participants who had completed 38 electives (71%, n=27, during pre-clinical years) spend-ing a mean 6.9 weeks abroad, and having visited 23 countries. Sixty percent (n=23) had pre-departure training while 36% (n=14) had post-experience debriefing. Three macro-level themes were identified: resource disparities and provision of care; navigating clinical ethical dilemmas; and threats to trainee safety. Conclusions Medical schools have a responsibility to ensure ethical and safe global health experiences. However, our findings suggest that medical students are often poorly prepared for the ethical and safety dilemmas they encounter during these electives. Medical students require intensive pre-departure training that will prepare them emotionally to deal with these dilemmas. Such training should include discussions of how to comply with clinical limitations. PMID:25341214

  17. Medical volunteers: guidelines for success and safety.

    PubMed Central

    Hoover, Eddie L.; Cole-Hoover, Gwendolyn; Berry, Paula K.; Hoover, Evan T.; Harris, Betsy; Rageh, Deman; Weaver, W. Lynn

    2005-01-01

    Many African Americans from a variety of medical specialties are interested in satisfying a life-long dream of visiting Africa by volunteering their services to faith-based and private volunteer organizations doing missionary work on the continent. While this can be an extremely rewarding experience in which measurable good can be accomplished, this path can also be strewn with many obstacles that will affect both the success of the mission and the personal well-being of the volunteer. The American Medical Team for Africa is a nonprofit, tax-exempt, volunteer organization that has been doing medical missionary work in Africa since 1993. This manuscript is a compilation of this 10-year experience that has established some very useful guidelines for insuring a successful and safe mission if you are fortunate enough to have this opportunity. PMID:15719877

  18. A Medication Safety Model: A Case Study in Thai Hospital

    PubMed Central

    Rattanarojsakul, Phichai; Thawesaengskulthai, Natcha

    2013-01-01

    Reaching zero defects is vital in medication service. Medication error can be reduced if the causes are recognized. The purpose of this study is to search for a conceptual framework of the causes of medication error in Thailand and to examine relationship between these factors and its importance. The study was carried out upon an in-depth case study and survey of hospital personals who were involved in the drug use process. The structured survey was based on Emergency Care Research Institute (ECRI) (2008) questionnaires focusing on the important factors that affect the medication safety. Additional questionnaires included content to the context of Thailand's private hospital, validated by five-hospital qualified experts. By correlation Pearson analysis, the result revealed 14 important factors showing a linear relationship with drug administration error except the medication reconciliation. By independent sample t-test, the administration error in the hospital was significantly related to external impact. The multiple regression analysis of the detail of medication administration also indicated the patient identification before administration of medication, detection of the risk of medication adverse effects and assurance of medication administration at the right time, dosage and route were statistically significant at 0.05 level. The major implication of the study is to propose a medication safety model in a Thai private hospital. PMID:23985110

  19. Safety and Complications of Medical Thoracoscopy

    PubMed Central

    Nour Moursi Ahmed, Shimaa; Mohammadien, Hamdy Ali; Tanikawa, Yoshimasa; Tsuboi, Rie; Sugiyama, Keiji

    2016-01-01

    Objectives. To highlight the possible complications of medical thoracoscopy (MT) and how to avoid them. Methods. A retrospective and prospective analysis of 127 patients undergoing MT in Nagoya Medical Center (NMC) and Toyota Kosei Hospital. The data about complications was obtained from the patients, notes on the computer system, and radiographs. Results. The median age was 71.0 (range, 33.0–92.0) years and 101 (79.5%) were males. The median time with chest drain after procedure was 7.0 (range, 0.0–47.0) days and cases with talc poudrage were 30 (23.6%). Malignant histology was reported in 69 (54.3%), including primary lung cancer in 35 (27.5), mesothelioma in 18 (14.2), and metastasis in 16 (12.6). 58 (45.7%) revealed benign pleural diseases and TB was diagnosed in 15 (11.8%). 21 (16.5%) patients suffered from complications including lung laceration in 3 (2.4%), fever in 5 (3.9%) (due to hospital acquired infection (HAI) in 2, talc poudrage in 2, and malignancy in 1), HAI in 2 (1.6%), prolonged air-leak in 14 (11.0%), and subcutaneous emphysema in 1 (0.8%). Conclusions. MT is generally a safe procedure. Lung laceration is the most serious complication and should be managed well. HAI is of low risk and can be controlled by medical treatment. PMID:27413774

  20. WWC Quick Review of the Article "Impact of For-Profit and Nonprofit Management on Student Achievement: The Philadelphia Intervention, 2002-2008"

    ERIC Educational Resources Information Center

    What Works Clearinghouse, 2010

    2010-01-01

    "Impact of For-Profit and Nonprofit Management on Student Achievement: The Philadelphia Intervention, 2002-2008" examined whether shifting from traditional district management to management by a for-profit or nonprofit organization improves student achievement. The study analyzed data on six cohorts of elementary and middle school students…

  1. A RFID grouping proof protocol for medication safety of inpatient.

    PubMed

    Huang, Hsieh-Hong; Ku, Cheng-Yuan

    2009-12-01

    In order to provide enhanced medication safety for inpatients, the medical mechanism which adopts the modified grouping proof protocol is proposed in this paper. By using the grouping proof protocol, the medical staffs could confirm the authentication and integrity of a group of Radio-Frequency Identification (RFID) tags which are embedded on inpatient bracelets and the containers of drugs. This mechanism is designed to be compatible with EPCglobal Class-1 Generation-2 standard which is the most popular specification of RFID tags. Due to the light-weight computational capacity of passive tags, only the pseudo-random number generator (PRNG) and cyclic redundancy code (CRC) are allowed to be used in the communication protocol. Furthermore, a practical scenario of using this proposed mechanism in hospital to examine the medication safety is also presented. PMID:20052898

  2. Drug safety: withdrawn medications are only part of the picture.

    PubMed

    Rawson, Nigel S B

    2016-01-01

    In a research article published in BMC Medicine, Onakpoya and colleagues provide a historical review of withdrawals of medications for safety reasons. However, withdrawn medications are only one part of the picture about how regulatory agencies manage drug risks. Moreover, medications introduced before the increased pre-marketing regulations and post-marketing monitoring systems instituted after the thalidomide tragedy have little relevance when considering the present drug safety picture because the circumstances under which they were introduced were completely different. To more fully understand drug safety management and regulatory agency actions, withdrawals should be evaluated within the setting and timeframe in which the medications are approved, which requires information about approvals and safety warnings. Studies are needed that provide a more comprehensive current picture of the identification and evaluation of drug safety risks as well as how regulatory agencies deal with them. Please see related research article: http://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-016-0553-2. PMID:26873482

  3. The effects of physical environments in medical wards on medication communication processes affecting patient safety.

    PubMed

    Liu, Wei; Manias, Elizabeth; Gerdtz, Marie

    2014-03-01

    Physical environments of clinical settings play an important role in health communication processes. Effective medication management requires seamless communication among health professionals of different disciplines. This paper explores how physical environments affect communication processes for managing medications and patient safety in acute care hospital settings. Findings highlighted the impact of environmental interruptions on communication processes about medications. In response to frequent interruptions and limited space within working environments, nurses, doctors and pharmacists developed adaptive practices in the local clinical context. Communication difficulties were associated with the ward physical layout, the controlled drug key and the medication retrieving device. Health professionals should be provided with opportunities to discuss the effects of ward environments on medication communication processes and how this impacts medication safety. Hospital administrators and architects need to consider health professionals' views and experiences when designing hospital spaces. PMID:24486620

  4. Optical radiation safety of medical light sources

    NASA Astrophysics Data System (ADS)

    Sliney, David H.

    1997-05-01

    The phototoxicity of medical ultraviolet (UV) sources used in dermatology has long been recognized. Less obvious are potential hazards to the eye and skin from many other optical sources - both to the patient and to the health-care worker. To assess potential hazards, one must consider not only the optical and radiometric parameters of the optical source in question but also the geometrical exposure factors. This knowledge is required to accurately determine the irradiances (dose rates) to exposed tissues. Both photochemically and thermally induced damage are possible from intense light sources used in medicine and surgery; however, thermal injury is rare unless the light source is pulsed or nearly in contact with tissue. Generally, photochemical interaction mechanisms are most pronounced at short wavelengths (UV) where photon energies are greatest, and also will be most readily observed for lengthy exposure durations.

  5. Pharmacogenomically actionable medications in a safety net health care system

    PubMed Central

    Carpenter, Janet S; Rosenman, Marc B; Knisely, Mitchell R; Decker, Brian S; Levy, Kenneth D; Flockhart, David A

    2016-01-01

    Objective: Prior to implementing a trial to evaluate the economic costs and clinical outcomes of pharmacogenetic testing in a large safety net health care system, we determined the number of patients taking targeted medications and their clinical care encounter sites. Methods: Using 1-year electronic medical record data, we evaluated the number of patients who had started one or more of 30 known pharmacogenomically actionable medications and the number of care encounter sites the patients had visited. Results: Results showed 7039 unique patients who started one or more of the target medications within a 12-month period with visits to 73 care sites within the system. Conclusion: Findings suggest that the type of large-scale, multi-drug, multi-gene approach to pharmacogenetic testing we are planning is widely relevant, and successful implementation will require wide-scale education of prescribers and other personnel involved in medication dispensing and handling. PMID:26835014

  6. Patient safety: helping medical students understand error in healthcare

    PubMed Central

    Patey, Rona; Flin, Rhona; Cuthbertson, Brian H; MacDonald, Louise; Mearns, Kathryn; Cleland, Jennifer; Williams, David

    2007-01-01

    Objective To change the culture of healthcare organisations and improve patient safety, new professionals need to be taught about adverse events and how to trap and mitigate against errors. A literature review did not reveal any patient safety courses in the core undergraduate medical curriculum. Therefore a new module was designed and piloted. Design A 5‐h evidence‐based module on understanding error in healthcare was designed with a preliminary evaluation using self‐report questionnaires. Setting A UK medical school. Participants 110 final year students. Measurements and main results Participants completed two questionnaires: the first questionnaire was designed to measure students' self‐ratings of knowledge, attitudes and behaviour in relation to patient safety and medical error, and was administered before and approximately 1 year after the module; the second formative questionnaire on the teaching process and how it could be improved was administered after completion of the module. Conclusions Before attending the module, the students reported they had little understanding of patient safety matters. One year later, only knowledge and the perceived personal control over safety had improved. The students rated the teaching process highly and found the module valuable. Longitudinal follow‐up is required to provide more information on the lasting impact of the module. PMID:17693671

  7. Using RFID yoking proof protocol to enhance inpatient medication safety.

    PubMed

    Chen, Chin-Ling; Wu, Chun-Yi

    2012-10-01

    The low birth rate has led to an aging society; the burgeoning number of elderly patients may affect the medical quality and result in negative medical incidents. There are many factors that lead to medical errors, such as similar medication names, erroneous labels and packaging, as well as staff shortages, fatigue and carelessness. Determining how to reduce medical errors has become an important issue. As RFID exhibits powerful identification characteristics, it can help nurses to quickly identify patients and their corresponding medicine. Currently, there are numerous practical applications for improving the efficiency of Radio Frequency Identification (RFID) systems. In this paper, we use an RFID yoking proof mechanism which conforms to EPCglobal Class 1 Generation 2 standards to improve patient safety and reduce medical errors. Our scheme can achieve different goals such as resist numerous known attacks, achieve mutual authentication, anonymity and non-repudiation. It also provides a practical medical care and offer higher quality of medical care. The pharmacist cannot deny that this prescription was confirmed for the patient and the nurse cannot also deny he or she dispensed this medicine to the patient for protecting the patients' interests. PMID:21811800

  8. Safety and tolerability of medications approved for chronic weight management.

    PubMed

    Fujioka, Ken

    2015-04-01

    In 2014 we have 4 new weight loss medications and one older medication with very different mechanisms of action – all approved for chronic weight management. Each medication has its own unique risk profile that makes patient selection important. Knowledge of the contraindications and safety issues can guide physicians to the most appropriate choice for a particular patient. Obesity medicine is entering a new era where our available options for prescribing have been very well studied. There should be no surprises, because bupropion, naltrexone, phentermine, topiramate and liraglutide have been prescribed for many years in millions of patients and lorcaserin has high specificity for a single receptor subtype. The FDA demanded very detailed risk-oriented studies to have these medications approved. In addition, the FDA has established REMS programs or risk management strategies to help ensure that the patients do not receive inappropriate medications. These medications were approved by the US FDA after very thorough testing. The decision to approve these medications was based on the benefits out-weighing the risks. Thus, if following the appropriate guidelines according to package labels, the practitioner can feel safe in prescribing these medications. PMID:25900872

  9. Global Ocean Reanalysis Simulations at Mercator Océan GLORYS1: the Argo years 2002-2008

    NASA Astrophysics Data System (ADS)

    Parent, L.; Ferry, N.; Barnier, B.; Drevillon, M.; Greiner, E.

    2009-04-01

    Since a decade ago, Mercator Océan develops and operates different ocean forecasting systems based on OGCM models and advanced data assimilation schemes using in situ and remotely sensed data. In the framework of the European GMES MyOcean project (FP7, 2009-2011), Mercator Océan will become a main contributor for the delivery of regular and systematic information to intermediate users & downstream service provider. Conjointly to this operational activity, the generation of global reanalysis simulations is a growing priority to satisfy scientist demands for climate studies. During this presentation, we will expose the results of the first global eddy-permitting (1/4°) ocean reanalysis simulation performed by Mercator Océan. It covers the 2002-2008 time period, which benefits from the ARGO float measurements. This significant improvement of the Global Ocean Observing System tends to indicate that the last decade is the primary test bed period for the development and the validation of any ocean reanalysis system. The "reanalysis system" is based on the current operational global ocean forecasting system, available since April 2008: the ocean and sea ice model NEMO is coupled with the SAM2 (Système d'Assimilation Mercator V2) data assimilation system, a reduced order extended Kalman filter with the capability to manage various and high number of observations and specially designed for expensive configurations. Dedicated altimetry database (from CLS) and in situ database (from CORIOLIS data center / Ifremer) have been used for the integration of this reanalysis simulation and the temporal continuity is assured by the IAU (Incremental Analysis Updates) method. An overall assessment of this reanalysis simulation will be given, with its strengths, its limitations and its necessary update in order to obtain a better depiction of the ocean state along the 2000's or the Altimetry years (1992-today).

  10. Global Ocean Reanalysis Simulations at Mercator Océan GLORYS1: the Argo years 2002-2008

    NASA Astrophysics Data System (ADS)

    Drevillon, M.; Parent, L.; Ferry, N.; Greiner, E.; Barnier, B.

    2009-12-01

    Since a decade ago, Mercator Océan develops and operates different ocean forecasting systems based on OGCM models and advanced data assimilation schemes using in situ and remotely sensed data. In the framework of the European GMES MyOcean project (FP7, 2009-2011), Mercator Océan will become a main contributor for the delivery of regular and systematic information to intermediate users & downstream service provider. Conjointly to this operational activity, the generation of global reanalysis simulations is a growing priority to satisfy scientist demands for climate studies. During this presentation, we will expose the results of the first global eddy-permitting (1/4°) ocean reanalysis simulation performed by Mercator Océan. It covers the 2002-2008 time period, which benefits from the ARGO float measurements. This significant improvement of the Global Ocean Observing System tends to indicate that the last decade is the primary test bed period for the development and the validation of any ocean reanalysis system. The “reanalysis system” is based on the current operational global ocean forecasting system, available since April 2008: the ocean and sea ice model NEMO is coupled with the SAM2 (Système d'Assimilation Mercator V2) data assimilation system, a reduced order extended Kalman filter with the capability to manage various and high number of observations and specially designed for expensive configurations. Dedicated altimetry database (from CLS) and in situ database (from CORIOLIS data center / Ifremer) have been used for the integration of this reanalysis simulation and the temporal continuity is assured by the IAU (Incremental Analysis Updates) method. An overall assessment of this reanalysis simulation will be given, with its strengths, its limitations and its necessary update in order to obtain a better depiction of the ocean state along the 2000's or the Altimetry years (1992-today). contact:lparent@mercator-ocean.fr

  11. Impact of prescribed medications on patient safety in older people

    PubMed Central

    Anathhanam, Sujo; Powis, Rachel A.; Robson, Jeremy

    2012-01-01

    Appropriate prescribing for older adults presents unique challenges to the prescriber. An understanding of the scale of the problems and contributing factors is essential when designing interventions to improve patient safety. The altered pharmacology of ageing, the existence of multiple medical conditions and the exclusion of elderly patients from many trials render this subgroup of the population particularly vulnerable to underprescribing and overprescribing. Adverse drug events are common, causing significant morbidity and mortality as well as having economic implications. ‘High-risk’ medications such as opioids, anticoagulants and antipsychotics can have benefits in this group of patients but strategies to optimize their safety are required. Tools exist that help to identify those at risk of adverse drug reactions and to screen for inappropriate prescribing. Developments in information technology are ongoing, and it is hoped that these may enhance the process of medication reconciliation across healthcare transitions and alert the prescriber to potential adverse drug events. This review addresses commonly encountered issues when prescribing for older people, considers strategies to improve medication safety and offers a list of ‘top tips’ to aid the clinician. PMID:25083234

  12. Patient safety through intelligent procedures in medication: the PSIP project.

    PubMed

    Beuscart, Régis; McNair, Peter; Brender, Jytte

    2009-01-01

    The European project Patient Safety through Intelligent Procedures in medication (PSIP) aims at preventing medical errors. The objective are: (1) to facilitate the systematic production of epidemiological knowledge on Adverse Drug Events (ADE) and (2) to improve the entire medication cycle in a hospital environment. The first sub-objective is to produce knowledge on ADE: to know, as exactly as possible, per hospital, per medical department, their number, type, consequences and causes, including human factors. Data Mining of structured hospital data bases, and semantic mining of free-texts will provide a list of observed ADE, with frequencies and probabilities, thus giving a better understanding of potential risks. The second sub-objective is to develop innovative knowledge based on the mining results and to deliver professionals and patients contextualized alerts and recommendations fitting the local risk parameters. This knowledge will be implemented in a PSIP-Platform independent of existing ICT applications. PMID:19745230

  13. Interprofessional collaborative practice for medication safety: Nursing, pharmacy, and medical graduates' experiences and perspectives.

    PubMed

    Wilson, Amanda Jane; Palmer, Lorinda; Levett-Jones, Tracy; Gilligan, Conor; Outram, Sue

    2016-09-01

    Medication errors are the second most prevalent cause of adverse patient incidents in Australian hospital settings. Although numerous strategies to address this patient safety issue have been implemented, the impact of interprofessional collaborative practice (IPCP) on medication safety has received limited attention. The aim of this article is to report the perspectives and experiences of recently graduated, currently practicing Australian nurses, pharmacists, and doctors in relation to IPCP and medication safety. Sixty-eight graduates from three Australian states participated in focus groups. Thematic analysis of transcripts was conducted using an iterative process. The findings from this study illustrate how knowing about and valuing the skills and responsibilities of other team members and respecting each person's unique contribution to the work of the team can lead to more effective communication and collaboration in the context of medication safety. Although collaborative practice is critical to safe medication prescribing, dispensing, and administration, there are recurring and pervasive challenges to its achievement. This study indicated the need for improved preparation of graduates to equip them with the knowledge and skills needed to participate in an interprofessional team; and we advocate that deliberate, structured, and meaningful interprofessional clinical education initiatives are required. PMID:27351385

  14. Spatial patterns and temporal trends in mercury concentrations, precipitation depths, and mercury wet deposition in the North American Great Lakes region, 2002-2008

    USGS Publications Warehouse

    Risch, Martin R.; Gay, David A.; Fowler, Kathleen K.; Keeler, Gerard J.; Backus, Sean M.; Blanchard, Pierrette; Barres, James A.; Dvonch, J. Timothy

    2012-01-01

    Annual and weekly mercury (Hg) concentrations, precipitation depths, and Hg wet deposition in the Great Lakes region were analyzed by using data from 5 monitoring networks in the USA and Canada for a 2002-2008 study period. High-resolution maps of calculated annual data, 7-year mean data, and net interannual change for the study period were prepared to assess spatial patterns. Areas with 7-year mean annual Hg concentrations higher than the 12 ng per liter water-quality criterion were mapped in 4 states. Temporal trends in measured weekly data were determined statistically. Monitoring sites with significant 7-year trends in weekly Hg wet deposition were spatially separated and were not sites with trends in weekly Hg concentration. During 2002-2008, Hg wet deposition was found to be unchanged in the Great Lakes region and its subregions. Any small decreases in Hg concentration apparently were offset by increases in precipitation.

  15. A performance improvement plan to increase nurse adherence to use of medication safety software.

    PubMed

    Gavriloff, Carrie

    2012-08-01

    Nurses can protect patients receiving intravenous (IV) medication by using medication safety software to program "smart" pumps to administer IV medications. After a patient safety event identified inconsistent use of medication safety software by nurses, a performance improvement team implemented the Deming Cycle performance improvement methodology. The combined use of improved direct care nurse communication, programming strategies, staff education, medication safety champions, adherence monitoring, and technology acquisition resulted in a statistically significant (p < .001) increase in nurse adherence to using medication safety software from 28% to above 85%, exceeding national benchmark adherence rates (Cohen, Cooke, Husch & Woodley, 2007; Carefusion, 2011). PMID:22703685

  16. Challenges to and the future of medication safety in Saudi Arabia: A qualitative study

    PubMed Central

    Aljadhey, Hisham; Mahmoud, Mansour Adam; Hassali, Mohamed Azmi; Alrasheedy, Alian; Alahmad, Amjad; Saleem, Fahad; Sheikh, Aziz; Murray, Michael; Bates, David W.

    2013-01-01

    Background Medication safety is a global concern among healthcare providers. However, the challenges to and the future of medication safety in Saudi Arabia have not been explored. Objectives We explored the perspectives of healthcare practitioners on current issues about medication safety in hospitals and community settings in Saudi Arabia in order to identify challenges to improving it and explore the future of medication safety practice. Methods A total of 65 physicians, pharmacists, academics and nurses attended a one-day meeting in March 2010, designed especially for the purpose of this study. The participants were divided into nine round-table discussion sessions. Three major themes were explored in these sessions, including: major factors contributing to medication safety problems, challenges to improving medication safety practice, and participants’ suggestions for improving medication safety. The round-table discussion sessions were videotaped and transcribed verbatim and analyzed by two independent researchers. Results The round-table discussions revealed that major factors contributing to medication safety problems included unrestricted public access to medications from various hospitals and community pharmacies, communication gaps between healthcare institutions, limited use of important technologies such as computerized provider order entry, and the lack of medication safety programs in hospitals. Challenges to current medication safety practice identified by participants included underreporting of medication errors and adverse drug reactions, multilingualism and differing backgrounds of healthcare professionals, lack of communication between healthcare providers and patients, and high workloads. Suggestions for improving medication safety practices in Saudi Arabia included continuous education for healthcare professionals and competency assessment focusing on medication safety, development of a culture that encourages medication error and adverse

  17. 78 FR 12067 - Extreme Weather Effects on Medical Device Safety and Quality

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-21

    ... HUMAN SERVICES Food and Drug Administration Extreme Weather Effects on Medical Device Safety and Quality... medical device safety and quality. FDA is announcing at this time its request for comments on the topic of extreme weather effects on medical device safety and quality. DATES: Submit either electronic or...

  18. Premarket Safety and Efficacy Studies for ADHD Medications in Children

    PubMed Central

    Bourgeois, Florence T.; Kim, Jeong Min; Mandl, Kenneth D.

    2014-01-01

    Background Attention-deficit hyperactivity disorder (ADHD) is a chronic condition and pharmacotherapy is the mainstay of treatment, with a variety of ADHD medications available to patients. However, it is unclear to what extent the long-term safety and efficacy of ADHD drugs have been evaluated prior to their market authorization. We aimed to quantify the number of participants studied and their length of exposure in ADHD drug trials prior to marketing. Methods We identified all ADHD medications approved by the Food and Drug Administration (FDA) and extracted data on clinical trials performed by the sponsor and used by the FDA to evaluate the drug’s clinical efficacy and safety. For each ADHD medication, we measured the total number of participants studied and the length of participant exposure and identified any FDA requests for post-marketing trials. Results A total of 32 clinical trials were conducted for the approval of 20 ADHD drugs. The median number of participants studied per drug was 75 (IQR 0, 419). Eleven drugs (55%) were approved after <100 participants were studied and 14 (70%) after <300 participants. The median trial length prior to approval was 4 weeks (IQR 2, 9), with 5 (38%) drugs approved after participants were studied <4 weeks and 10 (77%) after <6 months. Six drugs were approved with requests for specific additional post-marketing trials, of which 2 were performed. Conclusions Clinical trials conducted for the approval of many ADHD drugs have not been designed to assess rare adverse events or long-term safety and efficacy. While post-marketing studies can fill in some of the gaps, better assurance is needed that the proper trials are conducted either before or after a new medication is approved. PMID:25007171

  19. Assisted reproductive technologies: medical safety issues in the older woman.

    PubMed

    Segev, Yakir; Riskin-Mashiah, Shlomit; Lavie, Ofer; Auslender, Ron

    2011-06-01

    Abstract Previous study has shown that in the United States, most maternal deaths and severe obstetric complications due to chronic disease are potentially preventable through improved medical care before conception. Many women who need assisted reproductive technology (ART) because of infertility are older than the average pregnant woman. Risks for such chronic diseases as obesity, diabetes mellitus, chronic hypertension, cardiovascular disease (CVD), and malignancy greatly increase with maternal age. Chronic illness increases the risk of the in vitro fertilization (IVF) procedure and is also associated with increased obstetric risk and even death. The objective of this review is to outline the potential risks for older women who undergo ART procedures and pregnancy and to characterize guidelines for evaluation before enrollment in ART programs. A PubMed search revealed that very few studies have related to pre-ART medical evaluation. Therefore, we suggest a pre-ART medical assessment, comparable to the recommendations of the American Heart Association before noncompetitive physical activity and the American Society of Anesthesiologists before elective surgery. This assessment should include a thorough medical questionnaire and medical examination. Further evaluation and treatment should follow to ensure the safety of ART procedures and of ensuing pregnancies. PMID:21510806

  20. 77 FR 74196 - Draft Guidance for Industry on Safety Considerations for Product Design To Minimize Medication...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-13

    ... Product Design To Minimize Medication Errors; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Safety Considerations for Product Design to Minimize Medication Errors... using a systems approach to minimize medication errors relating to product design. The draft...

  1. Understanding Safety in Prehospital Emergency Medical Services for Children

    PubMed Central

    Cottrell, Erika K.; O’Brien, Kerth; Curry, Merlin; Meckler, Garth D.; Engle, Philip P.; Jui, Jonathan; Summers, Caitlin; Lambert, William; Guise, Jeanne-Marie

    2014-01-01

    Objective For over a decade, the field of medicine has recognized the importance of studying and designing strategies to prevent safety issues in hospitals and clinics. However, there has been less focus on understanding safety in prehospital emergency medical services, particularly in regard to children. Roughly 27.7 million (or 27%) of the annual ED visits are by children under the age of 19, and about 2 million of these children reach the hospital via EMS. This paper adds to our qualitative understanding of the nature and contributors to safety events in the prehospital emergency care of children. Methods We conducted four 8–12 person focus groups among paid and volunteer Emergency Medical Services providers to understand: 1) patient safety issues that occur in the prehospital care of children, and 2) factors that contribute to these safety issues (e.g. patient, family, systems, environmental, or individual provider factors). Focus groups were conducted in rural and urban settings. Interview transcripts were coded for overarching themes. Results Key factors and themes identified in the analysis were grouped into categories using an ecological approach that distinguishes between systems, team, child and family, and individual provider level contributors. At the systems level, focus group participants cited challenges such as lack of appropriately sized equipment or standardized pediatric medication dosages, insufficient human resources, limited pediatric training and experience, and aspects of emergency medical services culture. EMS team level factors centered on communication with other EMS providers (both prehospital and hospital). Family and child factors included communication barriers and challenging clinical situations or scene characteristics. Finally, focus group participants highlighted a range of provider level factors including heightened levels of anxiety, insufficient experience and training with children and errors in assessment and decision

  2. [Drug safeguards to ensure the ambulatory medication safety of elderly people].

    PubMed

    Yeh, Min-Li

    2013-04-01

    Medication safety is a primary patient safety goal. Medication safety addresses a comprehensive process that includes prescription issuance, medication dispensing, administration, and patient consumption. The application of mobile communication technology to healthcare products and to the extension of medication safety beyond the hospital into daily life are important trends. The elderly are a high risk group for adverse drug events due to age and higher incidences of chronic disease, multiple medication use, and improper medication behavior. Drug safeguards delivered through mobile services can enhance the medication safety of elders. Such services provide an education, care giving, and response link among institutions, homes, and the community, making it easier to integrate medication safety technology into daily life. PMID:23588691

  3. Does non-medical grade power cord compromise the safety of medical equipment?

    PubMed Central

    Padmavathi, V; Prasad, PS Vishnu; Kundra, Pankaj

    2015-01-01

    A tertiary care 1000 bedded hospital contains more than 10,000 pieces of equipment worth approximately 41 million USD, while the power cords supplied along with the imported equipment do not comply with country-specific norms. Moreover, the local vendors procure power cords with type D/M plug to complete installation and also on-site electrical safety test is not performed. Hence, this project was undertaken to evaluate the electrical safety of all life-saving equipment purchased in the year 2013, referring to the guidelines of International Electrotechnical Commission 62353, the Association for the Advancement of Medical Instrumentation (AAMI) and National Fire Protection Association (NFPA)-99 hospital standard for the analysis of protective earth resistance and chassis leakage current. This study was done with a measuring device namely electrical safety analyser 612 model from Fluke Biomedical. PMID:26903668

  4. Does non-medical grade power cord compromise the safety of medical equipment?

    PubMed

    Padmavathi, V; Prasad, Ps Vishnu; Kundra, Pankaj

    2015-12-01

    A tertiary care 1000 bedded hospital contains more than 10,000 pieces of equipment worth approximately 41 million USD, while the power cords supplied along with the imported equipment do not comply with country-specific norms. Moreover, the local vendors procure power cords with type D/M plug to complete installation and also on-site electrical safety test is not performed. Hence, this project was undertaken to evaluate the electrical safety of all life-saving equipment purchased in the year 2013, referring to the guidelines of International Electrotechnical Commission 62353, the Association for the Advancement of Medical Instrumentation (AAMI) and National Fire Protection Association (NFPA)-99 hospital standard for the analysis of protective earth resistance and chassis leakage current. This study was done with a measuring device namely electrical safety analyser 612 model from Fluke Biomedical. PMID:26903668

  5. Tolerability and safety of the new anti-obesity medications.

    PubMed

    Hainer, Vojtech; Aldhoon-Hainerová, Irena

    2014-09-01

    Worldwide obesity prevalence has nearly doubled since 1980. Due to numerous co-morbidities, obesity represents a serious health and socioeconomic problem worldwide. Pharmacotherapy should be an integral part of comprehensive obesity management. Drug therapy can assist in weight loss and its maintenance in those individuals who do not achieve appropriate weight loss through lifestyle interventions alone. After the withdrawal of sibutramine from the market in 2010, orlistat, a lipase inhibitor, was the only remaining prescription drug approved for the long-term treatment of obesity. In 2012, phentermine/topiramate extended-release (PHEN/TPM ER) combination and lorcaserin were approved by the US FDA as novel medications for long-term weight management. Three major phase III trials conducted with each drug confirmed their efficacy in terms of weight loss/maintenance and improvement of cardiometabolic risks. No head-to-head studies between the two new anti-obesity drugs have been carried out. However, in the existing studies PHEN/TPM ER had a superior weight loss profile to lorcaserin but the incidence of adverse effects was lower with lorcaserin. Both drugs were well-tolerated, and adverse events were modest in intensity, dose dependent, rather rare, and tended to decrease with the duration of treatment. Major safety concerns regarding PHEN/TPM ER include elevations in resting pulse rate, teratogenicity, mild metabolic acidosis, and psychiatric and cognitive adverse events. Valvulopathy, cognitive impairment, psychiatric disorders, and hypoglycemia represent major safety concerns for lorcaserin. Although existing trials have not demonstrated any significant issues with PHEN/TPM ER-induced heart rate elevation and lorcaserin-induced valvulopathy, all safety concerns should be seriously taken into account in patients treated with either of these novel anti-obesity medications. PMID:25096956

  6. Pharmacist Staffing, Technology Use, and Implementation of Medication Safety Practices in Rural Hospitals

    ERIC Educational Resources Information Center

    Casey, Michelle M.; Moscovice, Ira S.; Davidson, Gestur

    2006-01-01

    Context: Medication safety is clearly an important quality issue for rural hospitals. However, rural hospitals face special challenges implementing medication safety practices in terms of their staffing and financial and technical resources. Purpose: This study assessed the capacity of small rural hospitals to implement medication safety…

  7. Hyperspectral imaging applied to medical diagnoses and food safety

    NASA Astrophysics Data System (ADS)

    Carrasco, Oscar; Gomez, Richard B.; Chainani, Arun; Roper, William E.

    2003-08-01

    This paper analyzes the feasibility and performance of HSI systems for medical diagnosis as well as for food safety. Illness prevention and early disease detection are key elements for maintaining good health. Health care practitioners worldwide rely on innovative electronic devices to accurately identify disease. Hyperspectral imaging (HSI) is an emerging technique that may provide a less invasive procedure than conventional diagnostic imaging. By analyzing reflected and fluorescent light applied to the human body, a HSI system serves as a diagnostic tool as well as a method for evaluating the effectiveness of applied therapies. The safe supply and production of food is also of paramount importance to public health illness prevention. Although this paper will focus on imaging and spectroscopy in food inspection procedures -- the detection of contaminated food sources -- to ensure food quality, HSI also shows promise in detecting pesticide levels in food production (agriculture.)

  8. Safety of dermatologic medications in pregnancy and lactation: Part II. Lactation.

    PubMed

    Butler, Daniel C; Heller, Misha M; Murase, Jenny E

    2014-03-01

    Dermatologists are frequently faced with questions from women who are breastfeeding about the safety of commonly prescribed topical and systemic medications during lactation. Safety data in lactation, particularly regarding medications that are unique to dermatology, are limited and can be difficult to locate. We have consolidated the available safety data in a single reference guide for clinicians. We review literature pertaining to the safety of common dermatologic therapies in lactation and offer recommendations based on the available evidence. PMID:24528912

  9. Medical safety and community practice: necessary elements and barriers to implement a safety learning system.

    PubMed

    O'Beirne, Maeve; Sterling, Pam D

    2009-01-01

    A safety learning system (SLS) is a system that monitors patient safety incident information and analyzes it to develop and implement improvement strategies to increase patient safety. The purpose of this paper is to discuss the necessary elements of a community-based family medicine practice SLS in Alberta Health Services - Calgary zone, and barriers to, and facilitators of, the implementation of this system. An SLS was developed in the research program Medical Safety in Community Practice. To determine the elements necessary to implement an SLS in community-based family medicine practice, we performed a comprehensive literature review, internal investigator discussions and internal investigator and external stakeholder reviews of key design elements. The system is currently being implemented and tested in community-based family practices as part of the program. Steps identified for implementation: included determining key design elements including creating a website and ascertaining a classification system or taxonomy; developing recruitment strategies; establishing an incident analysis methodology; building a knowledge translation strategy; and pursuing sustainability. These elements produced an SLS that is easily incorporated into community-based family medicine clinics. PMID:19667792

  10. Safety and cleaning of medical materials and devices.

    PubMed

    Merritt, K; Hitchins, V M; Brown, S A

    2000-01-01

    A study was undertaken to evaluate different procedures to safely remove microorganisms, protein, and mammalian cells from materials and provide a suitable method for cleaning and assessing effectiveness of cleaning medical devices for reuse or for analysis of failure. Safety considerations for the personnel performing the cleaning or handling the device after cleaning are important issues. Polystyrene plates (96 well) were used to simulate device surfaces not amenable to manual scrubbing. Staphylococcus epidermidis, Candida albicans, Escherichia coli, Pseudomonas aeruginosa, and oral flora were grown in the plates. The plates were stained with crystal violet and the optical densities recorded. The results indicated that E. coli did not adhere well and Pseudomonas formed clumps that were easily detached from the surface of the plates. However, S. epi, C. albicans, and the oral organisms formed adherent biofilms that were difficult to remove from the plates. Detergents with enzymes and sodium hypochlorite (NaOCl) bleach were both effective in removing the biofilm. Other detergents and surfactants were not effective. The aldehyde agents did not remove the organisms and made further cleaning difficult. Allowing the biofilm to dry first made cleaning very difficult. Only the NaOCl bleach could subsequently remove the dried or aldehyde fixed organisms from the wells. The same 96-well polystyrene plate format was used to measure the amount of protein and cell adherence as well as the effectiveness of subsequent cleaning. Bradford reagent was used to detect protein as a measure of the cleaning efficacy. As with the bacteria, NaOCl bleach was effective at removing the protein and cells that had been dried or fixed by formalin or alcohol, whereas detergent with enzymes was not very effective. This study confirmed that used medical devices, contaminated with microorganisms, protein, and/or mammalian cells, should not be allowed to dry before cleaning and that a thorough

  11. Phylogenetic analysis of Foot-and-Mouth Disease Virus type O circulating in the Andean region of South America during 2002-2008.

    PubMed

    Malirat, Viviana; Bergmann, Ingrid Evelyn; Campos, Renata de Mendonça; Salgado, Gustavo; Sánchez, Camilo; Conde, Florangel; Quiroga, José Luis; Ortiz, Salomón

    2011-08-26

    At present, Foot-and-Mouth Disease (FMD) has been successfully controlled in most territories of South America, where only Ecuador and Venezuela remain as endemic countries. In this context, the precise characterization of circulating viruses is of utmost importance. This work describes the first molecular epidemiology study performed with the complete VP(1)-coding region of 114 field isolates of FMD virus (FMDV) type O, collected in the Andean countries mainly during 2002-2008. Sequences were aligned and compared to isolates responsible for emergencies in the Southern Cone of the continent between the years 2000 and 2006, and to other representative type O viruses worldwide. The results showed that FMD type O viruses isolated in South America and analyzed up to date are placed in 11 different lineages within the Euro SA topotype. Five of these lineages included viruses circulating in Ecuador and Venezuela during 2002-2008. The last emergencies reported in already-free areas in the Andean region, showed close relationships with viruses circulating in these endemic countries. Andean lineages showed a clear separation from the unique lineage containing viruses responsible for the emergencies in the Southern Cone, reflecting the different livestock circuits and providing evidence that support the ecosystem dynamics in the region. A wide geographical dissemination of the same strain in short time intervals has been observed, pointing to animal movements as the most significant risk parameter. This fact, together with an important generation of viral variants in areas under weak control strategies, reinforce the need of stronger official controls, as well as for establishing multinational cooperative measures in the border areas. PMID:21601999

  12. 77 FR 38294 - Patient Safety Organizations: Delisting for Cause for Medical Informatics

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-27

    ... HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety Organizations: Delisting for Cause for Medical Informatics AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Notice of Delisting. SUMMARY: AHRQ has delisted Medical Informatics as a Patient Safety Organization...

  13. A Secure ECC-based RFID Mutual Authentication Protocol to Enhance Patient Medication Safety.

    PubMed

    Jin, Chunhua; Xu, Chunxiang; Zhang, Xiaojun; Li, Fagen

    2016-01-01

    Patient medication safety is an important issue in patient medication systems. In order to prevent medication errors, integrating Radio Frequency Identification (RFID) technology into automated patient medication systems is required in hospitals. Based on RFID technology, such systems can provide medical evidence for patients' prescriptions and medicine doses, etc. Due to the mutual authentication between the medication server and the tag, RFID authentication scheme is the best choice for automated patient medication systems. In this paper, we present a RFID mutual authentication scheme based on elliptic curve cryptography (ECC) to enhance patient medication safety. Our scheme can achieve security requirements and overcome various attacks existing in other schemes. In addition, our scheme has better performance in terms of computational cost and communication overhead. Therefore, the proposed scheme is well suitable for patient medication systems. PMID:26573649

  14. 10 CFR 35.57 - Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist. 35.57 Section 35.57 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE...

  15. Work Domain Analysis for understanding medication safety in care homes in England: an exploratory study.

    PubMed

    Lim, Rosemary H M; Anderson, Janet E; Buckle, Peter W

    2016-01-01

    Medication safety and errors are a major concern in care homes. In addition to the identification of incidents, there is a need for a comprehensive system description to avoid the danger of introducing interventions that have unintended consequences and are therefore unsustainable. The aim of this study was to explore the impact and uniqueness of Work Domain Analysis (WDA) to facilitate an in-depth understanding of medication safety problems within the care home system and identify the potential benefits of WDA to design safety interventions to improve medication safety. A comprehensive, systematic and contextual overview of the care home medication system was developed for the first time. The novel use of the abstraction hierarchy (AH) to analyse medication errors revealed the value of the AH to guide a comprehensive analysis of errors and generate system improvement recommendations that took into account the contextual information of the wider system. PMID:26037621

  16. 78 FR 10181 - Global Quality Systems-An Integrated Approach To Improving Medical Product Safety; Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-13

    ... Medical Product Safety; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of... ``Global Quality Systems--An Integrated Approach to Improving Medical Product Safety.'' This 2-day public... Safety of our Drugs and Devices--the Complex Reality. Nanotechnology. Drug and Medical Device...

  17. Safety Analysis Report: X17B2 beamline Synchrotron Medical Research Facility

    SciTech Connect

    Gmuer, N.F.; Thomlinson, W.

    1990-02-01

    This report contains a safety analysis for the X17B2 beamline synchrotron medical research facility. Health hazards, risk assessment and building systems are discussed. Reference is made to transvenous coronary angiography. (LSP)

  18. An Update on Geriatric Medication Safety and Challenges Specific to the Care of Older Adults

    PubMed Central

    Koronkowski, Michael; Eisenhower, Christine; Marcum, Zachary

    2016-01-01

    The prescribing of drug therapies in older adults presents a number of safety challenges. The increased complexity of chronic care for older adults has led to polypharmacy and potentially inappropriate medication use, which can contribute to drug-induced diseases, adverse drug reactions, drug interactions, cognitive impairment, falls, hospitalization, and mortality. In this review, the authors discuss recent medication safety literature pertaining to the classes of medications commonly prescribed to older adults: anticholinergics, psychiatric medications, and antibiotics. Safety concerns associated with the use of these medications and the implications for long-term care practitioners are reviewed. The information provided can be used to inform and improve geriatric care delivered by practitioners across health care environments. PMID:27340375

  19. Patient safety education at Japanese medical schools: results of a nationwide survey

    PubMed Central

    2012-01-01

    Background Patient safety education, including error prevention strategies and management of adverse events, has become a topic of worldwide concern. The importance of the patient safety is also recognized in Japan following two serious medical accidents in 1999. Furthermore, educational curriculum guideline revisions in 2008 by relevant the Ministry of Education includes patient safety as part of the core medical curriculum. However, little is known about the patient safety education in Japanese medical schools partly because a comprehensive study has not yet been conducted in this field. Therefore, we have conducted a nationwide survey in order to clarify the current status of patient safety education at medical schools in Japan. Results Response rate was 60.0% (n = 48/80). Ninety-eight-percent of respondents (n = 47/48) reported integration of patient safety education into their curricula. Thirty-nine percent reported devoting less than five hours to the topic. All schools that teach patient safety reported use of lecture based teaching methods while few used alternative methods, such as role-playing or in-hospital training. Topics related to medical error theory and legal ramifications of error are widely taught while practical topics related to error analysis such as root cause analysis are less often covered. Conclusions Based on responses to our survey, most Japanese medical schools have incorporated the topic of patient safety into their curricula. However, the number of hours devoted to the patient safety education is far from the sufficient level with forty percent of medical schools that devote five hours or less to it. In addition, most medical schools employ only the lecture based learning, lacking diversity in teaching methods. Although most medical schools cover basic error theory, error analysis is taught at fewer schools. We still need to make improvements to our medical safety curricula. We believe that this study has the implications for

  20. Medication safety in community pharmacy: a qualitative study of the sociotechnical context

    PubMed Central

    Phipps, Denham L; Noyce, Peter R; Parker, Dianne; Ashcroft, Darren M

    2009-01-01

    Background While much research has been conducted on medication safety, few of these studies have addressed primary care, despite the high volume of prescribing and dispensing of medicines that occurs in this setting. Those studies that have examined primary care dispensing emphasised the need to understand the role of sociotechnical factors (that is, the interactions between people, tasks, equipment and organisational structures) in promoting or preventing medication incidents. The aim of this study was to identify sociotechnical factors that community pharmacy staff encounter in practice, and suggest how these factors might impact on medication safety. Methods Sixty-seven practitioners, working in the North West of England, took part in ten focus groups on risk management in community pharmacy. The data obtained from these groups was subjected to a qualitative analysis to identify recurrent themes pertaining to sociotechnical aspects of medication safety. Results The findings indicated several characteristics of participants' work settings that were potentially related to medication safety. These were broadly classified as relationships involving the pharmacist, demands on the pharmacist and management and governance of pharmacists. Conclusion It is recommended that the issues raised in this study be considered in future work examining medication safety in primary care. PMID:19735550

  1. Model-Driven Safety Analysis of Closed-Loop Medical Systems

    PubMed Central

    Pajic, Miroslav; Mangharam, Rahul; Sokolsky, Oleg; Arney, David; Goldman, Julian; Lee, Insup

    2013-01-01

    In modern hospitals, patients are treated using a wide array of medical devices that are increasingly interacting with each other over the network, thus offering a perfect example of a cyber-physical system. We study the safety of a medical device system for the physiologic closed-loop control of drug infusion. The main contribution of the paper is the verification approach for the safety properties of closed-loop medical device systems. We demonstrate, using a case study, that the approach can be applied to a system of clinical importance. Our method combines simulation-based analysis of a detailed model of the system that contains continuous patient dynamics with model checking of a more abstract timed automata model. We show that the relationship between the two models preserves the crucial aspect of the timing behavior that ensures the conservativeness of the safety analysis. We also describe system design that can provide open-loop safety under network failure. PMID:24177176

  2. Implementing a medication safety and poison prevention program at a senior center.

    PubMed

    Gershman, Jennifer A

    2013-10-01

    The Institute for Safe Medication Practices encourages pharmacists to assist in preventing medication misuse. The purpose of this article is to discuss a medication-safety education session conducted by a pharmacy professor, the faculty advisor to the American Society of Consultant Pharmacists university student chapter and students in a pharmacovigilance rotation, which was conducted at a local senior center. The author attended a train-the-trainer Webinar and then educated the pharmacy students. Participants at the senior center were taught about poison prevention, drug interactions, and appropriate drug disposal through an interactive format. We plan to continue the medication safety program at the senior center as a longitudinal project to promote patient safety. Pharmacists should be encouraged to play an active role in community outreach programs. PMID:24129222

  3. A study on the necessity of medical facilities safety design adoption.

    PubMed

    Park, Bora; Yang, Yeongae; Yang, Dongjoo; Shin, Joong-Il; Park, Sujong; Park, Soohee; Park, Yunhee

    2013-07-01

    [Purpose] The purpose of this study was to investigate the requirements of the introduction of a safety design and certification system for medical facilities. [Subjects] A survey was carried out of one hundred nurses, physical therapists, occupational therapists, speech and language therapists from May to August in 2012. [Methods] The survey was conducted after giving subjects some information about safety design. [Results] The participants were aware of the need for establishing a safety design certification system. Total responses to services, facilities and space were analyzed in order to evaluate the priorities of safety, user characteristics, functionality, convenience and aesthetics. Regarding the application of a safety design certification system to services, items were prioritized in the order of children's items, household supplies and hospital supplies. For facilities, the priorities were, living space, social welfare and medical facilities; space, they were public and transportation-related places. The requirements for operating a safety design system were in order development of: highly skilled manpower, the legal system, educational promotion and qualifying facilities. [Conclusion] In conclusion, in order to implement safety design in medical facilities, a safety design certification system should be introduced first, and to do this a systematic and comprehensive study is needed. PMID:24259877

  4. Safety of Aquaflor(c)-medicated feed to sunshine bass

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Aquaflor® (florfenicol, 50% type A medicated article) is a relatively new antibiotic used in U.S. aquaculture and has been widely accepted as a safe and effective therapeutant. Some peer-reviewed studies have suggested that 15 mg FFC/kg BW/d for 10 d can control mortality to a greater extent than 1...

  5. Medical Problems. Child Health and Safety Series (Module IV).

    ERIC Educational Resources Information Center

    Iscoe, Louise; And Others

    This manual for child care personnel in day care homes and centers provides guidelines and information on the detection, treatment, and control of medical problems of children. Introductory materials focus on signs of illness which carepersons can recognize. Section II concentrates on insect, animal and human bites. Section III discusses skin…

  6. An efficient RFID authentication protocol to enhance patient medication safety using elliptic curve cryptography.

    PubMed

    Zhang, Zezhong; Qi, Qingqing

    2014-05-01

    Medication errors are very dangerous even fatal since it could cause serious even fatal harm to patients. In order to reduce medication errors, automated patient medication systems using the Radio Frequency Identification (RFID) technology have been used in many hospitals. The data transmitted in those medication systems is very important and sensitive. In the past decade, many security protocols have been proposed to ensure its secure transition attracted wide attention. Due to providing mutual authentication between the medication server and the tag, the RFID authentication protocol is considered as the most important security protocols in those systems. In this paper, we propose a RFID authentication protocol to enhance patient medication safety using elliptic curve cryptography (ECC). The analysis shows the proposed protocol could overcome security weaknesses in previous protocols and has better performance. Therefore, the proposed protocol is very suitable for automated patient medication systems. PMID:24733525

  7. Confirming delivery: understanding the role of the hospitalized patient in medication administration safety.

    PubMed

    Macdonald, Marilyn T; Heilemann, MarySue V; MacKinnon, Neil J; Lang, Ariella; Gregory, David; Gurnham, Mary Ellen; Fillatre, Theresa

    2014-04-01

    The purpose of our study was to gain an understanding of current patient involvement in medication administration safety from the perspectives of both patients and nursing staff members. Administering medication is taken for granted and therefore suited to the development of theory to enhance its understanding. We conducted a constructivist, grounded theory study involving 24 patients and 26 nursing staff members and found that patients had the role of confirming delivery in the administration of medication. Confirming delivery was characterized by three interdependent subprocesses: engaging in the medication administration process, being "half out of it" (patient mental status), and perceiving time. We believe that ours is one of the first qualitative studies on the role of hospitalized patients in administering medication. Medication administration and nursing care systems, as well as patient mental status, impose limitations on patient involvement in safe medication administration. PMID:24598773

  8. Safety climate and use of personal protective equipment and safety medical devices among home care and hospice nurses.

    PubMed

    Leiss, Jack K

    2014-01-01

    Use of personal protective equipment (PPE) and safety medical devices is mandated for healthcare workers to reduce the risk of infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) from exposure to patients' blood. Research has shown that a strong safety climate may promote increased use of PPE. Therefore, the objective of this study was to examine the association between safety climate and use of PPE among homecare/hospice nurses in North Carolina. To this end, a mail survey was conducted in 2006. The response rate, adjusted on the assumption that the proportion of eligible nurses from among those who did not return the questionnaire or could not be contacted was similar to the proportion among those who did return the questionnaire, was 69% (n=833 eligibles). The percentage of nurses who used the specified PPE was two to three times greater among nurses who had a strong safety climate. Safety climate was only weakly associated with using safety devices. These results suggest that improving safety climate may be a powerful tool for increasing use of PPE. PMID:25055845

  9. Safety of dermatologic medications in pregnancy and lactation: Part I. Pregnancy.

    PubMed

    Murase, Jenny E; Heller, Misha M; Butler, Daniel C

    2014-03-01

    Dermatologists are frequently faced with questions about the safety of commonly prescribed topical and systemic medications during pregnancy and lactation from women of childbearing age who are pregnant, considering pregnancy, or breastfeeding. Safety data, particularly regarding medications that are unique to dermatology, can be difficult to locate and are not consolidated in a single reference guide for clinicians. Parts I and II of this continuing medical education article provide a capsule summary of key points for the most commonly prescribed dermatologic medications to facilitate patient medication risk counseling in pregnancy. A summary table details safety classification data for 3 primary international classification systems: the US Food and Drug Administration, the Swedish Catalogue of Approved Drugs, and the Australian Drug Evaluation Committee. In addition, this table includes an alternative pregnancy classification system developed by a consortium of active members of teratology societies in the US and Europe detailed in Drugs during Pregnancy and Lactation: Treatment Options and Risk Assessment and a safety classification system developed for breastfeeding mothers detailed in Medications and Mother's Milk. PMID:24528911

  10. Teaching vaccine safety communication to medical students and health professionals.

    PubMed

    Rath, Barbara; Muhlhans, Susann; Gaedicke, Gerhard

    2015-01-01

    Not only the general public, but also those studying to become health professionals, are struggling to keep up with a growing body of evidence and increasingly complex information about the many different types of vaccines available to date. At the same time, a number of increasingly complex subjects of study are competing for their attention during undergraduate and graduate education. In many medical school curricula in German-speaking countries, the subject of vaccines has been entirely omitted, or is regarded a minor subtopic. During the studies, most medical school curricula in German-speaking countries do not offer obligatory courses and/ or hands-on training vaccinology in vaccination. In Germany, private pediatricians administer the majority of immunizations. Even during postgraduate training programs in pediatrics, which are largely hospital-based, vaccinations are rarely a topic, and vaccinology remains a "hobby" and a "field without lobby" lacking specific certification requirements. Studies of acceptance of vaccines among health professionals and medical students have shown that many may still have their own doubts and uncertainties about vaccines revealing a number of unanswered questions during their studies and postgraduate training. PMID:25859671

  11. Biophysical and medical safety basis of laser emission

    NASA Astrophysics Data System (ADS)

    Paltsev, Yu.; Levina, A.

    1996-01-01

    Laser equipment may inflict serious losses to human health if safety norms established by relevant standards and other documentation are not properly observed. It is explained by physical properties of laser emission (LE) which differs from general light sources by quantitative behavior of such parameters as the degrees of coherence, monochromaticity, brightness, polarization. Thus, biological effects due to laser emission, as a rule, are more expressed comparing with other types of emission from other spontaneous light sources. LE effects biological tissues through the density of energy flow and impulse duration. It is common knowledge nowadays that LE biological action is assessed by two criteria: physical parameters and absorptive properties of tissues exposed to rays. LE causes the greatest danger to the eyes due to their specific structure. The next target organ vulnerable to LE is skin. Pathological changes of skin depend on the LE power, time of exposure, wave length, and the extent of skin pigmentation. Along with different kinds of damage directly in the tissues exposed to rays, LE may cause changes in organs and body systems subject to indirect exposure. It is important that these changes may develop due to low intensity levels of LE that do not cause local damage. National and international standards on LE safety are based on maximum allowable levels (MAL) of exposure. It has been generally accepted that the main MAL criterion is LE threshold minimal exposure which causes damage to retina, eyes, and skin. As distinct from foreign safety standards, hygienic norms and regulations are in force in the Russian Federation where additional co-efficients along with standard generally accepted MAL values have been introduced for the persons who are subject to occupational regular exposure to lasers. This approach has been chosen after the results of follow-up and health studies of these occupational contingents have been analyzed, and experiments on laboratory

  12. Medication safety issue brief. Eliminating dangerous abbreviations, acronyms and symbols.

    PubMed

    2005-06-01

    The use of abbreviations, acronyms and symbols in prescribing and transcribing medication orders too often results in the misinterpretation of the order's intent. Busy health care practitioners often use these shortcuts to indicate drug names, dosages, the patient's condition and route of administration. The result can be omission errors, extra or improper doses, administering the wrong drug, or giving a drug in the wrong manner. Stopping the use of unapproved abbreviations, acronyms and symbols can go a long way toward preventing these errors, but that's proven difficult to accomplish. This briefing examines ways that hospitals can put an end to the practice. PMID:16047621

  13. Permanent internal pacemaker safety in air medical transport.

    PubMed

    Gordon, R S; O'Dell, K B

    1991-02-01

    Helicopter and fixed-wing air medical transportation provides an important role in the management of critically-ill patients. As the use of cardiac pacemakers continues to grow, knowledge of their expanding capabilities and sophistication is important. The environments of our "airborne intensive care units" are subject to many sources of electromagnetic and vibrational interference. Although pacemaker shielding mechanisms have become quite elaborate, further studies are needed to define their reliability in modern aircraft. Further, the possible effects of electromagnetic and vibrational interference upon inflight reprogramming require further study. PMID:10109075

  14. Cetacean distribution and abundance in relation to oceanographic domains on the eastern Bering Sea shelf, June and July of 2002, 2008, and 2010

    NASA Astrophysics Data System (ADS)

    Friday, Nancy A.; Zerbini, Alexandre N.; Waite, Janice M.; Moore, Sue E.; Clapham, Phillip J.

    2013-10-01

    As part of the Bering Sea Project, cetacean surveys were conducted to describe distribution and estimate abundance on the eastern Bering Sea shelf. Three marine mammal observers conducted visual surveys along transect lines sampled during the Alaska Fisheries Science Center walleye pollock assessment survey in June and July of 2008 and 2010. Distribution and abundance in 2008 and 2010 (cold years) are compared with results from a similar survey conducted in 2002 (a warm year), as the only three years that the entire survey area was sampled; patterns largely match those previously observed. Abundance estimates for comparable areas in 2002, 2008 and 2010 were as follows: humpback whales (Megaptera novaeangliae): 231 (CV=0.63), 436 (CV=0.45), and 675 (CV=0.80); fin whales (Balaenoptera physalus): 419 (CV=0.33), 1368 (CV=0.34), and 1061 (CV=0.38); minke whales (Balaenoptera acutorostrata): 389 (CV=0.52), 517 (CV=0.69), and 2020 (CV=0.73); Dall's porpoise (Phocoenoides dalli): 35,303 (CV=0.53), 14,543 (CV=0.32), and 11,143 (CV=0.32); and harbor porpoise (Phocoena phocoena): 1971 (CV=0.46), 4056 (CV=0.40), and 833 (CV=0.66). It should be noted that these abundance estimates are not corrected for biases due to perception, availability, or responsive movement. Estimates for humpback, fin and minke whales increased from 2002 to 2010, while those for harbor and Dall's porpoise decreased; trends were significant for fin whales. It is likely that changes in estimated abundance are due at least in part to shifts in distribution and not just changes in overall population size. Annual abundance estimates were examined by oceanographic domain. Humpback whales were consistently concentrated in coastal waters north of Unimak Pass. Fin whales were broadly distributed in the outer domain and slope in 2008 and 2010, but sightings were sparse in 2002. Minke whales were distributed throughout the study area in 2002 and 2008, but in 2010 they were concentrated in the outer domain and

  15. [Medical aspects of current flight safety concept of air forces of the Russian Federation].

    PubMed

    Blaginin, A A; Lizogub, I N

    2012-12-01

    Issues of medical supply of aviation operations, that is part of general system of flight safety are analyzed in this article. One of the main issues is development of the system of vocational preparation of medical personnel, taking part in organization and carrying flights. This issue consists of several themes: formation of united system of education from primary to post graduate; formation of modern training facility; assurance of high potential in academic and teaching staff and providing of good basic training and high learning motivation of applicants, who wants to become a air medical officer. Fundamental principles of developed concept of medical supply of flight safety are presented. It is shown that the essential condition of good implementation of the given concept is informaltion support of all its structures. PMID:23479904

  16. Improving Medication Administration Safety in a Community Hospital Setting Using Lean Methodology.

    PubMed

    Critchley, Sandy

    2015-01-01

    Virtually all health care organizations have goals of improving patient safety, but despite clear goals and considerable investments, gains have been limited. This article explores a community hospital's resounding success using Lean methodology to improve medication administration safety with process changes designed by engaged employees and leaders with the knowledge and skill to effect improvements. This article inspires an interdisciplinary approach to quality improvement using reproducible strategies. PMID:25599523

  17. Association between poor sleep, fatigue, and safety outcomes in Emergency Medical Services providers

    PubMed Central

    Patterson, P. Daniel; Weaver, Matthew D.; Frank, Rachel C.; Warner, Charles W.; Martin-Gill, Christian; Guyette, Francis X.; Fairbanks, Rollin J.; Hubble, Michael W.; Songer, Thomas J.; Callaway, Clifton W.; Kelsey, Sheryl F.; Hostler, David

    2011-01-01

    Objective To determine the association between poor sleep quality, fatigue, and self-reported safety outcomes among Emergency Medical Services (EMS) workers. Methods We used convenience sampling of EMS agencies and a cross-sectional survey design. We administered the 19-item Pittsburgh Sleep Quality Index (PSQI), 11-item Chalder Fatigue Questionnaire (CFQ), and 44-item EMS Safety Inventory (EMS-SI) to measure sleep quality, fatigue, and safety outcomes, respectively. We used a consensus process to develop the EMS-SI, which was designed to capture three composite measurements of EMS worker injury, medical errors and adverse events (AE), and safety compromising behaviors. We used hierarchical logistic regression to test the association between poor sleep quality, fatigue, and three composite measures of EMS worker safety outcomes. Results We received 547 surveys from 30 EMS agencies (a 35.6% mean agency response rate). The mean PSQI score exceeded the benchmark for poor sleep (6.9, 95%CI 6.6, 7.2). Greater than half of respondents were classified as fatigued (55%, 95%CI 50.7, 59.3). Eighteen percent of respondents reported an injury (17.8%, 95%CI 13.5, 22.1), forty-one percent a medical error or AE (41.1%, 95%CI 36.8, 45.4), and 89% (95%CI 87, 92) safety compromising behaviors. After controlling for confounding, we identified 1.9 greater odds of injury (95%CI 1.1, 3.3), 2.2 greater odds of medical error or AE (95%CI 1.4, 3.3), and 3.6 greater odds of safety compromising behavior (95%CI 1.5, 8.3) among fatigued respondents versus non-fatigued respondents. Conclusions In this sample of EMS workers, poor sleep quality and fatigue is common. We provide preliminary evidence of an association between sleep quality, fatigue, and safety outcomes. PMID:22023164

  18. Analysis of medical equipment management in relation to the mandatory medical equipment safety manager (MESM) in Japan.

    PubMed

    Ishida, Kai; Hirose, Minoru; Fujiwara, Kousaku; Tsuruta, Harukazu; Ikeda, Noriaki

    2014-01-01

    Half a decade has passed since the fifth revision of the medical law and mandatory appointment of a medical equipment safety manager (MESM) in hospitals in Japan. During this period, circumstances have changed regarding maintenance of medical equipment (ME). We conducted a survey to examine these changes and the current situation in ME management. Maintenance of ME and related work were found to have increased in many hospitals, but the number of clinical engineering technologists (CETs) has only slightly increased. The appointed MESM was a CET or physician in most hospitals. In hospitals where physicians were appointed as the MESM, 81% had operation managers. Many respondents commented that it was difficult for one person to cover all the tasks required by the MESM, due to a lack of knowledge, too much work, or other reasons. This suggests the importance of an operation manager for ME to work under the MESM. PMID:25193371

  19. How to overcome violence against Healthcare professionals, reduce medical disputes and ensure patient safety

    PubMed Central

    Yu, Hongxing; Hu, Zhenglu; Zhang, Xifan; Li, Bin; Zhou, Shangcheng

    2015-01-01

    Background & Objective: In recent years there have been many cases of violence against healthcare professionals (HCPs) in China leading to the death of some doctors as well as nurses by patient’s relatives. Our objective was to identify the causative factors for these violent acts and address these isssues which is vital to ensure patient safety. Methods: A multidisciplinary research task force was formed to do a root cause analysis of the violent acts against the healthcare professionals. A flowchart was developed to identify the steps in the process and discover the potential links. Results: There are complex reasons behind the violence against HCPs. However, the main reasons were found to be poor quality of medical services and increased awareness of patients’ rights and their willingness to knock at the doors of courts to seek justice. The feasible counter measures includes stimulating hospital directors to improve patient safety, aligning incentives with quality of service provided in healthcare facilities, monitoring educational quality of HCPs, making necessary changes in medical education programmes besides setting up a reasonable academic promotion mechanism for health professionals based on merit and competence. Conclusion: Poor quality of medical services, increased awareness among patients about their rights has resulted in increase in medical disputes and at times violence against healthcare professionals. A number of effective measures can be undertaken by the government, hospitals, and medical schools ensuring patient safety. However, it is essential to sensitize the hospital directors to elevate their quality of medical services. PMID:25878605

  20. Medication safety in neonatal care: a review of medication errors among neonates

    PubMed Central

    Krzyzaniak, Natalia; Bajorek, Beata

    2016-01-01

    Objective: The objective of this study was to describe the medication errors in hospitalized patients, comparing those in neonates with medication errors across the age spectrum. Method: In tier 1, PubMed, Embase and Google Scholar were searched, using selected MeSH terms relating to hospitalized paediatric, adult and elderly populations. Tier 2 involved a search of the same electronic databases for literature relating to hospitalized neonatal patients. Results: A total of 58 articles were reviewed. Medication errors were well documented in each patient group. Overall, prescribing and administration errors were most commonly identified across each population, and mostly related to errors in dosing. Errors due to patient misidentification and overdosing were particularly prevalent in neonates, with 47% of administration errors involving at least tenfold overdoses. Unique errors were identified in elderly patients, comprising duplication of therapy and unnecessary prescribing of medicines. Overall, the medicines most frequently identified with error across each patient group included: heparin, antibiotics, insulin, morphine and parenteral nutrition. While neonatal patients experience the same types of medication errors as other hospitalized patients, the medication-use process within this group is more complex and has greater consequences resulting from error. Suggested strategies to help overcome medication error most commonly involved the integration of a clinical pharmacist into the treating team. Conclusion: This review highlights that each step of the medication-use process is prone to error across the age spectrum. Further research is required to develop targeted strategies relevant to specific patient groups that integrate key pharmacy services into wards. PMID:27298721

  1. Sensemaking and the co-production of safety: a qualitative study of primary medical care patients.

    PubMed

    Rhodes, Penny; McDonald, Ruth; Campbell, Stephen; Daker-White, Gavin; Sanders, Caroline

    2016-02-01

    This study explores the ways in which patients make sense of 'safety' in the context of primary medical care. Drawing on qualitative interviews with primary care patients, we reveal patients' conceptualisation of safety as fluid, contingent, multi-dimensional, and negotiated. Participant accounts drew attention to a largely invisible and inaccessible (but taken for granted) architecture of safety, the importance of psycho-social as well as physical dimensions and the interactions between them, informal strategies for negotiating safety, and the moral dimension of safety. Participants reported being proactive in taking action to protect themselves from potential harm. The somewhat routinised and predictable nature of the primary medical care consultation, which is very different from 'one off' inpatient spells, meant that patients were not passive recipients of care. Instead they had a stock of accumulated knowledge and experience to inform their actions. In addition to highlighting the differences and similarities between hospital and primary care settings, the study suggests that a broad conceptualisation of patient safety is required, which encompasses the safety concerns of patients in primary care settings. PMID:26547907

  2. ECC-based grouping-proof RFID for inpatient medication safety.

    PubMed

    Lin, Qiping; Zhang, Fangguo

    2012-12-01

    Several papers were proposed in which symmetric cryptography was used to design RFID grouping-proof for medication safety in the Journal of Medical Systems. However, if we want to ensure privacy, authentication and protection against the tracking of RFID-tags without losing system scalability, we must design an asymmetric cryptography-based RFID. This paper will propose a new ECC-based grouping-proof for RFID. Our ECC-based grouping-proof reduces the computation of tags and prevents timeout problems from occurring in n-party grouping-proof protocol. Based on asymmetric cryptography, the proposed scheme is practical, secure and efficient for medication applications. PMID:21785968

  3. Medication Safety: Simulation Education for New RNs Promises an Excellent Return on Investment.

    PubMed

    Zimmerman, Dawn M; House, Patricia

    2016-01-01

    High-fidelity simulation (HFS) education is a valuable tool for acquisition and maintenance of nursing competencies. Simulation education for new hospital nurses, who are most likely to make medication errors, is an appropriate and urgently needed application, in that the frequency and costs of inpatient medication errors are now a significant threat to both patient safety and operating budgets. Four factors, including baccalaureate preparation, that have converged to make the need for HFS education a cost-appropriate approach to the reduction of inpatient medication errors are reviewed. Most hospitals should be able to recover HFS investment costs within 12 months. PMID:27055312

  4. The Challenges of Balancing Safety and Security in Implantable Medical Devices.

    PubMed

    Katzis, Konstantinos; Jones, Richard W; Despotou, George

    2016-01-01

    Modern Implantable Medical Devices (IMDs), implement capabilities that have contributed significantly to patient outcomes, as well as quality of life. The ever increasing connectivity of IMD's does raise security concerns though there are instances where implemented security measures might impact on patient safety. The paper discusses challenges of addressing both of these attributes in parallel. PMID:27350457

  5. 42 CFR 483.372 - Medical treatment for injuries resulting from an emergency safety intervention.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Psychiatric Residential Treatment Facilities Providing Inpatient Psychiatric Services for Individuals Under Age 21 § 483.372 Medical treatment for injuries resulting from an emergency safety intervention. (a... participation under the Medicaid program that reasonably ensure that— (1) A resident will be transferred...

  6. 42 CFR 483.372 - Medical treatment for injuries resulting from an emergency safety intervention.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Psychiatric Residential Treatment Facilities Providing Inpatient Psychiatric Services for Individuals Under Age 21 § 483.372 Medical treatment for injuries resulting from an emergency safety intervention. (a... participation under the Medicaid program that reasonably ensure that— (1) A resident will be transferred...

  7. 42 CFR 483.372 - Medical treatment for injuries resulting from an emergency safety intervention.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Psychiatric Residential Treatment Facilities Providing Inpatient Psychiatric Services for Individuals Under Age 21 § 483.372 Medical treatment for injuries resulting from an emergency safety intervention. (a... participation under the Medicaid program that reasonably ensure that— (1) A resident will be transferred...

  8. 42 CFR 483.372 - Medical treatment for injuries resulting from an emergency safety intervention.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Psychiatric Residential Treatment Facilities Providing Inpatient Psychiatric Services for Individuals Under Age 21 § 483.372 Medical treatment for injuries resulting from an emergency safety intervention. (a... participation under the Medicaid program that reasonably ensure that— (1) A resident will be transferred...

  9. Improving medication safety in UK care homes: challenges and current perspective.

    PubMed

    Fahrni, Mathumalar Loganathan; Franklin, Bryony Dean; Rawaf, Salman; Majeed, Azeem

    2014-02-01

    In the UK, there are policy and regulatory concerns regarding the governance of care homes and healthcare provision within these homes. From a public health perspective, these issues can pose significant challenges to the provision of safe and quality medication use services to care home residents. The objective of this paper is to highlight an important and neglected issue for the growing population of institutionalized older adults. We reviewed relevant literature for the years 2000 to present and identified recent efforts undertaken to improve medication safety standards in UK care homes. We consider the limitations and reasons for the National Health Service's restricted role and lack of leadership in providing medical services for this institutionalized population. The efforts taken by the Department of Health and other healthcare authorities targeting medication safety in care homes are also highlighted. In order to improve the quality of healthcare, specifically in areas related to medication safety and quality use of medicines, interventions need to be taken by the national government and similarly by local authorities and NHS commissioners. PMID:25057369

  10. Nurses' Perceptions of the Impact of Work Systems and Technology on Patient Safety during the Medication Administration Process

    ERIC Educational Resources Information Center

    Gallagher Gordon, Mary

    2012-01-01

    This dissertation examines nurses' perceptions of the impacts of systems and technology utilized during the medication administration process on patient safety and the culture of medication error reporting. This exploratory research study was grounded in a model of patient safety based on Patricia Benner's Novice to Expert Skill…

  11. [Electronic medical records: medical and legal aspects, privacy, safety, and legal validity].

    PubMed

    Ravizza, P; Pasini, E

    2001-03-01

    Medical records must collect all data concerning in-hospital management of patients: data have to be verified and easily retrievable. Clinicians are responsible for both format and content of medical records. Respect of patient's privacy must be made sure both during on-line management and long-term storage of records. Computerization can offer many advantages to clinicians, but needs some significant adjustments: training and motivation of operators, arrangement of clinical processes and of administrative rules to technological developments. Nevertheless, some important results can be afforded: standardization of procedures, distribution of univocal, verified and ubiquitous data to all concerned operators, protection against undesired retrieval, reliability of effective reports. Preliminary condition is a clinical local area network, widespread into the institution. Database implementation must follow well accepted methodology: flow chart design of data dictionary, standardization of data coding, input of verified data, effective reporting. Access to data must be controlled by sophisticated and sure password system. Back-up of data must be automatically available with adequate timing and methodology. Respect of rules on patient's privacy must be realized whenever possible. Complex clinical records should be made available, containing data, signals and images (both single frames and dynamic sequences), due to continuous technical progress of diagnostic tools. Medical records must be available for long periods of time: database engine and managing tools must be selected among well accepted and largely available producers; informatic assistance must be assured for management and evolution of systems over the years. PMID:11307785

  12. Management of radioactive material safety programs at medical facilities. Final report

    SciTech Connect

    Camper, L.W.; Schlueter, J.; Woods, S.

    1997-05-01

    A Task Force, comprising eight US Nuclear Regulatory Commission and two Agreement State program staff members, developed the guidance contained in this report. This report describes a systematic approach for effectively managing radiation safety programs at medical facilities. This is accomplished by defining and emphasizing the roles of an institution`s executive management, radiation safety committee, and radiation safety officer. Various aspects of program management are discussed and guidance is offered on selecting the radiation safety officer, determining adequate resources for the program, using such contractual services as consultants and service companies, conducting audits, and establishing the roles of authorized users and supervised individuals; NRC`s reporting and notification requirements are discussed, and a general description is given of how NRC`s licensing, inspection and enforcement programs work.

  13. The Learning Objective Catalogue for Patient Safety in Undergraduate Medical Education – A Position Statement of the Committee for Patient Safety and Error Management of the German Association for Medical Education

    PubMed Central

    Kiesewetter, Jan; Gutmann, Johanna; Drossard, Sabine; Gurrea Salas, David; Prodinger, Wolfgang; Mc Dermott, Fiona; Urban, Bert; Staender, Sven; Baschnegger, Heiko; Hoffmann, Gordon; Hübsch, Grit; Scholz, Christoph; Meier, Anke; Wegscheider, Mirko; Hoffmann, Nicolas; Ohlenbusch-Harke, Theda; Keil, Stephanie; Schirlo, Christian; Kühne-Eversmann, Lisa; Heitzmann, Nicole; Busemann, Alexandra; Koechel, Ansgar; Manser, Tanja; Welbergen, Lena; Kiesewetter, Isabel

    2016-01-01

    Background: Since the report “To err is human” was published by the Institute of Medicine in the year 2000, topics regarding patient safety and error management are in the focal point of interest of science and politics. Despite international attention, a structured and comprehensive medical education regarding these topics remains to be missing. Goals: The Learning Objective Catalogue for Patient Safety described below the Committee for Patient Safety and Error Management of the German Association for Medical Education (GMA) has aimed to establish a common foundation for the structured implementation of patient safety curricula at the medical faculties in German-speaking countries. Methods: The development the Learning Objective Catalogue resulted via the participation of 13 faculties in two committee meetings, two multi-day workshops, and additional judgments of external specialists. Results: The Committee of Patient Safety and Error Management of GMA developed the present Learning Objective Catalogue for Patient Safety in Undergraduate Medical Education, structured in three chapters: Basics, Recognize Causes as Foundation for Proactive Behavior, and Approaches for Solutions. The learning objectives within the chapters are organized on three levels with a hierarchical organization of the topics. Overall, the Learning Objective Catalogue consists of 38 learning objectives. All learning objectives are referenced with the National Competency-based Catalogue of Learning Objectives for Undergraduate Medical Education. Discussion: The Learning Objective Catalogue for Patient Safety in Undergraduate Medical Education is a product that was developed through collaboration of members from 13 medical faculties. In the German-speaking countries, the Learning Objective Catalogue should advance discussion regarding the topics of patient safety and error management and help develop subsequent educational structures. The Learning Objective Catalogue for Patient Safety can

  14. Improving medication safety in primary care. A review and consensus procedure by the LINNEAUS collaboration on patient safety in primary care

    PubMed Central

    Lainer, Miriam; Vögele, Anna; Wensing, Michel; Sönnichsen, Andreas

    2015-01-01

    ABSTRACT Background: Drug treatment is an important clinical process in primary care that is associated with risk of error and adverse events. Objective: To review currently available research evidence on the topic and to develop a framework, which can help to guide improvement of medication safety. Methods: Systematic reviews were performed on adverse drug events (ADE), their preventability, and on available tools and methods to improve medication safety with a particular focus on information technology. Consensus methods were used to develop a framework to guide the improvement of medication safety based on the findings of our literature review. Results: The median prevalence rate of ADEs in primary care patients was 12.8%. Only a median of 16.5% of ADEs were preventable and thus could be classified as medication errors. Our review of information technology interventions found that only about half of the studies found a reduction of medication errors. In both reviews, the wide range between studies emphasizes the necessity of a validated medication error classification system. Another important aspect of medication safety appears to be a general lack of safety culture in primary care, which led us to the development of the Salzburg medication safety framework (SaMSaF), based on the MaPSaF tool to improve patient safety. The tool proved to be feasible and useful in a pilot study with several GP practices. Conclusion: A number of tools and interventions to investigate and enhance medication safety have been identified. Further research is necessary to implement and evaluate current concepts. PMID:26339830

  15. [Medication errors: importance of notification in the management of patient safety].

    PubMed

    Bohomol, Elena; Ramos, Laís Helena

    2007-01-01

    Notifying medication errors is an important instrument in managing assistance quality and safety for the patient. The objective of this study was to verify with the nursing team their understanding that a medication error had been committed, and to observe how they notified responsible physicians of the event. To achieve this, researchers used a descriptive/exploratory survey with 89 professionals. The results demonstrate a lack of uniformity in understanding that medication errors had been committed, when these errors must be communicated to a physician, and when an event report must be filled out. The research shows the necessity to develop educational programs that shed light on exactly what constitutes a medication error, clarifying causes of the problem and providing solutions to solve it. PMID:17477164

  16. Cost-Effectiveness of a Computerized Provider Order Entry System in Improving Medication Safety Ambulatory Care

    PubMed Central

    Forrester, Sara H.; Hepp, Zsolt; Roth, Joshua A.; Wirtz, Heidi S.; Devine, Emily Beth

    2014-01-01

    Background Computerized provider order entry (CPOE) is the process of entering physician orders directly into an electronic health record. Although CPOE has been shown to improve medication safety and reduce health care costs, these improvements have been demonstrated largely in the inpatient setting; the cost-effectiveness in the ambulatory setting remains uncertain. Objective The objective was to estimate the cost-effectiveness of CPOE in reducing medication errors and adverse drug events (ADEs) in the ambulatory setting. Methods We created a decision-analytic model to estimate the cost-effectiveness of CPOE in a midsized (400 providers) multidisciplinary medical group over a 5-year time horizon— 2010 to 2014— the time frame during which health systems are implementing CPOE to meet Meaningful Use criteria. We adopted the medical group’s perspective and utilized their costs, changes in efficiency, and actual number of medication errors and ADEs. One-way and probabilistic sensitivity analyses were conducted. Scenario analyses were explored. Results In the base case, CPOE dominated paper prescribing, that is, CPOE cost $18 million less than paper prescribing, and was associated with 1.5 million and 14,500 fewer medication errors and ADEs, respectively, over 5 years. In the scenario that reflected a practice group of five providers, CPOE cost $265,000 less than paper prescribing, was associated with 3875 and 39 fewer medication errors and ADEs, respectively, over 5 years, and was dominant in 80% of the simulations. Conclusions Our model suggests that the adoption of CPOE in the ambulatory setting provides excellent value for the investment, and is a cost-effective strategy to improve medication safety over a wide range of practice sizes. PMID:24968993

  17. Automating patient safety incident reporting to improve healthcare quality in the defence medical services.

    PubMed

    Lamb, Di; Piper, N

    2015-12-01

    There are many reasons for poor compliance with patient safety incident reporting in the UK. The Defence Medical Services has made a significant investment to address the culture and process by which risk to patient safety is managed within its organisation. This paper describes the decision process and technical considerations in the design of an automated reporting system together with the implementation procedure aimed to maximise compliance. The elimination of inherent weaknesses in feedback mechanisms from the three Armed Forces, which had been uniquely different, ensured the quality of data improved, which enabled resources to be prioritised that would also have a direct impact upon the quality of patient care. PMID:26400974

  18. Military Medical Students' Awareness and Practice Concerning Occupational Health and Safety.

    PubMed

    Babayigit, Mustafa Alparslan; Ilhan, Mustafa Necmi; Oysul, Fahrettin Guven

    2016-09-01

    This study aimed to investigate the awareness and practices of military medical students concerning occupational health and safety. In this cross-sectional study, a questionnaire composed of 20 open- and closed-ended questions was administered to medical students of the Gulhane Military Medical Faculty (n = 754). The response rate of the questionnaire was 82.4% (n = 622/754). The mean age of the participants was 21.5 ± 1.84 years, and the majority of participants were male (94.1%). A substantial number of participants (41.1%) described their level of awareness and practice as "low/very low," although 95.0% and 76.7% of them had never acquired any occupational disease or had any work accidents, respectively. In total, 28.1% of all students had at least one vaccination, and 5th- and 6th-year students were 92 times and 63 times more likely to have been vaccinated than 1st-year students, respectively (odds ratio = 92.66, 95% confidence interval = 26.70-321.59; odds ratio = 63.01, 95% confidence interval = 17.96-221.01). The knowledge and practice level of medical students concerning occupational health and safety appeared to be increasing by the grades of medical faculty, however students expressed themselves as insufficient about their knowledge and practice level. PMID:27612358

  19. Drug-related problems (DRPs) identified from geriatric medication safety review clinics.

    PubMed

    Chan, Ding-Cheng; Chen, Jen-Hau; Kuo, Hsu-Ko; We, Chiung-Jung; Lu, I-Shu; Chiu, Lee-Shu; Wu, Shwu-Chong

    2012-01-01

    Drug-related problems (DRPs) were identified from baseline data of 193 Medication Safety Review Clinic (MSRC) patients. MSRCs enroll older adults (≥ 65 years) with either (1) prescriptions of ≥ 8 chronic medications (drugs prescribed for ≥ 28 days) or (2) a visit to ≥ 3 different physicians at the two participating hospitals in Taipei, Taiwan from August to October 2007. The Pharmaceutical Care Network Europe (PCNE) Classification Version 5.01 was used to report DRPs. Mean age was 76.2 ± 6.2 years and 53% of participants were male. Participants had, on average, 9.0 ± 2.6 chronic conditions and took 8.9 ± 3.1 chronic medications and 1.7 ± 1.8 dietary supplements. Eighty-seven percent had at least one DRP. Being older, having orthostatic hypotension and taking more chronic medications were associated with higher likelihood of having at least one DRP. For the 1713 medications and 331 diet supplements reviewed, 427 DRPs were found, 490 causes (1.1 ± 0.4 per problem) identified and 1067 interventions proposed (2.5 ± 0.6 per problem). The most common DRP category was "drug not taken/administered" (35%), and the most common offending drug category was cardiovascular agents (33%). Prevalence of DRPs was high among geriatric outpatients prescribed multiple medications. Careful medication review is needed in routine clinical practice to improve prescription quality. PMID:21353318

  20. Computerised clinical decision support systems to improve medication safety in long-term care homes: a systematic review

    PubMed Central

    Marasinghe, Keshini Madara

    2015-01-01

    Objectives Computerised clinical decision support systems (CCDSS) are used to improve the quality of care in various healthcare settings. This systematic review evaluated the impact of CCDSS on improving medication safety in long-term care homes (LTC). Medication safety in older populations is an important health concern as inappropriate medication use can elevate the risk of potentially severe outcomes (ie, adverse drug reactions, ADR). With an increasing ageing population, greater use of LTC by the growing ageing population and increasing number of medication-related health issues in LTC, strategies to improve medication safety are essential. Methods Databases searched included MEDLINE, EMBASE, Scopus and Cochrane Library. Three groups of keywords were combined: those relating to LTC, medication safety and CCDSS. One reviewer undertook screening and quality assessment. Results Overall findings suggest that CCDSS in LTC improved the quality of prescribing decisions (ie, appropriate medication orders), detected ADR, triggered warning messages (ie, related to central nervous system side effects, drug-associated constipation, renal insufficiency) and reduced injury risk among older adults. Conclusions CCDSS have received little attention in LTC, as attested by the limited published literature. With an increasing ageing population, greater use of LTC by the ageing population and increased workload for health professionals, merely relying on physicians’ judgement on medication safety would not be sufficient. CCDSS to improve medication safety and enhance the quality of prescribing decisions are essential. Analysis of review findings indicates that CCDSS are beneficial, effective and have potential to improve medication safety in LTC; however, the use of CCDSS in LTC is scarce. Careful assessment on the impact of CCDSS on medication safety and further modifications to existing CCDSS are recommended for wider acceptance. Due to scant evidence in the current literature

  1. Modifying the ECC-based grouping-proof RFID system to increase inpatient medication safety.

    PubMed

    Ko, Wen-Tsai; Chiou, Shin-Yan; Lu, Erl-Huei; Chang, Henry Ker-Chang

    2014-09-01

    RFID technology is increasingly used in applications that require tracking, identification, and authentication. It attaches RFID-readable tags to objects for identification and execution of specific RFID-enabled applications. Recently, research has focused on the use of grouping-proofs for preserving privacy in RFID applications, wherein a proof of two or more tags must be simultaneously scanned. In 2010, a privacy-preserving grouping proof protocol for RFID based on ECC in public-key cryptosystem was proposed but was shown to be vulnerable to tracking attacks. A proposed enhancement protocol was also shown to have defects which prevented proper execution. In 2012, Lin et al. proposed a more efficient RFID ECC-based grouping proof protocol to promote inpatient medication safety. However, we found this protocol is also vulnerable to tracking and impersonation attacks. We then propose a secure privacy-preserving RFID grouping proof protocol for inpatient medication safety and demonstrate its resistance to such attacks. PMID:24997856

  2. Oral medications regarding their safety and efficacy in the management of patent ductus arteriosus

    PubMed Central

    Oncel, Mehmet Yekta; Erdeve, Omer

    2016-01-01

    Patent ductus arteriosus (PDA) is a common clinical condition in preterm infants which is inversely related to birth weight and gestational age. Cyclooxygenase inhibitors such as indomethacin and ibuprofen which block the prostaglandin conversion from arachidonic acid are the most commonly used drugs for ductal closure. This review focuses on the safety and efficacy oral medications in the management of PDA in preterm infants. Ibuprofen seems to be the first choice due to its higher safety profile, as it is associated with fewer gastrointestinal and renal side effects when compared to indomethacin. PDA closure rates are better with oral than with intravenous ibuprofen probably due to the pharmacokinetic of the drug. However, these medications were reported to be associated with several adverse including transient renal failure, gastrointestinal bleeding and perforation, hyperbilirubinemia and platelet dysfunction. Paracetamol seems be an alternative to PDA therapy with lower adverse events and side effects. PMID:26862505

  3. The Role of Hospital Inpatients in Supporting Medication Safety: A Qualitative Study

    PubMed Central

    Garfield, Sara; Jheeta, Seetal; Husson, Fran; Lloyd, Jill; Taylor, Alex; Boucher, Charles; Jacklin, Ann; Bischler, Anna; Norton, Christine; Hayles, Rob; Dean Franklin, Bryony

    2016-01-01

    Background Inpatient medication errors are a significant concern. An approach not yet widely studied is to facilitate greater involvement of inpatients with their medication. At the same time, electronic prescribing is becoming increasingly prevalent in the hospital setting. In this study we aimed to explore hospital inpatients’ involvement with medication safety-related behaviours, facilitators and barriers to this involvement, and the impact of electronic prescribing. Methods We conducted ethnographic observations and interviews in two UK hospital organisations, one with established electronic prescribing and one that changed from paper to electronic prescribing during our study. Researchers and lay volunteers observed nurses’ medication administration rounds, pharmacists’ ward rounds, doctor-led ward rounds and drug history taking. We also conducted interviews with healthcare professionals, patients and carers. Interviews were audio-recorded and transcribed. Observation notes and transcripts were coded thematically. Results Paper or electronic medication records were shown to patients in only 4 (2%) of 247 cases. However, where they were available during patient-healthcare professional interactions, healthcare professionals often viewed them in order to inform patients about their medicines and answer any questions. Interprofessional discussions about medicines seemed more likely to happen in front of the patient where paper or electronic drug charts were available near the bedside. Patients and carers had more access to paper-based drug charts than electronic equivalents. However, interviews and observations suggest there are potentially more significant factors that affect patient involvement with their inpatient medication. These include patient and healthcare professional beliefs concerning patient involvement, the way in which healthcare professionals operate as a team, and the underlying culture. Conclusion Patients appear to have more access to

  4. Patient safety culture at neonatal intensive care units: perspectives of the nursing and medical team 1

    PubMed Central

    Tomazoni, Andréia; Rocha, Patrícia Kuerten; de Souza, Sabrina; Anders, Jane Cristina; de Malfussi, Hamilton Filipe Correia

    2014-01-01

    OBJECTIVE: to verify the assessment of the patient safety culture according to the function and length of experience of the nursing and medical teams at Neonatal Intensive Care Units. METHOD: quantitative survey undertaken at four Neonatal Intensive Care Units in Florianópolis, Brazil. The sample totaled 141 subjects. The data were collected between February and April 2013 through the application of the Hospital Survey on Patient Safety Culture. For analysis, the Kruskal-Wallis and Chi-Square tests and Cronbach's Alpha coefficient were used. Approval for the research project was obtained from the Ethics Committee, CAAE: 05274612.7.0000.0121. RESULTS: differences in the number of positive answers to the Hospital Survey on Patient Safety Culture, the safety grade and the number of reported events were found according to the professional characteristics. A significant association was found between a shorter Length of work at the hospital and Length of work at the unit and a larger number of positive answers; longer length of experience in the profession represented higher grades and less reported events. The physicians and nursing technicians assessed the patient safety culture more positively. Cronbach's alpha demonstrated the reliability of the instrument. CONCLUSION: the differences found reveal a possible relation between the assessment of the safety culture and the subjects' professional characteristics at the Neonatal Intensive Care Units. PMID:25493670

  5. Personal health records: a randomized trial of effects on elder medication safety

    PubMed Central

    Chrischilles, Elizabeth A; Hourcade, Juan Pablo; Doucette, William; Eichmann, David; Gryzlak, Brian; Lorentzen, Ryan; Wright, Kara; Letuchy, Elena; Mueller, Michael; Farris, Karen; Levy, Barcey

    2014-01-01

    Purpose To examine the impact of a personal health record (PHR) on medication-use safety among older adults. Background Online PHRs have potential as tools to manage health information. We know little about how to make PHRs accessible for older adults and what effects this will have. Methods A PHR was designed and pretested with older adults and tested in a 6-month randomized controlled trial. After completing mailed baseline questionnaires, eligible computer users aged 65 and over were randomized 3:1 to be given access to a PHR (n=802) or serve as a standard care control group (n=273). Follow-up questionnaires measured change from baseline medication use, medication reconciliation behaviors, and medication management problems. Results Older adults were interested in keeping track of their health and medication information. A majority (55.2%) logged into the PHR and used it, but only 16.1% used it frequently. At follow-up, those randomized to the PHR group were significantly less likely to use multiple non-steroidal anti-inflammatory drugs—the most common warning generated by the system (viewed by 23% of participants). Compared with low/non-users, high users reported significantly more changes in medication use and improved medication reconciliation behaviors, and recognized significantly more side effects, but there was no difference in use of inappropriate medications or adherence measures. Conclusions PHRs can engage older adults for better medication self-management; however, features that motivate continued use will be needed. Longer-term studies of continued users will be required to evaluate the impact of these changes in behavior on patient health outcomes. PMID:24326536

  6. Scanning for safety: an integrated approach to improved bar-code medication administration.

    PubMed

    Early, Cynde; Riha, Chris; Martin, Jennifer; Lowdon, Karen W; Harvey, Ellen M

    2011-03-01

    This is a review of lessons learned in the postimplementation evaluation of a bar-code medication administration technology implemented at a major tertiary-care hospital in 2001. In 2006, with a bar-code medication administration scan compliance rate of 82%, a near-miss sentinel event prompted review of this technology as part of an institutional recommitment to a "culture of safety." Multifaceted problems with bar-code medication administration created an environment of circumventing safeguards as demonstrated by an increase in manual overrides to ensure timely medication administration. A multiprofessional team composed of nursing, pharmacy, human resources, quality, and technical services formalized. Each step in the bar-code medication administration process was reviewed. Technology, process, and educational solutions were identified and implemented systematically. Overall compliance with bar-code medication administration rose from 82% to 97%, which resulted in a calculated cost avoidance of more than $2.8 million during this time frame of the project. PMID:21099677

  7. The role of the Pharmaceuticals and Medical Devices Agency and healthcare professionals in post-marketing safety.

    PubMed

    Mori, Kazuhiko; Watanabe, Meguru; Horiuchi, Naoya; Tamura, Atsushi; Kutsumi, Hiromu

    2014-04-01

    The development of drugs and medical devices is necessary for medical progress; however, safety measures need to be put in place to protect the health of the population. In order to ensure the safety of drugs and medical devices, it is important to determine measures for appropriate management of risks at any time during the development phase, the regulatory review and the post-marketing phase. Adverse events detected in clinical trials are limited due to the restricted numbers of patients enrolled in the trials. Therefore, it is almost impossible to predict rare serious adverse events during the post-marketing phase. The revised Pharmaceutical Affairs Act was established in Japan in November 20, 2013. The new act focuses on increased safety of drugs and medical devices. The Pharmaceuticals and Medical Devices Agency (PMDA) is the regulatory authority in Japan that promotes safety measures from the development phase through to the post-marketing phase. In the post-marketing phase, the PMDA collects information from the medical product companies and healthcare professionals, as well as instructing and advising them with regard to post-marketing safety measures for each drug and medical device. Since Japan has a national health insurance system, a new drug or a medical device is available throughout the country when the drug price or medical fee is listed in the National Health Insurance price list. Healthcare professionals in medical institutions must learn about the drugs and medical devices they handle, and should make an effort to maintain patient safety. The PMDA medi-navi is a very useful electronic mail delivery service that provides critical information for protecting patients from health hazards caused by adverse events. The 'risk management plan' is also important as it contains important information about safety profile and post-marketing measures of a new drug. PMID:26183623

  8. A proposed framework to improve the safety of medical devices in a Canadian hospital context

    PubMed Central

    Polisena, Julie; Jutai, Jeffrey; Chreyh, Rana

    2014-01-01

    Purpose Medical devices are used to monitor, replace, or modify anatomy or physiological processes. They are important health care innovations that enable effective treatment using less invasive techniques, and they improve health care delivery and patient outcomes. Devices can also introduce risk of harm to patients. Our objective was to propose a surveillance system framework to improve the safety associated with the use of medical devices in a hospital. Materials and methods The proposed medical device surveillance system incorporates multiple components to accurately document and assess the appropriate actions to reduce the risk of incidents, adverse events, and patient harm. The assumptions on which the framework is based are highlighted. The surveillance system was designed from the perspective of a tertiary teaching hospital that includes dedicated hospital staff whose mandate is to provide safe patient care to inpatients and outpatients and biomedical engineering services. Results The main components of the surveillance system would include an adverse medical device events database, a medical device/equipment library, education and training, and an open communication and feedback strategy. Close linkages among these components and with external medical device/equipment networks to the hospital must be established and maintained. A feedback mechanism on medical device-related incidents, as well as implementation and evaluation strategies for the surveillance system are described to ensure a seamless transition and a high satisfactory level among the hospital staff. The direct cost items of the proposed surveillance system for consideration, and its potential benefits are outlined. Conclusion The effectiveness of the proposed medical device surveillance system framework can be measured after it has been implemented in a Canadian hospital facility. PMID:24876796

  9. [Medical simulation as a professional tool which affect the safety of the patient used in the learning process].

    PubMed

    Czekajlo, Michael; Dąbrowski, Marek; Dąbrowska, Agata; Torres, Kamil; Torres, Anna; Witt, Magdalena; Gąsiorowski, Łukasz; Szukała, Magdalena

    2015-06-01

    Simulation is the methodology of teaching, learning process using educational equipment from simple simulators, designed to study individual tasks, through advanced mannequins called human patient stimulators faithfully mimic the human and its parameters. The medical simulation's main task is education and improvement patients' safety. Advanced human simulators can realistically cough, vomit with artificial chyme and bleed with artificial blood causing a real stress of medical personnel and the need for immediate action. Medical simulation gives the opportunity to prepare medical personnel to the profession more effectively, in less time than traditional education and also clearly affects the patients' safety. PMID:26098659

  10. The Future of Graduate Medical Education: A Systems-Based Approach to Ensure Patient Safety.

    PubMed

    Bagian, James P

    2015-09-01

    In the past 15 years, there has been growing recognition that improving patient safety must be more systems based and sophisticated than the traditional approach of simply telling health care providers to "be more careful." Drawing from his own experience, the author discusses barriers to systems-based patient safety initiatives and emphasizes the importance of overcoming those barriers. Physicians may be slow to adopt standardized patient safety initiatives because of a resistance to standardization, but faculty in training institutions have a responsibility to model safe, effective, systems-based approaches to patient care in order to instill these values in the residents they teach. Importantly, graduate medical education (GME) is well positioned to influence not only how future physicians provide care to patients but also how today's physicians and health care systems improve patient safety and care. The necessary systems-based knowledge and skills are rooted in both understanding and proficiently identifying threats to patient safety, their underlying causes, the development and implementation of effective countermeasures, and the measurement of whether the threat has been successfully addressed. This knowledge and its application is notably absent in the operation of most institutions that sponsor GME training programs in terms of didactic instruction and everyday demonstrated proficiency. Most important of all, faculty must model the behavior and competencies that are desirable in future physicians and not fall into the trap of the "do as I say, not as I do" mentality, which can have a corrosive deleterious effect on the next generation of physicians. PMID:26312603

  11. Medical and safety monitoring system over an in-cabin optical wireless network

    NASA Astrophysics Data System (ADS)

    Marinos, D.; Leonidas, F.; Vlissidis, N.; Giovanis, C.; Pagiatakis, G.; Aidinis, C.; Vassilopoulos, C.; Pistner, T.; Schmitt, N.; Klaue, J.

    2011-02-01

    An integrated health and safety monitoring system for aircraft environments using commercially available medical sensor modules and custom made safety sensors in conjunction with an appropriate database supervised through a human-machine interface is implemented. The application described aims at preventing critical health- or safety-related situations during the flight. The health monitoring part of the system is capable of collecting all relevant data, essential in analysing a passenger's health profile. These data, comprising of body temperature, blood pressure, pulse oximetry and electrocardiogram, are throughput and transmitted over a wireless optical intra-cabin link to a server. Furthermore, and in order to reduce the cabin crew workload, along with the health data from a specific passenger group, seat-embedded safety sensors provide information for all passengers' flight safety parameters (such as table upright, seat-belt closed, etc.). The data gathered by the system in a central server can, in its entirety, be stored, processed or acted upon in real time.

  12. Cardiovascular safety of type 2 diabetes medications: Review of existing literature and clinical implications.

    PubMed

    Paredes, Sílvia; Matta-Coelho, Claudia; Monteiro, Ana Margarida; Brás, Alice; Marques, Olinda; Alves, Marta; Ribeiro, Laura

    2016-04-01

    Type 2 diabetes mellitus (T2DM), cardiovascular disease (CVD) and the cardiovascular effect of antidiabetic drugs are today critical medical issues, with the prevalence of T2DM in particular showing a steep increase worldwide, mainly due to unhealthy lifestyle habits. T2DM in association with obesity and other cardiovascular risk factors, results in the development of CVD, the leading cause of morbidity and mortality in patients with T2DM. Thus, treatment of T2DM is an individualized and complex challenge in which targeting cardiovascular risk factors is an important component in the decision making. Given the cardiovascular adverse events associated with rosiglitazone, both the Food and Drug Administration and the European Medicines Agency currently require the demonstration of cardiovascular safety of new antidiabetic drugs. Consequently, clinical trials to guarantee their cardiovascular safety are now obligatory. This review aims to summarize the available evidence on the cardiovascular effects and safety of the major drugs used in T2DM treatment and also to provide an overview of upcoming and ongoing clinical trials in this field. Our belief is that this review will be of substantial assistance to all medical doctors who are treating diabetic patients, namely primary care physicians, internal medicine doctors, endocrinologists, diabetologists and less well experienced personnel such as young doctors in training. PMID:27376421

  13. Understanding safety-critical interactions with a home medical device through Distributed Cognition.

    PubMed

    Rajkomar, Atish; Mayer, Astrid; Blandford, Ann

    2015-08-01

    As healthcare shifts from the hospital to the home, it is becoming increasingly important to understand how patients interact with home medical devices, to inform the safe and patient-friendly design of these devices. Distributed Cognition (DCog) has been a useful theoretical framework for understanding situated interactions in the healthcare domain. However, it has not previously been applied to study interactions with home medical devices. In this study, DCog was applied to understand renal patients' interactions with Home Hemodialysis Technology (HHT), as an example of a home medical device. Data was gathered through ethnographic observations and interviews with 19 renal patients and interviews with seven professionals. Data was analyzed through the principles summarized in the Distributed Cognition for Teamwork methodology. In this paper we focus on the analysis of system activities, information flows, social structures, physical layouts, and artefacts. By explicitly considering different ways in which cognitive processes are distributed, the DCog approach helped to understand patients' interaction strategies, and pointed to design opportunities that could improve patients' experiences of using HHT. The findings highlight the need to design HHT taking into consideration likely scenarios of use in the home and of the broader home context. A setting such as home hemodialysis has the characteristics of a complex and safety-critical socio-technical system, and a DCog approach effectively helps to understand how safety is achieved or compromised in such a system. PMID:26056072

  14. Safety challenges of medical equipment in nurse anaesthetist training in Haiti.

    PubMed

    Santos, A L R; Wauben, L S G L; Guilavogui, S; Brezet, J C; Goossens, R; Rosseel, P M J

    2016-03-01

    Safety challenges related to the use of medical equipment were investigated during the training of nurse anaesthetists in Haiti, using a systems approach to Human Factors and Ergonomics (HFE). The Observable Performance Obstacles tool, based on the Systems Engineering Initiative for Patient Safety (SEIPS) model, was used in combination with exploratory observations during 13 surgical procedures, to identify performance obstacles created by the systemic interrelationships of medical equipment. The identification of performance obstacles is an effective way to study the accumulation of latent factors and risk hazards, and understand its implications in practice and behaviour of healthcare practitioners. In total, 123 performance obstacles were identified, of which the majority was related to environmental and organizational aspects. These findings show how the performance of nurse anaesthetists and their relation to medical equipment is continuously affected by more than user-related aspects. The contribution of systemic performance obstacles and coping strategies to enrich system design interventions and improve healthcare system is highlighted. In addition, methodological challenges of HFE research in low-resource settings related to professional culture and habits, and the potential of community ergonomics as a problem-managing approach are described. PMID:26154027

  15. A patient safety and transitions of care curriculum for third-year medical students.

    PubMed

    Bradley, Sara M; Chang, Dennis; Fallar, Robert; Karani, Reena

    2015-01-01

    The elderly are the most vulnerable to adverse events during and after hospitalization. This study sought to evaluate the effectiveness of a curriculum on patient safety and transitions of care for medical students during an Internal Medicine-Geriatrics Clerkship on students' knowledge, skills, and attitudes. The curriculum included didactics on patient safety, health literacy, discharge planning and transitions of care, and postdischarge visits to patients. Analysis of pre- and postassessments showed afterwards students were significantly more comfortable assessing a patient's health literacy and confident performing a medication reconciliation, providing education regarding medications, and identifying barriers during transitions. More students were able to identify the most common source of adverse events after discharge (86% vs. 62% before), risk factors for low health literacy (28% vs. 14%), and ways to assess a patient's health literacy (14% vs. 2%). It was feasible to implement a postdischarge visit assignment in an urban tertiary care setting and only required on average of approximately an one and one half hours for students to complete. PMID:25288373

  16. Reducing medication errors and increasing patient safety: case studies in clinical pharmacology.

    PubMed

    Benjamin, David M

    2003-07-01

    Today, reducing medication errors and improving patient safety have become common topics of discussion for the president of the United States, federal and state legislators, the insurance industry, pharmaceutical companies, health care professionals, and patients. But this is not news to clinical pharmacologists. Improving the judicious use of medications and minimizing adverse drug reactions have always been key areas of research and study for those working in clinical pharmacology. However, added to the older terms of adverse drug reactions and rational therapeutics, the now politically correct expression of medication error has emerged. Focusing on the word error has drawn attention to "prevention" and what can be done to minimize mistakes and improve patient safety. Webster's New Collegiate Dictionary has several definitions of error, but the one that seems to be most appropriate in the context of medication errors is "an act that through ingnorance, deficiency, or accident departs from or fails to achieve what should be done." What should be done is generally known as "the five rights": the right drug, right dose, right route, right time, and right patient. One can make an error of omission (failure to act correctly) or an error of commission (acted incorrectly). This article now summarizes what is currently known about medication errors and translates the information into case studies illustrating common scenarios leading to medication errors. Each case is analyzed to provide insight into how the medication error could have been prevented. "System errors" are described, and the application of failure mode effect analysis (FMEA) is presented to determine the part of the "safety net" that failed. Examples of reengineering the system to make it more "error proof" are presented. An error can be prevented. However, the practice of medicine, pharmacy, and nursing in the hospital setting is very complicated, and so many steps occur from "pen to patient" that there

  17. Safety subcultures in health-care organizations and managing medical error.

    PubMed

    Sirriyeh, Reema; Lawton, Rebecca; Armitage, Gerry; Gardner, Peter; Ferguson, Sally

    2012-02-01

    Leadership has been proposed as a key latent factor influencing the safety culture of an organization, the likelihood of errors occurring and the way in which these are managed. Therefore, when an error occurs, managers have an integral role to ensure that the most desirable outcomes are achieved for patients, health-care staff and their organization. Semistructured interviews were conducted in a large UK teaching hospital to explore the perspectives of staff who are tasked in some way with managing patient safety. Data from 26 transcripts were analysed using an adapted version of Spencer's (2003) qualitative framework, which revealed five primary themes. This paper reports findings from two overarching primary themes, described as being management and safety subcultures. These themes describe experiences of managing medical errors and the subgroup variations between professions, ranks and specialties in attitudes and behaviours towards error, and its management in a large National Health Service Trust. We discuss implications for health-care managers and health professionals in developing a stronger and more unified safety culture in their organizations, along with considerations for academic researchers when undertaking health services research. PMID:22323667

  18. 77 FR 70166 - Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical Gases...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-23

    ...The Food and Drug Administration (FDA) is establishing a public docket for information pertaining to FDA's implementation of the provisions of the Food and Drug Administration Safety and Innovation Act (FDASIA) related to medical gases. This action is intended to ensure that information submitted to FDA on the implementation of the medical gas provisions of FDASIA is available to all......

  19. Validation of completeness, correctness, relevance and understandability of the PSIP CDSS for medication safety.

    PubMed

    Ammenwerth, Elske; Hackl, Werner O; Massari, Philippe; Darmoni, Stefan

    2011-01-01

    Medication errors and resulting Adverse Drug Events (ADEs) are an important issue of global healthcare. Within the European PSIP project that aims at developing solutions to improve medication safety, contextualized decision support modules aiming to prevent ADEs are being developed. The objective of this work was to thoroughly validate part of the CDSS (Clinical Decision Support System) and the underlying Knowledge Base, in order to detect incorrect or unclear alerts. We systematically developed a repository of test cases and used them for validation. The development of the test cases showed that there are differences among experts in interpreting the correctness of an alert, and that the clinical context is important when judging whether it is adequate. Overall, validation did not find major errors in the Knoweldge Base, but developed several recommendations for further improvement. PMID:21685631

  20. Radiological safety status and quality assurance audit of medical X-ray diagnostic installations in India.

    PubMed

    Sonawane, A U; Singh, Meghraj; Sunil Kumar, J V K; Kulkarni, Arti; Shirva, V K; Pradhan, A S

    2010-10-01

    We conducted a radiological safety and quality assurance (QA) audit of 118 medical X-ray diagnostic machines installed in 45 major hospitals in India. The main objective of the audit was to verify compliance with the regulatory requirements stipulated by the national regulatory body. The audit mainly covered accuracy check of accelerating potential (kVp), linearity of tube current (mA station) and timer, congruence of radiation and optical field, and total filtration; in addition, we also reviewed medical X-ray diagnostic installations with reference to room layout of X-ray machines and conduct of radiological protection survey. A QA kit consisting of a kVp Test-O-Meter (ToM) (Model RAD/FLU-9001), dose Test-O-Meter (ToM) (Model 6001), ionization chamber-based radiation survey meter model Gun Monitor and other standard accessories were used for the required measurements. The important areas where there was noncompliance with the national safety code were: inaccuracy of kVp calibration (23%), lack of congruence of radiation and optical field (23%), nonlinearity of mA station (16%) and timer (9%), improper collimator/diaphragm (19.6%), faulty adjustor knob for alignment of field size (4%), nonavailability of warning light (red light) at the entrance of the X-ray room (29%), and use of mobile protective barriers without lead glass viewing window (14%). The present study on the radiological safety status of diagnostic X-ray installations may be a reasonably good representation of the situation in the country as a whole. The study contributes significantly to the improvement of radiological safety by the way of the steps already taken and by providing a vital feed back to the national regulatory body. PMID:21170188

  1. Collaborative Depression Care in a Safety Net Medical Home: Facilitators and Barriers to Quality Improvement.

    PubMed

    Price-Haywood, Eboni G; Dunn-Lombard, Donisha; Harden-Barrios, Jewel; Lefante, John J

    2016-02-01

    Little is known about how to integrate primary care with mental/behavioral services outside of clinical trials. The authors implemented a collaborative care model (CCM) for depression in a safety net patient-centered medical home. The model focused on universal screening for symptoms, risk stratification based on symptom severity, care management for intensive follow-up, and psychiatry consultation. CCM increased rates of primary care physician encounters, timely follow-up for monitoring symptoms of depression, and documentation of treatment response. Contextual factors that facilitated or hindered practice redesign included clinic leadership, quality improvement culture, staffing, technology infrastructure, and external incentives/disincentives for organizational change. PMID:26087153

  2. Self-reported patient safety competence among Canadian medical students and postgraduate trainees: a cross-sectional survey

    PubMed Central

    Doyle, Patricia; VanDenKerkhof, Elizabeth G; Edge, Dana S; Ginsburg, Liane; Goldstein, David H

    2015-01-01

    Background Quality and patient safety (PS) are critical components of medical education. This study reports on the self-reported PS competence of medical students and postgraduate trainees. Methods The Health Professional Education in Patient Safety Survey was administered to medical students and postgraduate trainees in January 2012. PS dimension scores were compared across learning settings (classroom and clinical) and year in programme. Results Sixty-three percent (255/406) of medical students and 32% (141/436) of postgraduate trainees responded. In general, both groups were most confident in their learning of clinical safety skills (eg, hand hygiene) and least confident in learning about sociocultural aspects of safety (eg, understanding human factors). Medical students’ confidence in most aspects of safety improved with years of training. For some of the more intangible dimensions (teamwork and culture), medical students in their final year had lower scores than students in earlier years. Thirty-eight percent of medical students felt they could approach someone engaging in unsafe practice, and the majority of medical students (85%) and postgraduate trainees (78%) agreed it was difficult to question authority. Conclusions Our results suggest the need to improve the overall content, structure and integration of PS concepts in both classroom and clinical learning environments. Decreased confidence in sociocultural aspects of PS among medical students in the final year of training may indicate that culture in clinical settings negatively affects students’ perceived PS competence. Alternatively, as medical students spend more time in the clinical setting, they may develop a clearer sense of what they do not know. PMID:25605953

  3. The Safety of Flavocoxid, a Medical Food, in the Dietary Management of Knee Osteoarthritis

    PubMed Central

    Baggott, Joseph E.; Moreland, Larry; Desmond, Renee; Kendrach, Angela C.

    2009-01-01

    Abstract This study was designed to determine the safety of a medical food, flavocoxid, a proprietary blend of free-B ring flavonoids and flavans from the root of Scutellaria baicalensis (Chinese skullcap) and the bark of Acacia catechu in the dietary management of knee osteoarthritis. The 12-week, randomized, double-blind, placebo-controlled trial in an academic medical center enrolled 59 patients with moderate osteoarthritis of at least one knee who were recruited who were classified as having “below average” to “a moderately above average cardiovascular risk” with a Framingham-based scoring tool. Subjects were randomized to flavocoxid 250 mg twice a day versus identical placebo. Safety measures, including recording of adverse events, incidence of serious adverse events, and results of routine laboratory values, were compared between the two groups. There were no major differences in the baseline demographic characteristics of the placebo and flavocoxid groups. With one exception no significant differences were found between the two groups with respect to adverse events by body system, blood pressure, or laboratory values. There was a significantly higher incidence of upper respiratory adverse events in the placebo group (35.4% vs. 5.8%, P = .0003). There were no intra- or inter-group differences in any of the laboratory parameters from study baseline to completion. Thus, flavocoxid is safe when used in a population with “below average” to “moderately above average cardiovascular risk” compared to placebo. PMID:19857081

  4. Medical accelerator safety considerations: report of AAPM Radiation Therapy Committee Task Group No. 35.

    PubMed

    Purdy, J A; Biggs, P J; Bowers, C; Dally, E; Downs, W; Fraass, B A; Karzmark, C J; Khan, F; Morgan, P; Morton, R

    1993-01-01

    Ensuring safe operation for a medical accelerator is a difficult task. Users must assume more responsibility in using contemporary equipment. Additionally, users must work closely with manufacturers in promoting the safe and effective use of such complex equipment. Complex treatment techniques and treatment modality changeover procedures merit detailed, unambiguous written procedural instruction at the control console. A thorough "hands on" training period after receiving instructions, and before assuming treatment responsibilities, is essential for all technologists. Unambiguous written instructions must also be provided to guide technologists in safe response when equipment malfunctions or exhibits unexpected behavior or after any component has been changed or readjusted. Technologists should be given a written list of the appropriate individuals to consult when unexpected machine behavior occurs. They should be assisted in identifying aberrant behavior of equipment. Many centers already provide this instruction, but others may not. Practiced response and discussion with technologists should be a part of an ongoing quality assurance program. An important aspect of a safety program is the need for continuous vigilance. Table III gives a summary of a comprehensive safety program for medical accelerators. Table IV gives a list of summary recommendations as an example of how one might mitigate the consequences of an equipment failure and improve procedures and operator response in the context of the environment described. Most of these recommendations can be implemented almost immediately at any individual treatment center. PMID:8413039

  5. Formoterol as relief medication in asthma: a worldwide safety and effectiveness trial.

    PubMed

    Pauwels, R A; Sears, M R; Campbell, M; Villasante, C; Huang, S; Lindh, A; Petermann, W; Aubier, M; Schwabe, G; Bengtsson, T

    2003-11-01

    The aim of the study was to compare the safety and effectiveness of as-needed formoterol with salbutamol in a large international real-life asthma study. Children and adults (n=18,124) were randomised to 6 months as-needed treatment with open-label formoterol 4.5 microg Turbuhaler or salbutamol 200 microg pressurised metered dose inhaler or equivalent. Primary safety variables were asthma-related and nonasthma-related serious adverse events (SAE)s and adverse events (AE)s resulting in discontinuation (DAE)s. The primary efficacy variable was time to first asthma exacerbation. The incidences of AEs, SAEs and DAEs arising from SAEs were not significantly different between treatments. DAEs for nonserious AEs were higher with formoterol. Asthma-related AEs decreased with formoterol (1,098 (12.3%) versus 1,206 (13.5%)), asthma-related SAEs were similar (108 (1.2%) versus 121 (1.4%)) but more asthma-related DAEs occurred in the formoterol group (89 (1.0%) versus 48 (0.5%)). Time to first exacerbation was prolonged (hazard ratio 0.86) and less as-needed and maintenance medication was used with formoterol. Reductions of exacerbations with as-needed formoterol versus salbutamol increased with increasing age and asthma medication level. This real-life study demonstrates that formoterol as-needed has a similar safety profile to salbutamol, and its use as a reliever therapy is associated with fewer asthma symptoms and exacerbations. PMID:14621086

  6. Safety in numbers 1: Essential numerical and scientific principles underpinning medication dose calculation.

    PubMed

    Young, Simon; Weeks, Keith W; Hutton, B Meriel

    2013-03-01

    Registered nurses spend up to 40% of their professional clinical practice engaged in the art and science of medication dosage calculation problem-solving (MDC-PS). In advancing this patient safety critical discipline it is our position that as a profession we must first situate MDC-PS within the context of the wider features of the nursing numeracy, medicines management and clinical pharmacokinetic domains that inform its practice. This paper focuses on the essential relationship between numeracy, healthcare numeracy, medicines management, pharmacokinetics and MDC-PS. We present a taxonomy of generic numerical competencies for the pre-registration curriculum, with examples of essential medication dosage calculation requirements mapped to each skills domain. This is followed by a review of the symbols and measurement units that represent essential components of calculation competence in healthcare and medicines management practice. Finally we outline the fundamental pharmacokinetic knowledge that explains how the body deals with medication and we illustrate through clinical correlations why numeric and scientific knowledge and skills must be mastered to ensure safe dosage calculation and medicines management practice. The findings inform nurse education practice via advancing our understanding of a number of issues, including a unified taxonomy of generic numerical competencies mapped to the 42 revised UK Nursing and Midwifery Council (NMC) Essential Skills Clusters (NMC, 2010a; NMC, 2010b). PMID:23273945

  7. Safety and efficacy considerations due to misuse of extended-release formulations of stimulant medications.

    PubMed

    Jain, Rakesh; Stark, Jeffrey G

    2016-09-01

    Amphetamine or methylphenidate are first-line options for treating attention-deficit/hyperactivity disorder (ADHD). Deviations from suggested routes of administration such as crushing, chewing, intravenous administration, or snorting stimulant medication may alter the release rate, absorption, and bioavailability of the active drug. Additionally, the pharmacokinetic (PK) profiles of extended-release formulations of certain medications (e.g., some opioids) are known to be dangerously altered when consumed with alcohol; specifically, there is an unintended, rapid release of a significant portion of the drug (dose dumping). In vitro data suggest some extended-release stimulants dose dump in the presence of alcohol, which is of concern because the ADHD patient population is at risk for alcohol abuse. This article reviews the available scientific literature concerning modifications to routes of administration that may alter PK properties of stimulant-based medication for treating ADHD. These modifications are of clinical interest because they may pose safety hazards and affect efficacy. Electronic databases were searched for appropriate studies using relevant search terms. The misuse and abuse potential for stimulants and the efforts to prevent misuse are also discussed. Future research should be focused on determining the PK ramifications of stimulant misuse, along with developing new formulations with abuse-deterrent properties. PMID:27467139

  8. Understanding the value of mixed methods research: the Children's Safety Initiative-Emergency Medical Services.

    PubMed

    Hansen, Matthew; O'Brien, Kerth; Meckler, Garth; Chang, Anna Marie; Guise, Jeanne-Marie

    2016-07-01

    Mixed methods research has significant potential to broaden the scope of emergency care and specifically emergency medical services investigation. Mixed methods studies involve the coordinated use of qualitative and quantitative research approaches to gain a fuller understanding of practice. By combining what is learnt from multiple methods, these approaches can help to characterise complex healthcare systems, identify the mechanisms of complex problems such as medical errors and understand aspects of human interaction such as communication, behaviour and team performance. Mixed methods approaches may be particularly useful for out-of-hospital care researchers because care is provided in complex systems where equipment, interpersonal interactions, societal norms, environment and other factors influence patient outcomes. The overall objectives of this paper are to (1) introduce the fundamental concepts and approaches of mixed methods research and (2) describe the interrelation and complementary features of the quantitative and qualitative components of mixed methods studies using specific examples from the Children's Safety Initiative-Emergency Medical Services (CSI-EMS), a large National Institutes of Health-funded research project conducted in the USA. PMID:26949970

  9. Graduate Medical Education as a Lever for Collaborative Change: One Institution's Experience with a Campuswide Patient Safety Initiative

    PubMed Central

    Vath, Richard J.; Musso, Mandi W.; Rabalais, Lauren S.; Dunbar, Alston; Hosea, Stephen; Johnson, Angela C.; Bolton, Michael; Rhynes, Vernon K.; Caffery, Terrell S.; Tynes, L. Lee; Mantzor, Savarra; Miller, Bahnsen; Calongne, Laurinda L.

    2016-01-01

    Background: The 2013 closure of a public hospital in Baton Rouge, LA transformed graduate medical education (GME) at Our Lady of the Lake Regional Medical Center (OLOL). Administrators were tasked with incorporating residents into patient safety and quality improvement initiatives to fulfill regulatory obligations. This report outlines our experiences as we built these patient safety and quality improvement initiatives in a rapidly expanding independent academic medical center. Methods: We joined the Alliance of Independent Academic Medical Centers (AIAMC) to meet and learn from national peers. To fulfill the scholarly activity requirement of the AIAMC's National Initiative IV, we formed a multidisciplinary team to develop a patient safety education project. Prioritized monthly team meetings allowed for project successes to be celebrated and circulated within the organization. Results: The public-private partnership that more than quadrupled the historic size of GME at OLOL has, in the past 2 years, led to the development of an interdisciplinary team. This team has expanded to accommodate residency program leadership from across the campus. Our National Initiative IV project won a national award and inspired several follow-up initiatives. In addition, this work led to the formation of a Patient Safety and Clinical Quality Improvement fellowship that matched its first fellow in 2015. Conclusion: Through the commitment and support of hospital and medical education leaders, as well as a focus on promoting cultural change through scholarly activity, we were able to greatly expand patient safety and quality improvement efforts in our institution. PMID:27046411

  10. 76 FR 7855 - Patient Safety Organizations: Voluntary Delisting From Community Medical Foundation for Patient...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-11

    ... safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety... patient safety and the quality of health care delivery. HHS issued the Patient Safety Rule to implement... HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety Organizations:......

  11. Improving the Safety and Effectiveness of Medical Device Therapy in Women.

    PubMed

    Zusterzeel, Robbert; O'Callaghan, Kathryn M; Caños, Daniel A; Sanders, William E; Marinac-Dabic, Danica; Strauss, David G

    2016-05-01

    When not enough women are included in many clinical trials, an information gap on medical device safety and effectiveness exists, which can make it difficult to detect sex-specific results. In this article we discuss potential reasons for the underrepresentation of women and the regulatory research conducted by the U.S. Food and Drug Administration (FDA) used in supporting regulatory decisions. We demonstrate that important differences in cardiovascular device performance between women and men exist. Furthermore, concrete steps are outlined on the possible ways these sex-specific results can be detected and how a recent FDA Action Plan and Guidance Document aim at encouraging female participation in clinical trials and the appropriate analysis thereof. PMID:27028582

  12. Quality and safety of medication use in primary care: consensus validation of a new set of explicit medication assessment criteria and prioritisation of topics for improvement

    PubMed Central

    2012-01-01

    Background Addressing the problem of preventable drug related morbidity (PDRM) in primary care is a challenge for health care systems internationally. The increasing implementation of clinical information systems in the UK and internationally provide new opportunities to systematically identify patients at risk of PDRM for targeted medication review. The objectives of this study were (1) to develop a set of explicit medication assessment criteria to identify patients with sub-optimally effective or high-risk medication use from electronic medical records and (2) to identify medication use topics that are perceived by UK primary care clinicians to be priorities for quality and safety improvement initiatives. Methods For objective (1), a 2-round consensus process based on the RAND/UCLA Appropriateness Method (RAM) was conducted, in which candidate criteria were identified from the literature and scored by a panel of 10 experts for 'appropriateness' and 'necessity'. A set of final criteria was generated from candidates accepted at each level. For objective (2), thematically related final criteria were clustered into 'topics', from which a panel of 26 UK primary care clinicians identified priorities for quality improvement in a 2-round Delphi exercise. Results (1) The RAM process yielded a final set of 176 medication assessment criteria organised under the domains 'quality' and 'safety', each classified as targeting 'appropriate/necessary to do' (quality) or 'inappropriate/necessary to avoid' (safety) medication use. Fifty-two final 'quality' assessment criteria target patients with unmet indications, sub-optimal selection or intensity of beneficial drug treatments. A total of 124 'safety' assessment criteria target patients with unmet needs for risk-mitigating agents, high-risk drug selection, excessive dose or duration, inconsistent monitoring or dosing instructions. (2) The UK Delphi panel identified 11 (23%) of 47 scored topics as 'high priority' for quality

  13. The outcomes of recent patient safety education interventions for trainee physicians and medical students: a systematic review

    PubMed Central

    Kirkman, Matthew A; Sevdalis, Nick; Arora, Sonal; Baker, Paul; Vincent, Charles; Ahmed, Maria

    2015-01-01

    Objective To systematically review the latest evidence for patient safety education for physicians in training and medical students, updating, extending and improving on a previous systematic review on this topic. Design A systematic review. Data sources Embase, Ovid Medline and PsycINFO databases. Study selection Studies including an evaluation of patient safety training interventions delivered to trainees/residents and medical students published between January 2009 and May 2014. Data extraction The review was performed using a structured data capture tool. Thematic analysis also identified factors influencing successful implementation of interventions. Results We identified 26 studies reporting patient safety interventions: 11 involving students and 15 involving trainees/residents. Common educational content included a general overview of patient safety, root cause/systems-based analysis, communication and teamwork skills, and quality improvement principles and methodologies. The majority of courses were well received by learners, and improved patient safety knowledge, skills and attitudes. Moreover, some interventions were shown to result in positive behaviours, notably subsequent engagement in quality improvement projects. No studies demonstrated patient benefit. Availability of expert faculty, competing curricular/service demands and institutional culture were important factors affecting implementation. Conclusions There is an increasing trend for developing educational interventions in patient safety delivered to trainees/residents and medical students. However, significant methodological shortcomings remain and additional evidence of impact on patient outcomes is needed. While there is some evidence of enhanced efforts to promote sustainability of such interventions, further work is needed to encourage their wider adoption and spread. PMID:25995240

  14. Needs and opportunities for improving the health, safety, and productivity of medical research facilities.

    PubMed Central

    Hodgson, M; Brodt, W; Henderson, D; Loftness, V; Rosenfeld, A; Woods, J; Wright, R

    2000-01-01

    Medical research facilities, indeed all the nation's constructed facilities, must be designed, operated, and maintained in a manner that supports the health, safety, and productivity of the occupants. The National Construction Goals, established by the National Science and Technology Council, envision substantial improvements in occupant health and worker productivity. The existing research and best practices case studies support this conclusion, but too frequently building industry professionals lack the knowledge to design, construct, operate, and maintain facilities at these optimum levels. There is a need for more research and more collaborative efforts between medical and facilities engineering researchers and practitioners in order to attain the National Construction Goals. Such collaborative efforts will simultaneously support attainment of the National Health Goals. This article is the summary report of the Healthy Buildings Committee for the Leadership Conference: Biomedical Facilities and the Environment sponsored by the National Institutes of Health, the National Association of Physicians for the Environment, and the Association of Higher Education Facilities Officers on 1--2 November 1999 in Bethesda, Maryland, USA. PMID:11124125

  15. Radiological protection, safety and security issues in the industrial and medical applications of radiation sources

    NASA Astrophysics Data System (ADS)

    Vaz, Pedro

    2015-11-01

    The use of radiation sources, namely radioactive sealed or unsealed sources and particle accelerators and beams is ubiquitous in the industrial and medical applications of ionizing radiation. Besides radiological protection of the workers, members of the public and patients in routine situations, the use of radiation sources involves several aspects associated to the mitigation of radiological or nuclear accidents and associated emergency situations. On the other hand, during the last decade security issues became burning issues due to the potential malevolent uses of radioactive sources for the perpetration of terrorist acts using RDD (Radiological Dispersal Devices), RED (Radiation Exposure Devices) or IND (Improvised Nuclear Devices). A stringent set of international legally and non-legally binding instruments, regulations, conventions and treaties regulate nowadays the use of radioactive sources. In this paper, a review of the radiological protection issues associated to the use of radiation sources in the industrial and medical applications of ionizing radiation is performed. The associated radiation safety issues and the prevention and mitigation of incidents and accidents are discussed. A comprehensive discussion of the security issues associated to the global use of radiation sources for the aforementioned applications and the inherent radiation detection requirements will be presented. Scientific, technical, legal, ethical, socio-economic issues are put forward and discussed.

  16. Patient Safety in Medication Nomenclature: Orthographic and Semantic Properties of International Nonproprietary Names

    PubMed Central

    Bryan, Rachel; Aronson, Jeffrey K.; ten Hacken, Pius; Williams, Alison; Jordan, Sue

    2015-01-01

    Background Confusion between look-alike and sound-alike (LASA) medication names (such as mercaptamine and mercaptopurine) accounts for up to one in four medication errors, threatening patient safety. Error reduction strategies include computerized physician order entry interventions, and ‘Tall Man’ lettering. The purpose of this study is to explore the medication name designation process, to elucidate properties that may prime the risk of confusion. Methods and Findings We analysed the formal and semantic properties of 7,987 International Non-proprietary Names (INNs), in relation to naming guidelines of the World Health Organization (WHO) INN programme, and have identified potential for errors. We explored: their linguistic properties, the underlying taxonomy of stems to indicate pharmacological interrelationships, and similarities between INNs. We used Microsoft Excel for analysis, including calculation of Levenshtein edit distance (LED). Compliance with WHO naming guidelines was inconsistent. Since the 1970s there has been a trend towards compliance in formal properties, such as word length, but longer names published in the 1950s and 1960s are still in use. The stems used to show pharmacological interrelationships are not spelled consistently and the guidelines do not impose an unequivocal order on them, making the meanings of INNs difficult to understand. Pairs of INNs sharing a stem (appropriately or not) often have high levels of similarity (<5 LED), and thus have greater potential for confusion. Conclusions We have revealed a tension between WHO guidelines stipulating use of stems to denote meaning, and the aim of reducing similarities in nomenclature. To mitigate this tension and reduce the risk of confusion, the stem system should be made clear and well ordered, so as to avoid compounding the risk of confusion at the clinical level. The interplay between the different WHO INN naming principles should be further examined, to better understand their

  17. Improving the quality and safety of care on the medical ward: A review and synthesis of the evidence base.

    PubMed

    Pannick, Samuel; Beveridge, Iain; Wachter, Robert M; Sevdalis, Nick

    2014-12-01

    Despite its place at the heart of inpatient medicine, the evidence base underpinning the effective delivery of medical ward care is highly fragmented. Clinicians familiar with the selection of evidence-supported treatments for specific diseases may be less aware of the evolving literature surrounding the organisation of care on the medical ward. This review is the first synthesis of that disparate literature. An iterative search identified relevant publications, using terms pertaining to medical ward environments, and objective and subjective patient outcomes. Articles (including reviews) were selected on the basis of their focus on medical wards, and their relevance to the quality and safety of ward-based care. Responses to medical ward failings are grouped into five common themes: staffing levels and team composition; interdisciplinary communication and collaboration; standardisation of care; early recognition and treatment of the deteriorating patient; and local safety climate. Interventions in these categories are likely to improve the quality and safety of care in medical wards, although the evidence supporting them is constrained by methodological limitations and inadequate investment in multicentre trials. Nonetheless, with infrequent opportunities to redefine their services, institutions are increasingly adopting multifaceted strategies that encompass groups of these themes. As the literature on the quality of inpatient care moves beyond its initial focus on the intensive care unit and operating theatre, physicians should be mindful of opportunities to incorporate evidence-based practice at a ward level. PMID:25457434

  18. An Examination of Safety Management Systems and Aviation Technologies in the Helicopter Emergency Medical Services Industry

    NASA Astrophysics Data System (ADS)

    Buckner, Steven A.

    The Helicopter Emergency Medical Service (HEMS) industry has a significant role in the transportation of injured patients, but has experienced more accidents than all other segments of the aviation industry combined. With the objective of addressing this discrepancy, this study assesses the effect of safety management systems implementation and aviation technologies utilization on the reduction of HEMS accident rates. Participating were 147 pilots from Federal Aviation Regulations Part 135 HEMS operators, who completed a survey questionnaire based on the Safety Culture and Safety Management System Survey (SCSMSS). The study assessed the predictor value of SMS implementation and aviation technologies to the frequency of HEMS accident rates with correlation and multiple linear regression. The correlation analysis identified three significant positive relationships. HEMS years of experience had a high significant positive relationship with accident rate (r=.90; p<.05); SMS had a moderate significant positive relationship to Night Vision Goggles (NVG) (r=.38; p<.05); and SMS had a slight significant positive relationship with Terrain Avoidance Warning System (TAWS) (r=.234; p<.05). Multiple regression analysis suggested that when combined with NVG, TAWS, and SMS, HEMS years of experience explained 81.4% of the variance in accident rate scores (p<.05), and HEMS years of experience was found to be a significant predictor of accident rates (p<.05). Additional quantitative regression analysis was recommended to replicate the results of this study and to consider the influence of these variables for continued reduction of HEMS accidents, and to induce execution of SMS and aviation technologies from a systems engineering application. Recommendations for practice included the adoption of existing regulatory guidance for a SMS program. A qualitative analysis was also recommended for future study SMS implementation and HEMS accident rate from the pilot's perspective. A

  19. Impact of technological innovation on a nursing home performance and on the medication-use process safety.

    PubMed

    Baril, Chantal; Gascon, Viviane; Brouillette, Christel

    2014-03-01

    Despite the fact that since 1985 the government of Québec increased by 5.75 % on average the amount of money spent on healthcare per year, little improvement was noted. It is obvious that an optimal use of resources is essential to reduce waiting times and provide safer and faster services to patients. The use of new technology can contribute to improve the healthcare system efficiency. Our study aims to assess the impact of a medication distribution technology on 1) the performance of a health and social services center's pharmacy, 2) the performance of one care unit in a nursing home and on 3) the medication-use process safety. To measure performance we were inspired by the Lean approach. The results show that medication distribution technology is considered as an effective way to significantly detect medication errors, to allow nurses to focus more on patients and pharmacy to react more rapidly to changes in patient medications. PMID:24627187

  20. The Automated Alert System for the Hospital Infection Control and the Safety of Medical Staff Based on EMR Data.

    PubMed

    Jo, Eunmi

    2016-01-01

    This report is about planning, developing, and implementing the automated alert system for the Hospital infection control and the safety of medical staffs about information on patients exposed to infection based on EMR Data in a tertiary hospital in Korea. PMID:27332375

  1. 78 FR 17611 - Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical Gases...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-22

    ... these new sections. On November 23, 2012 (77 FR 70166), FDA issued a Federal Register notice... FR 74852), FDA issued a notice of availability announcing publication of a draft guidance for... Administration Safety and Innovation Act Related to Medical Gases; Request for Comments Regarding...

  2. Implementation of unit-based interventions to improve teamwork and patient safety on a medical service.

    PubMed

    O'Leary, Kevin J; Creden, Amanda J; Slade, Maureen E; Landler, Matthew P; Kulkarni, Nita; Lee, Jungwha; Vozenilek, John A; Pfeifer, Pamela; Eller, Susan; Wayne, Diane B; Williams, Mark V

    2015-01-01

    In a prior study involving 2 medical units, Structured Interdisciplinary Rounds (SIDRs) improved teamwork and reduced adverse events (AEs). SIDR was implemented on 5 additional units, and a pre- versus postintervention comparison was performed. SIDR combined a structured format for communication with daily interprofessional meetings. Teamwork was assessed using the Safety Attitudes Questionnaire (score range = 0-100), and AEs were identified using queries of information systems confirmed by 2 physician researchers. Paired analyses for 82 professionals completing surveys both pre and post implementation revealed improved teamwork (mean 76.8 ± 14.3 vs 80.5 ± 11.6; P = .02), which was driven mainly by nurses (76.4 ± 14.1 vs 80.8 ± 10.4; P = .009). The AE rate was similar across study periods (3.90 vs 4.07 per 100 patient days; adjusted IRR = 1.08; P = .60). SIDR improved teamwork yet did not reduce AEs. Higher baseline teamwork scores and lower AE rates than the prior study may reflect a positive cultural shift that began prior to the current study. PMID:24919598

  3. Improving the Safety of Oral Chemotherapy at an Academic Medical Center

    PubMed Central

    Casella, Erica; Capozzi, Donna; McGettigan, Suzanne; Gangadhar, Tara C.; Schuchter, Lynn; Myers, Jennifer S.

    2016-01-01

    Purpose: Over the last decade, the use of oral chemotherapy (OC) for the treatment of cancer has dramatically increased. Despite their route of administration, OCs pose many of the same risks as intravenous agents. In this quality improvement project, we sought to examine our current process for the prescription of OC at the Abramson Cancer Center of the University of Pennsylvania and to improve on its safety. Methods: A multidisciplinary team that included oncologists, advanced-practice providers, and pharmacists was formed to analyze the current state of our OC practice. Using Lean Six Sigma quality improvement tools, we identified a lack of pharmacist review of the OC prescription as an area for improvement. To address these deficiencies, we used our electronic medical system to route OC orders placed by treating providers to an oncology-specific outpatient pharmacist at the Abramson Cancer Center for review. Results: Over 7 months, 63 orders for OC were placed for 45 individual patients. Of the 63 orders, all were reviewed by pharmacists, and, as a result, 22 interventions were made (35%). Types of interventions included dosage adjustment (one of 22), identification of an interacting drug (nine of 22), and recommendations for additional drug monitoring (12 of 22). Conclusion: OC poses many of the same risks as intravenous chemotherapy and should be prescribed and reviewed with the same oversight. At our institution, involvement of an oncology-trained pharmacist in the review of OC led to meaningful interventions in one third of the orders. PMID:26733627

  4. Evaluation of use of electronic patient controlled analgesia pumps to improve patient safety in an academic medical center.

    PubMed

    Ohashi, Kumiko; Dykes, Patricia; Mcintosh, Kathleen; Buckley, Elizabeth; Yoon, Catherine; Luppi, Carol; Bane, Anne; Bates, David W

    2014-01-01

    Patient controlled analgesia (PCA) and Patient-controlled epidural analgesia (PCEA) pumps are methods of pain control with complex smart infusion devices and are widely used in hospitals. Smart PCA/PCEA pumps can be programmed with the dose and rate of medications within pre-set ranges. However, adverse effects have been reported associated with these pumps' use. In this paper, we describe a prevalence observational study where observers used an electronic data collection tool to record pump settings and medications with PCA pumps, corresponding medication orders to identify errors. The results showed that there were many labeling and tubing change tag errors, which were a violation of hospital policy. A few potential harmful medication errors were identified but no critical errors. Study results suggest the importance of a standard process of PCA pump use. Next steps include implementing a safety bundle for improving PCA practice to support safe and effective pain management. PMID:24943538

  5. Teaching patient safety in the medical undergraduate program at the Universidade Federal de São Paulo

    PubMed Central

    Bohomol, Elena; Cunha, Isabel Cristina Kowal Olm

    2015-01-01

    Objective To analyze the Educational Project of the undergraduate medical course to verify what is taught regarding Patient Safety and to enable reflections on the educational practice. Methods A descriptive study, using document research as strategy. The document of investigation was the Educational Project of the medical course, in 2006, at the Escola Paulista de Medicina of the Universidade Federal de São Paulo. The theoretical framework adopted was the Multi-Professional Patient Safety Curriculum Guide of the World Health Organization, which led to the preparation of a list with 153 tracking terms. Results We identified 65 syllabus units in the Educational Project of the course, in which 40 (61.5%) addressed topics related to Patient Safety. Themes on the topic “Infection prevention and control” were found in 19 (47.5%) units and teaching of “Interaction with patients and caregivers” in 12 (32.5%); however content related to “Learning from errors to prevent harm” were not found. None of the framework topics had their proposed themes entirely taught during the period of education of the future physicians. Conclusion Patient safety is taught in a fragmented manner, which values clinical skills such as the diagnosis and treatment of diseases, post-treatment, surgical procedures, and follow-up. Since it is a recent movement, the teaching of patient safety confronts informative proposals based on traditional structures centered on subjects and on specific education, and it is still poorly valued. PMID:25993062

  6. Constructing a safety and security system by medical applications of a fast face recognition optical parallel correlator

    NASA Astrophysics Data System (ADS)

    Watanabe, Eriko; Ishikawa, Mami; Ohta, Maiko; Murakami, Yasuo; Kodate, Kashiko

    2006-01-01

    Medical errors and patient safety have always received a great deal of attention, as they can be critically life-threatening and significant matters. Hospitals and medical personnel are trying their utmost to avoid these errors. Currently in the medical field, patients' record is identified through their PIN numbers and ID cards. However, for patients who cannot speak or move, or who suffer from memory disturbances, alternative methods would be more desirable, and necessary in some cases. The authors previously proposed and fabricated a specially-designed correlator called FARCO (Fast Face Recognition Optical Correlator) based on the Vanderlugt Correlator1, which operates at the speed of 1000 faces/s 2,3,4. Combined with high-speed display devices, the four-channel processing could achieve such high operational speed as 4000 faces/s. Running trial experiments on a 1-to-N identification basis using the optical parallel correlator, we succeeded in acquiring low error rates of 1 % FMR and 2.3 % FNMR. In this paper, we propose a robust face recognition system using the FARCO for focusing on the safety and security of the medical field. We apply our face recognition system to registration of inpatients, in particular children and infants, before and after medical treatments or operations. The proposed system has recorded a higher recognition rate by multiplexing both input and database facial images from moving images. The system was also tested and evaluated for further practical use, leaving excellent results. Hence, our face recognition system could function effectively as an integral part of medical system, meeting these essential requirements of safety, security and privacy.

  7. [Medical and psychological aspects of safety measures maintenance among nuclear and power station personnel].

    PubMed

    Ipatov, P L; Sorokin, A V; Basov, V I

    2004-01-01

    The article deals with 15-year experience of medical and psychophysiologic service in Medical and Sanitary Establishment No. 156 and Balakovo nuclear power station on providing reliability of occupational activities for the station personnel. PMID:15124389

  8. Tackling Communication Barriers Between Long-Term Care Facility and Emergency Department Transfers to Improve Medication Safety in Older Adults.

    PubMed

    Callinan, Stephanie M; Brandt, Nicole J

    2015-07-01

    In 2013, the American College of Emergency Physicians, American Geriatrics Society, Emergency Nurses Association, and Society for Academic Emergency Medicine created geriatric emergency department guidelines, making recommendations for staffing/administration, follow up and transitions of care, education, quality improvement, equipment/supplies, and other policies, procedures, and protocols to be implemented. Awareness of these guidelines, as well as communication barriers, can help improve the delivery of care for older adults during transitions in care, particularly regarding medication safety. PMID:26126025

  9. Integrating patient safety into health professionals’ curricula: a qualitative study of medical, nursing and pharmacy faculty perspectives

    PubMed Central

    Tregunno, Deborah; Ginsburg, Liane; Clarke, Beth; Norton, Peter

    2014-01-01

    Background As efforts to integrate patient safety into health professional curricula increase, there is growing recognition that the rate of curricular change is very slow, and there is a shortage of research that addresses critical perspectives of faculty who are on the ‘front-lines’ of curricular innovation. This study reports on medical, nursing and pharmacy teaching faculty perspectives about factors that influence curricular integration and the preparation of safe practitioners. Methods Qualitative methods were used to collect data from 20 faculty members (n=6 medical from three universities; n=6 pharmacy from two universities; n=8 nursing from four universities) engaged in medical, nursing and pharmacy education. Thematic analysis generated a comprehensive account of faculty perspectives. Results Faculty perspectives on key challenges to safe practice vary across the three disciplines, and these different perspectives lead to different priorities for curricular innovation. Additionally, accreditation and regulatory requirements are driving curricular change in medicine and pharmacy. Key challenges exist for health professional students in clinical teaching environments where the culture of patient safety may thwart the preparation of safe practitioners. Conclusions Patient safety curricular innovation depends on the interests of individual faculty members and the leveraging of accreditation and regulatory requirements. Building on existing curricular frameworks, opportunities now need to be created for faculty members to act as champions of curricular change, and patient safety educational opportunities need to be harmonises across all health professional training programmes. Faculty champions and practice setting leaders can collaborate to improve the culture of patient safety in clinical teaching and learning settings. PMID:24299734

  10. Encouraging research and development of pediatric medical devices through legislative and regulatory action: the Pediatric Medical Device Safety and Improvement Act of 2007 in context.

    PubMed

    Bleicher, Ester W B

    2009-01-01

    In September 2007, Congress passed the Food and Drug Administration Amendments Act of 2007 (FDAAA). Title III of the FDAAA, the Pediatric Medical Safety and Improvement Act (Title III), created new incentives, mandates, Food and Drug Administration (FDA) authority and funding with the aim of increasing the availability of devices for pediatric populations while assuring the safety and effectiveness of those devices. This article describes the complex problem Title III addresses and situates Title III within the context of the regulatory scheme previously in place, particularly in relation to the one in place to address the parallel problem for pediatric drugs, and the concerns and policy recommendations of diverse stakeholders voiced leading up to Title III. PMID:19999642

  11. Governing patient safety: lessons learned from a mixed methods evaluation of implementing a ward-level medication safety scorecard in two English NHS hospitals

    PubMed Central

    Ramsay, Angus I G; Turner, Simon; Cavell, Gillian; Oborne, C Alice; Thomas, Rebecca E; Cookson, Graham; Fulop, Naomi J

    2014-01-01

    Background Relatively little is known about how scorecards presenting performance indicators influence medication safety. We evaluated the effects of implementing a ward-level medication safety scorecard piloted in two English NHS hospitals and factors influencing these. Methods We used a mixed methods, controlled before and after design. At baseline, wards were audited on medication safety indicators; during the ‘feedback’ phase scorecard results were presented to intervention wards on a weekly basis over 7 weeks. We interviewed 49 staff, including clinicians and managers, about scorecard implementation. Results At baseline, 18.7% of patients (total n=630) had incomplete allergy documentation; 53.4% of patients (n=574) experienced a drug omission in the preceding 24 h; 22.5% of omitted doses were classified as ‘critical’; 22.1% of patients (n=482) either had ID wristbands not reflecting their allergy status or no ID wristband; and 45.3% of patients (n=237) had drugs that were either unlabelled or labelled for another patient in their drug lockers. The quantitative analysis found no significant improvement in intervention wards following scorecard feedback. Interviews suggested staff were interested in scorecard feedback and described process and culture changes. Factors influencing scorecard implementation included ‘normalisation’ of errors, study duration, ward leadership, capacity to engage and learning preferences. Discussion Presenting evidence-based performance indicators may potentially influence staff behaviour. Several practical and cultural factors may limit feedback effectiveness and should be considered when developing improvement interventions. Quality scorecards should be designed with care, attending to evidence of indicators’ effectiveness and how indicators and overall scorecard composition fit the intended audience. PMID:24029440

  12. Physical qualification of drivers; medical examination; certificate. Federal Motor Carrier Safety Administration (FMCSA), DOT. Final rule.

    PubMed

    2000-10-01

    This document updates and simplifies the medical examination form that is currently used to determine the physical qualification of commercial motor vehicle (CMV) drivers operating in interstate commerce. The FMCSA takes this action in response to numerous requests from medical examiners to update and simplify the medical examination form that is currently used. This action is intended to reduce the incidence of errors on such forms and to provide more uniform medical examinations of CMV drivers engaged in interstate commerce. The current Federal physical qualification standards tested by medical examiners and recorded on the form will not be revised in this rulemaking. PMID:11503655

  13. Discovering Innovation at the Intersection of Undergraduate Medical Education, Human Factors, and Collaboration: The Development of a Nasogastric Tube Safety Pack

    PubMed Central

    Bamford, Thomas; Haindl, Cornelia; Cracknell, Alison

    2016-01-01

    Problem Significant deficiencies exist in the knowledge and skills of medical students and residents around health care quality and safety. The theory and practice of quality and safety should be embedded into undergraduate medical practice so that health care professionals are capable of developing interventions and innovations to effectively anticipate and mitigate errors. Approach Since 2011, Leeds Medical School in the United Kingdom has used case study examples of nasogastric (NG) tube patient safety incidents within the undergraduate patient safety curriculum. In 2012, a medical undergraduate student approached a clinician with an innovative idea after undertaking an NG tubes root cause analysis case study. Simultaneously, a separate local project demonstrated low compliance (11.6%) with the United Kingdom’s National Patient Safety Agency NG tubes guideline for use of the correct method to check tube position. These separate endeavors led to interdisciplinary collaboration between a medical student, health care professionals, researchers, and industry to develop the Initial Placement Nasogastric Tube Safety Pack. Outcomes Human factors engineering was used to inform pack design to allow guideline recommendations to be accessible and easy to follow. A timeline of product development, mapped against key human factors and medical device design principles used throughout the process, is presented. The safety pack has since been launched in five UK National Health Service (NHS) hospitals, and the pack has been introduced into health care professional staff training for NG tubes. Next Steps A mixed-methods evaluation is currently under way in five NHS organizations. PMID:26579792

  14. Lab Safety and Bioterrorism Readiness Curricula Using Active Learning and Hands-on Strategies as Continuing Education for Medical Technologists

    PubMed Central

    Fiester, Steven; Redfearn, James; Helfinstine, Shannon; Meilander, Tracey; Woolverton, Christopher J.

    2010-01-01

    Frequent reports of laboratory- (and hospital-) acquired infection suggest a deficiency in safety training or lack of compliance. To assess the need for continuing education (CE) addressing this problem, an original education needs assessment survey was designed and administered to medical technologists (med-techs) in Northeast Ohio. Survey results were used to design a learner-centered training curriculum (for example, Lab Safety and Bioterrorism Readiness trainings) that engaged med-techs in active learning, integrative peer-to-peer teaching, and hands-on exercises in order to improve microbiology safety knowledge and associated laboratory techniques. The Lab Safety training was delivered six times and the Bioterrorism Readiness training was delivered five times. Pre/posttesting revealed significant gains in knowledge and techniques specific to laboratory safety, security, risk assessment, and bioterrorism readiness amongst the majority of med-techs completing the CE trainings. The majority of participants felt that the hands-on exercises met their needs and that their personal laboratory practices would change as a result of the training course, as measured by attitudinal surveys. We conclude that active learning techniques and peer education significantly enhance microbiology learning amongst participating med-techs. PMID:23914281

  15. The safety of 17a-Methyltestosterone medicated feed to tilapia

    Technology Transfer Automated Retrieval System (TEKTRAN)

    17a-Methyltestosterone (17MT) is used in U.S. aquaculture under an Investigational New Animal Drug exemption to produce male populations of tilapia. Efforts to gain FDA-approval include this Target Animal Safety study. A study was designed to determine its histological safety to tilapia when fed a...

  16. 78 FR 52233 - Motor Carrier Safety Advisory Committee (MCSAC) and Medical Review Board (MRB): Public Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-22

    ....'' The MRB operates in accordance with FACA, as announced in the Federal Register (70 FR 57642, October 3... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration Motor Carrier Safety Advisory Committee (MCSAC) and...

  17. 10 CFR 35.57 - Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... of radium-226, or both, for medical uses or in the practice of nuclear pharmacy at a Government... radioactive materials, discrete sources of radium-226, or both, for medical uses performed at a Government..., or podiatrist, who used only accelerator-produced radioactive materials, discrete sources of...

  18. Undergoing Transformation to the Patient Centered Medical Home in Safety Net Health Centers: Perspectives from the Front Lines

    PubMed Central

    Quinn, Michael T.; Gunter, Kathryn E.; Nocon, Robert S.; Lewis, Sarah E.; Vable, Anusha M.; Tang, Hui; Park, Seo-Young; Casalino, Lawrence P.; Huang, Elbert S.; Birnberg, Jonathan; Burnet, Deborah L.; Summerfelt, W. Thomas; Chin, Marshall H.

    2013-01-01

    Objectives Safety Net Health Centers (SNHCs), which include Federally Qualified Health Centers (FQHCs) provide primary care for underserved, minority and low income patients. SNHCs across the country are in the process of adopting the Patient Centered Medical Home (PCMH) model, based on promising early implementation data from demonstration projects. However, previous demonstration projects have not focused on the safety net and we know little about PCMH transformation in SNHCs. Design This qualitative study characterizes early PCMH adoption experiences at SNHCs. Setting and Participants We interviewed 98 staff,(administrators, providers, and clinical staff) at 20 of 65 SNHCs, from five states, who were participating in the first of a five-year PCMH collaborative, the Safety Net Medical Home Initiative. Main Measures We conducted 30-45 minute, semi-structured telephone interviews. Interview questions addressed benefits anticipated, obstacles encountered, and lessons learned in transition to PCMH. Results Anticipated benefits for participating in the PCMH included improved staff satisfaction and patient care and outcomes. Obstacles included staff resistance and lack of financial support for PCMH functions. Lessons learned included involving a range of staff, anticipating resistance, and using data as frequent feedback. Conclusions SNHCs encounter unique challenges to PCMH implementation, including staff turnover and providing care for patients with complex needs. Staff resistance and turnover may be ameliorated through improved healthcare delivery strategies associated with the PCMH. Creating predictable and continuous funding streams may be more fundamental challenges to PCMH transformation. PMID:23914423

  19. Cognitive performance-altering effects of electronic medical records: An application of the human factors paradigm for patient safety

    PubMed Central

    Holden, Richard J.

    2010-01-01

    According to the human factors paradigm for patient safety, health care work systems and innovations such as electronic medical records do not have direct effects on patient safety. Instead, their effects are contingent on how the clinical work system, whether computerized or not, shapes health care providers' performance of cognitive work processes. An application of the human factors paradigm to interview data from two hospitals in the Midwest United States yielded numerous examples of the performance-altering effects of electronic medical records, electronic clinical documentation, and computerized provider order entry. Findings describe both improvements and decrements in the ease and quality of cognitive performance, both for interviewed clinicians and for their colleagues and patients. Changes in cognitive performance appear to have desirable and undesirable implications for patient safety as well as for quality of care and other important outcomes. Cognitive performance can also be traced to interactions between work system elements, including new technology, allowing for the discovery of problems with “fit” to be addressed through design interventions. PMID:21479125

  20. Toward a treaty on safety and cost-effectiveness of pharmaceuticals and medical devices: enhancing an endangered global public good

    PubMed Central

    Faunce, Thomas Alured

    2006-01-01

    • Expert evaluations of the safety, efficacy and cost-effectiveness of pharmaceutical and medical devices, prior to marketing approval or reimbursement listing, collectively represent a globally important public good. The scientific processes involved play a major role in protecting the public from product risks such as unintended or adverse events, sub-standard production and unnecessary burdens on individual and governmental healthcare budgets. • Most States now have an increasing policy interest in this area, though institutional arrangements, particularly in the area of cost-effectiveness analysis of medical devices, are not uniformly advanced and are fragile in the face of opposing multinational industry pressure to recoup investment and maintain profit margins. • This paper examines the possibility, in this context, of States commencing negotiations toward bilateral trade agreement provisions, and ultimately perhaps a multilateral Treaty, on safety, efficacy and cost-effectiveness analysis of pharmaceuticals and medical devices. Such obligations may robustly facilitate a conceptually interlinked, but endangered, global public good, without compromising the capacity of intellectual property laws to facilitate local product innovations. PMID:16569240

  1. Ethical and legal implications of the risks of medical tourism for patients: a qualitative study of Canadian health and safety representatives’ perspectives

    PubMed Central

    Crooks, Valorie A; Turner, Leigh; Cohen, I Glenn; Bristeir, Janet; Snyder, Jeremy; Casey, Victoria; Whitmore, Rebecca

    2013-01-01

    Objectives Medical tourism involves patients’ intentional travel to privately obtain medical care in another country. Empirical evidence regarding health and safety risks facing medical tourists is limited. Consideration of this issue is dominated by speculation and lacks meaningful input from people with specific expertise in patient health and safety. We consulted with patient health and safety experts in the Canadian province of British Columbia to explore their views concerning risks that medical tourists may be exposed to. Herein, we report on the findings, linking them to existing ethical and legal issues associated with medical tourism. Design We held a focus group in September 2011 in Vancouver, British Columbia with professionals representing different domains of patient health and safety expertise. The focus group was transcribed verbatim and analysed thematically. Participants Seven professionals representing the domains of tissue banking, blood safety, health records, organ transplantation, dental care, clinical ethics and infection control participated. Results Five dominant health and safety risks for outbound medical tourists were identified by participants: (1) complications; (2) specific concerns regarding organ transplantation; (3) transmission of antibiotic-resistant organisms; (4) (dis)continuity of medical documentation and (5) (un)informed decision-making. Conclusions Concern was expressed that medical tourism might have unintended and undesired effects upon patients’ home healthcare systems. The individual choices of medical tourists could have significant public consequences if healthcare facilities in their home countries must expend resources treating postoperative complications. Participants also expressed concern that medical tourists returning home with infections, particularly antibiotic-resistant infections, could place others at risk of exposure to infections that are refractory to standard treatment regimens and thereby pose

  2. Oxytocin as a high-alert medication: implications for perinatal patient safety.

    PubMed

    Simpson, Kathleen Rice; Knox, G Eric

    2009-01-01

    Patient injury from drug therapy is the single most common type of adverse event that occurs in the in-patient setting. When medication errors result in patient injury, there are significant costs to the patient, healthcare providers, and institution. Some medications that have a heightened risk of causing significant patient harm when they are used in error are called "high-alert medications."In 2007, the Institute for Safe Medication Practices added intravenous (IV) oxytocin to their list of high-alert medications. This is significant for perinatal care providers because oxytocin is a drug that they use quite freguently. Errors that involve IV oxytocin administration for labor induction or augmentation are most commonly dose related and often involve lack of timely recognition and appropriate treatment of excessive uterine activity (tachysystole). Other types of oxytocin errors involve mistaken administration of IV fluids with oxytocin for IV fluid resuscitation during nonreassuring (abnormal or indeterminate) fetal heart rate patterns and/or maternal hypotension and inappropriate elective administration of oxytocin to women who are less than 39 completed weeks' gestation. Oxytocin medication errors and subsequent patient harm are generally preventable. The perinatal team can develop strategies to minimize risk of maternal-fetal injuries related to oxytocin administration consistent with safe care practices used with other high-alert medications. PMID:19104313

  3. Potential medications for the treatment of alcohol use disorder: An evaluation of clinical efficacy and safety.

    PubMed

    Litten, Raye Z; Wilford, Bonnie B; Falk, Daniel E; Ryan, Megan L; Fertig, Joanne B

    2016-01-01

    Alcohol use disorder (AUD), as currently defined in the Diagnostic and Statistical Manual, 5th Edition (DSM-5), is a heterogeneous disorder stemming from a complex interaction of neurobiological, genetic, and environmental factors. As a result of this heterogeneity, there is no one treatment for AUD that will work for everyone. During the past 2 decades, efforts have been made to develop a menu of medications to give patients and clinicians more choices when seeking a therapy that is both effective and which has limited side effects. To date, 3 medications have been approved by the US Food and Drug Administration (FDA) to treat alcohol dependence: disulfiram, naltrexone, and acamprosate. In addition to these approved medications, researchers have identified new therapeutic targets and, as a result, a number of alternative medications are now being evaluated for treatment of AUD in human studies. Although not approved by the FDA for the treatment of AUD, in some cases, these alternative medications are being used off-label by clinicians for this purpose. These potential medications are reviewed here. They include nalmefene, varenicline, gabapentin, topiramate, zonisamide, baclofen, ondansetron, levetiracetam, quetiapine, aripiprazole, and serotonin reuptake inhibitors. The effectiveness of these medications has been mixed-some show good efficacy with side effects that are mild to moderate in intensity; others have mixed or promising results but are awaiting findings from ongoing studies; and still others show poor efficacy, despite promising preliminary results. Medications development remains a high priority. Key initiatives for the National Institute on Alcohol Abuse and Alcoholism (NIAAA) include supporting the discovery and development of more effective and safer medications, advancing the field of personalized medicine, and forging public and private partnerships to investigate new and more effective compounds. PMID:26928397

  4. A web-based medical safety reporting system for a large multicenter clinical trial - The ALIAS experience

    PubMed Central

    Zhao, Wenle; Waldman, Bonnie D.; Dillon, Catherine; Pauls, Keith; Kim, Jaemyung; Patterson, Lynn; Ginsberg, Myron D.; Hill, Michael D.; Palesch, Yuko

    2010-01-01

    An Electronic Safety Reporting (ESR) module was developed and integrated into a home-grown web-based Clinical Trial Management System (CTMS) to enhance the efficiency, completeness and consistency of reporting and reviewing serious adverse events, monitoring safety, and submitting safety reports to regulatory authorities for a large multicenter clinical trial. The architecture of this integrated module provided many advantages. First, the ESR module was developed based on a comprehensive procedure which incorporated both computer logic processing steps and human intervention steps in order to deal with the complex and unexpected situations where pre-programmed computer logic may fail. Secondly, safety and efficacy data were managed within the same relational database. Relevant data captured on efficacy case report forms, such as demographics, medical history, lab data and concomitant medications, were directly retrievable for MedWatch report composition without requiring redundant data entry. Finally, the ESR module shared the same generic user interfaces and data processing functions with other modules in the CTMS. These generic components include data editing, data retrieving, data reporting, dictionary-based automatic and interactive coding, event driven and calendar driven automatic email notifications, and user privilege management. This integrated ESR module was implemented in the Albumin in Acute Stroke (ALIAS) Trial - Part 1. A total of 397 serious adverse event reports were processed and 33 FDA MedWatch reports, 28 initial reports, and 5 follow-up reports were submitted to FDA and Health Canada using this system. Experiences and lessons learned from the development and implementation of this system are presented in this paper. PMID:20828636

  5. Advanced biosensing methodologies developed for evaluating performance quality and safety of emerging biophotonics technologies and medical devices (Conference Presentation)

    NASA Astrophysics Data System (ADS)

    Ilev, Ilko K.; Walker, Bennett; Calhoun, William; Hassan, Moinuddin

    2016-03-01

    Biophotonics is an emerging field in modern biomedical technology that has opened up new horizons for transfer of state-of-the-art techniques from the areas of lasers, fiber optics and biomedical optics to the life sciences and medicine. This field continues to vastly expand with advanced developments across the entire spectrum of biomedical applications ranging from fundamental "bench" laboratory studies to clinical patient "bedside" diagnostics and therapeutics. However, in order to translate these technologies to clinical device applications, the scientific and industrial community, and FDA are facing the requirement for a thorough evaluation and review of laser radiation safety and efficacy concerns. In many cases, however, the review process is complicated due the lack of effective means and standard test methods to precisely analyze safety and effectiveness of some of the newly developed biophotonics techniques and devices. There is, therefore, an immediate public health need for new test protocols, guidance documents and standard test methods to precisely evaluate fundamental characteristics, performance quality and safety of these technologies and devices. Here, we will overview our recent developments of novel test methodologies for safety and efficacy evaluation of some emerging biophotonics technologies and medical devices. These methodologies are based on integrating the advanced features of state-of-the-art optical sensor technologies and approaches such as high-resolution fiber-optic sensing, confocal and optical coherence tomography imaging, and infrared spectroscopy. The presentation will also illustrate some methodologies developed and implemented for testing intraocular lens implants, biochemical contaminations of medical devices, ultrahigh-resolution nanoscopy, and femtosecond laser therapeutics.

  6. A web-based medical safety reporting system for a large multicenter clinical trial: the ALIAS experience.

    PubMed

    Zhao, Wenle; Waldman, Bonnie D; Dillon, Catherine; Pauls, Keith; Kim, Jaemyung; Patterson, Lynn; Ginsberg, Myron D; Hill, Michael D; Palesch, Yuko

    2010-11-01

    An electronic safety reporting (ESR) module was developed and integrated into a home-grown web-based clinical trial management system (CTMS) to enhance the efficiency, completeness and consistency of reporting and reviewing serious adverse events, monitoring safety, and submitting safety reports to regulatory authorities for a large multicenter clinical trial. The architecture of this integrated module provided many advantages. First, the ESR module was developed based on a comprehensive procedure which incorporated both computer logic processing steps and human intervention steps in order to deal with the complex and unexpected situations where pre-programmed computer logic may fail. Second, safety and efficacy data were managed within the same relational database. Relevant data captured on efficacy case report forms, such as demographics, medical history, lab data and concomitant medications, were directly retrievable for MedWatch report composition without requiring redundant data entry. Finally, the ESR module shared the same generic user interfaces and data processing functions with other modules in the CTMS. These generic components include data editing, data retrieving, data reporting, dictionary-based automatic and interactive coding, event-driven and calendar-driven automatic email notifications, and user privilege management. This integrated ESR module was implemented in the Albumin in Acute Stroke (ALIAS) Trial-Part 1. A total of 397 serious adverse event reports were processed and 33 FDA MedWatch reports, 28 initial reports, and 5 follow-up reports were submitted to FDA and Health Canada using this system. Experiences and lessons learned from the development and implementation of this system are presented in this paper. PMID:20828636

  7. Impact on Drug Safety of Variation in Adherence: The Need for Routinely Reporting Measures of Dose Intensity in Medication Safety Studies Using Electronic Health Data.

    PubMed

    Roughead, Elizabeth E; Pratt, Nicole L

    2015-12-01

    Randomized controlled trials always report the dose assessed and usually include a measure of adherence. By comparison, observational studies assessing medication safety often fail to report the dose used and rarely report any measure of adherence to therapy. This limits the ability to control for differences in doses used when undertaking meta-analyses. Non-adherence with therapy is common in the practice setting and varies across countries and settings. Inter-country differences in the registration of medicines may also result in different product strengths being available in different countries. These two factors combined means that observational studies undertaken for the same medicine in different settings may be assessing the same medicine but in circumstances where quite different dosages are used. Given that many adverse drug effects are dose dependent, differences in dosages used could be a factor explaining differences in risk estimates observed across studies. We argue that dose intensity, which can be defined as a product of the dose prescribed and adherence to the dose prescribed over the course of treatment, should be routinely reported in observational studies of medication safety. We illustrate the issue with the example of dabigatran. The randomized controlled trial evidence underpinning dabigatran's marketing authorization resulted in uncertainty about the appropriate dose for efficacy versus safety. As a result, different dosages of dabigatran were registered in the USA and Europe. The USA registered the 150- and 75-mg dabigatran products, while the 150- and 110-mg dabigatran products were registered in Europe. Among five observational studies subsequently undertaken to resolve the safety question concerning dabigatran and risk of bleeding, only one stratified results by dose. None of the US studies stratified results by the 75-mg dabigatran dose, despite this dose not being assessed in the original trial. None of the five studies reported

  8. Safety.

    ERIC Educational Resources Information Center

    Education in Science, 1996

    1996-01-01

    Discusses safety issues in science, including: allergic reactions to peanuts used in experiments; explosions in lead/acid batteries; and inspection of pressure vessels, such as pressure cookers or model steam engines. (MKR)

  9. Balancing the interests of patient data protection and medication safety monitoring in a public-private partnership.

    PubMed

    Dreyer, Nancy A; Blackburn, Stella; Hliva, Valerie; Mt-Isa, Shahrul; Richardson, Jonathan; Jamry-Dziurla, Anna; Bourke, Alison; Johnson, Rebecca

    2015-01-01

    Obtaining data without the intervention of a health care provider represents an opportunity to expand understanding of the safety of medications used in difficult-to-study situations, like the first trimester of pregnancy when women may not present for medical care. While it is widely agreed that personal data, and in particular medical data, needs to be protected from unauthorized use, data protection requirements for population-based studies vary substantially by country. For public-private partnerships, the complexities are enhanced. The objective of this viewpoint paper is to illustrate the challenges related to data protection based on our experiences when performing relatively straightforward direct-to-patient noninterventional research via the Internet or telephone in four European countries. Pregnant women were invited to participate via the Internet or using an automated telephone response system in Denmark, the Netherlands, Poland, and the United Kingdom. Information was sought on medications, other factors that may cause birth defects, and pregnancy outcome. Issues relating to legal controllership of data were most problematic; assuring compliance with data protection requirements took about two years. There were also inconsistencies in the willingness to accept nonwritten informed consent. Nonetheless, enrollment and data collection have been completed, and analysis is in progress. Using direct reporting from consumers to study the safety of medicinal products allows researchers to address a myriad of research questions relating to everyday clinical practice, including treatment heterogeneity in population subgroups not traditionally included in clinical trials, like pregnant women, children, and the elderly. Nonetheless, there are a variety of administrative barriers relating to data protection and informed consent, particularly within the structure of a public-private partnership. PMID:25881627

  10. Comparative evaluation of different medication safety measures for the emergency department: physicians’ usage and acceptance of training, poster, checklist and computerized decision support

    PubMed Central

    2013-01-01

    Background Although usage and acceptance are important factors for a successful implementation of clinical decision support systems for medication, most studies only concentrate on their design and outcome. Our objective was to comparatively investigate a set of traditional medication safety measures such as medication safety training for physicians, paper-based posters and checklists concerning potential medication problems versus the additional benefit of a computer-assisted medication check. We concentrated on usage, acceptance and suitability of such interventions in a busy emergency department (ED) of a 749 bed acute tertiary care hospital. Methods A retrospective, qualitative evaluation study was conducted using a field observation and a questionnaire-based survey. Six physicians were observed while treating 20 patient cases; the questionnaire, based on the Technology Acceptance Model 2 (TAM2), has been answered by nine ED physicians. Results During field observations, we did not observe direct use of any of the implemented interventions for medication safety (paper-based and electronic). Questionnaire results indicated that the electronic medication safety check was the most frequently used intervention, followed by checklist and posters. However, despite their positive attitude, physicians most often stated that they use the interventions in only up to ten percent for subjectively “critical” orders. Main reasons behind the low usage were deficits in ease-of-use and fit to the workflow. The intention to use the interventions was rather high after overcoming these barriers. Conclusions Methodologically, the study contributes to Technology Acceptance Model (TAM) research in an ED setting and confirms TAM2 as a helpful diagnostic tool in identifying barriers for a successful implementation of medication safety interventions. In our case, identified barriers explaining the low utilization of the implemented medication safety interventions - despite their

  11. Measuring the impact of an interprofessional multimedia learning resource on Japanese nurses and nursing students using the Theory of Planned Behavior Medication Safety Questionnaire.

    PubMed

    Omura, Mieko; Levett-Jones, Tracy; Stone, Teresa Elizabeth; Maguire, Jane; Lapkin, Samuel

    2015-12-01

    Interprofessional communication and teamwork are essential for medication safety; however, limited educational opportunities for health professionals and students to develop these skills exist in Japan. This study evaluated the impact of an interprofessional multimedia learning resource on registered nurses' and nursing students' intention to practice in a manner promoting medication safety. Using a quasi-experimental design, Japanese registered nurses and nursing students (n = 203) were allocated to an experimental (n = 109) or control group (n = 94). Behavioral intentions of medication safety and the predictor variables of attitudes, perceived behavioral control, and subjective norms were measured using a Japanese version of the Theory of Planned Behavior Medication Safety Questionnaire. Registered nurses in the experimental group demonstrated a greater intention to collaborate and practice in a manner that enhanced medication safety, evidenced by higher scores than the control group on all predictor variables. The results demonstrate the potential for interprofessional multimedia learning resources to positively impact the behaviors of Japanese registered nurses in relation to safe medication practices. Further research in other contexts and with other cohorts is warranted. PMID:26138636

  12. Medication safety issue brief. Series II, Part 6: Tapping into your staff's energy.

    PubMed

    2003-11-01

    The front-line workers in a hospital are its greatest resources, particularly when it comes to improving safety. After all, they know the crucial details about day-to-day operations and can offer innovative solutions to problems. But staff members don't always feel comfortable getting involved in change. To tap this hidden well of talent, hospitals leaders should train staff in systems thinking, cultivate a culture of safety and make it easy for employees to contribute their ideas. PMID:14689965

  13. Specific safety and tolerability considerations in the use of anticonvulsant medications in children

    PubMed Central

    Crepeau, Amy Z; Moseley, Brian D; Wirrell, Elaine C

    2012-01-01

    Epilepsy is one of the most common neurological disorders in the pediatric age range, and the majority of affected children can be safely and effectively treated with antiepileptic medication. While there are many antiepileptic agents on the market, specific drugs may be more efficacious for certain seizure types or electroclinical syndromes. Furthermore, certain adverse effects are more common with specific classes of medication. Additionally patient-specific factors, such as age, race, other medical conditions, or concurrent medication use may result in higher rates of side effects or altered efficacy. Significant developmental changes in gastric absorption, protein binding, hepatic metabolism, and renal clearance are seen over the pediatric age range, which impact pharmacokinetics. Such changes must be considered to determine optimal dosing and dosing intervals for children at specific ages. Furthermore, approximately one third of children require polytherapy for seizure control, and many more take concurrent medications for other conditions. In such children, drug–drug interactions must be considered to minimize adverse effects and improve efficacy. This review will address issues of antiepileptic drug efficacy, tolerability and ease of use, pharmacokinetics, and drug–drug interactions in the pediatric age range. PMID:22792008

  14. The Efficacy and Safety of Antipsychotic Medications in the Treatment of Psychosis in Patients with Parkinson's Disease

    PubMed Central

    Stojanović, Radan; Damjanović, Aleksandar; Prostran, Milica

    2016-01-01

    Psychotic symptoms are present in up to 50% of patients with Parkinson's disease. These symptoms have detrimental effects on patients' and caregivers' quality of life and may predict mortality. The pathogenesis of psychotic symptoms in Parkinson's disease is complex, but the use of dopaminergic medications is one of the risk factors. The treatment of psychotic symptoms in Parkinson's disease is complicated due to the ability of antipsychotic medications to worsen motor symptoms. The efficacy of clozapine in the treatment of psychosis in patients with Parkinson's disease has been confirmed in several clinical trials; however, the adverse effects and the necessity of blood count monitoring are the reasons why the use of this drug is challenging. The studies on safety and efficacy of other antipsychotics conflicting results. The use of antipsychotics in these patients is also associated with increased mortality. Psychotic symptoms in Parkinson's disease per se are also proven predictors of mortality. Thus it is necessary to treat psychotic symptoms but the choice of an antipsychotic should be based on careful risk/benefit assessment. Pimavanserin as a novel therapeutic option with more favorable adverse effects profile is now available for this indication, but careful postmarketing monitoring is necessary to establish the true picture of this drug's long-term safety and efficacy. PMID:27504054

  15. The safety of Aquaflor® medicated feed to sunshine bass

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Aquaflor(C) (florfenicol) is a relatively new antibiotic used in U.S. aquaculture and has reached wide acceptance as a safe and effective therapeutant for its approved indications. A study was designed to determine its histological safety to sunshine bass when fed at the therapeutic rate of 15 mg f...

  16. A new method for the assessment of patient safety competencies during a medical school clerkship using an objective structured clinical examination

    PubMed Central

    Daud-Gallotti, Renata Mahfuz; Morinaga, Christian Valle; Arlindo-Rodrigues, Marcelo; Velasco, Irineu Tadeu; Arruda Martins, Milton; Tiberio, Iolanda Calvo

    2011-01-01

    INTRODUCTION: Patient safety is seldom assessed using objective evaluations during undergraduate medical education. OBJECTIVE: To evaluate the performance of fifth-year medical students using an objective structured clinical examination focused on patient safety after implementation of an interactive program based on adverse events recognition and disclosure. METHODS: In 2007, a patient safety program was implemented in the internal medicine clerkship of our hospital. The program focused on human error theory, epidemiology of incidents, adverse events, and disclosure. Upon completion of the program, students completed an objective structured clinical examination with five stations and standardized patients. One station focused on patient safety issues, including medical error recognition/disclosure, the patient-physician relationship and humanism issues. A standardized checklist was completed by each standardized patient to assess the performance of each student. The student's global performance at each station and performance in the domains of medical error, the patient-physician relationship and humanism were determined. The correlations between the student performances in these three domains were calculated. RESULTS: A total of 95 students participated in the objective structured clinical examination. The mean global score at the patient safety station was 87.59±1.24 points. Students' performance in the medical error domain was significantly lower than their performance on patient-physician relationship and humanistic issues. Less than 60% of students (n = 54) offered the simulated patient an apology after a medical error occurred. A significant correlation was found between scores obtained in the medical error domains and scores related to both the patient-physician relationship and humanistic domains. CONCLUSIONS: An objective structured clinical examination is a useful tool to evaluate patient safety competencies during the medical student clerkship

  17. Ensuring the Health, Safety and Preparedness of U.S. Medical Students Participating in Global Health Electives Overseas.

    PubMed

    Imperato, Pascal James; Bruno, Denise M; Monica Sweeney, M

    2016-04-01

    Global health electives based in resource-poor countries have become extremely popular with medical students from resource rich ones. As the number of such programs and participants increase, so too do the absolute health and safety risks. It is clear from a number of published reports that many institutions provide little or no meaningful preparedness for students and do little to ensure their health and safety. These deficiencies together can affect students, their foreign hosts, and sponsoring institutions. The School of Public Health at the State University of New York, Downstate Medical Center, and its predecessor, the Department of Preventive Medicine and Community Health, have sponsored a 6-8 week global health elective for fourth year medical students since 1980. The purposes of this elective are to provide students with an opportunity to observe the health care and public health systems in resource-poor countries, provide medical service, and have a cross-cultural experience. Over the course of the past 35 years, 386 students have participated in this global health elective in more than 41 resource-poor countries. Recent annual applications for this elective have been as high as 44 out of a class of 200 students. Over the past 10 years, annual acceptance rates have varied, ranging from a low of 32 % in 2007-2008 to a high of 74 % in 2010-2011 and 2013-2014. Careful screening, including a written application, review of academic records and personal interviews, has resulted in the selection of highly mature, adaptable, and dedicated students who have performed well at overseas sites. Appropriately preparing students for an overseas global health experience in resource-poor countries requires the investment of much professional and staff time and effort. At the SUNY Downstate School of Public Health, these resources have underpinned our Global Health in Developing Countries elective for many years. As a result, the elective is characterized by meticulous

  18. 10 CFR 35.57 - Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... nuclear pharmacist, who used only accelerator-produced radioactive materials, discrete sources of radium... radioactive materials, discrete sources of radium-226, or both, for medical uses performed at a Government..., or podiatrist, who used only accelerator-produced radioactive materials, discrete sources of...

  19. 77 FR 3546 - Motor Carrier Safety Advisory Committee (MCSAC): Public Meeting Medical Review Board: Joint...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-24

    ... Administrator on obstructive sleep apnea. The MCSAC will meet separately on Tuesday- Thursday, February 7-8... medical standards. The MRB operates in accordance with FACA. Sleep Apnea and Other Sleep Disorders The MCSAC and the MRB joint subcommittee on obstructive sleep apnea will report to the full MCSAC and...

  20. 10 CFR 35.57 - Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... chapter. (b)(1) Physicians, dentists, or podiatrists identified as authorized users for the medical use of... training requirements of Subparts D through H of this part. (2) Physicians, dentists, or podiatrists... H of this part. (3) Physicians, dentists, or podiatrists who used only...

  1. 10 CFR 35.57 - Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... chapter. (b)(1) Physicians, dentists, or podiatrists identified as authorized users for the medical use of... training requirements of Subparts D through H of this part. (2) Physicians, dentists, or podiatrists... H of this part. (3) Physicians, dentists, or podiatrists who used only...

  2. Systematic review: Efficacy and safety of medical marijuana in selected neurologic disorders

    PubMed Central

    Koppel, Barbara S.; Brust, John C.M.; Fife, Terry; Bronstein, Jeff; Youssof, Sarah; Gronseth, Gary; Gloss, David

    2014-01-01

    Objective: To determine the efficacy of medical marijuana in several neurologic conditions. Methods: We performed a systematic review of medical marijuana (1948–November 2013) to address treatment of symptoms of multiple sclerosis (MS), epilepsy, and movement disorders. We graded the studies according to the American Academy of Neurology classification scheme for therapeutic articles. Results: Thirty-four studies met inclusion criteria; 8 were rated as Class I. Conclusions: The following were studied in patients with MS: (1) Spasticity: oral cannabis extract (OCE) is effective, and nabiximols and tetrahydrocannabinol (THC) are probably effective, for reducing patient-centered measures; it is possible both OCE and THC are effective for reducing both patient-centered and objective measures at 1 year. (2) Central pain or painful spasms (including spasticity-related pain, excluding neuropathic pain): OCE is effective; THC and nabiximols are probably effective. (3) Urinary dysfunction: nabiximols is probably effective for reducing bladder voids/day; THC and OCE are probably ineffective for reducing bladder complaints. (4) Tremor: THC and OCE are probably ineffective; nabiximols is possibly ineffective. (5) Other neurologic conditions: OCE is probably ineffective for treating levodopa-induced dyskinesias in patients with Parkinson disease. Oral cannabinoids are of unknown efficacy in non–chorea-related symptoms of Huntington disease, Tourette syndrome, cervical dystonia, and epilepsy. The risks and benefits of medical marijuana should be weighed carefully. Risk of serious adverse psychopathologic effects was nearly 1%. Comparative effectiveness of medical marijuana vs other therapies is unknown for these indications. PMID:24778283

  3. Quality and Safety in Health Care, Part X: Other Technology to Reduce Medication Errors.

    PubMed

    Harolds, Jay A; Harolds, Laura B

    2016-05-01

    There are many devices, as well as computer programs, that have the potential to reduce medication errors. In the prior article, computer provider order entry linked to electronic clinical decision support was discussed. The current article discusses bar coding, automated dispensing cabinets, and smart intravenous infusion pumps. PMID:26914567

  4. Incentivizing Primary Care Providers to Innovate: Building Medical Homes in the Post-Katrina New Orleans Safety Net

    PubMed Central

    Rittenhouse, Diane R; Schmidt, Laura A; Wu, Kevin J; Wiley, James

    2014-01-01

    ObjectiveTo evaluate safety-net clinics’ responses to a novel community-wide Patient-Centered Medical Home (PCMH) financial incentive program in post-Katrina New Orleans. Data Sources/Study SettingBetween June 2008 and June 2010, we studied 50 primary care clinics in New Orleans receiving federal funds to expand services and improve care delivery. Study DesignMultiwave, longitudinal, observational study of a local safety-net primary care system. Data CollectionClinic-level data from a semiannual survey of clinic leaders (89.3 percent response rate), augmented by administrative records. Principal FindingsOverall, 62 percent of the clinics responded to financial incentives by achieving PCMH recognition from the National Committee on Quality Assurance (NCQA). Higher patient volume, higher baseline PCMH scores, and type of ownership were significant predictors of achieving NCQA recognition. The steepest increase in adoption of PCMH processes occurred among clinics achieving the highest, Level 3, NCQA recognition. Following NCQA recognition, 88.9 percent stabilized or increased their use of PCMH processes, although several specific PCMH processes had very low rates of adoption overall. ConclusionsFindings demonstrate that widespread PCMH implementation is possible in a safety-net environment when external financial incentives are aligned with the goal of practice innovation. PMID:23800148

  5. Review of radio wave for power transmission in medical applications with safety

    NASA Astrophysics Data System (ADS)

    Day, John; Geddis, Demetris; Kim, Jaehwan; Choi, Sang H.; Yoon, Hargsoon; Song, Kyo D.

    2015-04-01

    The integration of biosensors with radio frequency (RF) wireless power transmission devices is becoming popular, but there are challenges for implantable devices in medical applications. Integration and at the same time miniaturization of medical devices in a single embodiment are not trivial. The research reported herein, seeks to review possible effects of RF signals ranging from 900 MHz to 100 GHz on the human tissues and environment. Preliminary evaluation shows that radio waves selected for test have substantial influence on human tissues based on their dielectric properties. In the advancement of RF based biosensors, it is imperative to set up necessary guidelines that specify how to use RF power safely. In this paper, the dielectric properties of various human tissues will be used for estimation of influence within the selected RF frequency ranges.

  6. Selected Medication Safety Risks to Manage in 2016-Part I Intravenous Fat Emulsion Needs a Filter.

    PubMed

    Cohen, Michael R; Smetzer, Judy L

    2016-05-01

    These medication errors have occurred in health care facilities at least once. They will happen again-perhaps where you work. Through education and alertness of personnel and procedural safeguards, they can be avoided. You should consider publishing accounts of errors in your newsletters and/or presenting them at your inservice training programs. Your assistance is required to continue this feature. The reports described here were received through the Institute for Safe Medication Practices (ISMP) Medication Errors Reporting Program. Any reports published by ISMP will be anonymous. Comments are also invited; the writers' names will be published if desired. ISMP may be contacted at the address shown below. Errors, close calls, or hazardous conditions may be reported directly to ISMP through the ISMP Web site (www.ismp.org), by calling 800-FAIL-SAFE, or via e-mail at ismpinfo@ismp.org. ISMP guarantees the confidentiality and security of the information received and respects reporters' wishes as to the level of detail included in publications. PMID:27303086

  7. Selected Medication Safety Risks to Manage in 2016-Part II; Methylergonovine Errors in Obstetrics.

    PubMed

    Cohen, Michael R; Smetzer, Judy L

    2016-06-01

    These medication errors have occurred in health care facilities at least once. They will happen again-perhaps where you work. Through education and alertness of personnel and procedural safeguards, they can be avoided. You should consider publishing accounts of errors in your newsletters and/or presenting them at your inservice training programs. Your assistance is required to continue this feature. The reports described here were received through the Institute for Safe Medication Practices (ISMP) Medication Errors Reporting Program. Any reports published by ISMP will be anonymous. Comments are also invited; the writers' names will be published if desired. ISMP may be contacted at the address shown below. Errors, close calls, or hazardous conditions may be reported directly to ISMP through the ISMP Web site (www.ismp.org), by calling 800-FAIL-SAFE, or via e-mail at ismpinfo@ismp.org. ISMP guarantees the confidentiality and security of the information received and respects reporters' wishes as to the level of detail included in publications. PMID:27354742

  8. Improving Patient Safety by Identifying Side Effects from Introducing Bar Coding in Medication Administration

    PubMed Central

    Patterson, Emily S.; Cook, Richard I.; Render, Marta L.

    2002-01-01

    Objective. In addition to providing new capabilities, the introduction of technology in complex, sociotechnical systems, such as health care and aviation, can have unanticipated side effects on technical, social, and organizational dimensions. To identify potential accidents in the making, the authors looked for side effects from a natural experiment, the implementation of bar code medication administration (BCMA), a technology designed to reduce adverse drug events (ADEs). Design. Cross-sectional observational study of medication passes before (21 hours of observation of 7 nurses at 1 hospital) and after (60 hours of observation of 26 nurses at 3 hospitals) BCMA implementation. Measurements. Detailed, handwritten field notes of targeted ethnographic observations of in situ nurse–BCMA interactions were iteratively analyzed using process tracing and five conceptual frameworks. Results. Ethnographic observations distilled into 67 nurse–BCMA interactions were classified into 12 categories. We identified five negative side effects after BCMA implementation: (1) nurses confused by automated removal of medications by BCMA, (2) degraded coordination between nurses and physicians, (3) nurses dropping activities to reduce workload during busy periods, (4) increased prioritization of monitored activities during goal conflicts, and (5) decreased ability to deviate from routine sequences. Conclusion. These side effects might create new paths to ADEs. We recommend design revisions, modification of organizational policies, and “best practices” training that could potentially minimize or eliminate these side effects before they contribute to adverse outcomes. PMID:12223506

  9. OZIS and the politics of safety: using ICT to create a regionally accessible patient medication record.

    PubMed

    Stoop, Arjen P; Bal, Roland; Berg, Marc

    2007-06-01

    In studies on success and failure of ICT applications in health care, the 'context' is often used to explain the failure of a system and seldom to explain the success of a system. Science and Technology Studies (STS) have showed that for understanding success and failure of phenomena, one has to take a symmetrical approach and thus use the same concept for analyzing success and failure. In this article we analyze the success of OZIS, a communication protocol that makes it possible for pharmacists to exchange medication data by sharing a regionally accessible electronic medication record. Though OZIS serves a common goal - reducing medication errors - the stakeholders that are involved also have other, competing, interests. By focussing on the context and more specifically the interests of the stakeholders, we will show how the success of OZIS can be explained. By doing this, we will also show that this context is highly dynamic and that continuously changing incentives and constraints within the context lead to both facilitating and threatening the success of OZIS. PMID:16824793

  10. SU-D-18C-06: Initial Experience with Implementing MRI Safety Guidelines for Patients with Pacemakers - Medical Physicist Perspective

    SciTech Connect

    James, J; Place, V; Panda, A; Edmonson, H; Felmlee, J; Pooley, R

    2014-06-01

    Purpose: Several institutions have developed MRI guidelines for patients with MR-unsafe or MR-conditional pacemakers. Here we highlight the role of a medical physicist in implementing these guidelines for non-pacemaker dependent patients. Guidelines: Implementing these guidelines requires involvement from several medical specialties and a strong collaboration with the site MRI supervisor to develop a structured workflow. A medical physicist is required to be present during the scan to supervise the MR scanning and to maintain a safety checklist that ensures: 1) uninterrupted patient communication with the technologist, 2) continuous patient physiologic monitoring (e.g. blood pressure and electrocardiography) by a trained nurse, 3) redundant patient vitals monitoring (e.g. pulse oximetry) due to the possibility of in vivo electrocardiography reading fluctuations during image acquisition. A radiologist is strongly recommended to be available to review the images before patients are discharged from the scanner. Pacemaker MRI should be restricted to 1.5T field strength. The MRI sequences should be optimized by the physicist with regards to: a) SAR: limited to <1.5 W/Kg for MR-unsafe pacemakers in normal operating mode, b) RF exposure time: <30 min, c) Coils: use T/R coils but not restricted to such, d) Artifacts: further optimization of sequences whenever image quality is compromised due to the pacemaker. In particular, cardiac, breast and left-shoulder MRIs are most susceptible to these artifacts. Possible strategies to lower the SAR include: a) BW reduction, 2) echo-train-length reduction, 3) increase TR, 4) decrease number of averages, 5) decrease flip angle, 6) reduce slices and/or a combination of all the options. Conclusion: A medical physicist in collaboration with the MR supervisor plays an important role in the supervision/implementation of safe MR scanning of pacemaker patients. Developing and establishing a workflow has enabled our institution to scan over

  11. Confidentiality laws and secrecy in medical research: improving public access to data on drug safety.

    PubMed

    Kesselheim, Aaron S; Mello, Michelle M

    2007-01-01

    Pharmaceutical manufacturers have long considered results collected from drugs' clinical trials to be confidential information or trade secrets, even after submission to the Food and Drug Administration (FDA). We describe FDA policies regarding disclosure of clinical trial data and evaluate how courts have interpreted the Freedom of Information Act in cases seeking access to unreleased information. Recent examples of approved drugs later found to have dangerous side effects show the importance of complete dissemination of safety information. We suggest regulatory and legislative policy changes regarding how the FDA handles confidential information that can improve understanding of the risks of prescription drugs. PMID:17339677

  12. The very large airplane: safety, health, and comfort considerations. Air Transport Medicine Committee, Aerospace Medical Association.

    PubMed

    1997-10-01

    In recent years, aircraft manufacturers have been considering a very large airplane with a capacity of 600-1000 passengers. The human factors aspects of such an unprecedented enterprise demand that the aerospace medicine community take an active role early on in the design phase. Consequently, the Aerospace Medical Association formed an international task force to prepare a paper containing pertinent human factors recommendations for the manufacturers. This paper, including the recommendations herein, has been forwarded to Boeing and Airbus as well as to 50 major airlines of the world. PMID:9327122

  13. Quality and safety of herbal medical products: regulation and the need for quality assurance along the value chains

    PubMed Central

    Heinrich, Michael

    2015-01-01

    Herbal medicines and products derived from them are a diverse group of products for which different (and often limited) levels of evidence are available. As importantly, such products generally vary in their composition and are at the end of an often poorly understood value chain, which often links producers in biodiversity rich countries with the large markets in the North. This paper discusses the current regulatory framework of such herbal medical products (with a focus on the UK) and using examples from our own metabolomic research on Curcumal longa L. (turmeric, Zingiberaceae) how value chains impact on the composition and quality (and thus the safety) of such products. Overall, our recent research demonstrates the need for studying the links between producers and consumers of commodities produced in provider countries and that plant metabolomics offer a novel way of assessing the chemical variability along a value chain. PMID:25581270

  14. Medication Errors

    MedlinePlus

    ... to reduce the risk of medication errors to industry and others at FDA. Additionally, DMEPA prospectively reviews ... List of Abbreviations Regulations and Guidances Guidance for Industry: Safety Considerations for Product Design to Minimize Medication ...

  15. MERIS (Medical Error Reporting Information System) as an innovative patient safety intervention: a health policy perspective.

    PubMed

    Riga, Marina; Vozikis, Athanassios; Pollalis, Yannis; Souliotis, Kyriakos

    2015-04-01

    The economic crisis in Greece poses the necessity to resolve problems concerning both the spiralling cost and the quality assurance in the health system. The detection and the analysis of patient adverse events and medical errors are considered crucial elements of this course. The implementation of MERIS embodies a mandatory module, which adopts the trigger tool methodology for measuring adverse events and medical errors an intensive care unit [ICU] environment, and a voluntary one with web-based public reporting methodology. A pilot implementation of MERIS running in a public hospital identified 35 adverse events, with approx. 12 additional hospital days and an extra healthcare cost of €12,000 per adverse event or of about €312,000 per annum for ICU costs only. At the same time, the voluntary module unveiled 510 reports on adverse events submitted by citizens or patients. MERIS has been evaluated as a comprehensive and effective system; it succeeded in detecting the main factors that cause adverse events and discloses severe omissions of the Greek health system. MERIS may be incorporated and run efficiently nationally, adapted to the needs and peculiarities of each hospital or clinic. PMID:25554702

  16. US Food and Drug Administration Regulation of Medical Devices and Radiation Oncology: Can Reform Improve Safety?

    PubMed Central

    Hattangadi, Jona A.; O'Reilly, James T.; Recht, Abram

    2012-01-01

    Although radiation therapy is highly safe and effective in treating cancer, recent reports of dangerous radiation-related errors have focused a national spotlight on the field of radiation oncology and, more specifically, on the rapidly evolving and complex nature of radiation devices and how they are regulated. The purpose of this review is to explore the issues involved in medical device regulation in radiation oncology. We start with a general review of federal medical device regulation, including explanations of the legal and regulatory framework, and then discuss issues specific to radiation oncology with real-world examples. We also provide our thoughts on potential solutions and reforms to the current system, including better reporting of radiation-related errors in a centralized database, well-defined criteria for establishing substantial equivalence of a new device, and standard postmarket surveillance of radiation devices. Modern radiation therapy is a powerful tool that can help cure many patients' cancers and alleviate others' suffering with limited adverse effects. We must ensure that this promise is never compromised by avoidable mistakes. PMID:22548012

  17. Innovative Strategies Designed to Improve Adult Pneumococcal Immunizations in Safety Net Patient-Centered Medical Homes.

    PubMed

    Park, Nina J; Sklaroff, Laura Myerchin; Gross-Schulman, Sandra; Hoang, Khathy; Tran, Helen; Campa, David; Scheib, Geoffrey; Guterman, Jeffrey J

    2016-08-01

    Streptococcus pneumoniae is a principal cause of serious illness, including bacteremia, meningitis, and pneumonia, worldwide. Pneumococcal immunization is proven to reduce morbidity and mortality in high-risk adult and elderly populations. Current pneumococcal vaccination practices are suboptimal in part because of recommendation complexity, the high cost of provider-driven immunization interventions, and outreach methods that are not patient-centric. These barriers are amplified within the safety net. This paper identifies efforts by the Los Angeles County Department of Health Services to increase pneumococcal immunization rates for adult indigent patient populations. A 4-part approach will be used to increase vaccination rates: (1) protocol driven care, (2) staff education, (3) electronic identification of eligible patients, and (4) automated patient outreach and scheduling. The proposed analytics plan and potential for scalability are described. (Population Health Management 2016;19:240-247). PMID:26824148

  18. Noninvasive Mechanical Ventilation in Helicopter Emergency Medical Services Saves Time and Oxygen and Improves Patient and Mission Safety: A Pilot Study.

    PubMed

    Garrote, Jose Ignacio; Aylagas, Diego; Gutierrez, Jose M; Sinisterra, Juan A; Gowran, Brian Mc; Medina, Alberto; Díaz-Tendero, Javier; Gómez-Calcerrada, Pablo; Crespo, Ricardo

    2015-01-01

    Noninvasive mechanical ventilation (NIMV) is used increasingly in patients with severe respiratory distress and has clear benefits over standard medical therapy (SMT) in terms of patient safety. NIMV is particularly useful in cardiogenic acute pulmonary edema and in exacerbations of chronic obstructive pulmonary disease, both of which are frequent reasons for an emergency medical services dispatch. Early use of NIMV avoids complications in these patients in many cases. To date, the use of noninvasive positive-pressure ventilation in the air medical environment has been minimally researched. We evaluated NIMV versus SMT in the helicopter emergency medical services environment in patients with cardiogenic acute pulmonary edema and exacerbated chronic obstructive pulmonary disease. The parameters assessed were stabilization time, tolerance, safety, clinical response, and oxygen consumption. Bilevel noninvasive positive-pressure ventilation was the ventilatory mode used for all patients. The technique of NIMV in medical air transport is useful, easy to operate, and safe. It offers increased patient safety, reducing the need for invasive mechanical ventilation and its complications; better intervention times (35.8 minutes [NIMV] vs. 57.65 minutes [SMT], P < .05); improvement in aircraft operability; and a reduction in oxygen consumption (6.2 L/min vs. 9.8 L/min, P < .05), contributing to mission operability and safety. PMID:26206548

  19. Outcome and Safety of Anterograde and Retrograde Single-Balloon Enteroscopy: Clinical Experience at a Tertiary Medical Center in Taiwan

    PubMed Central

    Lin, Meng-Chiung; Chen, Peng-Jen; Shih, Yu-Lueng; Huang, Hsin-Hung; Chang, Wei-Kuo; Hsieh, Tsai-Yuan; Huang, Tien-Yu

    2016-01-01

    Single-balloon enteroscopy (SBE) is designed for identifying possible small bowel lesions with balloon-assisted enteroscopy that allows deep intubation of the intestine. However, data regarding the outcome and safety of SBE remain limited. We conducted this study to evaluate the outcome and safety of anterograde and retrograde SBE approaches. This retrospective review from a tertiary medical center in Taiwan included endoscopic reports and chart data from 128 patients with 200 anterograde and retrograde procedures from September 2009 to November 2014. In this study, the most common indication for both anterograde and retrograde SBE was obscure gastrointestinal bleeding (64.4% vs. 60.6%). There were no significant differences between anterograde and retrograde approaches in terms of the diagnostic yield (69.3% vs. 52.5%) and intervention rate (23.8% vs. 17.2%). The procedure time was shorter for anterograde SBE than for retrograde SBE (68.1 ± 23.9 vs. 76.8 ± 27.7 min, P = 0.018). In addition, among the subgroup of patients with obscure gastrointestinal bleeding, the most common etiologies for those in different age-groups were angiodysplasia (≥ 65 years), non-specific ulcers (30–64 years), and Meckel’s diverticulum (< 30 years). The major complication rate during the study was 1.5%; the rate of asymptomatic hyperamylasemia was higher for patients who underwent anterograde SBE than for those who underwent retrograde SBE (13.9% vs. 2%, P = 0.005). The outcome and safety of anterograde and retrograde SBE are similar. However, anterograde SBE has a shorter procedural time and a higher rate of asymptomatic hyperamylasemia. PMID:27548619

  20. Detecting Delayed Microbiology Results After Hospital Discharge: Improving Patient Safety Through an Automated Medical Informatics Tool

    PubMed Central

    Wilson, John W.; Marshall, William F.; Estes, Lynn L.

    2011-01-01

    We developed a computerized medical informatics tool to identify patients who had a culture performed on a sterile body site specimen during their hospitalization that subsequently turned positive after hospital dismissal. During a 13-month period, 533 patients had a positive culture identified by our Computer-Based Antimicrobial Monitoring (CBAM) program after hospital dismissal, and 112 (21%) of these culture results necessitated an intervention and communication with the primary health care professional. Thirty-two (29%) of positive cultures were from the blood. Thirty-eight (34%) of the CBAM interventions with available outcome data resulted in initiation of, change in, or prolongation of outpatient antimicrobial therapy. The CBAM program serves an important role in optimizing patient care and communication with the health care professional during the transition from inpatient to outpatient management. PMID:22134937

  1. Ensuring medical device effectiveness and safety: a cross--national comparison of approaches to regulation.

    PubMed

    Kramer, Daniel B; Tan, Yongtian T; Sato, Chiaki; Kesselheim, Aron S

    2014-01-01

    Regulatory bodies weighing market approval for novel medical devices must balance the benefits and potential hazards carefully. We performed a legal and policy review of appraoches in the US, EU, Japan, and China to device regulation with a focus on postmarket surveillance. These markets share broad features such as a heavy reliance on passive adverse event collection, reflected by growing enthusiasm for more active and dynamic mechanisms such as unique device identification. More immediately, US and EU systems might benefit from scheduled, compulsory, and consequential re-examination of select devices, as is done in Japan and China, in order to strengthen post-market protection of patients and bolster public health. PMID:24772683

  2. Radiological safety of medical devices sterilized with X-rays at 7.5 MeV

    NASA Astrophysics Data System (ADS)

    Grégoire, O.; Cleland, M. R.; Mittendorfer, J.; Vander Donckt, M.; Meissner, J.

    2003-06-01

    The induced radioactivity in medical devices when sterilized with 7.5 MeV X-rays has been investigated theoretically and verified by dedicated experiments. The experimental setup has been chosen to simulate closely the situation in a commercial irradiation facility. The purpose of this study is twofold: compare activation of medical devices with regulatory limits and evaluate corresponding dose exposure of persons in contact with those devices. Samples of medical devices, classified in several test groups, were located in a stack of low-density material at the position of the highest photoneutron fluence and irradiated to X-ray doses between 25 and 30 kGy. The induced activities were measured with high purity germanium (HPGe) gamma ray spectrometers. The X-rays were generated in a tantalum target using a 7.3 MeV electron beam with a narrow energy spread during the first experiment and with a broad energy spectrum for a second one. Results have been scaled to 50 kGy and compared with theoretical estimates. In addition, the radiation exposure of four categories of persons (logistics personnel in the irradiation facility, truck drivers, doctors and patients) has been calculated from the measured activities. The measured activities are higher than theoretical expectations but still below governmental regulations. The annual dose received by the person category with the highest exposure is about 1% of the worldwide average environmental exposure, and for other categories it is negligible. The paper concludes that provided some precautions are considered, sterilization with X-rays from 7.5 MeV electrons can be regarded safe from the standpoint of public health and personal safety.

  3. Seeking Safety Pilot Outcome Study at Walter Reed National Military Medical Center.

    PubMed

    Najavits, Lisa M; Lande, R Gregory; Gragnani, Cynthia; Isenstein, Debra; Schmitz, Martha

    2016-08-01

    Post-traumatic stress disorder (PTSD) and substance use disorder are two of the most prominent psychiatric disorders among military service members. Seeking Safety (SS) is an evidence-based behavioral therapy model for this comorbidity. This article reports results of a study of SS conducted in a military setting. Our pilot trial addressed outcomes, feasibility, and satisfaction. SS was conducted as is to evaluate its impact without adaptation for military culture. The sample was 24 outpatient service members (from the Army, Navy, Air Force, and Marines) with 33% minority representation. Inclusion criteria were current PTSD and/or SUD. Ten clinicians participated in this study after receiving SS training. Results showed significant improvements on most outcomes, including substance use on the Brief Addiction Monitor; PTSD symptoms on the PTSD Checklist-Military Version (total and criterion D); and the Trauma Symptom Checklist-40 (sexual abuse trauma index and anxiety subscale); functioning on the Sheehan Disability Scale (total and family subscale); psychopathology on the Zung Depression Scale total; the Behavior and Symptom Identification Scale (BASIS)-24 (total and subscales depression functioning, emotional liability, and psychosis); and the Brief Symptom Inventory-18 (total and anxiety subscale); and coping on the Coping Self-Efficacy Scale (total). Satisfaction was strong. Discussion includes methodology limitations and next steps. PMID:27483508

  4. Medical simulation is needed in anesthesia training to achieve patient's safety

    PubMed Central

    2013-01-01

    Many medical schools and hospitals throughout the world are equipped with a simulation center for the purpose of training anesthesiologists to perform both technical and non-technical skills. Because induction, maintenance, and emergence of general anesthesia are critical to patient welfare, various simulation mannequins and tools are utilized for the purpose of training anesthesiologists for safer patient care. Traditionally, anesthesia residency training mostly consisted of didactic lectures and observations. After completion of "traditional" training, anesthesia residents were allowed to perform procedures on patients under supervision. However, simulation would be a more effective training tool for which to teach anesthesiologists the skills necessary to perform invasive procedures, such as endotracheal intubation, central venous catheter insertion, and epidural catheter insertion. Recently, non-technical skills, such as the Anesthesia Non-Technical Skills developed by anesthesiologists from Aberdeen University, have been emphasized as an important training resource. Technical skills and non-technical skills can be learned by anesthesiology residents through a standardized and organized simulation program. Such programs would be beneficial in training anesthesia residents to work efficiently as a team in the operation room. PMID:23560184

  5. Safety of Acupuncture and Pharmacopuncture in 80,523 Musculoskeletal Disorder Patients: A Retrospective Review of Internal Safety Inspection and Electronic Medical Records.

    PubMed

    Kim, Me-Riong; Shin, Joon-Shik; Lee, Jinho; Lee, Yoon Jae; Ahn, Yong-Jun; Park, Ki Byung; Lee, Hwa Dong; Lee, Yoonmi; Kim, Sung Geun; Ha, In-Hyuk

    2016-05-01

    We investigated the range and frequency of significant adverse events (AEs) in use of pharmacopuncture and acupuncture using large-scale, single-center safety data as evidence supporting safety of acupuncture with pharmacopuncture, used extensively in Asia, is scarce. Status reports (nurse records in ambulatory and inpatient care units, and administrative event records) as a part of an internal audit at a Korean Medicine hospital specializing in the treatment of musculoskeletal disorders, patient complaints filed through the hospital website, and medical records of patients visiting from December, 2010 (inception of internal audit) to October, 2014 were retrospectively reviewed. A total 80,523 patients (5966 inpatients and 74,557 outpatients) visited during this period. Inpatients received an average 31.9 ± 20.7 acupuncture, 23.0 ± 15.6 pharmacopuncture, and 15.4 ± 11.3 bee venom pharmacopuncture sessions, and outpatients were administered 8.2 ± 12.2 acupuncture, 7.8 ± 11.5 pharmacopuncture, and 10.0 ± 12.3 bee venom sessions, respectively. AEs associated with acupuncture/pharmacopuncture were forgotten needle (n = 47), hypersensitivity to bee venom (n = 37), presyncopic episode (n = 4), pneumothorax (n = 4), and infection (n = 2). Most cases were mild requiring little or no additional intervention and leaving no sequelae. Although serious AEs including infection (n = 2) and anaphylaxis associated with bee venom treatment (n = 3) were also reported, incidence was rare at 0.002% in infection and 0.019% in anaphylaxis. Incidence of AEs associated with acupuncture/pharmacopuncture treatment was low, and most cases were not serious. Still, however rare, avoidable AEs can and should be prevented through education and corrective action. Further prospective studies on the effect of error reduction strategies on incidence of adverse effects are warranted. PMID:27149503

  6. Effects of mental demands during dispensing on perceived medication safety and employee well being: A study of workload in pediatric hospital pharmacies

    PubMed Central

    Holden, Richard J.; Patel, Neal R.; Scanlon, Matthew C.; Shalaby, Theresa M.; Arnold, Judi M.; Karsh, Ben-Tzion

    2009-01-01

    Background Pharmacy workload is a modifiable work system factor believed to affect both medication safety outcomes and employee outcomes such as job satisfaction. Objectives This study sought to measure the effect of workload on safety and employee outcomes in two pediatric hospitals and to do so using a novel approach to pharmacy workload measurement. Methods Rather than measuring prescription volume or other similar indicators, this study measured the type and intensity of mental demands experienced during the medication dispensing tasks. The effects of external (interruptions, divided attention, rushing) and internal (concentration, effort) task demands on perceived medication error likelihood, adverse drug event likelihood, job dissatisfaction, and burnout were statistically estimated using multiple linear and logistic regression. Results Pharmacists and pharmacy technicians reported high levels of external and internal mental demands during dispensing. The study supported the hypothesis that external demands (interruptions, divided attention, rushing) negatively impacted medication safety and employee well being outcomes. However, as hypothesized, increasing levels of internal demands (concentration and effort) were not associated with greater perceived likelihood of error, adverse drug events, or burnout, and even had a positive effect on job satisfaction. Conclusion Replicating a prior study in nursing, this study shows that new conceptualizations and measures of workload can generate important new findings about both detrimental and beneficial effects of workload on patient safety and employee well being. This study discusses what those findings imply for policy, management, and design concerning automation, cognition, and staffing. PMID:21111387

  7. Methods and pitfalls in searching drug safety databases utilising the Medical Dictionary for Regulatory Activities (MedDRA).

    PubMed

    Brown, Elliot G

    2003-01-01

    The Medical Dictionary for Regulatory Activities (MedDRA) is a unified standard terminology for recording and reporting adverse drug event data. Its introduction is widely seen as a significant improvement on the previous situation, where a multitude of terminologies of widely varying scope and quality were in use. However, there are some complexities that may cause difficulties, and these will form the focus for this paper. Two methods of searching MedDRA-coded databases are described: searching based on term selection from all of MedDRA and searching based on terms in the safety database. There are several potential traps for the unwary in safety searches. There may be multiple locations of relevant terms within a system organ class (SOC) and lack of recognition of appropriate group terms; the user may think that group terms are more inclusive than is the case. MedDRA may distribute terms relevant to one medical condition across several primary SOCs. If the database supports the MedDRA model, it is possible to perform multiaxial searching: while this may help find terms that might have been missed, it is still necessary to consider the entire contents of the SOCs to find all relevant terms and there are many instances of incomplete secondary linkages. It is important to adjust for multiaxiality if data are presented using primary and secondary locations. Other sources for errors in searching are non-intuitive placement and the selection of terms as preferred terms (PTs) that may not be widely recognised. Some MedDRA rules could also result in errors in data retrieval if the individual is unaware of these: in particular, the lack of multiaxial linkages for the Investigations SOC, Social circumstances SOC and Surgical and medical procedures SOC and the requirement that a PT may only be present under one High Level Term (HLT) and one High Level Group Term (HLGT) within any single SOC. Special Search Categories (collections of PTs assembled from various SOCs by

  8. Mortality as an indicator of patient safety in orthopaedics: lessons from qualitative analysis of a database of medical errors

    PubMed Central

    2012-01-01

    Background Orthopaedic surgery is a high-risk specialty in which errors will undoubtedly occur. Patient safety incidents can yield valuable information to generate solutions and prevent future cases of avoidable harm. The aim of this study was to understand the causative factors leading to all unnecessary deaths in orthopaedics and trauma surgery reported to the National Patient Safety Agency (NPSA) over a four-year period (2005–2009), using a qualitative approach. Methods Reports made to the NPSA are categorised and stored in the database as free-text data. A search was undertaken to identify the cases of all-cause mortality in orthopaedic and trauma surgery, and the free-text elements were used for thematic analysis. Descriptive statistics were calculated based on the incidents reported. This included presenting the number of times categories of incidents had the same or similar response. Superordinate and subordinate categories were created. Results A total of 257 incident reports were analysed. Four main thematic categories emerged. These were: (1) stages of the surgical journey – 118/191 (62%) of deaths occurred in the post-operative phase; (2) causes of patient deaths – 32% were related to severe infections; (3) reported quality of medical interventions – 65% of patients experienced minimal or delayed treatment; (4) skills of healthcare professionals – 44% of deaths had a failure in non-technical skills. Conclusions Most complications in orthopaedic surgery can be dealt with adequately, provided they are anticipated and that risk-reduction strategies are instituted. Surgeons take pride in the precision of operative techniques; perhaps it is time to enshrine the multimodal tools available to ensure safer patient care. PMID:22682470

  9. Attitudes towards the surgical safety checklist and factors associated with its use: A global survey of frontline medical professionals☆

    PubMed Central

    Vohra, Ravinder S.; Cowley, Jonathan B.; Bhasin, Neeraj; Barakat, Hashem M.; Gough, Michael J.

    2015-01-01

    Background The Surgical Safety Checklist (SSC) has been shown to reduce perioperative errors and complications and its implementation is recommended by the World Health Organisation (WHO). However, it is unknown how widely this intervention is used. We investigated attitudes and factors associated with use of WHO SSC in frontline medical professionals across the globe using a survey distributed through social networks. Methods A survey of usage and opinions regarding the SSC was posted on the Facebook and Twitter pages of a not-for-profit surgical news website for one month (March 2013). Respondents were grouped into four groups based on their country's Gross National Income: high, upper middle, lower middle and low income. Univariate and multivariate analyses were performed to investigate how different factors were associated with the use of the SSC. Results 6269 medical professionals from 69 countries responded to the survey: most respondents were from lower middle (47.4%) countries, followed by: high (35.0%), upper middle (14.6%), and low (3.0%) income countries. In total, 57.5% reported that they used the WHO SSC perioperatively. Fewer respondents used the WHO SSC in upper middle, lower middle and low income countries (LMICs) compared to high income countries (43.5% vs. 83.5%, p < 0.001). Female (61.3% vs. 56.4% males, p = 0.001), consultant surgeons (59.6% vs. 53.2% interns, p < 0.001) and working in university hospitals (61.4% vs. 53.7% non-university hospitals, p < 0.001) were more likely to use the SSC. Believing the SSC was useful, did not work or caused delays was independently associated with the respondents reported use of the SSC (OR 1.22 95% CI 1.07–1.39; OR 0.47 95% CI 0.36–0.60; OR 0.64 95% CI 0.53–0.77, respectively). Conclusion This study suggests the use of the WHO SSC is variable across countries, especially in LMICs where it has the most potential to improve patient safety. Critical appraisal of the documented benefits of the WHO

  10. Initial experience with an 11 MeV self-shielded medical cyclotron on operation and radiation safety

    PubMed Central

    Pant, G. S.; Senthamizhchelvan, S.

    2007-01-01

    A self-shielded medical cyclotron (11 MeV) was commissioned at our center, to produce positron emitters, namely, 18F, 15O, 13N and 11C for positron emission tomography (PET) imaging. Presently the cyclotron has been exclusively used for the production of 18F- for 18F-FDG imaging. The operational parameters which influence the yield of 18F- production were monitored. The radiation levels in the cyclotron and radiochemistry laboratory were also monitored to assess the radiation safety status in the facility. The target material, 18O water, is bombarded with proton beam from the cyclotron to produce 18F- ion that is used for the synthesis of 18F-FDG. The operational parameters which influence the yield of 18F- were observed during 292 production runs out of a total of more than 400 runs. The radiation dose levels were also measured in the facility at various locations during cyclotron production runs and in the radiochemistry laboratory during 18F-FDG syntheses. It was observed that rinsing the target after delivery increased the number of production runs in a given target, as well as resulted in a better correlation between the duration of bombardment and the end of bombardment 18F- activity with absolutely clean target after being rebuilt. The radiation levels in the cyclotron and radiochemistry laboratory were observed to be well within prescribed limits with safe work practice. PMID:21157531

  11. Safety of aquaflor (florfenicol, 50% type a medicated article), administered in feed to channel catfish, Ictalurus punctatus

    USGS Publications Warehouse

    Gaikowski, Mark P.; Wolf, Jeffery C.; Endris, Richard G.; Gingerich, William H.

    2003-01-01

    Aquaflor, a feed premix containing the broad spectrum antibacterial agent florfenicol (50% w/w), is being developed for use to control enteric septicemia (ESC) in channel catfish Ictalurus punctatus caused by the gram-negative enterobacterium Edwardsiella ictaluri. The recommended dose of Aquaflor to control ESC is 10 mg/kg body weight (BW)/day for 10 days. The study objective was to determine the safety of Aquaflor administered in feed to channel catfish at doses of 0 (control), 10, 30, and 50 mg/kg BW/day for 20 consecutive days. Parameters evaluated included daily mortality, behavioral (appetite, distribution, flight/fright response), and water chemistry observations, initial and terminal weight measurements, and gross and microscopic pathology. Medicated feed consumption was 67-86% of target with group mean doses of 8.5 mg/kg BW/day, 24.6 mg/kg BW/day, and 34.9 mg/kg BW/day. There were no mortalities or clinically observable changes noted at any of the dose levels tested. Aquaflor-related changes were limited to the food consumption and histopathology data. Although Aquaflor-related decreased feed consumption was noted in the 30 and 50 mg/kg BW/day groups, there were no differences in fish growth among the treatment groups. Aquaflor-related histopathology findings were limited to a histomorphologically evident dose-dependent decrease in hematopoietic/lymphopoietic tissue in the anterior kidneys, posterior kidneys, and spleens of channel catfish.

  12. Safety of Aquaflor (Florfenicol, 50% Type A Medicated Article), Administered in Feed to Channel Catfish, Ictalurus punctatus

    USGS Publications Warehouse

    Gaikowski, M.P.; Wolf, J.C.; Endris, R.G.; Gingerich, W.H.

    2003-01-01

    Aquaflor, a feed premix containing the broad spectrum antibacterial agent florfenicol (50% w/w), is being developed for use to control enteric septicemia (ESC) in channel catfish Ictalurus punctatus caused by the gram-negative enterobacterium Edwardsiella ictaluri. The recommended dose of Aquaflor to control ESC is 10 mg/kg body weight (BW)/day for 10 days. The study objective was to determine the safety of Aquaflor administered in feed to channel catfish at doses of 0 (control), 10, 30, and 50 mg/kg BW/day for 20 consecutive days. Parameters evaluated included daily mortality, behavioral (appetite, distribution, flight/fright response), and water chemistry observations, initial and terminal weight measurements, and gross and microscopic pathology. Medicated feed consumption was 67-86% of target with group mean doses of 8.5 mg/kg BW/day, 24.6 mg/kg BW/day, and 34.9 mg/kg BW/day. There were no mortalities or clinically observable changes noted at any of the dose levels tested. Aquaflor-related changes were limited to the food consumption and histopathology data. Although Aquaflor-related decreased feed consumption was noted in the 30 and 50 mg/kg BW/day groups, there were no differences in fish growth among the treatment groups. Aquaflor-related histopathology findings were limited to a histomorphologically evident dose-dependent decrease in hematopoietic/lymphopoietic tissue in the anterior kidneys, posterior kidneys, and spleens of channel catfish.

  13. Reach and Validity of An Objective Medication Adherence Measure among Safety Net Health Plan Members with Diabetes: A Cross-Sectional Study

    PubMed Central

    Ratanawongsa, Neda; Karter, Andrew J.; Quan, Judy; Parker, Melissa M.; Handley, Margaret; Sarkar, Urmimala; Schmittdiel, Julie A.; Schillinger, Dean

    2015-01-01

    Background With the expansion of Medicaid and low-cost health insurance plans among diverse patient populations, objective measures of medication adherence using pharmacy claims could advance clinical care and translational research for safety net care. However, safety net patients may experience fluctuating prescription drug coverage, affecting the performance of adherence measures. Objective To evaluate the performance of continuous medication gap (CMG) for diverse, low-income managed care members with diabetes. Methods We conducted this cross-sectional analysis using administrative and clinical data for 680 members eligible for a self-management support trial at a non-profit, government-sponsored managed care plan. We applied CMG methodology to cardiometabolic medication claims for English-, Cantonese-, or Spanish-speaking members with diabetes. We examined inclusiveness (the proportion with calculable CMG) and selectivity (sociodemographic and medical differences from members without CMG). To examine validity, we examined unadjusted associations of suboptimal adherence (CMG>20%) with suboptimal cardiometabolic control. Results 429 members (63%) had calculable CMG. Compared to members without CMG, members with CMG were younger; more likely employed; and had poorer glycemic control, but better blood pressure and lipid control. Suboptimal adherence occurred more frequently among members with poor cardiometabolic control than among members with optimal control (28% vs. 12%, p=0.02). Conclusions CMG demonstrated acceptable inclusiveness and validity in a diverse, low-income safety net population, comparable to its performance in studies among other insured populations. CMG may provide a useful tool to measure adherence among increasingly diverse Medicaid populations, complemented by other strategies to reach those not captured by CMG. Trial Registration NCT00683020 PMID:26233541

  14. Iatrogenic phenol injury: a case report and review of medication safety and labeling practices with flexible laryngoscopy.

    PubMed

    Cote, Valerie; Prager, Jeremy D

    2014-10-01

    Medication errors can be reduced by following standards in patient identification and medication labeling. We present an investigation of a life-threatening event from medication error: A newborn that received intranasal phenol instead of topical anesthetic prior to flexible laryngoscopy. The patient required urgent intubation for respiratory distress and suffered chemical burns of the face, neck, and upper aerodigestive tract. The hospital course was prolonged and included intensive care, delayed oral feeding with enteral support, and the need for several endoscopies. Current standards of medication labeling are reviewed as well as evidence for and against using topical agents for flexible laryngoscopy. PMID:25103774

  15. Seeing Through Google Glass: Using an Innovative Technology to Improve Medication Safety Behaviors in Undergraduate Nursing Students.

    PubMed

    Schneidereith, Tonya

    2015-01-01

    Addressing safe medication administration skills and behaviors is integrated throughout many nursing curricula using high-fidelity simulation. Simulation allows students to practice on electronic manikins in a safe environment, allowing for independent, critical thinking as medications are administered. However, the restricted physical environment, often behind a one-way mirror, inhibits faculty from observing the processes students use to calculate or reference medication dosages. This article describes the errors in medication administration identified through use of Google Glass, an innovative technology that allows video recording from the student's perspective. PMID:26521507

  16. Narrative review of the safety and efficacy of marijuana for the treatment of commonly state-approved medical and psychiatric disorders.

    PubMed

    Belendiuk, Katherine A; Baldini, Lisa L; Bonn-Miller, Marcel O

    2015-01-01

    The present investigation aimed to provide an objective narrative review of the existing literature pertaining to the benefits and harms of marijuana use for the treatment of the most common medical and psychological conditions for which it has been allowed at the state level. Common medical conditions for which marijuana is allowed (i.e., those conditions shared by at least 80 percent of medical marijuana states) were identified as: Alzheimer's disease, amyotrophic lateral sclerosis, cachexia/wasting syndrome, cancer, Crohn's disease, epilepsy and seizures, glaucoma, hepatitis C virus, human immunodeficiency virus/acquired immunodeficiency syndrome, multiple sclerosis and muscle spasticity, severe and chronic pain, and severe nausea. Post-traumatic stress disorder was also included in the review, as it is the sole psychological disorder for which medical marijuana has been allowed. Studies for this narrative review were included based on a literature search in PsycINFO, MEDLINE, and Google Scholar. Findings indicate that, for the majority of these conditions, there is insufficient evidence to support the recommendation of medical marijuana at this time. A significant amount of rigorous research is needed to definitively ascertain the potential implications of marijuana for these conditions. It is important for such work to not only examine the effects of smoked marijuana preparations, but also to compare its safety, tolerability, and efficacy in relation to existing pharmacological treatments. PMID:25896576

  17. On Research Methodology in Applied Linguistics in 2002-2008

    ERIC Educational Resources Information Center

    Martynychev, Andrey

    2010-01-01

    This dissertation examined the status of data-based research in applied linguistics through an analysis of published research studies in nine peer-reviewed applied linguistics journals ("Applied Language Learning, The Canadian Modern Language Review / La Revue canadienne des langues vivantes, Current Issues in Language Planning, Dialog on Language…

  18. Typing of the rabies virus in Chile, 2002-2008.

    PubMed

    Yung, V; Favi, M; Fernandez, J

    2012-12-01

    In Chile, dog rabies has been controlled and insectivorous bats have been identified as the main rabies reservoir. This study aimed to determine the rabies virus (RABV) variants circulating in the country between 2002 and 2008. A total of 612 RABV isolates were tested using a panel with eight monoclonal antibodies against the viral nucleoprotein (N-mAbs) for antigenic typing, and a product of 320-bp of the nucleoprotein gene was sequenced from 99 isolates. Typing of the isolates revealed six different antigenic variants but phylogenetic analysis identified four clusters associated with four different bat species. Tadarida brasiliensis bats were confirmed as the main reservoir. This methodology identified several independent rabies enzootics maintained by different species of insectivorous bats in Chile. PMID:22458941

  19. Improving the safety and efficiency of nurse medication rounds through the introduction of an automated dispensing cabinet

    PubMed Central

    Cottney, Alan

    2014-01-01

    Information technology (IT) systems are being utilised with increasing frequency at the prescribing and dispensing stage of the medicines-use process in UK hospitals. However, much less development has taken place with regard to the implementation of IT systems at the administration stage of medicines-use. A technology that has been implemented widely at the administration stage in North American hospitals is the automated dispensing cabinet (ADC), which has been shown to reduce nurse medication administration errors and reduce the time that nurses spend administering medication. The current project was undertaken to assess whether these benefits would be realised with the introduction of an ADC on an inpatient ward in a UK mental health hospital. Nurses were observed administering medication before and after the implementation of an ADC on a ward at East London NHS Foundation Trust (ELFT). The findings from these observations showed that the use of the ADC led to a reduction in the medication administration error rate from 8.9% to 7.2%; however, this reduction was solely accounted for by a reduction in errors of negligible clinical severity. The types of administration errors noted after implementation of the ADC remained largely unchanged from beforehand. The ADC was found to reduce the amount of time that nurses spent administering medication from 2.94 min per dose to 2.37 min per dose. It is estimated that this reduction could generate around 66 min of additional free nursing time per ward per day. As a standalone device, the ADC was found to improve the efficiency of the medicines-use process, but had little meaningful effect on medication administration error rate at ELFT. However, it could be anticipated that additional benefit with regard to reducing medication administration errors may be demonstrated if the ADC was used in combination with other IT systems, such as electronic prescribing. PMID:26734256

  20. Occupational Safety and Health Symposia (37th American Medical Association Congress on Occupational Health. St. Louis, Missouri, 1977).

    ERIC Educational Resources Information Center

    Douglass, Bruce E.; And Others

    The papers compiled here were presented at the fourth symposium in a series designed to provide a continuing introduction to current aspects of occupational safety and health. The papers represent eight topics: (1) special health programs, (2) degenerative disease and injury of the back, (3) job stress and work performance, (4) role of industry in…

  1. Transfusion safety in francophone African countries: an analysis of strategies for the medical selection of blood donors

    PubMed Central

    Tayou, Claude Tagny; Kouao, Maxime Diané; Touré, Hamane; Gargouri, Jalel; Fazul, Ahamada Said; Ouattara, Siaka; Anani, Ludovic; Othmani, Habiba; Feteke, Lochina; Dahourou, Honorine; Mbensa, Guy Olivier; Molé, Simplice; Nébié, Yacouba; Mbangue, Madeleine; Toukam, Michel; Boulahi, Mahommed Ould; Andriambelo, Lalatiana Valisoa; Rakoto, Olivat; Baby, Mounirou; Yahaya, Rakia; Bokilo, Amelia; Senyana, Florent; Mbanya, Dora; Shiboski, Caroline; Murphy, Edward L.; Lefrère, Jean Jacques

    2013-01-01

    BACKGROUND The goal of selecting a healthy blood donor is to safeguard donors and reduce the risks of infections and immunologic complications for recipients. STUDY DESIGN AND METHODS To evaluate the blood donor selection process, a survey was conducted in 28 blood transfusion centers located in 15 francophone African countries. Data collected included availability of blood products, risk factors for infection identified among blood donor candidates, the processing of the information collected before blood collection, the review process for the medical history of blood donor candidates, and deferral criteria for donor candidates. RESULTS During the year 2009, participating transfusion centers identified 366,924 blood donor candidates. A mean of 13% (range, 0%–36%) of the donor candidates were excluded based solely on their medical status. The main risk factors for blood-borne infections were having multiple sex partners, sexual intercourse with occasional partners, and religious scarification. Most transfusion centers collected this information verbally instead of having a written questionnaire. The topics least addressed were the possible complications relating to the donation, religious scarifications, and history of sickle cell anemia and hemorrhage. Only three centers recorded the temperature of the blood donors. The deferral criteria least reported were sickle cell anemia, piercing, scarification, and tattoo. CONCLUSIONS The medical selection process was not performed systemically and thoroughly enough, given the regional epidemiologic risks. It is essential to identify the risk factors specific to francophone African countries and modify the current medical history questionnaires to develop a more effective and relevant selection process. PMID:22014098

  2. 76 FR 72030 - Public Meeting of Motor Carrier Safety Advisory Committee and Joint Public Meeting With Medical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-21

    ... consider expert presentations on obstructive sleep apnea and its relationship to the population of CMV... realistic and responsible medical standards. The MRB operates in accordance with FACA. Sleep Apnea and Other Sleep Disorders The MCSAC and the MRB will discuss ideas and concepts the Agency should consider...

  3. Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study

    PubMed Central

    Hwang, Thomas J; Sokolov, Elisaveta; Franklin, Jessica M; Kesselheim, Aaron S

    2016-01-01

    Objective To evaluate safety alerts and recalls, publication of key trial outcomes, and subsequent US approval of high profile medical devices introduced in the European Union. Design Cohort study. Setting Novel cardiovascular, orthopedic, and neurologic devices approved in the EU through Conformité Européenne marking between 2005 and 2010. Data sources Public and commercial databases searched up to January 2016 for press releases and announcements of approvals; public Food and Drug Administration and European regulatory authority databases for US approvals and safety alerts and recalls; and Medline, Embase, and Web of Science for peer reviewed publications. Main outcome measures We categorized the novelty of the devices in the study sample as a “major innovation” or an “other change,” and extracted descriptive data about the devices and information on any safety alerts and withdrawals. Linear regression models examined factors associated with differential EU and US approvals. Cox proportional hazards regression models were used to evaluate factors associated with safety alerts and recalls and the publication of trial outcomes for devices categorized as major innovations. Models controlled for time, therapeutic category, regulatory pathway, size of sponsoring company, and indicator variables for devices approved first in the EU and devices approved only in the EU. Results 67% (206/309) of devices identified were approved in both the US and the EU, of which 63% (129/206) were approved first in the EU. The unadjusted rate of safety alerts and recalls for devices approved first in the EU was 27% (62/232) compared with 14% (11/77) for devices approved first in the US. The adjusted hazard ratio for safety alerts and recalls was 2.9 (95% confidence interval 1.4 to 6.2) for devices approved first in the EU. The results of pivotal trials were published for 49% (37/75) of devices categorized as major innovations, with an overall publication rate of 37% five

  4. Safety of Carbamazepine Extended-Release Capsules Used in Combination with Other Psychotropic Medications for the Treatment of Bipolar I Disorder

    PubMed Central

    Weisler, Richard H.; Kalali, Amir H.; Cutler, Andrew J.; Gazda, Thomas D.; Ginsberg, Lawrence

    2008-01-01

    Objective To evaluate the safety and efficacy of carbamazepine extended-release capsules (CBZ-ERC) in combination with other psychotropic medications for the treatment of bipolar I disorder. Design In this Phase IIIb, open-label, eight-week, observational, polypharmacy study, adult subjects were started on CBZ-ERC 200mg and titrated over four weeks to optimal dose (1600mg/d maximum). Concomitant lithium and atypical antipsychotics (olanzapine, risperidone, quetiapine, aripiprazole) were permitted. Safety assessments included adverse events, laboratory parameters, physical examination, medication history, vital signs, and electrocardiogram. Efficacy measures included the Young Mania Rating Scale (YMRS), Hamilton Rating Scale for Depression (HAM-D), Montgomery-Åsberg Depression Rating Scale (MADRS), and Clinical Global Impressions Scale–Bipolar Version (CGI-BP). All data were summarized using descriptive statistics. Results Overall, 45 (84.9%) subjects reported treatment-emergent adverse events (TEAEs); most were mild or moderate in severity. The most commonly reported TEAEs were somnolence (n=14, 26.4%), sedation (n=12, 22.6%), dizziness (n=11, 20.8%), headache (n=9, 17.0%), and nausea (n=7, 13.2%). There were no clinically significant changes in vital signs, including weight. Mean changes in laboratory parameters were small, with values that were within the normal range for the majority of subjects. Few changes relative to screening for other safety parameters occurred. Mean total YMRS score decreased from baseline at each study visit. HAM-D and MADRS scores decreased from baseline at Weeks 4 and 8, and all three CGI-BP components (overall bipolar disorder, mania, and depression) improved during the study. Conclusion CBZ-ERC appears to be safe and effective for use in combination with atypical antipsychotics and lithium for treatment of bipolar I disorder. PMID:19727252

  5. Evaluating Aspects of Online Medication Safety in Long-Term Follow-Up of 136 Internet Pharmacies: Illegal Rogue Online Pharmacies Flourish and Are Long-Lived

    PubMed Central

    2013-01-01

    Background A growing number of online pharmacies have been established worldwide. Among them are numerous illegal websites selling medicine without valid medical prescriptions or distributing substandard or counterfeit drugs. Only a limited number of studies have been published on Internet pharmacies with regard to patient safety, professionalism, long-term follow-up, and pharmaceutical legitimacy verification. Objective In this study, we selected, evaluated, and followed 136 Internet pharmacy websites aiming to identify indicators of professional online pharmacy service and online medication safety. Methods An Internet search was performed by simulating the needs of potential customers of online pharmacies. A total of 136 Internet pharmacy websites were assessed and followed for four years. According to the LegitScript database, relevant characteristics such as longevity, time of continuous operation, geographical location, displayed contact information, prescription requirement, medical information exchange, and pharmaceutical legitimacy verification were recorded and evaluated. Results The number of active Internet pharmacy websites decreased; 23 of 136 (16.9%) online pharmacies ceased operating within 12 months and only 67 monitored websites (49.3%) were accessible at the end of the four-year observation period. However, not all operated continuously, as about one-fifth (31/136) of all observed online pharmacy websites were inaccessible provisionally. Thus, only 56 (41.2%) Internet-based pharmacies were continuously operational. Thirty-one of the 136 online pharmacies (22.8%) had not provided any contact details, while only 59 (43.4%) displayed all necessary contact information on the website. We found that the declared physical location claims did not correspond to the area of domain registration (according to IP address) for most websites. Although the majority (120/136, 88.2%) of the examined Internet pharmacies distributed various prescription

  6. Criteria for use of blue "Star of Life" for emergency medical services. National Highway Traffic Safety Administration. Notice.

    PubMed

    1994-08-11

    This notice amends NHTSA's guidelines for the authorized use of the blue "Star of Life" symbols for emergency medical services. Comments received in response to an earlier notice suggested uses for this symbol that were not considered when these guidelines were first developed. These amendments are intended to provide additional flexibility to the States within the purposes for which the blue Star of Life was originally registered as a certification mark. PMID:10136913

  7. A critical reappraisal of dietary practices in methylmalonic acidemia raises concerns about the safety of medical foods. Part 1: Isolated methylmalonic acidemias (MMA)

    PubMed Central

    Manoli, Irini; Myles, Jennifer; Sloan, Jennifer L.; Shchelochkov, Oleg A.; Venditti, Charles P.

    2015-01-01

    PURPOSE Medical foods for methylmalonic and propionic acidemias (MMA/PA) contain minimal valine, isoleucine, methionine and threonine, but have been formulated with increased leucine. We aimed to assess the effects of imbalanced branched-chain amino acid intake on metabolic and growth parameters in a cohort of MMA patients ascertained via a natural history study. METHODS Cross-sectional anthropometric and body composition measurements were correlated with diet content and disease-related biomarkers in 61 patients with isolated MMA (46 mut, 9 cblA and 6 cblB). RESULTS Patients with MMA tolerated close to the recommended daily allowance (RDA) of complete protein (mut0: 99.45 ± 32.05% RDA). However, 85% received medical foods, the protein-equivalent in which often exceeded complete protein intake (35%). Medical food consumption resulted in low plasma valine and isoleucine concentrations, prompting paradoxical supplementation with these propiogenic amino acids. Weight and height–for age Z-scores correlated negatively with the leucine/valine intake ratio (r=−0.453, P=0.014, R2=0.209 and r=−0.341, P=0.05, R2=0.123, respectively). CONCLUSION Increased leucine intake in patients with MMA resulted in iatrogenic amino acid deficiencies and was associated with adverse growth outcomes. Medical foods for propionate oxidation disorders need to be redesigned and studied prospectively, to ensure efficacy and safety. TRIAL REGISTRATION This clinical study is registered in www.clinicaltrials.gov with the ID: NCT00078078. Study URL: http://clinicaltrials.gov/ct2/show/NCT00078078 PMID:26270765

  8. SU-D-BRD-06: Creating a Safety Net for a Fully Automated, Script Driven Electronic Medical Record

    SciTech Connect

    Sheu, R; Ghafar, R; Powers, A; Green, S; Lo, Y

    2015-06-15

    Purpose: Demonstrate the effectiveness of in-house software in ensuring EMR workflow efficiency and safety. Methods: A web-based dashboard system (WBDS) was developed to monitor clinical workflow in real time using web technology (WAMP) through ODBC (Open Database Connectivity). Within Mosaiq (Elekta Inc), operational workflow is driven and indicated by Quality Check Lists (QCLs), which is triggered by automation software IQ Scripts (Elekta Inc); QCLs rely on user completion to propagate. The WBDS retrieves data directly from the Mosaig SQL database and tracks clinical events in real time. For example, the necessity of a physics initial chart check can be determined by screening all patients on treatment who have received their first fraction and who have not yet had their first chart check. Monitoring similar “real” events with our in-house software creates a safety net as its propagation does not rely on individual users input. Results: The WBDS monitors the following: patient care workflow (initial consult to end of treatment), daily treatment consistency (scheduling, technique, charges), physics chart checks (initial, EOT, weekly), new starts, missing treatments (>3 warning/>5 fractions, action required), and machine overrides. The WBDS can be launched from any web browser which allows the end user complete transparency and timely information. Since the creation of the dashboards, workflow interruptions due to accidental deletion or completion of QCLs were eliminated. Additionally, all physics chart checks were completed timely. Prompt notifications of treatment record inconsistency and machine overrides have decreased the amount of time between occurrence and execution of corrective action. Conclusion: Our clinical workflow relies primarily on QCLs and IQ Scripts; however, this functionality is not the panacea of safety and efficiency. The WBDS creates a more thorough system of checks to provide a safer and near error-less working environment.

  9. Product Failures in Respirators and Consumables: Analysis of Field Safety Notices of 2005-2013 Publicized by the Federal Institute for Drugs and Medical Devices in Germany.

    PubMed

    Hannig, Jürgen; Siekmeier, Rüdiger

    2015-01-01

    The current European system governed by the three EC directives 93/42/EEC (Medical Device Directive), 98/79/EC (In-Vitro Diagnostic Directive) and 90/385/EEC (Active Implantable Medical Device Directive) regulates marketing and post-market surveillance of medical devices in the European Economic Area (EEA). In cases of incidents raising the field safety corrective actions (FSCA), manufacturers have to inform the responsible Competent Authority (CA; in Germany this is the Federal Institute for Drugs and Medical Devices, BfArM) and the public by field safety notices (FSN). In this study we analyzed FSN of respirators and consumables directly required for their function, whereas devices for anesthesia and gas delivery were excluded. FSCA and FSN of 2005-2013 publicized by BfArM for the included products were analyzed with respect to the MEDDEV 2.12-1 rev. 8. In total, 60 FSCA were publicized. German and English FSN were found in 59/53 cases, respectively. FSN were clearly characterized as FSN in 44/38 cases and declaration of the type of action in 45/44 cases, respectively. Product names were provided in all cases. Lot numbers or other information for product characterization were available in 7/7 and 43/40 cases, respectively. Detailed information regarding FSCA and product malfunction was found in all cases. Information on product related risks with previous use of affected devices was provided in 42/38 cases. In 53/53 cases manufacturers provided information to mitigate product related risks. Requests to pass FSN to persons needing awareness in the organization were found in 27/24 cases. Contact data were provided in 53/48 cases, respectively. Confirmation that a CA was informed was found in 28/26 cases and in 19/15 cases a customer confirmation was included. The identified risks were: total loss of function (19/16), short circuit (1/1) and burn (3/3), and inhalation of foreign particles (1/1) which might cause severe risk to patients and users. The most frequent

  10. Impact of North Atlantic Treaty Organization Policies and Procedures on Combined Medical Operations: Food and Water Safety and Veterinary Support.

    PubMed

    Stevenson, Timothy H; Chevalier, Nicole A; Scher, Gregory R; Burke, Ronald L

    2016-01-01

    Effective multilateral military operations such as those conducted by the North Atlantic Treaty Organization (NATO) require close cooperation and standardization between member nations to ensure interoperability. Failure to standardize policies, procedures, and doctrine prior to the commencement of military operations will result in critical interoperability gaps, which jeopardize the health of NATO forces and mission success. To prevent these gaps from occurring, US forces must be actively involved with NATO standardization efforts such as the Committee of the Chiefs of Medical Services to ensure US interests are properly represented when NATO standards are developed and US doctrine and procedures will meet the established NATO requirements. PMID:27215889