26 CFR 1.55-1 - Alternative minimum taxable income.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 1 2010-04-01 2010-04-01 true Alternative minimum taxable income. 1.55-1... TAXES Tax Surcharge § 1.55-1 Alternative minimum taxable income. (a) General rule for computing alternative minimum taxable income. Except as otherwise provided by statute, regulations, or other published...

Case outsourcing medical device reprocessing.

PubMed

Haley, Deborah

2004-04-01

IN THE INTEREST OF SAVING MONEY, many hospitals are considering extending the life of some single-use medical devices by using medical device reprocessing programs. FACILITIES OFTEN LACK the resources required to meet the US Food and Drug Administration's tough quality assurance standards. BY OUTSOURCING, hospitals can reap the benefits of medical device reprocessing without assuming additional staffing and compliance burdens. OUTSOURCING enables hospitals to implement a medical device reprocessing program quickly, with no capital investment and minimal effort.

20 CFR 404.428 - Earnings in a taxable year.

Code of Federal Regulations, 2010 CFR

2010-04-01

... satisfaction that you have a different taxable year. If you are self-employed, your taxable year is a calendar year unless you have a different taxable year for the purposes of subtitle A of the Internal Revenue... rule that applies to the earnings of a beneficiary who attains full retirement age (as described in...

Candida Infections of Medical Devices

PubMed Central

Kojic, Erna M.; Darouiche, Rabih O.

2004-01-01

The number of indwelling medical devices is escalating, and an increasing proportion of device-related infections are being caused by Candida spp. Candida spp. produce biofilms on synthetic materials, which facilitates adhesion of the organisms to devices and renders them relatively refractory to medical therapy. Management of device-related Candida infections can be challenging. Removal of the infected device is generally needed to establish cure of Candida infections of medical devices. However, since the pathogenesis of Candida bloodstream infection is complicated, more studies are necessary to determine the role of catheter exchange in patients with both gastrointestinal tract mucositis and indwelling catheters. The medical and economic impact of these infections is enormous. PMID:15084500

[Medical Devices Law for pain therapists].

PubMed

Regner, M; Sabatowski, R

2016-08-01

Medical Devices Law is a relatively new legal system, which has replaced the Medical Devices Regulations still well-known in Germany. German Medical Devices Law is based on European directives, which are, in turn, incorporated into national law by the Medical Devices Act. The Medical Devices Act is a framework law and covers a number of regulations that address specific topics within Medical Devices Law. In turn, in individual regulations, reference is made to guidelines, recommendations, etc. from other sources that provide detailed technical information on specific topics. Medical Devices Law is a very complex legal system, which needs to be permanently observed due to constant updating and adjustment. In the current article, the design and the structure of the system will be described, but special emphasis will be laid on important problem areas that need to be considered when applying and operating medical products, in this case by pain therapists in particular.

26 CFR 1.802-4 - Life insurance company taxable income.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 26 Internal Revenue 8 2013-04-01 2013-04-01 false Life insurance company taxable income. 1.802-4... TAX (CONTINUED) INCOME TAXES (CONTINUED) Life Insurance Companies § 1.802-4 Life insurance company taxable income. (a) Life insurance company taxable income defined. Section 802(b) defines the term life...

26 CFR 1.802-4 - Life insurance company taxable income.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 26 Internal Revenue 8 2012-04-01 2012-04-01 false Life insurance company taxable income. 1.802-4... TAX (CONTINUED) INCOME TAXES (CONTINUED) Life Insurance Companies § 1.802-4 Life insurance company taxable income. (a) Life insurance company taxable income defined. Section 802(b) defines the term life...

26 CFR 1.802-4 - Life insurance company taxable income.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 26 Internal Revenue 8 2014-04-01 2014-04-01 false Life insurance company taxable income. 1.802-4... TAX (CONTINUED) INCOME TAXES (CONTINUED) Life Insurance Companies § 1.802-4 Life insurance company taxable income. (a) Life insurance company taxable income defined. Section 802(b) defines the term life...

26 CFR 1.802-4 - Life insurance company taxable income.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 26 Internal Revenue 8 2011-04-01 2011-04-01 false Life insurance company taxable income. 1.802-4... TAX (CONTINUED) INCOME TAXES (CONTINUED) Life Insurance Companies § 1.802-4 Life insurance company taxable income. (a) Life insurance company taxable income defined. Section 802(b) defines the term life...

26 CFR 1.802-4 - Life insurance company taxable income.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 8 2010-04-01 2010-04-01 false Life insurance company taxable income. 1.802-4... TAX (CONTINUED) INCOME TAXES Life Insurance Companies § 1.802-4 Life insurance company taxable income. (a) Life insurance company taxable income defined. Section 802(b) defines the term life insurance...

26 CFR 1.441-3 - Taxable year of a personal service corporation.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 26 Internal Revenue 6 2011-04-01 2011-04-01 false Taxable year of a personal service corporation... personal service corporation. (a) Taxable year—(1) Required taxable year. Except as provided in paragraph (a)(2) of this section, the taxable year of a personal service corporation (PSC) (as defined in...

[Risk management for medical devices].

PubMed

Xie, Ying-jie; Xu, Xing-gang

2007-07-01

Based on the practices of the risk management activities by Chinese medical device manufacturers and theoretical study of the latest international standard ISO 14971:2007, this article analyses the risk management in medical device manufacturing industry by introducing the status quo of applications, four requirements at operational stages, and future trends of development. Methods and suggestions are therefore given to medical device manufacturers for risk management.

26 CFR 1.1378-1 - Taxable year of S corporation.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 26 Internal Revenue 11 2012-04-01 2012-04-01 false Taxable year of S corporation. 1.1378-1 Section... TAX (CONTINUED) INCOME TAXES (CONTINUED) Small Business Corporations and Their Shareholders § 1.1378-1 Taxable year of S corporation. (a) In general. The taxable year of an S corporation must be a permitted...

26 CFR 1.1378-1 - Taxable year of S corporation.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 11 2010-04-01 2010-04-01 true Taxable year of S corporation. 1.1378-1 Section... TAX (CONTINUED) INCOME TAXES Small Business Corporations and Their Shareholders § 1.1378-1 Taxable year of S corporation. (a) In general. The taxable year of an S corporation must be a permitted year. A...

26 CFR 1.1378-1 - Taxable year of S corporation.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 26 Internal Revenue 11 2011-04-01 2011-04-01 false Taxable year of S corporation. 1.1378-1 Section... TAX (CONTINUED) INCOME TAXES (CONTINUED) Small Business Corporations and Their Shareholders § 1.1378-1 Taxable year of S corporation. (a) In general. The taxable year of an S corporation must be a permitted...

26 CFR 1.1378-1 - Taxable year of S corporation.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 26 Internal Revenue 11 2013-04-01 2013-04-01 false Taxable year of S corporation. 1.1378-1 Section... TAX (CONTINUED) INCOME TAXES (CONTINUED) Small Business Corporations and Their Shareholders § 1.1378-1 Taxable year of S corporation. (a) In general. The taxable year of an S corporation must be a permitted...

26 CFR 1.1378-1 - Taxable year of S corporation.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 26 Internal Revenue 11 2014-04-01 2014-04-01 false Taxable year of S corporation. 1.1378-1 Section... TAX (CONTINUED) INCOME TAXES (CONTINUED) Small Business Corporations and Their Shareholders § 1.1378-1 Taxable year of S corporation. (a) In general. The taxable year of an S corporation must be a permitted...

26 CFR 1.444-1T - Election to use a taxable year other than the required taxable year (temporary).

Code of Federal Regulations, 2010 CFR

2010-04-01

... Election to use a taxable year other than the required taxable year (temporary). (a) General rules—(1) Year... how and when to make a section 444 election. (2) Effect of section 444 election—(i) In general. A... election—(i) In general. A section 444 election is terminated when— (A) A partnership, S corporation, or...

MEDICAL DEVICE PRICES IN ECONOMIC EVALUATIONS.

PubMed

Akpinar, Ilke; Jacobs, Philip; Husereau, Don

2015-01-01

Economic evaluations, although not formally used in purchasing decisions for medical devices in Canada, are still being conducted and published. The aim of this study was to examine the way that prices have been included in Canadian economic evaluations of medical devices. We conducted a review of the economic concepts and implications of methods used for economic evaluations of the eleven most implanted medical devices from the Canadian perspective. We found Canadian economic studies for five of the eleven medical devices and identified nineteen Canadian studies. Overall, the device costs were important components of total procedure cost, with an average ratio of 44.1 %. Observational estimates of the device costs were obtained from buyers or sellers in 13 of the 19 studies. Although most of the devices last more than 1 year, standard costing methods for capital equipment was never used. In addition, only eight studies included a sensitivity analysis for the device cost. None of the sensitivity analyses were based on actual price distributions. Economic evaluations are potentially important for policy making, but although they are being conducted, there is no standardized approach for incorporating medical device prices in economic analyses. Our review provides suggestions for improvements in how the prices are incorporated for economic evaluations of medical devices.

Medical device software: defining key terms.

PubMed

Pashkov, Vitalii; Gutorova, Nataliya; Harkusha, Andrii

one of the areas of significant growth in medical devices has been the role of software - as an integral component of a medical device, as a standalone device and more recently as applications on mobile devices. The risk related to a malfunction of the standalone software used within healthcare is in itself not a criterion for its qualification or not as a medical device. It is therefore, necessary to clarify some criteria for the qualification of stand-alone software as medical devices Materials and methods: Ukrainian, European Union, United States of America legislation, Guidelines developed by European Commission and Food and Drug Administration's, recommendations represented by international voluntary group and scientific works. This article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. the legal regulation of software which is used for medical purpose in Ukraine limited to one definition. In European Union and United States of America were developed and applying special guidelines that help developers, manufactures and end users to difference software on types standing on medical purpose criteria. Software becomes more and more incorporated into medical devices. Developers and manufacturers may not have initially appreciated potential risks to patients and users such situation could have dangerous results for patients or users. It is necessary to develop and adopt the legislation that will intend to define the criteria for the qualification of medical device software and the application of the classification criteria to such software, provide some illustrative examples and step by step recommendations to qualify software as medical device.

21 CFR 892.2020 - Medical image communications device.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical image communications device. 892.2020... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of medical...

21 CFR 892.2020 - Medical image communications device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical image communications device. 892.2020... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of medical...

21 CFR 892.2020 - Medical image communications device.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image communications device. 892.2020... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of medical...

21 CFR 892.2020 - Medical image communications device.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical image communications device. 892.2020... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of medical...

21 CFR 892.2040 - Medical image hardcopy device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical image hardcopy device. 892.2040 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical...

21 CFR 892.2040 - Medical image hardcopy device.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical image hardcopy device. 892.2040 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical...

21 CFR 892.2040 - Medical image hardcopy device.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image hardcopy device. 892.2040 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical...

21 CFR 892.2040 - Medical image hardcopy device.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical image hardcopy device. 892.2040 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical...

[Consideration of Mobile Medical Device Regulation].

PubMed

Peng, Liang; Yang, Pengfei; He, Weigang

2015-07-01

The regulation of mobile medical devices is one of the hot topics in the industry now. The definition, regulation scope and requirements, potential risks of mobile medical devices were analyzed and discussed based on mobile computing techniques and the FDA guidance of mobile medical applications. The regulation work of mobile medical devices in China needs to adopt the risk-based method.

Formal verification of software-based medical devices considering medical guidelines.

PubMed

Daw, Zamira; Cleaveland, Rance; Vetter, Marcus

2014-01-01

Software-based devices have increasingly become an important part of several clinical scenarios. Due to their critical impact on human life, medical devices have very strict safety requirements. It is therefore necessary to apply verification methods to ensure that the safety requirements are met. Verification of software-based devices is commonly limited to the verification of their internal elements without considering the interaction that these elements have with other devices as well as the application environment in which they are used. Medical guidelines define clinical procedures, which contain the necessary information to completely verify medical devices. The objective of this work was to incorporate medical guidelines into the verification process in order to increase the reliability of the software-based medical devices. Medical devices are developed using the model-driven method deterministic models for signal processing of embedded systems (DMOSES). This method uses unified modeling language (UML) models as a basis for the development of medical devices. The UML activity diagram is used to describe medical guidelines as workflows. The functionality of the medical devices is abstracted as a set of actions that is modeled within these workflows. In this paper, the UML models are verified using the UPPAAL model-checker. For this purpose, a formalization approach for the UML models using timed automaton (TA) is presented. A set of requirements is verified by the proposed approach for the navigation-guided biopsy. This shows the capability for identifying errors or optimization points both in the workflow and in the system design of the navigation device. In addition to the above, an open source eclipse plug-in was developed for the automated transformation of UML models into TA models that are automatically verified using UPPAAL. The proposed method enables developers to model medical devices and their clinical environment using clinical workflows as one

A guide to taxable debt financing alternatives.

PubMed

Aderholdt, J M; Pardue, C R

1989-07-01

The 1986 Tax Reform Act placed new restrictions on the use of tax-exempt financing for certain healthcare projects, and policymakers are considering further restrictions. In light of these developments, financial managers should become familiar with the available taxable debt financing options. These include commercial paper, taxable variable rate demand notes, floating rate notes, medium-term notes, long-term domestic public offerings, and domestic private placements.

26 CFR 1.4-4 - Short taxable year caused by death.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 26 Internal Revenue 1 2012-04-01 2012-04-01 false Short taxable year caused by death. 1.4-4... TAXES Normal Taxes and Surtaxes § 1.4-4 Short taxable year caused by death. An individual making a... taxable year results from the death of the taxpayer. Tax on Corporations ...

26 CFR 1.4-4 - Short taxable year caused by death.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 26 Internal Revenue 1 2013-04-01 2013-04-01 false Short taxable year caused by death. 1.4-4... TAXES Normal Taxes and Surtaxes § 1.4-4 Short taxable year caused by death. An individual making a... taxable year results from the death of the taxpayer. Tax on Corporations ...

26 CFR 1.803-7 - Taxable years affected.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 26 Internal Revenue 8 2013-04-01 2013-04-01 false Taxable years affected. 1.803-7 Section 1.803-7 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES (CONTINUED) Life Insurance Companies § 1.803-7 Taxable years affected. Sections 1.803-1...

26 CFR 1.803-7 - Taxable years affected.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 26 Internal Revenue 8 2014-04-01 2014-04-01 false Taxable years affected. 1.803-7 Section 1.803-7 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES (CONTINUED) Life Insurance Companies § 1.803-7 Taxable years affected. Sections 1.803-1...

26 CFR 1.803-7 - Taxable years affected.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 26 Internal Revenue 8 2012-04-01 2012-04-01 false Taxable years affected. 1.803-7 Section 1.803-7 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES (CONTINUED) Life Insurance Companies § 1.803-7 Taxable years affected. Sections 1.803-1...

26 CFR 1.803-7 - Taxable years affected.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 26 Internal Revenue 8 2011-04-01 2011-04-01 false Taxable years affected. 1.803-7 Section 1.803-7 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES (CONTINUED) Life Insurance Companies § 1.803-7 Taxable years affected. Sections 1.803-1...

26 CFR 301.7701(b)-6 - Taxable year.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 18 2010-04-01 2010-04-01 false Taxable year. 301.7701(b)-6 Section 301.7701(b)-6 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) PROCEDURE AND ADMINISTRATION PROCEDURE AND ADMINISTRATION Definitions § 301.7701(b)-6 Taxable year. (a) In general. An alien...

Legislation to regulate medical devices.

PubMed

Harris, M

1975-01-01

The history of medical device regulation began with the need to rid the marketplace of bogus inventions which were either harmful in themselves or harmful because they delayed meaningful treatment of illness. Since World War II, sophistication in medical technology and development of electronic and other types of medical devices has created a new need for regulation of safety and performance of devices used to cure and mitigate disease in man. The 1938 amendments to the Food, Drug, and Cosmetic Act gave FDA authority over labeling and advertising of devices, enforceable only after devices were marketed. In 1969 a study by an HEW commission documented the need for further legislation. The commission recommended three categories of medical devices: those requiring premarket clearance or scientific review, those for which standards could be established to protect the public, and those which are generally recognized as safe and for which nor standards would be necessary. In 1974 the Senate unanimously approved Senator Kennedy's "Medical Device Amendments of 1973" legislation which fulfills the recommendations of the HEW commission report. The House of Representatives failed to pass their version of the legislation in the 93rd Congress. Senator Kennedy re-introduced the bill in the 94th Congress and it passed the Senate in April 1975. Representative Rogers re-introduced an amended bill. The bill is expected to become law in 1975.

21 CFR 880.6310 - Medical device data system.

Code of Federal Regulations, 2011 CFR

2011-04-01

... medical device data; (ii) The electronic storage of medical device data; (iii) The electronic conversion... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical device data system. 880.6310 Section 880... Devices § 880.6310 Medical device data system. (a) Identification. (1) A medical device data system (MDDS...

21 CFR 880.6310 - Medical device data system.

Code of Federal Regulations, 2012 CFR

2012-04-01

... medical device data; (ii) The electronic storage of medical device data; (iii) The electronic conversion... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical device data system. 880.6310 Section 880... Devices § 880.6310 Medical device data system. (a) Identification. (1) A medical device data system (MDDS...

21 CFR 880.6310 - Medical device data system.

Code of Federal Regulations, 2014 CFR

2014-04-01

... medical device data; (ii) The electronic storage of medical device data; (iii) The electronic conversion... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical device data system. 880.6310 Section 880... Devices § 880.6310 Medical device data system. (a) Identification. (1) A medical device data system (MDDS...

21 CFR 880.6310 - Medical device data system.

Code of Federal Regulations, 2013 CFR

2013-04-01

... medical device data; (ii) The electronic storage of medical device data; (iii) The electronic conversion... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical device data system. 880.6310 Section 880... Devices § 880.6310 Medical device data system. (a) Identification. (1) A medical device data system (MDDS...

Medical device development.

PubMed

Panescu, Dorin

2009-01-01

The development of a successful medical product requires not only engineering design efforts, but also clinical, regulatory, marketing and business expertise. This paper reviews items related to the process of designing medical devices. It discusses the steps required to take a medical product idea from concept, through development, verification and validation, regulatory approvals and market release.

21 CFR 892.2010 - Medical image storage device.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and retrieval...

21 CFR 892.2010 - Medical image storage device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and retrieval...

21 CFR 892.2010 - Medical image storage device.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and retrieval...

21 CFR 892.2010 - Medical image storage device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and retrieval...

21 CFR 892.2010 - Medical image storage device.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and retrieval...

The new collaborative path in medical device development: the medical device innovation consortium.

PubMed

Kampfrath, Thomas; Cotten, Steven W

2013-10-01

The United States medical device market is the world's largest with over $100 billion in sales in 2011. Despite robust industry growth, the efficiency of the FDA approval process for moderate-risk (Class II) and high-risk devices (Class III) requiring 510(k) submission or pre-market approval (PMA) has been criticized. Recently, the FDA's Center for Devices and Radiological Health (CDRH) announced the creation of a Medical Device Innovation Consortium (MDIC), a public-private partnership (PPP) to share knowledge in regulatory science. Overarching goals include creating a forum for the exchange of ideas among the FDA, industry, and non-profit entities; providing monetary investments for project proposals prioritized by key working groups; and developing tools that support cost effective innovation, data-driven methodology, and implementation strategies. Clinical chemists and clinical laboratory scientists have several unique opportunities to contribute to the MDIC. These laboratory professionals have invaluable experience with the real-life performance of a variety of medical devices and their expertise can recognize unmet needs and contribute towards the acceleration of device development. Copyright © 2013 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

26 CFR 1.832-3 - Taxable years affected.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 26 Internal Revenue 8 2011-04-01 2011-04-01 false Taxable years affected. 1.832-3 Section 1.832-3 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES (CONTINUED) Other Insurance Companies § 1.832-3 Taxable years affected. Sections 1.832-1 and...

26 CFR 1.832-3 - Taxable years affected.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 26 Internal Revenue 8 2014-04-01 2014-04-01 false Taxable years affected. 1.832-3 Section 1.832-3 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES (CONTINUED) Other Insurance Companies § 1.832-3 Taxable years affected. Sections 1.832-1 and...

26 CFR 1.832-3 - Taxable years affected.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 26 Internal Revenue 8 2012-04-01 2012-04-01 false Taxable years affected. 1.832-3 Section 1.832-3 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES (CONTINUED) Other Insurance Companies § 1.832-3 Taxable years affected. Sections 1.832-1 and...

26 CFR 1.832-3 - Taxable years affected.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 26 Internal Revenue 8 2013-04-01 2013-04-01 false Taxable years affected. 1.832-3 Section 1.832-3 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES (CONTINUED) Other Insurance Companies § 1.832-3 Taxable years affected. Sections 1.832-1 and...

26 CFR 1.522-4 - Taxable years affected.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 7 2010-04-01 2010-04-01 true Taxable years affected. 1.522-4 Section 1.522-4 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES (CONTINUED) Farmers' Cooperatives § 1.522-4 Taxable years affected. Section 522 and §§ 1.522...

26 CFR 1.832-3 - Taxable years affected.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 8 2010-04-01 2010-04-01 false Taxable years affected. 1.832-3 Section 1.832-3 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES Other Insurance Companies § 1.832-3 Taxable years affected. Sections 1.832-1 and 1.832-2 are...

26 CFR 1.803-7 - Taxable years affected.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 8 2010-04-01 2010-04-01 false Taxable years affected. 1.803-7 Section 1.803-7 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES Life Insurance Companies § 1.803-7 Taxable years affected. Sections 1.803-1 through 1.803-6...

The economic evaluation of medical devices: challenges.

PubMed

Kingkaew, Pritaporn; Teerawattananon, Yot

2014-05-01

While many of the principles that guide the economic evaluation of medical devices are somewhat similar to those that guide the evaluation of other health technologies, most outline a methodology that focuses on pharmaceutical products rather providing specific guidance for medical devices. Given that medical devices use a wide range of technologies and can be used for many purposes, conducting an economic analysis for medical devices is not straightforward. The cost and effectiveness of a given technology may depend on a number of factors. The objective of this paper is to provide a summary of issues that need to be addressed before undertaking an economic evaluation of medical devices and to outline a number of suggested approaches for undertaking an economic evaluation of medical devices.

26 CFR 1.545-2 - Adjustments to taxable income.

Code of Federal Regulations, 2014 CFR

2014-04-01

....545-2 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES (CONTINUED) Personal Holding Companies § 1.545-2 Adjustments to taxable income. (a) Taxes—(1) General rule. (i) In computing undistributed personal holding company income for any taxable...

Using Zigbee to integrate medical devices.

PubMed

Frehill, Paul; Chambers, Desmond; Rotariu, Cosmin

2007-01-01

Wirelessly enabling Medical Devices such as Vital Signs Monitors, Ventilators and Infusion Pumps allows central data collection. This paper discusses how data from these types of devices can be integrated into hospital systems using wireless sensor networking technology. By integrating devices you are protecting investment and opening up the possibility of networking with similar devices. In this context we present how Zigbee meets our requirements for bandwidth, power, security and mobility. We have examined the data throughputs for various medical devices, the requirement of data frequency, security of patient data and the logistics of moving patients while connected to devices. The paper describes a new tested architecture that allows this data to be seamlessly integrated into a User Interface or Healthcare Information System (HIS). The design supports the dynamic addition of new medical devices to the system that were previously unsupported by the system. To achieve this, the hardware design is kept generic and the software interface for different types of medical devices is well defined. These devices can also share the wireless resources with other types of sensors being developed in conjunction on this project such as wireless ECG (Electrocardiogram) and Pulse-Oximetry sensors.

26 CFR 31.3502-1 - Nondeductibility of taxes in computing taxable income.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 15 2010-04-01 2010-04-01 false Nondeductibility of taxes in computing taxable... 1954) § 31.3502-1 Nondeductibility of taxes in computing taxable income. For provisions relating to the nondeductibility, in computing taxable income under subtitle A, of the taxes imposed by sections 3101, 3201, and...

26 CFR 1.852-3 - Investment company taxable income.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 9 2010-04-01 2010-04-01 false Investment company taxable income. 1.852-3... TAX (CONTINUED) INCOME TAXES Regulated Investment Companies and Real Estate Investment Trusts § 1.852-3 Investment company taxable income. Section 852(b)(2) requires certain adjustments to be made to...

26 CFR 1.852-3 - Investment company taxable income.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 26 Internal Revenue 9 2011-04-01 2011-04-01 false Investment company taxable income. 1.852-3... TAX (CONTINUED) INCOME TAXES (CONTINUED) Regulated Investment Companies and Real Estate Investment Trusts § 1.852-3 Investment company taxable income. Section 852(b)(2) requires certain adjustments to be...

26 CFR 1.852-3 - Investment company taxable income.

Code of Federal Regulations, 2014 CFR

2014-04-01

... TAX (CONTINUED) INCOME TAXES (CONTINUED) Regulated Investment Companies and Real Estate Investment Trusts § 1.852-3 Investment company taxable income. Section 852(b)(2) requires certain adjustments to be... 26 Internal Revenue 9 2014-04-01 2014-04-01 false Investment company taxable income. 1.852-3...

26 CFR 1.852-3 - Investment company taxable income.

Code of Federal Regulations, 2013 CFR

2013-04-01

... TAX (CONTINUED) INCOME TAXES (CONTINUED) Regulated Investment Companies and Real Estate Investment Trusts § 1.852-3 Investment company taxable income. Section 852(b)(2) requires certain adjustments to be... 26 Internal Revenue 9 2013-04-01 2013-04-01 false Investment company taxable income. 1.852-3...

26 CFR 1.852-3 - Investment company taxable income.

Code of Federal Regulations, 2012 CFR

2012-04-01

... TAX (CONTINUED) INCOME TAXES (CONTINUED) Regulated Investment Companies and Real Estate Investment Trusts § 1.852-3 Investment company taxable income. Section 852(b)(2) requires certain adjustments to be... 26 Internal Revenue 9 2012-04-01 2012-04-01 false Investment company taxable income. 1.852-3...

Innovation and the medical devices Farady partnership.

PubMed

Tavakoli, M; Dunkerton, S B

2005-06-01

Demand for development of new generation medical devices has led many governments to support medical-sector research. In the United Kingdom, the Medical Devices Faraday Partnership was created to establish a collaborative network that would enhance the transfer of good ideas into new products and processes. The services it offers medical device manufacturers are outlined here.

Body Implanted Medical Device Communications

NASA Astrophysics Data System (ADS)

Yazdandoost, Kamya Yekeh; Kohno, Ryuji

The medical care day by day and more and more is associated with and reliant upon concepts and advances of electronics and electromagnetics. Numerous medical devices are implanted in the body for medical use. Tissue implanted devices are of great interest for wireless medical applications due to the promising of different clinical usage to promote a patient independence. It can be used in hospitals, health care facilities and home to transmit patient measurement data, such as pulse and respiration rates to a nearby receiver, permitting greater patient mobility and increased comfort. As this service permits remote monitoring of several patients simultaneously it could also potentially decrease health care costs. Advancement in radio frequency communications and miniaturization of bioelectronics are supporting medical implant applications. A central component of wireless implanted device is an antenna and there are several issues to consider when designing an in-body antenna, including power consumption, size, frequency, biocompatibility and the unique RF transmission challenges posed by the human body. The radiation characteristics of such devices are important in terms of both safety and performance. The implanted antenna and human body as a medium for wireless communication are discussed over Medical Implant Communications Service (MICS) band in the frequency range of 402-405MHz.

26 CFR 1.803-4 - Taxable income and deductions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) INCOME TAXES Life Insurance Companies § 1.803-4 Taxable income and deductions. (a) In general. The taxable income of a life insurance company is its gross amount of income received or accrued... occupied by a life insurance company provided in section 803(h), the limitations on the adjustment for...

26 CFR 1.545-2 - Adjustments to taxable income.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 7 2010-04-01 2010-04-01 true Adjustments to taxable income. 1.545-2 Section 1.545-2 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES (CONTINUED) Personal Holding Companies § 1.545-2 Adjustments to taxable income. (a...

26 CFR 1.15-1 - Changes in rate during a taxable year.

Code of Federal Regulations, 2010 CFR

2010-04-01

... ending during 1976 constitutes a change in rate for such portion of the taxable year (if less than the... taxable years beginning on or after March 1, 1954, and changed again for taxable years beginning on or... began before March 1, 1954, and ended on or after June 1, 1954: One tentative tax at the rate in effect...

26 CFR 1.803-4 - Taxable income and deductions.

Code of Federal Regulations, 2011 CFR

2011-04-01

... (CONTINUED) INCOME TAXES (CONTINUED) Life Insurance Companies § 1.803-4 Taxable income and deductions. (a) In general. The taxable income of a life insurance company is its gross amount of income received or accrued... occupied by a life insurance company provided in section 803(h), the limitations on the adjustment for...

26 CFR 1.803-4 - Taxable income and deductions.

Code of Federal Regulations, 2014 CFR

2014-04-01

... (CONTINUED) INCOME TAXES (CONTINUED) Life Insurance Companies § 1.803-4 Taxable income and deductions. (a) In general. The taxable income of a life insurance company is its gross amount of income received or accrued... occupied by a life insurance company provided in section 803(h), the limitations on the adjustment for...

26 CFR 1.803-4 - Taxable income and deductions.

Code of Federal Regulations, 2012 CFR

2012-04-01

... (CONTINUED) INCOME TAXES (CONTINUED) Life Insurance Companies § 1.803-4 Taxable income and deductions. (a) In general. The taxable income of a life insurance company is its gross amount of income received or accrued... occupied by a life insurance company provided in section 803(h), the limitations on the adjustment for...

26 CFR 1.803-4 - Taxable income and deductions.

Code of Federal Regulations, 2013 CFR

2013-04-01

... (CONTINUED) INCOME TAXES (CONTINUED) Life Insurance Companies § 1.803-4 Taxable income and deductions. (a) In general. The taxable income of a life insurance company is its gross amount of income received or accrued... occupied by a life insurance company provided in section 803(h), the limitations on the adjustment for...

26 CFR 48.4081-2 - Taxable fuel; tax on removal at a terminal rack.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 16 2010-04-01 2010-04-01 true Taxable fuel; tax on removal at a terminal rack..., Tread Rubber, and Taxable Fuel Taxable Fuel § 48.4081-2 Taxable fuel; tax on removal at a terminal rack... rack are subject to tax and the position holder with respect to the fuel is liable for the tax. (b...

26 CFR 25.2702-6 - Reduction in taxable gifts.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 14 2010-04-01 2010-04-01 false Reduction in taxable gifts. 25.2702-6 Section... AND GIFT TAXES GIFT TAX; GIFTS MADE AFTER DECEMBER 31, 1954 Special Valuation Rules § 25.2702-6 Reduction in taxable gifts. (a) Transfers of retained interests in trust—(1) Inter vivos transfers. If an...

26 CFR 1.857-2 - Real estate investment trust taxable income and net capital gain.

Code of Federal Regulations, 2010 CFR

2010-04-01

... estate investment trust taxable income and net capital gain. (a) Real estate investment trust taxable... paid during the taxable year, and the net capital gain is excluded in computing real estate investment... 26 Internal Revenue 9 2010-04-01 2010-04-01 false Real estate investment trust taxable income and...

21 CFR 892.2020 - Medical image communications device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical image communications device. 892.2020 Section 892.2020 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications...

26 CFR 1.15-1 - Changes in rate during a taxable year.

Code of Federal Regulations, 2011 CFR

2011-04-01

... (see § 1.51-1(d)(1)(i)) 56.26 Total tax for the taxable year 4,569.20 Example 3. H and W, husband and... beginning after December 31, 1969. H and W file a joint return on the basis of a taxable year ending August 31. For the taxable year ending August 31, 1970, H and W have adjusted gross income of $12,500. Their...

26 CFR 1.15-1 - Changes in rate during a taxable year.

Code of Federal Regulations, 2014 CFR

2014-04-01

... (see § 1.51-1(d)(1)(i)) 56.26 Total tax for the taxable year 4,569.20 Example 3. H and W, husband and... beginning after December 31, 1969. H and W file a joint return on the basis of a taxable year ending August 31. For the taxable year ending August 31, 1970, H and W have adjusted gross income of $12,500. Their...

26 CFR 1.15-1 - Changes in rate during a taxable year.

Code of Federal Regulations, 2013 CFR

2013-04-01

... (see § 1.51-1(d)(1)(i)) 56.26 Total tax for the taxable year 4,569.20 Example 3. H and W, husband and... beginning after December 31, 1969. H and W file a joint return on the basis of a taxable year ending August 31. For the taxable year ending August 31, 1970, H and W have adjusted gross income of $12,500. Their...

26 CFR 1.15-1 - Changes in rate during a taxable year.

Code of Federal Regulations, 2012 CFR

2012-04-01

... (see § 1.51-1(d)(1)(i)) 56.26 Total tax for the taxable year 4,569.20 Example 3. H and W, husband and... beginning after December 31, 1969. H and W file a joint return on the basis of a taxable year ending August 31. For the taxable year ending August 31, 1970, H and W have adjusted gross income of $12,500. Their...

Protecting and securing networked medical devices.

PubMed

Riha, Chris

2004-01-01

Designing, building, and maintaining a secure environment for medical devices is a critical component in health care technology management. This article will address several avenues to harden a health care information network to provide a secure enclave for medical devices.

A novel network module for medical devices.

PubMed

Chen, Ping-Yu

2008-01-01

In order to allow medical devices to upload the vital signs to a server on a network without manually configuring for end-users, a new network module is proposed. The proposed network module, called Medical Hub (MH), functions as a bridge to fetch the data from all connecting medical devices, and then upload these data to the server. When powering on, the MH can immediately establish network configuration automatically. Network Address Translation (NAT) traversal is also supported by the MH with the UPnP Internet Gateway Device (IGD) methodology. Besides the network configuration, other configuration in the MH is automatically established by using the remote management protocol TR-069. On the other hand, a mechanism for updating software automatically according to the variant connected medical device is proposed. With this mechanism, newcome medical devices can be detected and supported by the MH without manual operation.

Certain aspects on medical devices software law regulation.

PubMed

Pashkov, Vitalii; Harkusha, Andrii

some kind of easiness of entry in creating software products on various computing platforms has led to such products being made available perhaps without due consideration of potential risks to users and patients and the most valuable reason for this have been lack of regulatory clarity. Some key points on legal regulation of abovementioned sphere is a base of this study. Ukrainian legislation, European Union`s Guidelines on the qualification and classification of standalone software; Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices that works in United States of America. Article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. in accordance with Ukrainian legislation, software that has a medical purpose could be a medical device. Ukrainian legislation which is established on European Union Medical Devices Directives divide all medical devices on classes. But there aren't any special recommendations or advices on classifications for software medical devices in Ukraine. It is necessary to develop and adopt guidelines on the qualification and classification of medical device software in Ukraine especially considering the harmonization of Ukrainian legislation with the EU legislation, develop special rules for the application of the national mark of conformity for medical device software and defined the « responsible organization » for the medical device software approval process.

Medical device market in China.

PubMed

Boyer, Philip; Morshed, Bashir I; Mussivand, Tofy

2015-06-01

With China's growing old-age population and economic presence on the international stage, it has become important to evaluate its domestic and foreign market contribution to medical devices. Medical devices are instruments or apparatuses used in the prevention, rehabilitation, treatment, or knowledge generation with respect to disease or other abnormal conditions. This article provides information drawn from recent publications to describe the current state of the Chinese domestic market for medical devices and to define opportunities for foreign investment potential therein. Recent healthcare reforms implemented to meet rising demand due to an aging and migrating population are having a positive effect on market growth-a global market with a projected growth of 15% per year over the next decade. Copyright © 2015 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

Economic content in medical journal advertisements for medical devices and prescription drugs.

PubMed

Ackerly, D Clay; Glickman, Seth W; Schulman, Kevin A

2010-01-01

Previous studies of economic content in medical journal advertisements have not examined all types of economic content and have not included advertisements for medical devices. To examine trends in the economic content of medical device and pharmaceutical advertisements in medical journals. Three reviewers examined pharmaceutical and medical device advertisements in six leading medical journals from 1997 through 2006. Product characteristics, economic claims and evidence to support those claims were evaluated. Economic content appeared in 23.5% (561/2389) of pharmaceutical and device advertisements; 11.9% made market share claims and 12.7% made other economic claims. From 1997 through 2006, the percentage of medical device advertisements containing economic content declined from 26.7% to 6.7% (p = 0.02), whereas the percentage of pharmaceutical advertisements containing economic content remained stable (21.6-22.0%; p = 0.99). For pharmaceuticals, price claims declined significantly (15.7-4.2%; p < 0.01) and market share claims increased (2.8-11.5%; p = 0.09), and both consistently presented evidence (83% and 98%, respectively) while other types did not (e.g. 13.5% of formulary claims). Medical device economic claims differed from pharmaceutical economic claims; they made fewer market share claims (1.1% vs 12.8%) but more cost-effectiveness (6.5% vs 0.6%) and reimbursement (4.9% vs 0.8%) claims. Fewer than 2% of device advertisements with economic claims provided supporting evidence. The prevalence and type of economic content in pharmaceutical and device advertisements changed between 1997 and 2006, which may reflect evolving market dynamics, such as changes in reimbursement systems. Furthermore, the lack of supporting evidence in medical device advertisements and pharmaceutical formulary claims are potential areas of concern that require additional scrutiny by regulators and journal editors.

Technology assessment of medical devices at the Center for Devices and Radiological Health.

PubMed

Kessler, L; Richter, K

1998-09-25

We reviewed the Food and Drug Administration's regulatory process for medical devices and described the issues that arise in assessing device safety and effectiveness during the postmarket period. The Center for Devices and Radiological Health (CDRH), an organization within the Food and Drug Administration, has the legal authority and responsibility for ensuring that medical devices marketed in the United States are both reasonably safe and effective for their intended use. This is an enormous challenge given the diversity of medical devices and the large number of different types of devices on the market. Many scientific and regulatory activities are necessary to ensure device safety and effectiveness, including technology assessment, albeit in a manner quite different from that of conventional technology assessment. The basic approach taken at the CDRH to ensure device safety and effectiveness is to develop an understanding of the way in which a medical device works and how it will perform in clinical situations.

26 CFR 1.337(d)-4 - Taxable to tax-exempt.

Code of Federal Regulations, 2010 CFR

2010-04-01

... deductions. The tax-exempt entity also must use this same reasonable method of allocation for each taxable... 26 Internal Revenue 4 2010-04-01 2010-04-01 false Taxable to tax-exempt. 1.337(d)-4 Section 1.337(d)-4 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) INCOME TAX...

Registration of Medical Devices

PubMed Central

George, Bobby

2010-01-01

Globally the medical device (MD) market has been growing quite rapidly over the past decade. The regulatory framework for pharmaceuticals and devices differ substantially. The regulatory authorities in different regions of the world recognize different classes of medical devices (MDs), based on their design complexity, their use characteristics, and their potential for harm, if misused. With the vast majority of MDs in developing countries being imported, the respective governments need to put in place policies & regulations to address all elements related to MDs, ranging from its development, manufacturing, registration to post-marketing obligations & disposal so that public can have access to high quality, safe & affordable products for appropriate use. This article highlights current regulations pertaining to registration of MDs in India, in light of those existing in Global Harmonization Task Force (GHTF) member countries & Association of Southeast Asian Nations (ASEAN) countries. PMID:21814626

21 CFR 801.6 - Medical devices; misleading statements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; misleading statements. 801.6 Section 801.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.6 Medical devices; misleading...

21 CFR 801.6 - Medical devices; misleading statements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical devices; misleading statements. 801.6 Section 801.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.6 Medical devices; misleading...

Physician-industry cooperation in the medical device industry.

PubMed

Chatterji, Aaron K; Fabrizio, Kira R; Mitchell, Will; Schulman, Kevin A

2008-01-01

Anecdotal evidence suggests that innovative medical devices often arise from physicians' inventive activity, but no studies have documented the extent of such physician-engaged innovation. This paper uses patent data and the American Medical Association Physician Masterfile to provide evidence that physicians contribute to medical device innovation, accounting for almost 20 percent of approximately 26,000 medical device patents filed in the United States during 1990-1996. Moreover, two measures indicate that physician patents had more influence on subsequent inventive activity than nonphysician patents. This finding supports the maintenance of an open environment for physician-industry collaboration in the medical device discovery process.

Legislative aspects of the development of medical devices.

PubMed

Marešová, Petra; Klímová, Blanka; Krejcar, Ondřej; Kuča, Kamil

2015-09-01

European industry of medical device technologies represents 30% of all worlds sales. New health technologies bring effective treatment approaches, help shorten stays in hospital1),bring better treatment results and accelerate rehabilitation which leads to the earlier patients recovery.Legislative aspects are one of the key areas influencing the speed of development of medical devices and their launching. The aim of this article is to specify current state of legislation in the development of medical devices in the European Union in comparison with the market leaders such as China, Japan and USA.The best established market of medical devices is in the USA. Both Japan and China follow the USA model. However, a non-professional code of ethics in China in some respect contributes to the decrease of quality of medical devices, while Japan as well as the EU countries try really hard to conform to all the regulations imposed on the manufacturing of medical devices.

The Need to Apply Medical Device Informatics in Developing Standards for Safe Interoperable Medical Systems.

PubMed

Weininger, Sandy; Jaffe, Michael B; Goldman, Julian M

2017-01-01

Medical device and health information technology systems are increasingly interdependent with users demanding increased interoperability. Related safety standards must be developed taking into account these systems' perspective. In this article, we describe the current development of medical device standards and the need for these standards to address medical device informatics. Medical device information should be gathered from a broad range of clinical scenarios to lay the foundation for safe medical device interoperability. Five clinical examples show how medical device informatics principles, if applied in the development of medical device standards, could help facilitate the development of safe interoperable medical device systems. These examples illustrate the clinical implications of the failure to capture important signals and device attributes. We provide recommendations relating to the coordination between historically separate standards development groups, some of which focus on safety and effectiveness and others focus on health informatics. We identify the need for a shared understanding among stakeholders and describe organizational structures to promote cooperation such that device-to-device interactions and related safety information are considered during standards development.

The Need to Apply Medical Device Informatics in Developing Standards for Safe Interoperable Medical Systems

PubMed Central

Weininger, Sandy; Jaffe, Michael B.; Goldman, Julian M

2016-01-01

Medical device and health information technology systems are increasingly interdependent with users demanding increased interoperability. Related safety standards must be developed taking into account this systems perspective. In this article we describe the current development of medical device standards and the need for these standards to address medical device informatics. Medical device information should be gathered from a broad range of clinical scenarios to lay the foundation for safe medical device interoperability. Five clinical examples show how medical device informatics principles, if applied in the development of medical device standards, could help facilitate the development of safe interoperable medical device systems. These examples illustrate the clinical implications of the failure to capture important signals and device attributes. We provide recommendations relating to the coordination between historically separate standards development groups; some which focus on safety and effectiveness, and others that focus on health informatics. We identify the need for a shared understanding among stakeholders and describe organizational structures to promote cooperation such that device-to-device interactions and related safety information are considered during standards development. PMID:27584685

Analytical Chemistry in the Regulatory Science of Medical Devices.

PubMed

Wang, Yi; Guan, Allan; Wickramasekara, Samanthi; Phillips, K Scott

2018-06-12

In the United States, regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all Food and Drug Administration-regulated products. Good regulatory science facilitates consumer access to innovative medical devices that are safe and effective throughout the Total Product Life Cycle (TPLC). Because the need to measure things is fundamental to the regulatory science of medical devices, analytical chemistry plays an important role, contributing to medical device technology in two ways: It can be an integral part of an innovative medical device (e.g., diagnostic devices), and it can be used to support medical device development throughout the TPLC. In this review, we focus on analytical chemistry as a tool for the regulatory science of medical devices. We highlight recent progress in companion diagnostics, medical devices on chips for preclinical testing, mass spectrometry for postmarket monitoring, and detection/characterization of bacterial biofilm to prevent infections.

Regulatory science based approach in development of novel medical devices.

PubMed

Sakuma, Ichiro

2015-08-01

For development rational evaluation method for medical devices' safety and efficacy, regulatory science studies are important. Studies on regulatory affairs related to a medical device under development should be conducted as well as its technological development. Clinical performance of a medical device is influenced by performance of the device, medical doctors' skill, pathological condition of a patient, and so on. Thus it is sometimes difficult to demonstrate superiority of the device in terms of clinical outcome although its efficacy as a medical device is accepted. Setting of appropriate end points is required to evaluate a medical device appropriately. Risk assessment and risk management are the basis of medical device safety assurance. In case of medical device software, there are difficulties in identifying the risk due to its complexity of user environment and different design and manufacturing procedure compared with conventional hardware based medical devices. Recent technological advancement such as information and communication technologies (ICT) for medical devices and wireless network has raised new issue on risk management: cybersecurity. We have to watch closely the progress of safety standard development.

Privacy Challenges for Wireless Medical Devices

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lagesse, Brent J

2010-01-01

Implantable medical devices are becoming more pervasive as new technologies increase their reliability and safety. Furthermore, these devices are becoming increasingly reliant on wireless communication for interaction with the device. Such technologies have the potential to leak information that could be utilized by an attacker to threaten the lives of patients. Privacy of patient information is essential; however, this information is not the only privacy issue that must be considered. In this paper, we discuss why information privacy is insufficient for protecting patients from some attacks and how information regarding the presence of individual devices can leak vulnerabilities. Furthermore, wemore » examine existing privacy enhancing algorithms and discuss their applicability to implantable medical devices.« less

An update on mobile phones interference with medical devices.

PubMed

Mahmoud Pashazadeh, Ali; Aghajani, Mahdi; Nabipour, Iraj; Assadi, Majid

2013-10-01

Mobile phones' electromagnetic interference with medical devices is an important issue for the medical safety of patients who are using life-supporting medical devices. This review mainly focuses on mobile phones' interference with implanted medical devices and with medical equipment located in critical areas of hospitals. A close look at the findings reveals that mobile phones may adversely affect the functioning of medical devices, and the specific effect and the degree of interference depend on the applied technology and the separation distance. According to the studies' findings and the authors' recommendations, besides mitigating interference, using mobile phones at a reasonable distance from medical devices and developing technology standards can lead to their effective use in hospital communication systems.

26 CFR 48.4082-3 - Diesel fuel and kerosene; visual inspection devices. [Reserved

Code of Federal Regulations, 2012 CFR

2012-04-01

... 26 Internal Revenue 16 2012-04-01 2012-04-01 false Diesel fuel and kerosene; visual inspection devices. [Reserved] 48.4082-3 Section 48.4082-3 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF... Vehicles, Tires, Tubes, Tread Rubber, and Taxable Fuel Taxable Fuel § 48.4082-3 Diesel fuel and kerosene...

26 CFR 48.4082-3 - Diesel fuel and kerosene; visual inspection devices. [Reserved

Code of Federal Regulations, 2011 CFR

2011-04-01

... 26 Internal Revenue 16 2011-04-01 2011-04-01 false Diesel fuel and kerosene; visual inspection devices. [Reserved] 48.4082-3 Section 48.4082-3 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF... Vehicles, Tires, Tubes, Tread Rubber, and Taxable Fuel Taxable Fuel § 48.4082-3 Diesel fuel and kerosene...

26 CFR 48.4082-3 - Diesel fuel and kerosene; visual inspection devices. [Reserved

Code of Federal Regulations, 2013 CFR

2013-04-01

... 26 Internal Revenue 16 2013-04-01 2013-04-01 false Diesel fuel and kerosene; visual inspection devices. [Reserved] 48.4082-3 Section 48.4082-3 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF... Vehicles, Tires, Tubes, Tread Rubber, and Taxable Fuel Taxable Fuel § 48.4082-3 Diesel fuel and kerosene...

26 CFR 48.4082-3 - Diesel fuel and kerosene; visual inspection devices. [Reserved

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 16 2010-04-01 2010-04-01 true Diesel fuel and kerosene; visual inspection devices. [Reserved] 48.4082-3 Section 48.4082-3 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF... Vehicles, Tires, Tubes, Tread Rubber, and Taxable Fuel Taxable Fuel § 48.4082-3 Diesel fuel and kerosene...

78 FR 60291 - Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-01

...] Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY... Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.'' Through the...

Strengthening the Role of Nurses in Medical Device Development.

PubMed

Castner, Jessica; Sullivan, Suzanne S; Titus, Albert H; Klingman, Karen J

2016-01-01

Medical devices and innovative technology promise to revolutionize health care. Despite the importance of involving nurses in the collaborative medical device development processes, there are few learning opportunities in nursing programs. The purpose of this article is to provide a conceptual guide for nurse educators and researchers to engage nursing expertise in medical device development processes. A review of the literature guided the creation of the "Strengthening the Role of Nurses in Medical Device Development Roadmap" model. The model was used to describe how nurses can be engaged in multidisciplinary design of medical devices. An academic transdisciplinary team piloted the application of the model. The model includes the stages of needs assessment, planned brainstorm, feasibility determination, concept design, and prototype building. A transdisciplinary team case study of improving an asthma home-monitoring devices illustrates effective application of the model. Nurse leaders in the academic setting can effectively use the "Strengthening the Role of Nurses in Medical Device Development Roadmap" to inform their engagement of nurses in early medical device development and innovation processes. Copyright © 2016 Elsevier Inc. All rights reserved.

Model-based engineering for medical-device software.

PubMed

Ray, Arnab; Jetley, Raoul; Jones, Paul L; Zhang, Yi

2010-01-01

This paper demonstrates the benefits of adopting model-based design techniques for engineering medical device software. By using a patient-controlled analgesic (PCA) infusion pump as a candidate medical device, the authors show how using models to capture design information allows for i) fast and efficient construction of executable device prototypes ii) creation of a standard, reusable baseline software architecture for a particular device family, iii) formal verification of the design against safety requirements, and iv) creation of a safety framework that reduces verification costs for future versions of the device software. 1.

27 CFR 53.113 - Events subsequent to taxable use of article.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2010-04-01 2010-04-01 false Events subsequent to taxable use of article. 53.113 Section 53.113 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO... Importer Considered Sale § 53.113 Events subsequent to taxable use of article. Liability for tax incurred...

27 CFR 53.113 - Events subsequent to taxable use of article.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2014-04-01 2014-04-01 false Events subsequent to taxable use of article. 53.113 Section 53.113 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO... Importer Considered Sale § 53.113 Events subsequent to taxable use of article. Liability for tax incurred...

27 CFR 53.113 - Events subsequent to taxable use of article.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2011-04-01 2011-04-01 false Events subsequent to taxable use of article. 53.113 Section 53.113 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO... Importer Considered Sale § 53.113 Events subsequent to taxable use of article. Liability for tax incurred...

27 CFR 53.113 - Events subsequent to taxable use of article.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2013-04-01 2013-04-01 false Events subsequent to taxable use of article. 53.113 Section 53.113 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO... Importer Considered Sale § 53.113 Events subsequent to taxable use of article. Liability for tax incurred...

27 CFR 53.113 - Events subsequent to taxable use of article.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2012-04-01 2011-04-01 true Events subsequent to taxable use of article. 53.113 Section 53.113 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO... Importer Considered Sale § 53.113 Events subsequent to taxable use of article. Liability for tax incurred...

77 FR 18829 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-28

...] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory... and 11, 2012, the committee will discuss general issues related to medical devices intended for obese...

[Ethic review on clinical experiments of medical devices in medical institutions].

PubMed

Shuai, Wanjun; Chao, Yong; Wang, Ning; Xu, Shining

2011-07-01

Clinical experiments are always used to evaluate the safety and validity of medical devices. The experiments have two types of clinical trying and testing. Ethic review must be done by the ethics committee of the medical department with the qualification of clinical research, and the approval must be made before the experiments. In order to ensure the safety and validity of clinical experiments of medical devices in medical institutions, the contents, process and approval criterions of the ethic review were analyzed and discussed.

Regulatory approval of new medical devices: cross sectional study.

PubMed

Marcus, Hani J; Payne, Christopher J; Hughes-Hallett, Archie; Marcus, Adam P; Yang, Guang-Zhong; Darzi, Ara; Nandi, Dipankar

2016-05-20

 To investigate the regulatory approval of new medical devices.  Cross sectional study of new medical devices reported in the biomedical literature.  PubMed was searched between 1 January 2000 and 31 December 2004 to identify clinical studies of new medical devices. The search was carried out during this period to allow time for regulatory approval.  Articles were included if they reported a clinical study of a new medical device and there was no evidence of a previous clinical study in the literature. We defined a medical device according to the US Food and Drug Administration as an "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article."  Type of device, target specialty, and involvement of academia or of industry for each clinical study. The FDA medical databases were then searched for clearance or approval relevant to the device.  5574 titles and abstracts were screened, 493 full text articles assessed for eligibility, and 218 clinical studies of new medical devices included. In all, 99/218 (45%) of the devices described in clinical studies ultimately received regulatory clearance or approval. These included 510(k) clearance for devices determined to be "substantially equivalent" to another legally marketed device (78/99; 79%), premarket approval for high risk devices (17/99; 17%), and others (4/99; 4%). Of these, 43 devices (43/99; 43%) were actually cleared or approved before a clinical study was published.  We identified a multitude of new medical devices in clinical studies, almost half of which received regulatory clearance or approval. The 510(k) pathway was most commonly used, and clearance often preceded the first published clinical study. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

A concept ideation framework for medical device design.

PubMed

Hagedorn, Thomas J; Grosse, Ian R; Krishnamurty, Sundar

2015-06-01

Medical device design is a challenging process, often requiring collaboration between medical and engineering domain experts. This collaboration can be best institutionalized through systematic knowledge transfer between the two domains coupled with effective knowledge management throughout the design innovation process. Toward this goal, we present the development of a semantic framework for medical device design that unifies a large medical ontology with detailed engineering functional models along with the repository of design innovation information contained in the US Patent Database. As part of our development, existing medical, engineering, and patent document ontologies were modified and interlinked to create a comprehensive medical device innovation and design tool with appropriate properties and semantic relations to facilitate knowledge capture, enrich existing knowledge, and enable effective knowledge reuse for different scenarios. The result is a Concept Ideation Framework for Medical Device Design (CIFMeDD). Key features of the resulting framework include function-based searching and automated inter-domain reasoning to uniquely enable identification of functionally similar procedures, tools, and inventions from multiple domains based on simple semantic searches. The significance and usefulness of the resulting framework for aiding in conceptual design and innovation in the medical realm are explored via two case studies examining medical device design problems. Copyright © 2015 Elsevier Inc. All rights reserved.

26 CFR 1.4-4 - Short taxable year caused by death.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 1 2010-04-01 2010-04-01 true Short taxable year caused by death. 1.4-4 Section... Normal Taxes and Surtaxes § 1.4-4 Short taxable year caused by death. An individual making a return for a... results from the death of the taxpayer. Tax on Corporations ...

26 CFR 25.2504-1 - Taxable gifts for preceding calendar periods.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 14 2010-04-01 2010-04-01 false Taxable gifts for preceding calendar periods... (CONTINUED) ESTATE AND GIFT TAXES GIFT TAX; GIFTS MADE AFTER DECEMBER 31, 1954 Determination of Tax Liability § 25.2504-1 Taxable gifts for preceding calendar periods. (a) In order to determine the correct gift...

26 CFR 1.4-4 - Short taxable year caused by death.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 26 Internal Revenue 1 2011-04-01 2009-04-01 true Short taxable year caused by death. 1.4-4 Section... Normal Taxes and Surtaxes § 1.4-4 Short taxable year caused by death. An individual making a return for a... results from the death of the taxpayer. Tax on Corporations ...

76 FR 50485 - Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Amendment of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-15

...] Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice AGENCY... an amendment to the notice of meeting of the Obstetrics and Gynecology Devices Panel of the Medical... Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee would be held on September...

Learning from adverse incidents involving medical devices.

PubMed

Amoore, John; Ingram, Paula

While an adverse event involving a medical device is often ascribed to either user error or device failure, the causes are typically multifactorial. A number of incidents involving medical devices are explored using this approach to investigate the various causes of the incident and the protective barriers that minimised or prevented adverse consequences. User factors, including mistakes, omissions and lack of training, conspired with background factors--device controls and device design, storage conditions, hidden device damage and physical layout of equipment when in use--to cause the adverse events. Protective barriers that prevented or minimised the consequences included staff vigilance, operating procedures and alarms.

Power Approaches for Implantable Medical Devices.

PubMed

Ben Amar, Achraf; Kouki, Ammar B; Cao, Hung

2015-11-13

Implantable medical devices have been implemented to provide treatment and to assess in vivo physiological information in humans as well as animal models for medical diagnosis and prognosis, therapeutic applications and biological science studies. The advances of micro/nanotechnology dovetailed with novel biomaterials have further enhanced biocompatibility, sensitivity, longevity and reliability in newly-emerged low-cost and compact devices. Close-loop systems with both sensing and treatment functions have also been developed to provide point-of-care and personalized medicine. Nevertheless, one of the remaining challenges is whether power can be supplied sufficiently and continuously for the operation of the entire system. This issue is becoming more and more critical to the increasing need of power for wireless communication in implanted devices towards the future healthcare infrastructure, namely mobile health (m-Health). In this review paper, methodologies to transfer and harvest energy in implantable medical devices are introduced and discussed to highlight the uses and significances of various potential power sources.

Power Approaches for Implantable Medical Devices

PubMed Central

Ben Amar, Achraf; Kouki, Ammar B.; Cao, Hung

2015-01-01

Implantable medical devices have been implemented to provide treatment and to assess in vivo physiological information in humans as well as animal models for medical diagnosis and prognosis, therapeutic applications and biological science studies. The advances of micro/nanotechnology dovetailed with novel biomaterials have further enhanced biocompatibility, sensitivity, longevity and reliability in newly-emerged low-cost and compact devices. Close-loop systems with both sensing and treatment functions have also been developed to provide point-of-care and personalized medicine. Nevertheless, one of the remaining challenges is whether power can be supplied sufficiently and continuously for the operation of the entire system. This issue is becoming more and more critical to the increasing need of power for wireless communication in implanted devices towards the future healthcare infrastructure, namely mobile health (m-Health). In this review paper, methodologies to transfer and harvest energy in implantable medical devices are introduced and discussed to highlight the uses and significances of various potential power sources. PMID:26580626

26 CFR 1.441-1 - Period for computation of taxable income.

Code of Federal Regulations, 2010 CFR

2010-04-01

...), a taxable year may not cover a period of more than 12 calendar months. (b) General rules and... period of 12 consecutive months ending on December 31. A taxpayer who has not established a fiscal year... be made for a period known as the taxable year. For rules relating to methods of accounting, the...

26 CFR 1.706-1 - Taxable years of partner and partnership.

Code of Federal Regulations, 2010 CFR

2010-04-01

... a taxable year elected under section 444, or establishes a business purpose for such taxable year...: Test 12/31 Year end Interest inpartnership profits Months of deferral for 12/31 year end Interest×deferral Partner A 12/31 .5 0 0 Partner B 11/30 .5 11 5.5 Aggregate deferral 5.5 Test 11/30 Year end...

78 FR 77688 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-24

...] Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Ophthalmic Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To... Swink, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave...

Electronic medication packaging devices and medication adherence: a systematic review.

PubMed

Checchi, Kyle D; Huybrechts, Krista F; Avorn, Jerry; Kesselheim, Aaron S

2014-09-24

Medication nonadherence, which has been estimated to affect 28% to 31% of US patients with hypertension, hyperlipidemia, and diabetes, may be improved by electronic medication packaging (EMP) devices (adherence-monitoring devices incorporated into the packaging of a prescription medication). To investigate whether EMP devices are associated with improved adherence and to identify and describe common features of EMP devices. Systematic review of peer-reviewed studies testing the effectiveness of EMP systems in the MEDLINE, EMBASE, PsycINFO, CINAHL, International Pharmaceutical Abstracts, and Sociological Abstracts databases from searches conducted to June 13, 2014, with extraction of associations between the interventions and adherence, as well as other key findings. Each study was assessed for bias using the Cochrane Handbook for Systematic Reviews of Interventions; features of EMP devices and interventions were qualitatively assessed. Thirty-seven studies (32 randomized and 5 nonrandomized) including 4326 patients met inclusion criteria (10 patient interface-only "simple" interventions and 29 "complex" interventions integrated into the health care system [2 qualified for both categories]). Overall, the effect estimates for differences in mean adherence ranged from a decrease of 2.9% to an increase of 34.0%, and the those for differences in the proportion of patients defined as adherent ranged from a decrease of 8.0% to an increase of 49.5%. We identified 5 common EMP characteristics: recorded dosing events and stored records of adherence, audiovisual reminders to cue dosing, digital displays, real-time monitoring, and feedback on adherence performance. Many varieties of EMP devices exist. However, data supporting their use are limited, with variability in the quality of studies testing EMP devices. Devices integrated into the care delivery system and designed to record dosing events are most frequently associated with improved adherence, compared with other

Towards sustainable design for single-use medical devices.

PubMed

Hanson, Jacob J; Hitchcock, Robert W

2009-01-01

Despite their sophistication and value, single-use medical devices have become commodity items in the developed world. Cheap raw materials along with large scale manufacturing and distribution processes have combined to make many medical devices more expensive to resterilize, package and restock than to simply discard. This practice is not sustainable or scalable on a global basis. As the petrochemicals that provide raw materials become more expensive and the global reach of these devices continues into rapidly developing economies, there is a need for device designs that take into account the total life-cycle of these products, minimize the amount of non-renewable materials consumed and consider alternative hybrid reusable / disposable approaches. In this paper, we describe a methodology to perform life cycle and functional analyses to create additional design requirements for medical devices. These types of sustainable approaches can move the medical device industry even closer to the "triple bottom line"--people, planet, profit.

The role of the user within the medical device design and development process: medical device manufacturers' perspectives

PubMed Central

2011-01-01

Background Academic literature and international standards bodies suggest that user involvement, via the incorporation of human factors engineering methods within the medical device design and development (MDDD) process, offer many benefits that enable the development of safer and more usable medical devices that are better suited to users' needs. However, little research has been carried out to explore medical device manufacturers' beliefs and attitudes towards user involvement within this process, or indeed what value they believe can be added by doing so. Methods In-depth interviews with representatives from 11 medical device manufacturers are carried out. We ask them to specify who they believe the intended users of the device to be, who they consult to inform the MDDD process, what role they believe the user plays within this process, and what value (if any) they believe users add. Thematic analysis is used to analyse the fully transcribed interview data, to gain insight into medical device manufacturers' beliefs and attitudes towards user involvement within the MDDD process. Results A number of high-level themes emerged, relating who the user is perceived to be, the methods used, the perceived value and barriers to user involvement, and the nature of user contributions. The findings reveal that despite standards agencies and academic literature offering strong support for the employment formal methods, manufacturers are still hesitant due to a range of factors including: perceived barriers to obtaining ethical approval; the speed at which such activity may be carried out; the belief that there is no need given the 'all-knowing' nature of senior health care staff and clinical champions; a belief that effective results are achievable by consulting a minimal number of champions. Furthermore, less senior health care practitioners and patients were rarely seen as being able to provide valuable input into the process. Conclusions Medical device manufacturers often

Anti-malware software and medical devices.

PubMed

2010-10-01

Just as much as healthcare information systems, medical devices need protection against cybersecurity threats. Anti-malware software can help safeguard the devices in your facility-but it has limitations and even risks. Find out what steps you can take to manage anti-malware applications in your devices.

Practice of Regulatory Science (Development of Medical Devices).

PubMed

Niimi, Shingo

2017-01-01

Prototypes of medical devices are made in accordance with the needs of clinical practice, and for systems required during the initial process of medical device development for new surgical practices. Verification of whether these prototypes produce the intended performance specifications is conducted using basic tests such as mechanical and animal tests. The prototypes are then improved and modified until satisfactory results are obtained. After a prototype passes through a clinical trial process similar to that for new drugs, application for approval is made. In the approval application process, medical devices are divided into new, improved, and generic types. Reviewers judge the validity of intended use, indications, operation procedures, and precautions, and in addition evaluate the balance between risk and benefit in terms of efficacy and safety. Other characteristics of medical devices are the need for the user to attain proficiency in usage techniques to ensure efficacy and safety, and the existence of a variety of medical devices for which assessment strategies differ, including differences in impact on the body in cases in which a physical burden to the body or failure of a medical device develops. Regulatory science of medical devices involves prediction, judgment, and evaluation of efficacy, safety, and quality, from which data result which can become indices in the development stages from design to application for approval. A reduction in the number of animals used for testing, improvement in efficiency, reduction of the necessity for clinical trials, etc. are expected through rational setting of evaluation items.

75 FR 35495 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-22

...] Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Ophthalmic Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To... Glaukos iStent Trabecular Micro-Bypass Stent, Model GTS-100 L/R, sponsored by Glaukos Corp. The device is...

Effects and Satisfaction of Medical Device Safety Information Reporting System Using Electronic Medical Record.

PubMed

Jang, Hye Jung; Choi, Young Deuk; Kim, Nam Hyun

2017-04-01

This paper describes an evaluation study on the effectiveness of developing an in-hospital medical device safety information reporting system for managing safety information, including adverse incident data related to medical devices, following the enactment of the Medical Device Act in Korea. Medical device safety information reports were analyzed for 190 cases that took place prior to the application of a medical device safety information reporting system and during a period when the reporting system was used. Also, questionnaires were used to measure the effectiveness of the medical device safety information reporting system. The analysis was based on the questionnaire responses of 15 reporters who submitted reports in both the pre- and post-reporting system periods. Sixty-two reports were submitted in paper form, but after the system was set up, this number more than doubled to 128 reports in electronic form. In terms of itemized reporting, a total of 45 items were reported. Before the system was used, 23 items had been reported, but this increased to 32 items after the system was put to use. All survey variables of satisfaction received a mean of over 3 points, while positive attitude , potential benefits , and positive benefits all exceeded 4 points, each receiving 4.20, 4.20, and 4.13, respectively. Among the variables, time-consuming and decision-making had the lowest mean values, each receiving 3.53. Satisfaction was found to be high for system quality and user satisfaction , but relatively low for time-consuming and decision-making . We were able to verify that effective reporting and monitoring of adverse incidents and the safety of medical devices can be implemented through the establishment of an in-hospital medical device safety information reporting system that can enhance patient safety and medical device risk management.

Cost analysis of medical device spare parts

PubMed Central

Bektemur, Guven; Muzoglu, Nedim; Arici, Mehmet Ali; Karaaslan, Melike Kaya

2018-01-01

Objective: To establish estimation method on budget management of medical device spare parts and to evaluate the cost of medical device spare parts in affiliated hospitals of Istanbul Public Hospital Unions (PHUs). Methods: While this evaluation was performed, the relationship between paid cost for spare parts according to technological development level of device groups and total inventory value was used. Spare part cost analysis was carried out by using the normalized weighted arithmetic average method. Cost analysis of medical equipment spare parts of Istanbul PHUs was performed by using the data retrieved from Ministry of Health Business Intelligence Decision Support System for spending of spare parts in 2015. Results: The medical device spare part groups were categorized based on technological development. Among 1 to 6 PHUs, the cost ratios were acquired for high, middle, low and simple technology group as 17.31 – 40.08%, 29.14 – 43.36%, 22.62 – 27.44% and 8.16 – 11.89%, respectively. The ratio between the spare part and total inventory costs for 1-6 PHUs were calculated as 1.66%, 2.87%, 3.03%, 3.31%, 2.57% and 4.69% respectively. Expected rates based on normalized weighted method were obtained as follows; 5.76%, 4.67%, 5.31%, 4.87%, 4.34% and 4.27%. Conclusion: The expenditure analysis and budget planning for medical device spare parts in PHU could be predicted more accurately by taking into consideration the expected rate calculated by the normal weight method. In additon, the importance of Clinical Engineering Service Units in management of medical devices has been determined. PMID:29805429

26 CFR 53.4952-1 - Black lung trusts-taxes on taxable expenditures.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 26 Internal Revenue 17 2011-04-01 2011-04-01 false Black lung trusts-taxes on taxable expenditures... (CONTINUED) MISCELLANEOUS EXCISE TAXES (CONTINUED) FOUNDATION AND SIMILAR EXCISE TAXES Black Lung Benefit Trust Excise Taxes § 53.4952-1 Black lung trusts—taxes on taxable expenditures. (a) In general. Section...

26 CFR 53.4952-1 - Black lung trusts-taxes on taxable expenditures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 17 2010-04-01 2010-04-01 false Black lung trusts-taxes on taxable expenditures... (CONTINUED) MISCELLANEOUS EXCISE TAXES (CONTINUED) FOUNDATION AND SIMILAR EXCISE TAXES Black Lung Benefit Trust Excise Taxes § 53.4952-1 Black lung trusts—taxes on taxable expenditures. (a) In general. Section...

Making Medical Devices Safer at Home

MedlinePlus

... and maintain home use devices, which include blood glucose monitors, infusion pumps (a device that delivers fluids, including nutrients and medications, into a patient's body) and respirators. These efforts include issuing a draft ...

Multi-compartment medication devices and patient compliance.

PubMed

McGraw, Caroline

2004-07-01

Multi-compartment medication compliance devices are widely used in primary care. The aim of this review is to reveal whether they are effective in promoting adherence among non-adherent adults living at home. Searches were undertaken using two electronic databases (Medline (1966-2003) and International Pharmaceutical Abstracts (1970-2002)). Only randomized controlled trials (including crossover studies) were included in the review. Participants had to be non-institutionalized adults receiving one or more prescription medicines each day and displaying problems with adherence. Studies had to compare multi-compartment medication compliance devices to standard packaging and outcome measures and to include either pill counts, biological assays and/or clinical response. Articles were selected if they described a follow up period of at least three months and demonstrated that over 80% of participants had completed the trial. Two studies were identified that met the criteria, reporting data on a total of 148 patients. The findings from the first study found diabetic patients receiving medication in a compliance device demonstrated better glucose control than patients receiving medication in standard packaging. The second study found compliance devices had no impact on blood pressure control in hypertensive patients. Further research needs to be conducted to assess the effectiveness of multi-compartment medication compliance devices in promoting adherence among non-adherent adults living at home.

Use of mobile devices for medical imaging.

PubMed

Hirschorn, David S; Choudhri, Asim F; Shih, George; Kim, Woojin

2014-12-01

Mobile devices have fundamentally changed personal computing, with many people forgoing the desktop and even laptop computer altogether in favor of a smaller, lighter, and cheaper device with a touch screen. Doctors and patients are beginning to expect medical images to be available on these devices for consultative viewing, if not actual diagnosis. However, this raises serious concerns with regard to the ability of existing mobile devices and networks to quickly and securely move these images. Medical images often come in large sets, which can bog down a network if not conveyed in an intelligent manner, and downloaded data on a mobile device are highly vulnerable to a breach of patient confidentiality should that device become lost or stolen. Some degree of regulation is needed to ensure that the software used to view these images allows all relevant medical information to be visible and manipulated in a clinically acceptable manner. There also needs to be a quality control mechanism to ensure that a device's display accurately conveys the image content without loss of contrast detail. Furthermore, not all mobile displays are appropriate for all types of images. The smaller displays of smart phones, for example, are not well suited for viewing entire chest radiographs, no matter how small and numerous the pixels of the display may be. All of these factors should be taken into account when deciding where, when, and how to use mobile devices for the display of medical images. Copyright © 2014 American College of Radiology. Published by Elsevier Inc. All rights reserved.

27 CFR 70.21 - Canvass of regions for taxable persons and objects.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2010-04-01 2010-04-01 false Canvass of regions for taxable persons and objects. 70.21 Section 70.21 Alcohol, Tobacco Products and Firearms ALCOHOL AND... Canvass of regions for taxable persons and objects. Each appropriate TTB officer shall, to the extent...

A study of medical device regulation management model in Asia.

PubMed

Wu, Yi-Hui; Li, Fong-An; Fan, Yin-Ting; Tu, Pei-Weng

2016-06-01

With the aging of the post-war baby boomer generation, the increasing demands for healthcare are driving the growth of medical industry and development of new products in order to meet the immense needs from the aging population. However, medical devices are designed to maintain the health and safety of people, therefore, medical devices are undergoing rigorous management by competent health authorities in all countries. In recent years, Asian countries have been reforming their regulations and standards for medical devices with substantial changes. The study is a summary of the framework of medical device regulations in Asian countries, including Asian Harmonization Working Party (AHWP), Japan, China, Taiwan, South Korea, India and Singapore. Expert commentary: Asian countries are constantly reforming their medical device regulations. The emergence of brand-new technology and quality management issues arose by global manufacturing have imposed difficulties in harmonizing and reaching consensus between countries. The third-party conformity assessment system for medical devices can reduce the costs for competent health authorities and shorten the review time, which could facilitate the feasibility of harmonization of medical device regulations.

Development of Implantable Medical Devices: From an Engineering Perspective

PubMed Central

2013-01-01

From the first pacemaker implant in 1958, numerous engineering and medical activities for implantable medical device development have faced challenges in materials, battery power, functionality, electrical power consumption, size shrinkage, system delivery, and wireless communication. With explosive advances in scientific and engineering technology, many implantable medical devices such as the pacemaker, cochlear implant, and real-time blood pressure sensors have been developed and improved. This trend of progress in medical devices will continue because of the coming super-aged society, which will result in more consumers for the devices. The inner body is a special space filled with electrical, chemical, mechanical, and marine-salted reactions. Therefore, electrical connectivity and communication, corrosion, robustness, and hermeticity are key factors to be considered during the development stage. The main participants in the development stage are the user, the medical staff, and the engineer or technician. Thus, there are three different viewpoints in the development of implantable devices. In this review paper, considerations in the development of implantable medical devices will be presented from the viewpoint of an engineering mind. PMID:24143287

76 FR 48871 - Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Immunology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...

76 FR 6625 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Neurological Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...

78 FR 26786 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Microbiology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...

Product-based Safety Certification for Medical Devices Embedded Software.

PubMed

Neto, José Augusto; Figueiredo Damásio, Jemerson; Monthaler, Paul; Morais, Misael

2015-01-01

Worldwide medical device embedded software certification practices are currently focused on manufacturing best practices. In Brazil, the national regulatory agency does not hold a local certification process for software-intensive medical devices and admits international certification (e.g. FDA and CE) from local and international industry to operate in the Brazilian health care market. We present here a product-based certification process as a candidate process to support the Brazilian regulatory agency ANVISA in medical device software regulation. Center of Strategic Technology for Healthcare (NUTES) medical device embedded software certification is based on a solid safety quality model and has been tested with reasonable success against the Class I risk device Generic Infusion Pump (GIP).

26 CFR 1.451-1 - General rule for taxable year of inclusion.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 6 2010-04-01 2010-04-01 false General rule for taxable year of inclusion. 1... General rule for taxable year of inclusion. (a) General rule. Gains, profits, and income are to be... received during such year shall be included. (For rules relating to the inclusion of partnership income in...

31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false In-kind donations of medicine... Licensing Policy § 597.511 In-kind donations of medicine, medical devices, and medical services. (a... medicine, medical devices, and medical services to the Palestinian Authority Ministry of Health, provided...

A UK medical devices regulator's perspective on registries.

PubMed

Wilkinson, John; Crosbie, Andy

2016-04-01

Registries are powerful tools to support manufacturers in the fulfilment of their obligations to perform post-market surveillance and post-market clinical follow-up of implantable medical devices. They are also a valuable resource for regulators in support of regulatory action as well as in providing information around the safety of new and innovative technologies. Registries can provide valuable information on the relative performance of both generic types and manufacturer's individual products and they complement other sources of information about device performance such as post-market clinical studies and adverse incident reporting. This paper describes the experience of the UK medical device regulator - the Medicines and Healthcare Products Regulatory Agency (MHRA) - of working with registries to monitor the safety and performance of medical devices. Based upon this experience, the authors identify a number of attributes for a registry which they consider to be key if the registry is to contribute effectively to the work of regulators on patient safety monitoring and medical device regulation.

76 FR 12973 - Neurological Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-09

...] Neurological Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice AGENCY: Food and Drug... notice of meeting of the Neurological Devices Panel of the Medical Devices Advisory Committee. This... INFORMATION: In the Federal Register of February 7, 2011, FDA announced that a meeting of the Neurological...

26 CFR 1.404(a)-2 - Information to be furnished by employer claiming deductions; taxable years ending before December...

Code of Federal Regulations, 2011 CFR

2011-04-01

... deductions; taxable years ending before December 31, 1971. 1.404(a)-2 Section 1.404(a)-2 Internal Revenue... employer claiming deductions; taxable years ending before December 31, 1971. (a) For the first taxable year... 25 highest paid employees covered by the plan in the taxable year, listed in order of their...

31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false In-kind donations of medicine, medical... donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of medicine, medical devices...

31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false In-kind donations of medicine, medical... donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of medicine, medical devices...

31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false In-kind donations of medicine, medical... donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of medicine, medical devices...

31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false In-kind donations of medicine, medical... donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of medicine, medical devices...

26 CFR 1.1-3 - Change in rates applicable to taxable year.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Section 1.1-3 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY INCOME TAX INCOME TAXES Normal Taxes and Surtaxes § 1.1-3 Change in rates applicable to taxable year. For computation of the tax for a taxable year during which a change in the tax rates occurs, see section 21 and the...

26 CFR 1.451-1 - General rule for taxable year of inclusion.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 26 Internal Revenue 6 2013-04-01 2013-04-01 false General rule for taxable year of inclusion. 1....451-1 General rule for taxable year of inclusion. (a) General rule. Gains, profits, and income are to... received during such year shall be included. (For rules relating to the inclusion of partnership income in...

26 CFR 1.451-1 - General rule for taxable year of inclusion.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 26 Internal Revenue 6 2012-04-01 2012-04-01 false General rule for taxable year of inclusion. 1....451-1 General rule for taxable year of inclusion. (a) General rule. Gains, profits, and income are to... received during such year shall be included. (For rules relating to the inclusion of partnership income in...

26 CFR 1.451-1 - General rule for taxable year of inclusion.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 26 Internal Revenue 6 2014-04-01 2014-04-01 false General rule for taxable year of inclusion. 1....451-1 General rule for taxable year of inclusion. (a) General rule. Gains, profits, and income are to... received during such year shall be included. (For rules relating to the inclusion of partnership income in...

26 CFR 1.451-1 - General rule for taxable year of inclusion.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 26 Internal Revenue 6 2011-04-01 2011-04-01 false General rule for taxable year of inclusion. 1....451-1 General rule for taxable year of inclusion. (a) General rule. Gains, profits, and income are to... received during such year shall be included. (For rules relating to the inclusion of partnership income in...

26 CFR 1.441-3 - Taxable year of a personal service corporation.

Code of Federal Regulations, 2014 CFR

2014-04-01

... same facts as in Example 1, except that X desires to change to a 52-53-week taxable year ending with... Commissioner's permission to use a September 30 taxable year. Example 2. The facts are the same as in Example 1... performance of services in the fields of health, law, engineering, architecture, accounting, actuarial science...

[Industry regulation and its relationship to the rapid marketing of medical devices].

PubMed

Matsuoka, Atsuko

2012-01-01

In the market of medical devices, non-Japanese products hold a large part even in Japan. To overcome this situation, the Japanese government has been announcing policies to encourage the medical devices industry, such as the 5-year strategy for medical innovation (June 6, 2012). The Division of Medical Devices has been contributing to rapid marketing of medical devices by working out the standards for approval review and accreditation of medical devices, guidances on evaluation of medical devices with emerging technology, and test methods for biological safety evaluation of medical devices, as a part of practice in the field of regulatory science. The recent outcomes are 822 standards of accreditation for Class II medical devices, 14 guidances on safety evaluation of medical devices with emerging technology, and the revised test methods for biological safety evaluation (MHLW Notification by Director, OMDE, Yakushokuki-hatsu 0301 No. 20 "Basic Principles of Biological Safety Evaluation Required for Application for Approval to Market Medical Devices").

Home Use Devices: How to Prepare for and Handle Power Outages for Medical Devices That Require Electricity

MedlinePlus

... Handle Power Outages for Medical Devices that Require Electricity Center for De CDRH vices and Rad lth ... Handle Power Outages for Medical Devices that Require Electricity As a home medical device user, it is ...

The current situation and development of medical device testing institutes in China.

PubMed

Yang, Xiaofang; Mu, Ruihong; Fan, Yubo; Wang, Chunren; Li, Deyu

2017-04-01

This article analyses the current situation and development of Chinese medical device testing institutes from the perspectives of the two most important functions - testing functions and medical device standardization functions. Areas Covered: The objective of the Chinese government regulations for medical device industry is to ensure the safety and effectiveness of medical devices for Chinese patients. To support the regulation system, the Chinese government has established medical device testing institutes at different levels for example, the national, provincial, and municipal levels. These testing institutes also play an important role in technical support during medical device premarket registration and post market surveillance, they are also the vital practitioners of Chinese medical device standardization. Expert Commentary: Chinese medical device testing institutes are technical departments established by government, and serve the regulatory functions of government agency. In recent years, with the rapid development of medical device industry as well as constantly increasing international and domestic medical device market, the importance of medical device testing institute is more prominent, However, there are still some problems unsolved, such as their overall capacity remains to be improved, construction of standardization is to be strengthened, etc.

76 FR 45268 - Reprocessing of Reusable Medical Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-28

... personal information provided. For additional information on submitting comments, see the ``Comments... problems in all steps of medical device reprocessing,\\1\\ including cleaning, disinfecting, and sterilizing... following issues: 1. What are the nature, scope, and impact of reusable medical device reprocessing problems...

27 CFR 26.200 - Taxable status.

Code of Federal Regulations, 2013 CFR

2013-04-01

... OF THE TREASURY ALCOHOL LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Products Coming Into the United States From the Virgin Islands § 26.200 Taxable status. (a) Liquors coming into the... internal revenue tax imposed upon the production in the United States of like liquors. Articles coming into...

27 CFR 26.35 - Taxable status.

Code of Federal Regulations, 2011 CFR

2011-04-01

... OF THE TREASURY LIQUORS LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Products Coming Into the United States From Puerto Rico § 26.35 Taxable status. (a) Liquors coming into the United... revenue tax imposed on the production in the United States of like liquors. Articles coming into the...

27 CFR 26.200 - Taxable status.

Code of Federal Regulations, 2011 CFR

2011-04-01

... OF THE TREASURY LIQUORS LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Products Coming Into the United States From the Virgin Islands § 26.200 Taxable status. (a) Liquors coming into the... internal revenue tax imposed upon the production in the United States of like liquors. Articles coming into...

27 CFR 26.200 - Taxable status.

Code of Federal Regulations, 2014 CFR

2014-04-01

... OF THE TREASURY ALCOHOL LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Products Coming Into the United States From the Virgin Islands § 26.200 Taxable status. (a) Liquors coming into the... internal revenue tax imposed upon the production in the United States of like liquors. Articles coming into...

27 CFR 26.35 - Taxable status.

Code of Federal Regulations, 2013 CFR

2013-04-01

... OF THE TREASURY ALCOHOL LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Products Coming Into the United States From Puerto Rico § 26.35 Taxable status. (a) Liquors coming into the United... revenue tax imposed on the production in the United States of like liquors. Articles coming into the...

27 CFR 26.200 - Taxable status.

Code of Federal Regulations, 2010 CFR

2010-04-01

... OF THE TREASURY LIQUORS LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Products Coming Into the United States From the Virgin Islands § 26.200 Taxable status. (a) Liquors coming into the... internal revenue tax imposed upon the production in the United States of like liquors. Articles coming into...

27 CFR 26.200 - Taxable status.

Code of Federal Regulations, 2012 CFR

2012-04-01

... OF THE TREASURY LIQUORS LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Products Coming Into the United States From the Virgin Islands § 26.200 Taxable status. (a) Liquors coming into the... internal revenue tax imposed upon the production in the United States of like liquors. Articles coming into...

27 CFR 26.35 - Taxable status.

Code of Federal Regulations, 2010 CFR

2010-04-01

... OF THE TREASURY LIQUORS LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Products Coming Into the United States From Puerto Rico § 26.35 Taxable status. (a) Liquors coming into the United... revenue tax imposed on the production in the United States of like liquors. Articles coming into the...

27 CFR 26.35 - Taxable status.

Code of Federal Regulations, 2012 CFR

2012-04-01

... OF THE TREASURY LIQUORS LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Products Coming Into the United States From Puerto Rico § 26.35 Taxable status. (a) Liquors coming into the United... revenue tax imposed on the production in the United States of like liquors. Articles coming into the...

27 CFR 26.35 - Taxable status.

Code of Federal Regulations, 2014 CFR

2014-04-01

... OF THE TREASURY ALCOHOL LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Products Coming Into the United States From Puerto Rico § 26.35 Taxable status. (a) Liquors coming into the United... revenue tax imposed on the production in the United States of like liquors. Articles coming into the...

77 FR 16239 - Medical Device User Fee Act; Public Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-20

...] Medical Device User Fee Act; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of... public meeting to discuss proposed recommendations for the reauthorization of the Medical Device User Fee... use them for the process for the review of medical device applications. The current legislative...

76 FR 36548 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-22

...] Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and... of Committee: Circulatory System Devices Panel of the Medical Devices Advisory Committee. General... also comes with a sheath, introducer, loader, dilator, balloon (used to pre-dilate the native annulus...

75 FR 14170 - Medical Device Epidemiology Network: Developing Partnership Between the Center for Devices and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-24

... methods for medical device comparative analyses, best practices and best design and analysis methods. II... the performance of medical devices (including comparative effectiveness studies). The centers...

Medical devices; hematology and pathology devices; classification of the Factor V Leiden DNA mutation detection systems devices. Final rule.

PubMed

2004-03-16

The Food and Drug Administration (FDA) is classifying the Factor V Leiden deoxyribonucleic acid (DNA) mutation detections systems device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act of 2002. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.

76 FR 55398 - Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of Meeting AGENCY... postponing the meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee scheduled...

77 FR 25183 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-27

...] Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and... of Committee: Circulatory System Devices Panel of the Medical Devices Advisory Committee. General..., introducer, loader, dilator, balloon (used to pre-dilate the native annulus) and a crimper. FDA intends to...

75 FR 57968 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-23

...] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory... committee will discuss, make recommendations, and vote on information related to the PMA for the LAP-BAND...

26 CFR 301.7601-1 - Canvass of districts for taxable persons and objects.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 18 2010-04-01 2010-04-01 false Canvass of districts for taxable persons and objects. 301.7601-1 Section 301.7601-1 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE... Enforcement of Title Examination and Inspection § 301.7601-1 Canvass of districts for taxable persons and...

26 CFR 301.7601-1 - Canvass of districts for taxable persons and objects.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 26 Internal Revenue 18 2011-04-01 2011-04-01 false Canvass of districts for taxable persons and objects. 301.7601-1 Section 301.7601-1 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE... Enforcement of Title Examination and Inspection § 301.7601-1 Canvass of districts for taxable persons and...

Enabling Medical Device Interoperability for the Integrated Clinical Environment

DTIC Science & Technology

2016-12-01

else who is eager to work together to mature the healthcare technology ecosystem to enable the next generation of safe and intelligent medical device...Award Number: W81XWH-12-C-0154 TITLE: “Enabling Medical Device Interoperability for the Integrated Clinical Environment ” PRINCIPAL INVESTIGATOR...SUBTITLE 5a. CONTRACT NUMBER W81XWH-12-C-0154 “Enabling Medical Device Interoperability for the Integrated Clinical Environment ” 5b. GRANT NUMBER 5c

Quality management for the processing of medical devices

PubMed Central

Klosz, Kerstin

2008-01-01

Rules on the reprocessing of medical devices were put into place in Germany in 2001. The present article explains the background situation and the provisions that are currently in force. The implementation of these statutory requirements is described using the example of the quality management system of Germany’s market leader, Vanguard AG. This quality management system was successfully certified pursuant to DIN EN ISO 13485:2003 for the scope "reprocessing of medical devices", including class “critical C”, in accordance with the recommendation of the Commission for Hospital Hygiene and the Prevention of Infection at the Robert-Koch-Institute (RKI) and the German Federal Institute for Drugs and Medical Devices (BfArM) on the “Hygiene requirements for reprocessing of medical devices”. PMID:20204094

The FDA's role in medical device clinical studies of human subjects

NASA Astrophysics Data System (ADS)

Saviola, James

2005-03-01

This paper provides an overview of the United States Food and Drug Administration's (FDA) role as a regulatory agency in medical device clinical studies involving human subjects. The FDA's regulations and responsibilities are explained and the device application process discussed. The specific medical device regulatory authorities are described as they apply to the development and clinical study of retinal visual prosthetic devices. The FDA medical device regulations regarding clinical studies of human subjects are intended to safeguard the rights and safety of subjects. The data gathered in pre-approval clinical studies provide a basis of valid scientific evidence in order to demonstrate the safety and effectiveness of a medical device. The importance of a working understanding of applicable medical device regulations from the beginning of the device development project is emphasized particularly for novel, complex products such as implantable visual prosthetic devices.

76 FR 80081 - Section 482: Methods To Determine Taxable Income in Connection With a Cost Sharing Arrangement

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-22

... Service 26 CFR Parts 1, 301, and 602 Section 482: Methods To Determine Taxable Income in Connection With a... 26 CFR Parts 1, 301, and 602 [TD 9568] RIN 1545-BI47 Section 482: Methods To Determine Taxable Income... regulations regarding methods to determine taxable income in connection with a cost sharing arrangement under...

The grays of medical device color additives.

PubMed

Seidman, Brenda

2014-01-01

The United States' medical device color additive regulations are unknown to some, and confusing to many. This article reviews statutory language on color additives in the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended, including the Delaney Clause on carcinogenicity; color additive regulatory language as it relates to medical devices in Title 21 of the Code of Federal Regulations (C.F.R.), Parts 70-82; reports on the Food and Drug Administration's (FDA's) likely current and historical practices in dealing with color additives in medical devices; and speculates on what may have given rise to decades of seemingly ad hoc color additives practices, which may now be difficult to reconstruct and satisfactorily modify. Also addressed is the Center for Devices and Radiological Health's (CDRH's) recent publicly-vetted approach to color additives in Section 7 of its April 2013 draft guidance, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," which the author concludes is a change in the right direction, but which, at least in its current draft form, is not a fix to the CDRH's color additives dilemma. Lastly, the article suggests what the CDRH might consider in further developing a new approach to color additives. Such an approach would treat color additives as if they were any other potentially toxic group of chemicals, and could be fashioned in such a way that the CDRH could still satisfy the broad aspects of Congressional color additives mandates, and.yet be consistent with ISO 10993. In doing this, the CDRH would need to recommend a more directed use of its Quality System Regulation, 21 C.F.R. Part 820, for material and vendor qualification and validation in general; approach Congress for needed statutory changes; or make administrative changes. In order for any approach to be successful, whether it is a new twist on past practices, or an entirely new path forward, the FDA must, to the best of its

Treating the merger as a taxable versus tax-free combination.

PubMed

Finkler, S A; Karlinsky, S S

1985-04-01

A key issue in any business combination is whether the transaction is to be a taxable acquisition or a tax-free reorganization. Neither structure's benefits clearly dominate. Taxable acquisitions result in greater inventory cost and depreciation tax benefits to the buyer and more tax to the seller. Tax-free reorganizations allow the seller to avoid current payment of at least some taxes but result in less favorable tax benefits to the buyer. Each merger must therefore be tailored to fit the specific needs and wishes of the parties involved.

Medical devices manufactured from latex: European regulatory initiatives.

PubMed

De Jong, W H; Geertsma, R E; Tinkler, J J B

2002-05-01

In Europe the marketing of medical devices manufactured from latex is regulated by directives describing the essential (safety) requirements that products have to fulfill to obtain marketing approval. This paper describes the general requirements for marketing medical devices in Europe and, more specifically, the requirements for products manufactured from natural rubber latex. The requirements for marketing medical devices can be fulfilled by using the relevant harmonized European standards. These standards are regularly under revision to incorporate the latest scientific developments. For certain devices, for example, latex medical (examination and surgical) gloves, specific standards have been published. Medical devices manufactured from latex pose a serious problem because of the risk of induction of allergy both against the latex proteins inherently present (type I or immediate type allergy) and against chemicals added during processing (type IV or delayed type hypersensitivity) present as residues in the latex products. So, besides requirements for product quality in terms of barrier properties, strength, and sterility, the main focus consists of the allergy-inducing properties of the latex products. Recent developments have reopened the discussion on the value of total protein versus allergen determination in latex medical gloves. However, as long as minimal levels needed for both sensitization and elicitation have not been established, a safe maximum level for leachable proteins/allergens in latex products cannot be determined. A European Commission guidance document on the latex allergy problem is currently being drafted by experts from Competent Authorities. Copyright 2002 Elsevier Science (USA).

Medical Device Integration Model Based on the Internet of Things

PubMed Central

Hao, Aiyu; Wang, Ling

2015-01-01

At present, hospitals in our country have basically established the HIS system, which manages registration, treatment, and charge, among many others, of patients. During treatment, patients need to use medical devices repeatedly to acquire all sorts of inspection data. Currently, the output data of the medical devices are often manually input into information system, which is easy to get wrong or easy to cause mismatches between inspection reports and patients. For some small hospitals of which information construction is still relatively weak, the information generated by the devices is still presented in the form of paper reports. When doctors or patients want to have access to the data at a given time again, they can only look at the paper files. Data integration between medical devices has long been a difficult problem for the medical information system, because the data from medical devices are lack of mandatory unified global standards and have outstanding heterogeneity of devices. In order to protect their own interests, manufacturers use special protocols, etc., thus causing medical decices to still be the "lonely island" of hospital information system. Besides, unfocused application of the data will lead to failure to achieve a reasonable distribution of medical resources. With the deepening of IT construction in hospitals, medical information systems will be bound to develop towards mobile applications, intelligent analysis, and interconnection and interworking, on the premise that there is an effective medical device integration (MDI) technology. To this end, this paper presents a MDI model based on the Internet of Things (IoT). Through abstract classification, this model is able to extract the common characteristics of the devices, resolve the heterogeneous differences between them, and employ a unified protocol to integrate data between devices. And by the IoT technology, it realizes interconnection network of devices and conducts associate matching

Medical Device Integration Model Based on the Internet of Things.

PubMed

Hao, Aiyu; Wang, Ling

2015-01-01

At present, hospitals in our country have basically established the HIS system, which manages registration, treatment, and charge, among many others, of patients. During treatment, patients need to use medical devices repeatedly to acquire all sorts of inspection data. Currently, the output data of the medical devices are often manually input into information system, which is easy to get wrong or easy to cause mismatches between inspection reports and patients. For some small hospitals of which information construction is still relatively weak, the information generated by the devices is still presented in the form of paper reports. When doctors or patients want to have access to the data at a given time again, they can only look at the paper files. Data integration between medical devices has long been a difficult problem for the medical information system, because the data from medical devices are lack of mandatory unified global standards and have outstanding heterogeneity of devices. In order to protect their own interests, manufacturers use special protocols, etc., thus causing medical decices to still be the "lonely island" of hospital information system. Besides, unfocused application of the data will lead to failure to achieve a reasonable distribution of medical resources. With the deepening of IT construction in hospitals, medical information systems will be bound to develop towards mobile applications, intelligent analysis, and interconnection and interworking, on the premise that there is an effective medical device integration (MDI) technology. To this end, this paper presents a MDI model based on the Internet of Things (IoT). Through abstract classification, this model is able to extract the common characteristics of the devices, resolve the heterogeneous differences between them, and employ a unified protocol to integrate data between devices. And by the IoT technology, it realizes interconnection network of devices and conducts associate matching

Medical devices early assessment methods: systematic literature review.

PubMed

Markiewicz, Katarzyna; van Til, Janine A; IJzerman, Maarten J

2014-04-01

The aim of this study was to get an overview of current theory and practice in early assessments of medical devices, and to identify aims and uses of early assessment methods used in practice. A systematic literature review was conducted in September 2013, using computerized databases (PubMed, Science Direct, and Scopus), and references list search. Selected articles were categorized based on their type, objective, and main target audience. The methods used in the application studies were extracted and mapped throughout the early stages of development and for their particular aims. Of 1,961 articles identified, eighty-three studies passed the inclusion criteria, and thirty were included by searching reference lists. There were thirty-one theoretical papers, and eighty-two application papers included. Most studies investigated potential applications/possible improvement of medical devices, developed early assessment framework or included stakeholder perspective in early development stages. Among multiple qualitative and quantitative methods identified, only few were used more than once. The methods aim to inform strategic considerations (e.g., literature review), economic evaluation (e.g., cost-effectiveness analysis), and clinical effectiveness (e.g., clinical trials). Medical devices were often in the prototype product development stage, and the results were usually aimed at informing manufacturers. This study showed converging aims yet widely diverging methods for early assessment during medical device development. For early assessment to become an integral part of activities in the development of medical devices, methods need to be clarified and standardized, and the aims and value of assessment itself must be demonstrated to the main stakeholders for assuring effective and efficient medical device development.

Cybersecurity and the Medical Device Product Development Lifecycle.

PubMed

Jones, Richard W; Katzis, Konstantinos

2017-01-01

Protecting connected medical devices from evolving cyber related threats, requires a continuous lifecycle approach whereby cybersecurity is integrated within the product development lifecycle and both complements and re-enforces the safety risk management processes therein. This contribution reviews the guidance relating to medical device cybersecurity within the product development lifecycle.

75 FR 61507 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-05

...] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice... announcing an amendment to the notice of meeting of the General and Plastic Surgery Devices Panel of the..., FDA announced that a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices...

Older Adults’ Satisfaction with a Medication Dispensing Device in Home Care

PubMed Central

Demiris, George; Marek, Karen D.

2014-01-01

Introduction Older adults with multiple chronic conditions face the complex task of medication management involving multiple medications of varying doses at different times. Advances in telehealth technologies have resulted in home-based devices for medication management and health monitoring of older adults. We examined older adults’ perceptions of a telehealth medication dispensing device as part of a clinical trial involving home health care clients, nurse coordination and use of the medication dispensing device. Methods Ninety-six frail older adult participants who used the medication dispensing device for 12 months completed a satisfaction survey related to perceived usefulness and reliability. Results were analyzed and grouped by themes in the following areas: Ease of Use, Reliability, Medication Management Assistance, Routine Task Performance and Acceptability. Results Nearly all participants perceived the medication dispensing device as very easy to use, very reliable and helpful in management of their medications. Eighty-four percent of participants expressed a desire to use the machine in the future. Conclusion The technology-enhanced medication management device in this study is an acceptable tool for older adults to manage medication in collaboration with home care nurses. Improved usability and cost models for medication dispensers are areas for future research. Trial Registration clinicaltrials.gov identifier: NCT01321853 PMID:23323721

75 FR 47606 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee scheduled for August...

26 CFR 1.831-2 - Taxable years affected.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) INCOME TAXES Other Insurance Companies § 1.831-2 Taxable years affected. Section 1.831-1 is applicable....831-4 is applicable only with respect to the companies described therein, and only with respect to...

[Design and application of implantable medical device information management system].

PubMed

Cao, Shaoping; Yin, Chunguang; Zhao, Zhenying

2013-03-01

Through the establishment of implantable medical device information management system, with the aid of the regional joint sharing of resources, we further enhance the implantable medical device traceability management level, strengthen quality management, control of medical risk.

78 FR 30928 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

75 FR 49940 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

Design considerations for medical devices in the home environment.

PubMed

Kaufman-Rivi, Diana; Collins-Mitchell, Janette; Jetley, Raoul

2010-01-01

Patient demographics, economic forces, and technological advancements contribute to the rise in home care services. Advanced medical devices and equipment originally designed for use by trained personnel in hospitals and clinics are increasingly migrating into the home. Unlike the clinical setting, the home is an uncontrolled environment with additional hazards. The compatibility of the device with the recipient's knowledge, abilities, lifestyle, and home environment plays a significant role in their therapy and rehabilitation. The advent of new device technologies such as wireless devices and interoperability of systems lends a new and complex perspective for medical device use in the home that must also be addressed. Adequately assessing and matching the patient and their caregiver with the appropriate device technology while considering the suitability of the home environment for device operation and maintenance is a challenge that relies on good human factors principles. There is a need to address these challenges in the growing home care sector In this article, the authors take a look at some important considerations and design issues for medical devices used in the home care environment.

26 CFR 1.831-2 - Taxable years affected.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) INCOME TAXES (CONTINUED) Other Insurance Companies § 1.831-2 Taxable years affected. Section 1.831-1 is... amended. Section 1.831-4 is applicable only with respect to the companies described therein, and only with...

26 CFR 1.831-2 - Taxable years affected.

Code of Federal Regulations, 2013 CFR

2013-04-01

...) INCOME TAXES (CONTINUED) Other Insurance Companies § 1.831-2 Taxable years affected. Section 1.831-1 is... amended. Section 1.831-4 is applicable only with respect to the companies described therein, and only with...

26 CFR 1.831-2 - Taxable years affected.

Code of Federal Regulations, 2011 CFR

2011-04-01

...) INCOME TAXES (CONTINUED) Other Insurance Companies § 1.831-2 Taxable years affected. Section 1.831-1 is... amended. Section 1.831-4 is applicable only with respect to the companies described therein, and only with...

26 CFR 1.831-2 - Taxable years affected.

Code of Federal Regulations, 2012 CFR

2012-04-01

...) INCOME TAXES (CONTINUED) Other Insurance Companies § 1.831-2 Taxable years affected. Section 1.831-1 is... amended. Section 1.831-4 is applicable only with respect to the companies described therein, and only with...

76 FR 7222 - Medical Device Innovation Initiative; Public Meeting; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-09

...] Medical Device Innovation Initiative; Public Meeting; Request for Comments AGENCY: Food and Drug... Administration (FDA) is announcing a public meeting entitled ``CDRH's Medical Device Innovation Initiative Public... Center for Devices and Radiological Health's (CDRH) document, ``Medical Device Innovation Initiative...

Value-based purchasing of medical devices.

PubMed

Obremskey, William T; Dail, Teresa; Jahangir, A Alex

2012-04-01

Health care in the United States is known for its continued innovation and production of new devices and techniques. While the intention of these devices is to improve the delivery and outcome of patient care, they do not always achieve this goal. As new technologies enter the market, hospitals and physicians must determine which of these new devices to incorporate into practice, and it is important these devices bring value to patient care. We provide a model of a physician-engaged process to decrease cost and increase review of physician preference items. We describe the challenges, implementation, and outcomes of cost reduction and product stabilization of a value-based process for purchasing medical devices at a major academic medical center. We implemented a physician-driven committee that standardized and utilized evidence-based, clinically sound, and financially responsible methods for introducing or consolidating new supplies, devices, and technology for patient care. This committee worked with institutional finance and administrative leaders to accomplish its goals. Utilizing this physician-driven committee, we provided access to new products, standardized some products, decreased costs of physician preference items 11% to 26% across service lines, and achieved savings of greater than $8 million per year. The implementation of a facility-based technology assessment committee that critically evaluates new technology can decrease hospital costs on implants and standardize some product lines.

TAXONOMY OF MEDICAL DEVICES IN THE LOGIC OF HEALTH TECHNOLOGY ASSESSMENT.

PubMed

Henschke, Cornelia; Panteli, Dimitra; Perleth, Matthias; Busse, Reinhard

2015-01-01

The suitability of general HTA methodology for medical devices is gaining interest as a topic of scientific discourse. Given the broad range of medical devices, there might be differences between groups of devices that impact both the necessity and the methods of their assessment. Our aim is to develop a taxonomy that provides researchers and policy makers with an orientation tool on how to approach the assessment of different types of medical devices. Several classifications for medical devices based on varying rationales for different regulatory and reporting purposes were analyzed in detail to develop a comprehensive taxonomic model. The taxonomy is based on relevant aspects of existing classification schemes incorporating elements of risk and functionality. Its 9 × 6 matrix distinguishes between the diagnostic or therapeutic nature of devices and considers whether the medical device is directly used by patients, constitutes part of a specific procedure, or can be used for a variety of procedures. We considered the relevance of different device categories in regard to HTA to be considerably variable, ranging from high to low. Existing medical device classifications cannot be used for HTA as they are based on different underlying logics. The developed taxonomy combines different device classification schemes used for different purposes. It aims at providing decision makers with a tool enabling them to consider device characteristics in detail across more than one dimension. The placement of device groups in the matrix can provide decision support on the necessity of conducting a full HTA.

26 CFR 1.1402(f)-1 - Computation of partner's net earnings from self-employment for taxable year which ends as result...

Code of Federal Regulations, 2010 CFR

2010-04-01

...-employment for taxable year which ends as result of his death. 1.1402(f)-1 Section 1.1402(f)-1 Internal...-employment for taxable year which ends as result of his death. (a) Taxable years ending after August 28, 1958...'s taxable year ends after August 28, 1958, solely because of death, and on a day other than the last...

76 FR 12743 - Medical Device Reporting; Malfunction Reporting Frequency

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0097] Medical Device Reporting; Malfunction Reporting Frequency AGENCY: Food and Drug Administration, HHS... compliance with FDA's Medical Device Reporting regulation, pending future FDA notice under the Federal Food...

Instructions included? Make safety training part of medical device procurement process.

PubMed

Keller, James P

2010-04-01

Before hospitals embrace new technologies, it's important that medical personnel agree on how best to use them. Likewise, hospitals must provide the support to operate these sophisticated devices safely. With this in mind, it's wise for hospitals to include medical device training in the procurement process. Moreover, purchasing professionals can play a key role in helping to increase the amount of user training for medical devices and systems. What steps should you take to help ensure that new medical devices are implemented safely? Here are some tips.

The potential of medical device industry in technological and economical context

PubMed Central

Maresova, Petra; Penhaker, Marek; Selamat, Ali; Kuca, Kamil

2015-01-01

The high quality of public health improves not only healthy life expectancy, but also the productivity of labor. The most important part of the health care sector is the medical technology industry. The aim of this study is to analyze the current situation in the medical device industry in Europe, its potential strengths and weaknesses in the context of topical economic and demographic development. The contribution specifies an analysis of the economic state of the medical device industry in the context of demographic development of European Union’s macroeconomic indicators and views of experts in the field of medical device development, concerning the opportunities for entities involved in the medical device market. There is fierce competition on the European market. The innovative activity is stable and well regulated by responsible authorities. Worldwide, the medical device market is expected to grow. PMID:26491337

The potential of medical device industry in technological and economical context.

PubMed

Maresova, Petra; Penhaker, Marek; Selamat, Ali; Kuca, Kamil

2015-01-01

The high quality of public health improves not only healthy life expectancy, but also the productivity of labor. The most important part of the health care sector is the medical technology industry. The aim of this study is to analyze the current situation in the medical device industry in Europe, its potential strengths and weaknesses in the context of topical economic and demographic development. The contribution specifies an analysis of the economic state of the medical device industry in the context of demographic development of European Union's macroeconomic indicators and views of experts in the field of medical device development, concerning the opportunities for entities involved in the medical device market. There is fierce competition on the European market. The innovative activity is stable and well regulated by responsible authorities. Worldwide, the medical device market is expected to grow.

77 FR 14272 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2012-N-0165] Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus... AND MICROBIOLOGY DEVICES 0 1. The authority citation for 21 CFR part 866 continues to read as follows...

NEED FOR HARMONIZATION OF LABELING OF MEDICAL DEVICES: A REVIEW

PubMed Central

Songara, Raiendra K.; Sharma, Ganesh N.; Gupta, Vipul K.; Gupta, Promila

2010-01-01

Medical device labeling is any information associated with a device targeted to the patient or lay caregiver. It is intended to help assure that the device is used safely and effectively. Medical device labeling is supplied in many formats, for example, as patient brochures, patient leaflets, user manuals, and videotapes. The European commission has discussed a series of agreements with third countries, Australia, New Zealand, USA, Canada, Japan and Eastern European countries wishing to join the EU, concerning the mutual acceptance of inspection bodies, proof of conformity in connection with medical devices. Device labeling is exceedingly difficult for manufacturers for many reasons like regulations from government bodies to ensure compliance, increased competent authority surveillance, increased audits and language requirements. PMID:22247840

Standalone medical device software: The evolving regulatory framework.

PubMed

McCarthy, Avril D; Lawford, Patricia V

2014-01-01

The paper provides an introduction to the regulatory landscape affecting a particular category of medical technology, namely standalone software-sometimes referred to as 'software as a medical device'. To aid the reader's comprehension of an often complex area, six case studies are outlined and discussed before the paper continues to provide detail of how software with a medical purpose in its own right can potentially be classified as a medical device. The reader is provided an appreciation of how to go about classifying such software and references to support the developer new to the field in locating detailed regulatory support documents and contact points for advice.

[Design of medical devices management system supporting full life-cycle process management].

PubMed

Su, Peng; Zhong, Jianping

2014-03-01

Based on the analysis of the present status of medical devices management, this paper optimized management process, developed a medical devices management system with Web technologies. With information technology to dynamic master the use of state of the entire life-cycle of medical devices. Through the closed-loop management with pre-event budget, mid-event control and after-event analysis, improved the delicacy management level of medical devices, optimized asset allocation, promoted positive operation of devices.

The regulation of cognitive enhancement devices: extending the medical model

PubMed Central

Maslen, Hannah; Douglas, Thomas; Cohen Kadosh, Roi; Levy, Neil; Savulescu, Julian

2014-01-01

This article presents a model for regulating cognitive enhancement devices (CEDs). Recently, it has become very easy for individuals to purchase devices which directly modulate brain function. For example, transcranial direct current stimulators are increasingly being produced and marketed online as devices for cognitive enhancement. Despite posing risks in a similar way to medical devices, devices that do not make any therapeutic claims do not have to meet anything more than basic product safety standards. We present the case for extending existing medical device legislation to cover CEDs. Medical devices and CEDs operate by the same or similar mechanisms and pose the same or similar risks. This fact coupled with the arbitrariness of the line between treatment and enhancement count in favour of regulating these devices in the same way. In arguing for this regulatory model, the paper highlights potential challenges to its implementation, and suggests solutions. PMID:25243073

Human factors and the FDA's goals: improved medical device design.

PubMed

Burlington, D B

1996-01-01

The Food and Drug Administration's new human factors design requirements for medical devices were previewed by the director of the FDA's Center for Devices and Radiological Health (CDRH) at AAMI/FDA's Human Factors in Medical Devices Conference held in September 1995. Director Bruce Burlington, MD, said the FDA plans to take a closer look at how new medical devices are designed to ensure proper attention has been paid to human error prevention. As a medical practitioner who has witnessed use-related deaths and injuries, Burlington stressed the importance of the medical community's reporting use errors as they occur and manufacturers' creating easy-to-use labeling and packaging. He also called for simplicity and quality of design in medical products, and asked for a consolidated effort of all professionals involved in human factors issues to help implement and further the FDA's new human factors program. An edited version of his presentation appears here.

26 CFR 48.4081-7 - Taxable fuel; conditions for refunds of taxable fuel tax under section 4081(e).

Code of Federal Regulations, 2010 CFR

2010-04-01

... was paid to the government and not credited or refunded (the “first tax”); (2) After imposition of the first tax, another tax was imposed by section 4081 with respect to the same taxable fuel and was also... section; and (4) The person that paid the first tax to the government has met the reporting requirements...

26 CFR 48.4081-7 - Taxable fuel; conditions for refunds of taxable fuel tax under section 4081(e).

Code of Federal Regulations, 2011 CFR

2011-04-01

... was paid to the government and not credited or refunded (the “first tax”); (2) After imposition of the first tax, another tax was imposed by section 4081 with respect to the same taxable fuel and was also... section; and (4) The person that paid the first tax to the government has met the reporting requirements...

Image quality assessment for teledermatology: from consumer devices to a dedicated medical device

NASA Astrophysics Data System (ADS)

Amouroux, Marine; Le Cunff, Sébastien; Haudrechy, Alexandre; Blondel, Walter

2017-03-01

Aging population as well as growing incidence of type 2 diabetes induce a growing incidence of chronic skin disorders. In the meantime, chronic shortage of dermatologists leaves some areas underserved. Remote triage and assistance to homecare nurses (known as "teledermatology") appear to be promising solutions to provide dermatological valuation in a decent time to patients wherever they live. Nowadays, teledermatology is often based on consumer devices (digital tablets, smartphones, webcams) whose photobiological and electrical safety levels do not match with medical devices' levels. The American Telemedicine Association (ATA) has published recommendations on quality standards for teledermatology. This "quick guide" does not address the issue of image quality which is critical in domestic environments where lighting is rarely reproducible. Standardized approaches of image quality would allow clinical trial comparison, calibration, manufacturing quality control and quality insurance during clinical use. Therefore, we defined several critical metrics using calibration charts (color and resolution charts) in order to assess image quality such as resolution, lighting uniformity, color repeatability and discrimination of key couples of colors. Using such metrics, we compared quality of images produced by several medical devices (handheld and video-dermoscopes) as well as by consumer devices (digital tablet and cameras) widely spread among dermatologists practice. Since diagnosis accuracy may be impaired by "low quality-images", this study highlights that, from an optical point of view, teledermatology should only be performed using medical devices. Furthermore, a dedicated medical device should probably be developed for the time follow-up of skin lesions often managed in teledermatology such as chronic wounds that require i) noncontact imaging of ii) large areas of skin surfaces, both criteria that cannot be matched using dermoscopes.

21 CFR 801.15 - Medical devices; prominence of required label statements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; prominence of required label statements. 801.15 Section 801.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.15 Medical devices; prominence of required label statements. (a...

26 CFR 1.857-2 - Real estate investment trust taxable income and net capital gain.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 26 Internal Revenue 9 2014-04-01 2014-04-01 false Real estate investment trust taxable income and... TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES (CONTINUED) Real Estate Investment Trusts § 1.857-2 Real estate investment trust taxable income and net capital gain. (a) Real estate investment trust...

26 CFR 1.857-2 - Real estate investment trust taxable income and net capital gain.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 26 Internal Revenue 9 2011-04-01 2011-04-01 false Real estate investment trust taxable income and... TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES (CONTINUED) Real Estate Investment Trusts § 1.857-2 Real estate investment trust taxable income and net capital gain. (a) Real estate investment trust...

26 CFR 1.857-2 - Real estate investment trust taxable income and net capital gain.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 26 Internal Revenue 9 2012-04-01 2012-04-01 false Real estate investment trust taxable income and... TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES (CONTINUED) Real Estate Investment Trusts § 1.857-2 Real estate investment trust taxable income and net capital gain. (a) Real estate investment trust...

26 CFR 1.857-2 - Real estate investment trust taxable income and net capital gain.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 26 Internal Revenue 9 2013-04-01 2013-04-01 false Real estate investment trust taxable income and... TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES (CONTINUED) Real Estate Investment Trusts § 1.857-2 Real estate investment trust taxable income and net capital gain. (a) Real estate investment trust...

26 CFR 1.1382-3 - Taxable income of cooperatives; special deductions for exempt farmers' cooperatives.

Code of Federal Regulations, 2010 CFR

2010-04-01

... deductions for exempt farmers' cooperatives. 1.1382-3 Section 1.1382-3 Internal Revenue INTERNAL REVENUE... Patrons § 1.1382-3 Taxable income of cooperatives; special deductions for exempt farmers' cooperatives. (a) In general. (1) Section 1382(c) provides that in determining the taxable income of a farmers', fruit...

76 FR 65200 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-20

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of... Administration (FDA) is postponing the meeting of the General and Plastic Surgery Devices Panel of the Medical...

[Licensing of Pharmaceuticals and Medical Devices in Germany: Weaknesses and Opportunities].

PubMed

Reinhardt, D; Wildner, M

2016-12-01

The purpose of this study is to describe and compare the licensing of pharmaceuticals and medical devices in Germany. Weaknesses and opportunities of the respective processes are identified. Methods: To describe and compare the two approaches, a systematic literature review was conducted, followed by an archival analysis, guided by experts. Unstructured interviews were conducted with experts (users, financers, surveillants and producers) personally or by telephone to identify weaknesses and opportunities. The data were evaluated by content analysis according to Mayring and MAXQDA 11. The results were critically assessed by comparing them with the current academic literature. Results: A central market authorization for medical devices was mentioned often, but seems politically not viable. However, quality, methodology and depth of the analyses necessary for the licensing of medical devices, especially for high-risk devices, can and should strive for higher standards, comparable to those of pharmaceuticals. With regard to post-market surveillance, the systems for both pharmaceuticals and medical devices should be improved. Innovativeness and competitiveness of European medical device manufacturers should not be promoted by reduced evidence standards and patient safety. Subsidies or easier licensing procedures for small product lines with particular importance for public health, similar to orphan drug regulations, are more desirable. Conclusion: This study helps to identify areas of improvement for licensing of pharmaceuticals and medical devices. Concrete recommendations were developed. Higher evidence standards should be mandatory especially for high-risk devices, comparable to those of pharmaceuticals. Post-marketing surveillance should be improved for pharmaceuticals and medical devices. © Georg Thieme Verlag KG Stuttgart · New York.

31 CFR 561.327 - Food, medicine, and medical devices.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false Food, medicine, and medical devices... REGULATIONS General Definitions § 561.327 Food, medicine, and medical devices. (a) The term food means items...-grade gelatin powder, and peptones and their derivatives. (b) The term medicine has the same meaning...

Enabling Medical Device Interoperability for the Integrated Clinical Environment

DTIC Science & Technology

2016-02-01

Pajic M, Mangharam R, Sokolsky O, Arney D, Goldman JM, Lee I. Model-Driven Safety Analysis of Closed - Loop Medical Systems. IEEE Transactions on...Manigel J, Osborn D, Roellike T, Weininger S, Westenskow D, “Development of a Standard for Physiologic Closed Loop Controllers in Medical Devices...3 2010. 27. Arney D, Pajic M, Goldman JM, Lee I, Mangharam R, Sokolsky O, “Toward Patient Safety in Closed - Loop Medical Device Systems,” In

26 CFR 41.4482(c)-1 - Definition of State, taxable period, use, and customarily used.

Code of Federal Regulations, 2010 CFR

2010-04-01

... THE TREASURY (CONTINUED) MISCELLANEOUS EXCISE TAXES EXCISE TAX ON USE OF CERTAIN HIGHWAY MOTOR VEHICLES Tax on Use of Certain Highway Motor Vehicles § 41.4482(c)-1 Definition of State, taxable period... 26 Internal Revenue 16 2010-04-01 2010-04-01 true Definition of State, taxable period, use, and...

[Better medical devices regulations for better health care: enlightenment for medical devices regulatory reform in China, from experiences of the E.U. and the U.S.A].

PubMed

Sun, Qin; Yan, Liang

2006-01-01

The expansion of applications of medical devices has attracted the increased attention of government regulatory bodies around the world to the safety and effectiveness of these products. Most developed countries, such as the United States and European Union, have developed well-established regulatory systems for medical devices, which have also consistently been amended to accommodate the changing requirements of safety and the trend of globalization.The current "Regulations for the Supervision and Administration of Medical Device (China)", established in 2000, has brought about great improvements for the safety and effectiveness of products, safeguarding public health. But there are still, at present, a lot of counterfeit and poor quality devices and device-related adverse events for lack of powerful post -market and in-use regulatory controls for products. It is therefore very urgent for the Chinese government to reform its medical device administration and management. This research paper analyses and compares the different requirements and executions of medical devices regulations in the EU, the US and China, to draw some experiences of the EU and US regimes that are very useful to China's regulatory reform. It is suggested that when developing a new scheme of medical devices regulatory reform in China, two prominent aspects have to be considered by policy makers and regulators. Firstly, the global trend of medical devices regulations has to be taken into account. Secondly, the experiences learned from the EU and US systems should be applied to the Chinese regulatory reform in combination with the concrete practice of China.

Issues and challenges of involving users in medical device development.

PubMed

Bridgelal Ram, Mala; Grocott, Patricia R; Weir, Heather C M

2008-03-01

User engagement has become a central tenet of health-care policy. This paper reports on a case study in progress that highlights user engagement in the research process in relation to medical device development. To work with a specific group of medical device users to uncover unmet needs, translating these into design concepts, novel technologies and products. To validate a knowledge transfer model that may be replicated for a range of medical device applications and user groups. In depth qualitative case study to elicit and analyse user needs. The focus is on identifying design concepts for medical device applications from unmet needs, and validating these in an iterative feedback loop to the users. The case study has highlighted three interrelated challenges: ensuring unmet needs drive new design concepts and technology development; managing user expectations and managing the research process. Despite the challenges, active participation of users is crucial to developing usable and clinically effective devices.

Bluetooth Communication for Battery Powered Medical Devices

NASA Astrophysics Data System (ADS)

Babušiak, Branko; Borik, Štefan

2016-01-01

wireless communication eliminates obtrusive cables associated with wearable sensors and considerably increases patient comfort during measurement and collection of medical data. Wireless communication is very popular in recent years and plays a significant role in telemedicine and homecare applications. Bluetooth technology is one of the most commonly used wireless communication types in medicine. This paper describes the design of a universal wireless communication device with excellent price/performance ratio. The said device is based on the low-cost RN4020 Bluetooth module with Microchip Low-energy Data Profile (MLDP) and due to low-power consumption is especially suitable for the transmission of biological signals (ECG, EMG, PPG, etc.) from wearable medical/personal health devices. A unique USB dongle adaptor was developed for wireless communication via UART interface and power consumption was evaluated under various conditions.

Assurance Cases for Medical Devices

DTIC Science & Technology

2011-04-28

the patient, and the hospital setting. Some pumps allow the patient to control part of the injection process (e.g. to inject more painkiller ...overdose, incorrect therapy, etc.   Design and development decisions that bear on safety and effectiveness http://www.fda.gov/MedicalDevices

Electronic medical devices: a primer for pathologists.

PubMed

Weitzman, James B

2003-07-01

Electronic medical devices (EMDs) with downloadable memories, such as implantable cardiac pacemakers, defibrillators, drug pumps, insulin pumps, and glucose monitors, are now an integral part of routine medical practice in the United States, and functional organ replacements, such as the artificial heart, pancreas, and retina, will most likely become commonplace in the near future. Often, EMDs end up in the hands of the pathologist as a surgical specimen or at autopsy. No established guidelines for systematic examination and reporting or comprehensive reviews of EMDs currently exist for the pathologist. To provide pathologists with a general overview of EMDs, including a brief history; epidemiology; essential technical aspects, indications, contraindications, and complications of selected devices; potential applications in pathology; relevant government regulations; and suggested examination and reporting guidelines. Articles indexed on PubMed of the National Library of Medicine, various medical and history of medicine textbooks, US Food and Drug Administration publications and product information, and specifications provided by device manufacturers. Studies were selected on the basis of relevance to the study objectives. Descriptive data were selected by the author. Suggested examination and reporting guidelines for EMDs received as surgical specimens and retrieved at autopsy. Electronic medical devices received as surgical specimens and retrieved at autopsy are increasing in number and level of sophistication. They should be systematically examined and reported, should have electronic memories downloaded when indicated, will help pathologists answer more questions with greater certainty, and should become an integral part of the formal knowledge base, research focus, training, and practice of pathology.

Wearable Devices in Medical Internet of Things: Scientific Research and Commercially Available Devices

PubMed Central

Thurow, Kerstin; Stoll, Regina

2017-01-01

Objectives Wearable devices are currently at the heart of just about every discussion related to the Internet of Things. The requirement for self-health monitoring and preventive medicine is increasing due to the projected dramatic increase in the number of elderly people until 2020. Developed technologies are truly able to reduce the overall costs for prevention and monitoring. This is possible by constantly monitoring health indicators in various areas, and in particular, wearable devices are considered to carry this task out. These wearable devices and mobile apps now have been integrated with telemedicine and telehealth efficiently, to structure the medical Internet of Things. This paper reviews wearable health care devices both in scientific papers and commercial efforts. Methods MIoT is demonstrated through a defined architecture design, including hardware and software dealing with wearable devices, sensors, smart phones, medical application, and medical station analyzers for further diagnosis and data storage. Results Wearables, with the help of improved technology have been developed greatly and are considered reliable tools for long-term health monitoring systems. These are applied in the observation of a large variety of health monitoring indicators in the environment, vital signs, and fitness. Conclusions Wearable devices are now used for a wide range of healthcare observation. One of the most important elements essential in data collection is the sensor. During recent years with improvement in semiconductor technology, sensors have made investigation of a full range of parameters closer to realization. PMID:28261526

Wearable Devices in Medical Internet of Things: Scientific Research and Commercially Available Devices.

PubMed

Haghi, Mostafa; Thurow, Kerstin; Stoll, Regina

2017-01-01

Wearable devices are currently at the heart of just about every discussion related to the Internet of Things. The requirement for self-health monitoring and preventive medicine is increasing due to the projected dramatic increase in the number of elderly people until 2020. Developed technologies are truly able to reduce the overall costs for prevention and monitoring. This is possible by constantly monitoring health indicators in various areas, and in particular, wearable devices are considered to carry this task out. These wearable devices and mobile apps now have been integrated with telemedicine and telehealth efficiently, to structure the medical Internet of Things. This paper reviews wearable health care devices both in scientific papers and commercial efforts. MIoT is demonstrated through a defined architecture design, including hardware and software dealing with wearable devices, sensors, smart phones, medical application, and medical station analyzers for further diagnosis and data storage. Wearables, with the help of improved technology have been developed greatly and are considered reliable tools for long-term health monitoring systems. These are applied in the observation of a large variety of health monitoring indicators in the environment, vital signs, and fitness. Wearable devices are now used for a wide range of healthcare observation. One of the most important elements essential in data collection is the sensor. During recent years with improvement in semiconductor technology, sensors have made investigation of a full range of parameters closer to realization.

Vat rates on medical devices: foreign experience and Ukrainian practice.

PubMed

Pashkov, Vitalii; Hutorova, Nataliia; Harkusha, Andrii

2017-01-01

In Ukraine differentiated VAT rates is a matter of debate. Today the Cabinet approved a list of medical products that has been changed three times resulting in changed VAT rates for specific products. European Union provides another method of regulation of VAT rates on medical devices. The abovementioned demonstrates the relevance of this study. Comparative analysis of Ukrainian and European Union legislation based on dialectical, comparative, analytic, synthetic and comprehensive research methods were used in this article. In Ukraine general rate of VAT for all business activities is 20 %. But for medical devices, Tax Code of Ukraine provides special rules. VAT rate of 7% for transactions supplies into Ukraine and imported into the customs territory of Ukraine of medical products on the list approved by the Cabinet. The list generated by the medical product name and nomenclature code that does not correspond to European experience and Council Directive 2006/112/EC. In our opinion, reduced VAT rates should to be established for all medical devices that are in a stream of commerce, have all necessary documents, that proved their quality and safety and fall under definition of medical devices.

[Thoughts on the Witnessed Audit in Medical Device Single Audit Program].

PubMed

Wen, Jing; Xiao, Jiangyi; Wang, Aijun

2018-02-08

Medical Device Single Audit Program is one of the key projects in International Medical Device Regulators Forum, which has much experience to be used for reference. This paper briefly describes the procedures and contents of the Witnessed Audit in Medical Device Single Audit Program. Some revelations about the work of Witnessed Audit have been discussed, for reference by the Regulatory Authorities and the Auditing Organizations.

Medical device development: managing conflicts of interest encountered by physicians.

PubMed

Baim, Donald S; Donovan, Aine; Smith, John J; Briefs, Nancy; Geoffrion, Richard; Feigal, David; Kaplan, Aaron V

2007-04-01

New technologies introduced over the past three decades have transformed medical diagnosis and treatment, and significantly improved patient outcomes. These changes have been mediated by the introduction of new medical devices, particularly for the treatment of cardiovascular, orthopedic, and ophthalmic disorders. These devices, in turn, have created large markets and spawned a burgeoning medical device industry, including six Fortune 500 companies whose combined market capitalization now exceeds 400 billion dollars. This success story, which has unquestionably benefited patients and society alike, has been dependent upon an intense collaboration among industry, clinicians, and regulatory authorities. However, when physicians actively involved in patient care participate in such collaborations, they are increasingly vulnerable to creating potential conflicts between these two (clinical and device development) roles. Such conflicts, which may ultimately erode public trust, have important consequences not only for the individual physicians, but also for their parent institutions, their patients, sponsoring companies, and the entire clinical research enterprise that makes the development and introduction of new devices possible. The third Dartmouth Device Development Symposium held in October 2005 brought together thought leaders within the medical device community, including academicians, clinical investigators, regulators from the Food and Drug Administration and Centers for Medicare and Medicaid Services (CMS), large and small device manufacturers and the financial (venture capital and investment banks) community. The Symposium examined the conflicts of interest encountered during the early development and commercialization of a medical device. The goal of these discussions was to (1) identify and characterize the conflicts that arise and (2) provide strategies to address these conflicts. This manuscript was prepared by a writing committee to provide a summary

Identification of Bodies by Unique Serial Numbers on Implanted Medical Devices.

PubMed

Blessing, Melissa M; Lin, Peter T

2018-05-01

Visual identification is the most common identification method used by medical examiners but is not always possible. Alternative methods include X-ray, fingerprint, or DNA comparison, but these methods require additional resources. Comparison of serial numbers on implanted medical devices is a rapid and definitive method of identification. To assess the practicality of using this method, we reviewed 608 consecutive forensic autopsies performed at a regional medical examiner office. Of these, 56 cases required an alternative method of identification due to decomposition (n = 35), gunshot wound (n = 9), blunt trauma (n = 6), or charring (n = 6). Of these 56 cases, eight (14.3%) were known to have an implanted medical device. Of these eight cases, five (63%) could be positively identified by comparing serial numbers. If an implanted medical device is known to be present, and medical records are available, identification by medical device serial number should be a first-line method. © 2017 American Academy of Forensic Sciences.

MEDIC: medical embedded device for individualized care.

PubMed

Wu, Winston H; Bui, Alex A T; Batalin, Maxim A; Au, Lawrence K; Binney, Jonathan D; Kaiser, William J

2008-02-01

Presented work highlights the development and initial validation of a medical embedded device for individualized care (MEDIC), which is based on a novel software architecture, enabling sensor management and disease prediction capabilities, and commercially available microelectronic components, sensors and conventional personal digital assistant (PDA) (or a cell phone). In this paper, we present a general architecture for a wearable sensor system that can be customized to an individual patient's needs. This architecture is based on embedded artificial intelligence that permits autonomous operation, sensor management and inference, and may be applied to a general purpose wearable medical diagnostics. A prototype of the system has been developed based on a standard PDA and wireless sensor nodes equipped with commercially available Bluetooth radio components, permitting real-time streaming of high-bandwidth data from various physiological and contextual sensors. We also present the results of abnormal gait diagnosis using the complete system from our evaluation, and illustrate how the wearable system and its operation can be remotely configured and managed by either enterprise systems or medical personnel at centralized locations. By using commercially available hardware components and software architecture presented in this paper, the MEDIC system can be rapidly configured, providing medical researchers with broadband sensor data from remote patients and platform access to best adapt operation for diagnostic operation objectives.

Medical applications for pharmacists using mobile devices.

PubMed

Aungst, Timothy Dy

2013-01-01

Mobile devices (eg, smartphones, tablet computers) have become ubiquitous and subsequently there has been a growth in mobile applications (apps). Concurrently, mobile devices have been integrated into health care practice due to the availability and quality of medical apps. These mobile medical apps offer increased access to clinical references and point-of-care tools. However, there has been little identification of mobile medical apps suitable for the practice of pharmacy. To address the shortage of recommendations of mobile medical apps for pharmacists in daily practice. Mobile medical apps were identified via the iTunes and Google Play Stores via the "Medical" app categories and key word searches (eg, drug information, medical calculators). In addition, reviews provided by professional mobile medical app review websites were used to identify apps. Mobile medical apps were included if they had been updated in the previous 3 months, were available in the US, used evidence-based information or literature support, had dedicated app support, and demonstrated stability. Exclusion criteria included apps that were not available in English, had advertisement bias, used nonreferenced sources, were available only via an institution-only subscription, and were web-based portals. Twenty-seven mobile apps were identified and reviewed that involved general pharmacy practice, including apps that involved drug references, clinical references, medical calculators, laboratory references, news and continuing medical education, and productivity. Mobile medical apps have a variety of features that are beneficial to pharmacy practice. Individual clinicians should consider several characteristics of these apps to determine which are suitable to incorporate into their daily practice.

78 FR 9349 - Medical Devices; Ophthalmic Devices; Classification of the Eyelid Weight

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-08

... MR incompatibility or the conditions for safe use in an MR environment. Labeling will mitigate the... Amendments of 1976 (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), and the Food and...) and nonclinical testing evaluating the compatibility of the device in a MR environment. In addition...

Developing medical device software in compliance with regulations.

PubMed

Zema, M; Rosati, S; Gioia, V; Knaflitz, M; Balestra, G

2015-08-01

In the last decade, the use of information technology (IT) in healthcare has taken a growing role. In fact, the adoption of an increasing number of computer tools has led to several benefits related to the process of patient care and allowed easier access to social and health care resources. At the same time this trend gave rise to new challenges related to the implementation of these new technologies. Software used in healthcare can be classified as medical devices depending on the way they are used and on their functional characteristics. If they are classified as medical devices they must satisfy specific regulations. The aim of this work is to present a software development framework that can allow the production of safe and high quality medical device software and to highlight the correspondence between each software development phase and the appropriate standard and/or regulation.

21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.

Code of Federal Regulations, 2010 CFR

2010-04-01

....122 Medical devices for processing, repacking, or manufacturing. A device intended for processing... act if its label bears the statement “Caution: For manufacturing, processing, or repacking”. ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices for processing, repacking, or...

Handheld Diagnostic Device Delivers Quick Medical Readings

NASA Technical Reports Server (NTRS)

2014-01-01

To monitor astronauts' health remotely, Glenn Research Center awarded SBIR funding to Cambridge, Massachusetts-based DNA Medical Institute, which developed a device capable of analyzing blood cell counts and a variety of medical biomarkers. The technology will prove especially useful in rural areas without easy access to labs.

26 CFR 1.213-1 - Medical, dental, etc., expenses.

Code of Federal Regulations, 2011 CFR

2011-04-01

... medical care includes the diagnosis, cure, mitigation, treatment, or prevention of disease. Expenses paid..., the amounts paid during the taxable year for insurance that constitute expenses paid for medical care... be deductible, they must be for medical care of the taxpayer, his spouse, or a dependent of the...

Medical device problem reporting for the betterment of healthcare.

PubMed

1998-08-01

Given that there are nearly 5,000 individual classes of medical devices, tens of thousands of medical device suppliers, and millions of healthcare providers around the world, device-related problems are bound to happen. But effective problem reporting can help reduce or eliminate many of these problems--not only within an institution, but also potentially around the world. In this article, we trace the problem reporting process from its beginnings in the hospital to its global impact in making critical information available throughout the healthcare community.

Home Healthcare Medical Devices: A Checklist

MedlinePlus

... not using it. Contact your doctor and home healthcare team often to review your health condition. * Check ... assurance of their safety and effectiveness. A home healthcare medical device is any product or equipment used ...

26 CFR 1.536-1 - Short taxable years.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES (CONTINUED) Corporations Used to Avoid Income Tax on Shareholders § 1.536-1 Short taxable... not be placed on an annual basis for the purpose of the accumulated earnings tax imposed by section...

76 FR 7220 - Medical Device Innovation Initiative; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-09

...] Medical Device Innovation Initiative; Request for Comments AGENCY: Food and Drug Administration, HHS... availability of a document for public comment entitled ``Medical Device Innovation Initiative'' (the report... Innovation Initiative would consider the creation of a special Innovation Pathway intended to provide earlier...

26 CFR 301.6501(j)-1 - Investment credit carryback; taxable years ending after December 31, 1961.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 18 2010-04-01 2010-04-01 false Investment credit carryback; taxable years ending after December 31, 1961. 301.6501(j)-1 Section 301.6501(j)-1 Internal Revenue INTERNAL REVENUE... Limitations Limitations on Assessment and Collection § 301.6501(j)-1 Investment credit carryback; taxable...

Laser-generated shockwave for clearing medical device biofilms.

PubMed

Kizhner, Victor; Krespi, Yosef P; Hall-Stoodley, Luanne; Stoodley, Paul

2011-04-01

This study aimed to evaluate a laser method of biofilm interruption from the surface of various common medical devices and from surgically removed sinus tissue with adherent biofilms in a timely manner. Biofilm has emerged as a new threat not amenable to most antibiotic treatments. Biofilms, as opposed to planktonic bacteria, develop an extracellular polymeric slime matrix to facilitate adherence to host tissue or a prosthetic surface and to form a protective shield. A laser-induced biofilms disruption concept was previously described. Biofilms were grown in the laboratory on metallic and plastic medical device surfaces such as stents. Attempts to remove the biofilms with a laser were undertaken three times for each device. Q-switched Nd:YAG laser-generated shockwaves affecting Pseudomonas aeruginosa biofilms expressing yellow fluorescent protein (YFP) biofilm coating were applied with biologically safe parameters utilizing a fiber delivery system and a special probe. A confocal microscope was used to identify the biofilm structure prior to, during, and after laser application. The amount of biofilm removed from the medical devices in time was measured by quantifying green fluorescence. The biofilm fluctuated and eventually broke off the surface as shock waves neared the target. The time to remove 97.9 ± 0.4% (mean ± 1SD, n = 3) the biofilm from the surface of a Nitinol (NiTi) stent ranged from 4 to 10 s. The detached biofilm was observed floating in fluid media in various microscopic size particles. A new treatment modality using laser-generated shockwaves in the warfare against biofilms growing on surgical devices was demonstrated. Q-switched laser pulses stripped biofilm from the surface it adhered to, changing the bacteria to their planktonic form, making them amenable to conventional treatment. This therapeutic modality appears to be rapid, effective, and safe on metallic and plastic medical device surfaces.

Characterization of Therapeutic Coatings on Medical Devices

NASA Astrophysics Data System (ADS)

Wormuth, Klaus

Therapeutic coatings on medical devices such as catheters, guide wires, and stents improve biocompatibility by favorably altering the chemical nature of the device/tissue or device/blood interface. Such coatings often minimize tissue damage (reduce friction), decrease chances for blood clot formation (prevent platelet adsorption), and improve the healing response (deliver drugs). Confocal Raman microscopy provides valuable information about biomedical coatings by, for example, facilitating the measurement of the thickness and swelling of frictionreducing hydrogel coatings on catheters and by determining the distribution of drug within a polymer-based drug-eluting coatings on stents. This chapter explores the application of Raman microscopy to the imaging of thin coatings of cross-linked poly(vinyl pyrrolidone) gels, parylene films, mixtures of dexamethasone with various polymethacrylates, and mixtures of rapamycin with hydrolysable (biodegradable) poly(lactide-co-glycolide) polymers. Raman microscopy measures the thickness and swelling of coatings, reveals the degree of mixing of drug and polymer, senses the hydrolysis of biodegradable polymers, and determines the polymorphic forms of drug present within thin therapeutic coatings on medical devices.

75 FR 45641 - Medical Device User Fee Rates for Fiscal Year 2011

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-03

...] Medical Device User Fee Rates for Fiscal Year 2011 AGENCY: Food and Drug Administration, HHS. ACTION... payment procedures for medical device user fees for fiscal year (FY) 2011. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device User Fee Amendments of 2007 (title II of the Food...

78 FR 11612 - Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-19

... information that will have been reviewed by the applicant during the course of its development of the device..., infants, children, adolescents) that suffer from the disease or condition that the device is intended to.... FDA-2009-N-0458] RIN 0910-AG29 Medical Devices; Pediatric Uses of Devices; Requirement for Submission...

Medical Device Plug-and-Play Interoperability Standards and Technology Leadership

DTIC Science & Technology

2017-10-01

Award Number: W81XWH-09-1-0705 TITLE: “Medical Device Plug-and-Play Interoperability Standards and Technology Leadership” PRINCIPAL INVESTIGATOR...Sept 2016 – 20 Sept 2017 4. TITLE AND SUBTITLE “Medical Device Plug-and-Play Interoperability 5a. CONTRACT NUMBER Standards and Technology ...efficiency through interoperable medical technologies . We played a leadership role on interoperability safety standards (AAMI, AAMI/UL Joint

Transmitting patient and device data via GSM--central management for decentral mobile medical devices.

PubMed

Bachmor, T; Schöchlin, J; Bolz, A

2002-01-01

Equipping medical devices with long range telemetry opens completely new possibilities for emergency response, home care and remote diagnosis. Mobile communications nowadays seem to be a generally accepted part of our modern world, but bridging the gap between new (consumer-) technologies and medical devices still is a challenge today. Providing a telemetry link (GSM) is just the trivial part--ensuring security, reliability and service management are the more critical tasks that need to be addressed. Therefore, a complete system concept consists of an automatic fleet management (e.g. periodic device-initiated service calls) as well as customer relationship management (CRM), including technical service and a trouble-ticket system.

76 FR 43225 - Highway Use Tax; Filing and Payment for Taxable Period Beginning July 1, 2011

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-20

.... These regulations affect owners and operators of highway motor vehicles with a taxable gross weight of... temporary regulations that provide guidance on the filing of Form 2290 ``Heavy Highway Vehicle Use Tax... regulations are proposed to apply to taxable use of highway motor vehicles occurring on or after July 1, 2011...

Cybersecurity and medical devices: A practical guide for cardiac electrophysiologists

PubMed Central

Kramer, Daniel B.; Foo Kune, Denis; Auto de Medeiros, Julio; Yan, Chen; Xu, Wenyuan; Crawford, Thomas; Fu, Kevin

2017-01-01

Abstract Medical devices increasingly depend on software. While this expands the ability of devices to perform key therapeutic and diagnostic functions, reliance on software inevitably causes exposure to hazards of security vulnerabilities. This article uses a recent high‐profile case example to outline a proactive approach to security awareness that incorporates a scientific, risk‐based analysis of security concerns that supports ongoing discussions with patients about their medical devices. PMID:28512774

26 CFR 48.4101-1 - Taxable fuel; registration.

Code of Federal Regulations, 2012 CFR

2012-04-01

... vendors of diesel fuel and kerosene under section 6427. (2) A person is registered under section 4101 only... an enterer, refiner, terminal operator, or throughputter with respect to kerosene and is registered... store kerosene (and no other type of taxable fuel); or (C) Is a commercial airline, an operator of...

26 CFR 48.4101-1 - Taxable fuel; registration.

Code of Federal Regulations, 2013 CFR

2013-04-01

... vendors of diesel fuel and kerosene under section 6427. (2) A person is registered under section 4101 only... an enterer, refiner, terminal operator, or throughputter with respect to kerosene and is registered... store kerosene (and no other type of taxable fuel); or (C) Is a commercial airline, an operator of...

26 CFR 1.815-1 - Taxable years affected.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES Distributions to Shareholders § 1.815-1 Taxable years affected. Sections 1.815-2 through 1... Internal Revenue Code of 1954, as amended by the Life Insurance Company Income Tax Act of 1959 (73 Stat...

26 CFR 1.6655-5 - Short taxable year.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 3. Initial short year with three required installments. Corporation C began business on February 12... business on February 12, 2009, and adopted a calendar year as its taxable year. X adopts an accrual method... short year with four required installments. Corporation B began business on January 9, 2009, and adopted...

[Discussion on Technical Evaluation for Medical Device Registration Material].

PubMed

Chu, Yungao; Qian, Hong; Zhu, Yingfeng

2017-07-30

This article first introduces the main contents of the requirements for medical device registration. Secondly, this article chooses the vertebral forming surgery system as an example to discuss the technical evaluation for the registration research material. The article hopes to provide a reference for the applicant who prepare the registration material and the technical evaluator who make the evaluation for the medical device registration.

26 CFR 4.954-1 - Foreign base company income; taxable years beginning after December 31, 1986.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) Effective rate of foreign tax imposed on $320 of foreign personal holding company income under section 954(b... 26 Internal Revenue 14 2010-04-01 2010-04-01 false Foreign base company income; taxable years... 954 OF THE INTERNAL REVENUE CODE § 4.954-1 Foreign base company income; taxable years beginning after...

31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.

Code of Federal Regulations, 2011 CFR

2011-07-01

... commodities, medicine, and medical devices. 560.533 Section 560.533 Money and Finance: Treasury Regulations... Brokering sales of agricultural commodities, medicine, and medical devices. (a) General license for... agricultural commodities, medicine, and medical devices, provided that the sale and exportation or...

31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.

Code of Federal Regulations, 2010 CFR

2010-07-01

... commodities, medicine, and medical devices. 560.533 Section 560.533 Money and Finance: Treasury Regulations... Brokering sales of agricultural commodities, medicine, and medical devices. (a) General license for... agricultural commodities, medicine, and medical devices, provided that the sale and exportation or...

Medical Devices Transition to Information Systems: Lessons Learned

PubMed Central

Charters, Kathleen G.

2012-01-01

Medical devices designed to network can share data with a Clinical Information System (CIS), making that data available within clinician workflow. Some lessons learned by transitioning anesthesia reporting and monitoring devices (ARMDs) on a local area network (LAN) to integration of anesthesia documentation within a CIS include the following categories: access, contracting, deployment, implementation, planning, security, support, training and workflow integration. Areas identified for improvement include: Vendor requirements for access reconciled with the organizations’ security policies and procedures. Include clauses supporting transition from stand-alone devices to information integrated into clinical workflow in the medical device procurement contract. Resolve deployment and implementation barriers that make the process less efficient and more costly. Include effective field communication and creative alternatives in planning. Build training on the baseline knowledge of trainees. Include effective help desk processes and metrics. Have a process for determining where problems originate when systems share information. PMID:24199054

26 CFR 49.4262(a)-1 - Taxable transportation.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MISCELLANEOUS EXCISE TAXES FACILITIES AND SERVICES EXCISE TAXES Transportation of Persons § 49.4262(a)-1 Taxable... which begins after November 15, 1962, only if such portion is not part of “uninterrupted international... transportation which begins after November 15, 1962, the tax, if applicable, applies only to the amount paid for...

Optical tests for using smartphones inside medical devices

NASA Astrophysics Data System (ADS)

Bernat, Amir S.; Acobas, Jennifer K.; Phang, Ye Shang; Hassan, David; Bolton, Frank J.; Levitz, David

2018-02-01

Smartphones are currently used in many medical applications and are more frequently being integrated into medical imaging devices. The regulatory requirements in existence today however, particularly the standardization of smartphone imaging through validation and verification testing, only partially cover imaging characteristics with a smartphone. Specifically, it has been shown that smartphone camera specifications are of sufficient quality for medical imaging, and there are devices which comply with the FDA's regulatory requirements for a medical device such as a device's field of view, direction of viewing and optical resolution and optical distortion. However, these regulatory requirements do not call specifically for color testing. Images of the same object using automatic settings or different light sources can show different color composition. Experimental results showing such differences are presented. Under some circumstances, such differences in color composition could potentially lead to incorrect diagnoses. It is therefore critical to control the smartphone camera and illumination parameters properly. This paper examines different smartphone camera settings that affect image quality and color composition. To test and select the correct settings, a test methodology is proposed. It aims at evaluating and testing image color correctness and white balance settings for mobile phones and LED light sources. Emphasis is placed on color consistency and deviation from gray values, specifically by evaluating the ΔC values based on the CIEL*a*b* color space. Results show that such standardization minimizes differences in color composition and thus could reduce the risk of a wrong diagnosis.

Laser direct writing of micro- and nano-scale medical devices

PubMed Central

Gittard, Shaun D; Narayan, Roger J

2010-01-01

Laser-based direct writing of materials has undergone significant development in recent years. The ability to modify a variety of materials at small length scales and using short production times provides laser direct writing with unique capabilities for fabrication of medical devices. In many laser-based rapid prototyping methods, microscale and submicroscale structuring of materials is controlled by computer-generated models. Various laser-based direct write methods, including selective laser sintering/melting, laser machining, matrix-assisted pulsed-laser evaporation direct write, stereolithography and two-photon polymerization, are described. Their use in fabrication of microstructured and nanostructured medical devices is discussed. Laser direct writing may be used for processing a wide variety of advanced medical devices, including patient-specific prostheses, drug delivery devices, biosensors, stents and tissue-engineering scaffolds. PMID:20420557

Advertising and promotion of medical devices.

PubMed

Portnoy, Stuart

2006-01-01

Dr. Portnoy, a former senior clinical reviewer and manager for the FDA's Center for Devices and Radiological Health, provides guidance for determining acceptable practices for the claims, content, and appearance of advertising and promotional materials for medical devices. In the course of doing so, he discusses important regulatory and legal precedents, and provides examples of successful and problematic advertising and promotion strategies including those that resulted in FDA Warning Letters, enforcement activities, and in some cases, monetary and criminal penalties.

Open-source hardware for medical devices.

PubMed

Niezen, Gerrit; Eslambolchilar, Parisa; Thimbleby, Harold

2016-04-01

Open-source hardware is hardware whose design is made publicly available so anyone can study, modify, distribute, make and sell the design or the hardware based on that design. Some open-source hardware projects can potentially be used as active medical devices. The open-source approach offers a unique combination of advantages, including reducing costs and faster innovation. This article compares 10 of open-source healthcare projects in terms of how easy it is to obtain the required components and build the device.

Biocompatibility: meeting a key functional requirement of next-generation medical devices.

PubMed

Helmus, Michael N; Gibbons, Donald F; Cebon, David

2008-01-01

The array of polymeric, biologic, metallic, and ceramic biomaterials will be reviewed with respect to their biocompatibility, which has traditionally been viewed as a requirement to develop a safe medical device. With the emergence of combination products, a paradigm shift is occurring that now requires biocompatibility to be designed into the device. In fact, next-generation medical devices will require enhanced biocompatibility by using, for example, pharmacological agents, bioactive coatings, nano-textures, or hybrid systems containing cells that control biologic interactions to have desirable biologic outcomes. The concept of biocompatibility is moving from a "do no harm" mission (i.e., nontoxic, nonantigenic, nonmutagenic, etc.) to one of doing "good," that is, encouraging positive healing responses. These new devices will promote the formation of normal healthy tissue as well as the integration of the device into adjacent tissue. In some contexts, biocompatibility can become a disruptive technology that can change therapeutic paradigms (e.g., drug-coated stents). New database tools to access biocompatibility data of the materials of construction in existing medical devices will facilitate the use of existing and new biomaterials for new medical device designs.

Improving acute care through use of medical device data.

PubMed

Kennelly, R J

1998-02-01

The Medical Information Bus (MIB) is a data communications standard for bedside patient connected medical devices. It is formally titled IEEE 1073 Standard for Medical Device Communications. MIB defines a complete seven layer communications stack for devices in acute care settings. All of the design trade-offs in writing the standard were taken to optimize performance in acute care settings. The key clinician based constraints on network performance are: (1) the network must be able to withstand multiple daily reconfigurations due to patient movement and condition changes; (2) the network must be 'plug-and-play' to allow clinicians to set up the network by simply plugging in a connector, taking no other actions; (3) the network must allow for unambiguous associations of devices with specific patients. A network of this type will be used by clinicians, thus giving complete, accurate, real time data from patient connected devices. This capability leads to many possible improvements in patient care and hospital cost reduction. The possible uses for comprehensive automatic data capture are only limited by imagination and creativity of clinicians adapting to the new hospital business paradigm.

26 CFR 1.41-5 - Basic research for taxable years beginning after December 31, 1986. [Reserved

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 1 2010-04-01 2010-04-01 true Basic research for taxable years beginning after December 31, 1986. [Reserved] 1.41-5 Section 1.41-5 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY INCOME TAX INCOME TAXES Credits Against Tax § 1.41-5 Basic research for taxable years...

31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.

Code of Federal Regulations, 2014 CFR

2014-07-01

... commodities, medicine, and medical devices. 560.533 Section 560.533 Money and Finance: Treasury Regulations... Policy § 560.533 Brokering sales of agricultural commodities, medicine, and medical devices. (a) General... agricultural commodities, medicine, and medical devices, provided that the sale and exportation or...

Salespeople in the Surgical Suite: Relationships between Surgeons and Medical Device Representatives.

PubMed

O'Connor, Bonnie; Pollner, Fran; Fugh-Berman, Adriane

2016-01-01

Industry payments to surgeons have received public attention, but little is known about the relationships between surgeons and medical device representatives. Medical device representatives ("device reps") have become an integral part of operating room personnel. The effect of their presence on patient care deserves discussion. We conducted a qualitative, ethnographic study to explore relationships between surgeons and medical device representatives, and characterize industry involvement in the training of surgeons. We used group and individual open-ended interviews to gain insight into the beliefs, values, and perspectives of surgeons and device reps. We conducted two focus groups, one with ear, nose, and throat surgeons, and one with hospital-based attending orthopedic surgeons. We also conducted individual interviews with three former or current medical device representatives, a director of a surgical residency program at an academic medical center, and a medical assistant for a multi-physician orthopedic practice. While surgeons view themselves as indisputably in charge, device reps work hard to make themselves unobtrusively indispensable in order to establish and maintain influence, and to imbue the products they provide with personalized services that foster a surgeon's loyalty to the reps and their companies. Surgeons view industry-funded training opportunities as a necessary service. Device reps and some surgeons believe that reps benefit patient care, by increasing efficiency and mitigating deficiencies among operating room personnel (including the surgeons themselves). Our study raises ethical questions about the reliance of surgeons on device reps and device companies for education and surgical assistance and practical concerns regarding existing levels of competence among OR personnel.

31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false In-kind donations of medicine, medical... § 597.511 In-kind donations of medicine, medical devices, and medical services. (a) Effective July 6... provision by nongovernmental organizations that are U.S. persons of in-kind donations of medicine, medical...

31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false In-kind donations of medicine, medical... § 597.511 In-kind donations of medicine, medical devices, and medical services. (a) Effective July 6... provision by nongovernmental organizations that are U.S. persons of in-kind donations of medicine, medical...

31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false In-kind donations of medicine, medical... § 597.511 In-kind donations of medicine, medical devices, and medical services. (a) Effective July 6... provision by nongovernmental organizations that are U.S. persons of in-kind donations of medicine, medical...

31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false In-kind donations of medicine, medical... § 597.511 In-kind donations of medicine, medical devices, and medical services. (a) Effective July 6... provision by nongovernmental organizations that are U.S. persons of in-kind donations of medicine, medical...

31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.

Code of Federal Regulations, 2013 CFR

2013-07-01

... commodities, medicine, and medical devices. 560.533 Section 560.533 Money and Finance: Treasury Regulations... Policy § 560.533 Brokering sales of agricultural commodities, medicine, and medical devices. (a) General... of agricultural commodities, medicine, and medical devices, provided that the sale and exportation or...

31 CFR 538.526 - Brokering sales of agricultural commodities, medicine, and medical devices.

Code of Federal Regulations, 2011 CFR

2011-07-01

... commodities, medicine, and medical devices. 538.526 Section 538.526 Money and Finance: Treasury Regulations... Brokering sales of agricultural commodities, medicine, and medical devices. (a) General license for... agricultural commodities, medicine, and medical devices to the Government of Sudan, to any individual or entity...

31 CFR 538.526 - Brokering sales of agricultural commodities, medicine, and medical devices.

Code of Federal Regulations, 2010 CFR

2010-07-01

... commodities, medicine, and medical devices. 538.526 Section 538.526 Money and Finance: Treasury Regulations... Brokering sales of agricultural commodities, medicine, and medical devices. (a) General license for... agricultural commodities, medicine, and medical devices to the Government of Sudan, to any individual or entity...

Use-related risk analysis for medical devices based on improved FMEA.

PubMed

Liu, Long; Shuai, Ma; Wang, Zhu; Li, Ping

2012-01-01

In order to effectively analyze and control use-related risk of medical devices, quantitative methodologies must be applied. Failure Mode and Effects Analysis (FMEA) is a proactive technique for error detection and risk reduction. In this article, an improved FMEA based on Fuzzy Mathematics and Grey Relational Theory is developed to better carry out user-related risk analysis for medical devices. As an example, the analysis process using this improved FMEA method for a certain medical device (C-arm X-ray machine) is described.

77 FR 8143 - Section 482; Methods To Determine Taxable Income in Connection With a Cost Sharing Arrangement...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-14

... 482; Methods To Determine Taxable Income in Connection With a Cost Sharing Arrangement; Correction... on Thursday, December 22, 2011 (76 FR 80082), relating to section 482 and methods to determine... revisions read as follows: Sec. 1.482-7 Methods to determine taxable income in connection with a cost...

77 FR 3605 - Section 482; Methods To Determine Taxable Income in Connection With a Cost Sharing Arrangement...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-25

... DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [TD 9568] RIN 1545-BI47 Section 482; Methods To Determine Taxable Income in Connection With a Cost Sharing Arrangement; Correction... 22, 2011 (76 FR 80082), Relating to section 482 and methods to determine taxable income in connection...

77 FR 3606 - Section 482; Methods To Determine Taxable Income in Connection With a Cost Sharing Arrangement...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-25

... 482; Methods To Determine Taxable Income in Connection With a Cost Sharing Arrangement; Correction... 22, 2011 (76 FR 80082), Relating to section 482 and methods to determine taxable income in connection.... * * * * * (b) * * * (2) * * * (i) Methods. Sections 1.482-2 through 1.482-7 and 1.482-9 provide specific...

Open-source hardware for medical devices

PubMed Central

2016-01-01

Open-source hardware is hardware whose design is made publicly available so anyone can study, modify, distribute, make and sell the design or the hardware based on that design. Some open-source hardware projects can potentially be used as active medical devices. The open-source approach offers a unique combination of advantages, including reducing costs and faster innovation. This article compares 10 of open-source healthcare projects in terms of how easy it is to obtain the required components and build the device. PMID:27158528

Extended device profiles and testing procedures for the approval process of integrated medical devices using the IEEE 11073 communication standard.

PubMed

Janß, Armin; Thorn, Johannes; Schmitz, Malte; Mildner, Alexander; Dell'Anna-Pudlik, Jasmin; Leucker, Martin; Radermacher, Klaus

2018-02-23

Nowadays, only closed and proprietary integrated operating room systems (IORS) from big manufacturers are available on the market. Hence, the interconnection of components from third-party vendors is only possible with increased time and costs. In the context of the German Federal Ministry of Education and Research (BMBF)-funded project OR.NET (2012-2016), the open integration of medical devices from different manufacturers was addressed. An integrated operating theater based on the open communication standard IEEE 11073 shall give clinical operators the opportunity to choose medical devices independently of the manufacturer. This approach would be advantageous especially for hospital operators and small- and medium-sized enterprises (SME) of medical devices. Actual standards and concepts regarding technical feasibility and the approval process do not cope with the requirements for a modular integration of medical devices in the operating room (OR), based on an open communication standard. Therefore, innovative approval strategies and corresponding certification and test procedures, which cover actual legal and normative standards, have to be developed in order to support the future risk management and the usability engineering process of open integrated medical devices in the OR. The use of standardized device and service profiles and a three-step testing procedure, including conformity, interoperability and integration tests are described in this paper and shall support the manufacturers to integrate their medical devices without disclosing the medical devices' risk analysis and related confidential expertise or proprietary information.

76 FR 22322 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2010-N-0026] Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass Assessment Score Test System; Correction AGENCY: Food and Drug Administration, HHS. ACTION...

Salespeople in the Surgical Suite: Relationships between Surgeons and Medical Device Representatives

PubMed Central

O’Connor, Bonnie; Pollner, Fran; Fugh-Berman, Adriane

2016-01-01

Background Industry payments to surgeons have received public attention, but little is known about the relationships between surgeons and medical device representatives. Medical device representatives ("device reps") have become an integral part of operating room personnel. The effect of their presence on patient care deserves discussion. Study Design We conducted a qualitative, ethnographic study to explore relationships between surgeons and medical device representatives, and characterize industry involvement in the training of surgeons. We used group and individual open-ended interviews to gain insight into the beliefs, values, and perspectives of surgeons and device reps. We conducted two focus groups, one with ear, nose, and throat surgeons, and one with hospital-based attending orthopedic surgeons. We also conducted individual interviews with three former or current medical device representatives, a director of a surgical residency program at an academic medical center, and a medical assistant for a multi-physician orthopedic practice. Results While surgeons view themselves as indisputably in charge, device reps work hard to make themselves unobtrusively indispensable in order to establish and maintain influence, and to imbue the products they provide with personalized services that foster a surgeon's loyalty to the reps and their companies. Surgeons view industry-funded training opportunities as a necessary service. Device reps and some surgeons believe that reps benefit patient care, by increasing efficiency and mitigating deficiencies among operating room personnel (including the surgeons themselves). Conclusions Our study raises ethical questions about the reliance of surgeons on device reps and device companies for education and surgical assistance and practical concerns regarding existing levels of competence among OR personnel. PMID:27486992

26 CFR 1.801-2 - Taxable years affected.

Code of Federal Regulations, 2011 CFR

2011-04-01

...) INCOME TAXES (CONTINUED) Life Insurance Companies § 1.801-2 Taxable years affected. Section 1.801-1 is... Code are to the Internal Revenue Code of 1954, as amended by the Life Insurance Company Income Tax Act... Internal Revenue Code of 1954, as amended by the Life Insurance Company Income Tax Act of 1959 (73 Stat...

26 CFR 1.801-2 - Taxable years affected.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) INCOME TAXES Life Insurance Companies § 1.801-2 Taxable years affected. Section 1.801-1 is applicable... Internal Revenue Code of 1954, as amended by the Life Insurance Company Income Tax Act of 1959 (73 Stat... 1954, as amended by the Life Insurance Company Income Tax Act of 1959 (73 Stat. 112) and section 3 of...

26 CFR 1.801-2 - Taxable years affected.

Code of Federal Regulations, 2012 CFR

2012-04-01

...) INCOME TAXES (CONTINUED) Life Insurance Companies § 1.801-2 Taxable years affected. Section 1.801-1 is... Code are to the Internal Revenue Code of 1954, as amended by the Life Insurance Company Income Tax Act... Internal Revenue Code of 1954, as amended by the Life Insurance Company Income Tax Act of 1959 (73 Stat...

26 CFR 1.801-2 - Taxable years affected.

Code of Federal Regulations, 2013 CFR

2013-04-01

...) INCOME TAXES (CONTINUED) Life Insurance Companies § 1.801-2 Taxable years affected. Section 1.801-1 is... Code are to the Internal Revenue Code of 1954, as amended by the Life Insurance Company Income Tax Act... Internal Revenue Code of 1954, as amended by the Life Insurance Company Income Tax Act of 1959 (73 Stat...

26 CFR 1.801-2 - Taxable years affected.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) INCOME TAXES (CONTINUED) Life Insurance Companies § 1.801-2 Taxable years affected. Section 1.801-1 is... Code are to the Internal Revenue Code of 1954, as amended by the Life Insurance Company Income Tax Act... Internal Revenue Code of 1954, as amended by the Life Insurance Company Income Tax Act of 1959 (73 Stat...

26 CFR 1.802-2 - Taxable years affected.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) INCOME TAXES Life Insurance Companies § 1.802-2 Taxable years affected. Section 1.802(b)-1 is applicable... 1954, as amended by the Life Insurance Company Income Tax Act of 1959 (73 Stat. 112) and section 235(c..., chapter 1 of the Code are to the Internal Revenue Code of 1954, as amended by the Life Insurance Company...

Government health policy and the diffusion of new medical devices.

PubMed Central

Hillman, B J

1986-01-01

The combination of absent financial incentives, aspects of physicians' clinical training, and the uncertainty surrounding the appropriate application of expensive new medical devices have been the most significant factors in promoting their wasteful diffusion and use. This presentation summarizes the forces that have resulted in regulatory and reimbursement initiatives to make more efficient the acquisition and utilization of new medical devices. The case histories of computed tomography (CT) and magnetic resonance imaging (MRI) serve as a paradigm demonstrating why such initiatives have thus far proved ineffectual. More effective would be to abandon distinctions between inpatient and outpatient reimbursement for using new medical devices and to improve the relationship between reimbursement and technology assessment. PMID:3818311

New IEEE 11073 Standards for interoperable, networked Point-of-Care Medical Devices.

PubMed

Kasparick, Martin; Schlichting, Stefan; Golatowski, Frank; Timmermann, Dirk

2015-08-01

Surgical procedures become more and more complex and the number of medical devices in an operating room (OR) increases continuously. Today's vendor-dependent solutions for integrated ORs are not able to handle this complexity. They can only form isolated solutions. Furthermore, high costs are a result of vendor-dependent approaches. Thus we present a service-oriented device communication for distributed medical systems that enables the integration and interconnection between medical devices among each other and to (medical) information systems, including plug-and-play functionality. This system will improve patient's safety by making technical complexity of a comprehensive integration manageable. It will be available as open standards that are part of the IEEE 11073 family of standards. The solution consists of a service-oriented communication technology, the so called Medical Devices Profile for Web Services (MDPWS), a Domain Information & Service Model, and a binding between the first two mechanisms. A proof of this concept has been done with demonstrators of real world OR devices.

Protecting computer-based medical devices: defending against viruses and other threats.

PubMed

2005-07-01

The increasing integration of computer hardware has exposed medical devices to greater risks than ever before. More and more devices rely on commercial off-the-shelf software and operating systems, which are vulnerable to the increasing proliferation of viruses and other malicious programs that target computers. Therefore, it is necessary for hospitals to take steps such as those outlined in this article to ensure that their computer-based devices are made safe and continue to remain safe in the future. Maintaining the security of medical devices requires planning, careful execution, and a commitment of resources. A team should be created to develop a process for surveying the security status of all computerized devices in the hospital and making sure that patches and other updates are applied as needed. These patches and updates should be approved by the medical system supplier before being implemented. The team should consider using virtual local area networks to isolate susceptible devices on the hospital's network. All security measures should be carefully documented, and the documentation should be kept up-to-date. Above all, care must be taken to ensure that medical device security involves a collaborative, supportive partnership between the hospital's information technology staff and biomedical engineering personnel.

Global cardiovascular device innovation: Japan-USA synergies: Harmonization by Doing (HBD) program, a consortium of regulatory agencies, medical device industry, and academic institutions.

PubMed

Uchida, Takahiro; Ikeno, Fumiaki; Ikeda, Koji; Suzuki, Yuka; Todaka, Koji; Yokoi, Hiroyoshi; Thompson, Gary; Krucoff, Mitchel; Saito, Shigeru

2013-01-01

Global medical devices have become more popular, but investment money for medical device development is not easily available in the market. Worldwide health-care budget constraints mean that efficient medical device development has become essential. To achieve efficient development, globalization is a key to success. Spending large amounts of money in different regions for medical device development is no longer feasible. In order to streamline processes of global medical device development, an academic, governmental, and industrial consortium, called the Harmonization by Doing program, has been set up. The program has been operating between Japan and the USA since 2003. The program has 4 working groups: (1) Global Cardiovascular Device Trials; (2) Study on Post-Market Registry; (3) Clinical Trials; and (4) Infrastructure and Methodology Regulatory Convergence and Communication. Each working group has as its goals the achievement of speedy and efficient medical device development in Japan and the USA. The program has held multiple international meetings to deal with obstacles against efficient medical device development. This kind of program is very important to deliver novel medical devices. Involvement of physicians in this type of activity is also very helpful to achieve these goals.

31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false In-kind donations of medicine, medical...-kind donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of medicine...

31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false In-kind donations of medicine, medical...-kind donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of medicine...

31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false In-kind donations of medicine, medical...-kind donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of medicine...

31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false In-kind donations of medicine, medical...-kind donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of medicine...

The use of medication compliance devices by district nursing services.

PubMed

McGraw, C; Drennan, V

2000-07-01

This article presents a critical review of the literature relating to medication compliance devices and the findings of a survey that examined the use of such devices by district nursing services. The UKCC (1992) does not regard the loading of compliance devices by nurses as safe practice; however, compliance devices continue to be used by district nurses. The evidence base concerning the value and use of medication compliance devices is examined and significant gaps in the literature relating to the use of such devices are identified. There is an absence of studies that focus on the effect of compliance devices on adherence among older patients and the nature and frequency of drug administration errors involving these devices. The survey findings show that nurse-loaded compliance devices are used in over one-third of the sample. Further research is necessary to assess the clinical effectiveness of, and clinical risk attached to, compliance devices for older patients in the community. It is suggested that this is an issue of serious concern for primary care groups considering the principles of clinical governance.

Specific barriers to the conduct of randomised clinical trials on medical devices.

PubMed

Neugebauer, Edmund A M; Rath, Ana; Antoine, Sunya-Lee; Eikermann, Michaela; Seidel, Doerthe; Koenen, Carsten; Jacobs, Esther; Pieper, Dawid; Laville, Martine; Pitel, Séverine; Martinho, Cecilia; Djurisic, Snezana; Demotes-Mainard, Jacques; Kubiak, Christine; Bertele, Vittorio; Jakobsen, Janus C; Garattini, Silvio; Gluud, Christian

2017-09-13

Medical devices play an important role in the diagnosis, prevention, treatment and care of diseases. However, compared to pharmaceuticals, there is no rigorous formal regulation for demonstration of benefits and exclusion of harms to patients. The medical device industry argues that the classical evidence hierarchy cannot be applied for medical devices, as randomised clinical trials are impossible to perform. This article aims to identify the barriers for randomised clinical trials on medical devices. Systematic literature searches without meta-analysis and internal European Clinical Research Infrastructure Network (ECRIN) communications taking place during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project. In addition to the barriers that exist for all trials, we identified three major barriers for randomised clinical trials on medical devices, namely: (1) randomisation, including timing of assessment, acceptability, blinding, choice of the comparator group and considerations on the learning curve; (2) difficulties in determining appropriate outcomes; and (3) the lack of scientific advice, regulations and transparency. The present review offers potential solutions to break down the barriers identified, and argues for applying the randomised clinical trial design when assessing the benefits and harms of medical devices.

[Impact of an automated dispensing system for medical devices in cardiac surgery department].

PubMed

Clou, E; Dompnier, M; Kably, B; Leplay, C; Poupon, E; Archer, V; Paul, M

2018-01-01

To secure medical devices' management, the implementation of automated dispensing system in surgical service has been realized. The objective of this study was to evaluate security, organizational and economic impact of installing automated dispensing system for medical devices (ASDM). The implementation took place in a cardiac surgery department. Security impact was assessed by comparing traceability rate of implantable medical devices one year before and one year after installation. Questionnaire on nurses' perception and satisfaction completed this survey. Resupplying costs, stocks' evolution and investments for the implementation of ASDM were the subject of cost-benefit study. After one year, traceability rate is excellent (100%). Nursing staffs were satisfied with 87.5% by this new system. The introduction of ASDM allowed a qualitative and quantitative decrease in stocks, with a reduction of 30% for purchased medical devices and 15% for implantable medical devices in deposit-consignment. Cost-benefit analysis shows a rapid return on investment. Real stock decrease (purchased medical devices) is equivalent to 46.6% of investment. Implementation of ASDM allows to secure storage and dispensing of medical devices. This system has also an important economic impact and appreciated by users. Copyright © 2017 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.

A Review of Simulators with Haptic Devices for Medical Training.

PubMed

Escobar-Castillejos, David; Noguez, Julieta; Neri, Luis; Magana, Alejandra; Benes, Bedrich

2016-04-01

Medical procedures often involve the use of the tactile sense to manipulate organs or tissues by using special tools. Doctors require extensive preparation in order to perform them successfully; for example, research shows that a minimum of 750 operations are needed to acquire sufficient experience to perform medical procedures correctly. Haptic devices have become an important training alternative and they have been considered to improve medical training because they let users interact with virtual environments by adding the sense of touch to the simulation. Previous articles in the field state that haptic devices enhance the learning of surgeons compared to current training environments used in medical schools (corpses, animals, or synthetic skin and organs). Consequently, virtual environments use haptic devices to improve realism. The goal of this paper is to provide a state of the art review of recent medical simulators that use haptic devices. In particular we focus on stitching, palpation, dental procedures, endoscopy, laparoscopy, and orthopaedics. These simulators are reviewed and compared from the viewpoint of used technology, the number of degrees of freedom, degrees of force feedback, perceived realism, immersion, and feedback provided to the user. In the conclusion, several observations per area and suggestions for future work are provided.

[Regulatory Program for Medical Devices in Cuba: experiences and current challenges].

PubMed

Pereira, Dulce María Martínez; Rodríguez, Yadira Álvarez; Valdés, Yamila Cedeño; Ribas, Silvia Delgado

2016-05-01

Regulatory control of medical devices in Cuba is conducted through a system based on the Regulatory Program for Medical Devices as a way to ensure the safety, efficacy, and effectiveness of these technologies, which are in use by the National Health System. This program was launched in 1992, when the Regulations for State Evaluation and Registration of Medical Devices were approved. Its successive stages and the merging of regulatory activities for drugs and medical equipment have meant progress toward stronger, more transparent strategies and greater control of industry and the National Health System. Throughout its course the Cuban program has met with challenges and difficulties that it has addressed by drawing on its own experiences. During the new period, the greatest challenges revolve around ensuring that regulatory systems incorporate scientific evaluation, risk levels, maximum rigor through the use of technical standards, and the implementation of international recommendations, together with the application of the ISO 13485 certification scheme, enhanced market monitoring, and classification of medical devices in accordance with their relevance to the country's national health policies. From the regional standpoint, the greatest challenge lies in working toward regulatory convergence. The Collaborating Centre for the Regulation of Health Technologies will support the proposed regulatory strategy and established regional priorities, in particular in connection with the implementation of actions involving medical devices.

Design and implementation of a seamless and comprehensive integrated medical device interface system for outpatient electronic medical records in a general hospital.

PubMed

Choi, Jong Soo; Lee, Jean Hyoung; Park, Jong Hwan; Nam, Han Seung; Kwon, Hyuknam; Kim, Dongsoo; Park, Seung Woo

2011-04-01

Implementing an efficient Electronic Medical Record (EMR) system is regarded as one of the key strategies for improving the quality of healthcare services. However, the system's interoperability between medical devices and the EMR is a big barrier to deploying the EMR system in an outpatient clinical setting. The purpose of this study is to design a framework for a seamless and comprehensively integrated medical device interface system, and to develop and implement a system for accelerating the deployment of the EMR system. We designed and developed a framework that could transform data from medical devices into the relevant standards and then store them in the EMR. The framework is composed of 5 interfacing methods according to the types of medical devices utilized at an outpatient clinical setting, registered in Samsung Medical Center (SMC) database. The medical devices used for this study were devices that have microchips embedded or that came packaged with personal computers. The devices are completely integrated with the EMR based on SMC's long term IT strategies. First deployment of integrating 352 medical devices into the EMR took place in April, 2006, and it took about 48 months. By March, 2010, every medical device was interfaced with the EMR. About 66,000 medical examinations per month were performed taking up an average of 50GB of storage space. We surveyed users, mainly the technicians. Out of 73 that responded, 76% of the respondents replied that they were strongly satisfied or satisfied, 20% replied as being neutral and only 4% complained about the speed of the system, which was attributed to the slow speed of the old-fashioned medical devices and computers. The current implementation of the medical device interface system based on the SMC framework significantly streamlines the clinical workflow in a satisfactory manner. 2010 Elsevier Ireland Ltd. All rights reserved.

Principles and Benefits of Explicitly Designed Medical Device Safety Architecture.

PubMed

Larson, Brian R; Jones, Paul; Zhang, Yi; Hatcliff, John

The complexity of medical devices and the processes by which they are developed pose considerable challenges to producing safe designs and regulatory submissions that are amenable to effective reviews. Designing an appropriate and clearly documented architecture can be an important step in addressing this complexity. Best practices in medical device design embrace the notion of a safety architecture organized around distinct operation and safety requirements. By explicitly separating many safety-related monitoring and mitigation functions from operational functionality, the aspects of a device most critical to safety can be localized into a smaller and simpler safety subsystem, thereby enabling easier verification and more effective reviews of claims that causes of hazardous situations are detected and handled properly. This article defines medical device safety architecture, describes its purpose and philosophy, and provides an example. Although many of the presented concepts may be familiar to those with experience in realization of safety-critical systems, this article aims to distill the essence of the approach and provide practical guidance that can potentially improve the quality of device designs and regulatory submissions.

26 CFR 1.213-1 - Medical, dental, etc., expenses.

Code of Federal Regulations, 2010 CFR

2010-04-01

... medical care includes the diagnosis, cure, mitigation, treatment, or prevention of disease. Expenses paid... taxable year for insurance that constitute expenses paid for medical care shall, for purposes of computing... care of the taxpayer, his spouse, or a dependent of the taxpayer and not be compensated for by...

77 FR 52742 - Public Meeting-Strengthening the National Medical Device Postmarket Surveillance System; Request...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-30

...] Public Meeting--Strengthening the National Medical Device Postmarket Surveillance System; Request for... ``Public Meeting--Strengthening the National Medical Device Postmarket Surveillance System.'' The purpose of the meeting is to solicit public feedback regarding the medical device postmarket surveillance...

26 CFR 1.482-3 - Methods to determine taxable income in connection with a transfer of tangible property.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 26 Internal Revenue 6 2011-04-01 2011-04-01 false Methods to determine taxable income in... SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES (CONTINUED) Adjustments § 1.482-3 Methods to determine taxable income in connection with a transfer of tangible property...

Methodological considerations in observational comparative effectiveness research for implantable medical devices: an epidemiologic perspective.

PubMed

Jalbert, Jessica J; Ritchey, Mary Elizabeth; Mi, Xiaojuan; Chen, Chih-Ying; Hammill, Bradley G; Curtis, Lesley H; Setoguchi, Soko

2014-11-01

Medical devices play a vital role in diagnosing, treating, and preventing diseases and are an integral part of the health-care system. Many devices, including implantable medical devices, enter the market through a regulatory pathway that was not designed to assure safety and effectiveness. Several recent studies and high-profile device recalls have demonstrated the need for well-designed, valid postmarketing studies of medical devices. Medical device epidemiology is a relatively new field compared with pharmacoepidemiology, which for decades has been developed to assess the safety and effectiveness of medications. Many methodological considerations in pharmacoepidemiology apply to medical device epidemiology. Fundamental differences in mechanisms of action and use and in how exposure data are captured mean that comparative effectiveness studies of medical devices often necessitate additional and different considerations. In this paper, we discuss some of the most salient issues encountered in conducting comparative effectiveness research on implantable devices. We discuss special methodological considerations regarding the use of data sources, exposure and outcome definitions, timing of exposure, and sources of bias. © The Author 2014. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

[Study on the reform and improvement of the medical device registration system in China].

PubMed

Wang, Lanming

2012-11-01

Based on the theories of the Government Regulation and Administrative Licensure, aiming at the current situations of medical device registration system in China, some policy suggestions for future reform and improvement were provided as follows. (1) change the concepts of medical device registration administration. (2) perfect the regulations of medical device registration administration. (3) reform the medical device review organizational system. (4) Optimize the procedure of review and approval. (5) set up and maintain a professional team of review and approval staff. (6) reinforce the post-marketing supervision of medical devices. (7) foster and bring into play of the role of non-government organizations.

26 CFR 1.802-2 - Taxable years affected.

Code of Federal Regulations, 2012 CFR

2012-04-01

...) INCOME TAXES (CONTINUED) Life Insurance Companies § 1.802-2 Taxable years affected. Section 1.802(b)-1 is... Revenue Code of 1954, as amended by the Life Insurance Company Income Tax Act of 1959 (73 Stat. 112) and... Insurance Company Income Tax Act of 1959 (73 Stat. 112), section 3 of the Act of October 23, 1962 (76 Stat...

26 CFR 1.802-2 - Taxable years affected.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) INCOME TAXES (CONTINUED) Life Insurance Companies § 1.802-2 Taxable years affected. Section 1.802(b)-1 is... Revenue Code of 1954, as amended by the Life Insurance Company Income Tax Act of 1959 (73 Stat. 112) and... Insurance Company Income Tax Act of 1959 (73 Stat. 112), section 3 of the Act of October 23, 1962 (76 Stat...

26 CFR 1.802-2 - Taxable years affected.

Code of Federal Regulations, 2011 CFR

2011-04-01

...) INCOME TAXES (CONTINUED) Life Insurance Companies § 1.802-2 Taxable years affected. Section 1.802(b)-1 is... Revenue Code of 1954, as amended by the Life Insurance Company Income Tax Act of 1959 (73 Stat. 112) and... Insurance Company Income Tax Act of 1959 (73 Stat. 112), section 3 of the Act of October 23, 1962 (76 Stat...

26 CFR 1.802-2 - Taxable years affected.

Code of Federal Regulations, 2013 CFR

2013-04-01

...) INCOME TAXES (CONTINUED) Life Insurance Companies § 1.802-2 Taxable years affected. Section 1.802(b)-1 is... Revenue Code of 1954, as amended by the Life Insurance Company Income Tax Act of 1959 (73 Stat. 112) and... Insurance Company Income Tax Act of 1959 (73 Stat. 112), section 3 of the Act of October 23, 1962 (76 Stat...

Analysis of metallic medical devices after cremation: The importance in identification.

PubMed

De Angelis, Danilo; Collini, Federica; Muccino, Enrico; Cappella, Annalisa; Sguazza, Emanuela; Mazzucchi, Alessandra; Cattaneo, Cristina

2017-03-01

The recovery of a charred cadaver raises many issues concerning personal identification; the presence of prosthetic materials may provide very important and decisive information. Who is involved in the recovery of a charred body or of burnt human fragments, should therefore be able to recognize medical devices even if modified by fire effects. Metallic residues (585kg) that came from 2785 cremations were studied. Medical devices were then divided by type and material in order to esteem the representativeness of each typology. The study illustrates the great presence of metal medical devices that could be of great help in identifying bodies and underlines that metallic medical devices types and morphology should be known by forensic practitioner involved in identification cases and that this kind of material can still be identified by physician and dentists, even if exposed to very high temperatures. Copyright © 2016 The Chartered Society of Forensic Sciences. Published by Elsevier B.V. All rights reserved.

Sustaining the success of medical device innovation.

PubMed

Fearis, Paul J; Craft, Brandon

2016-11-01

Paul Fearis is CEO of Clinvue, Brandon Craft is COO of Clinvue. Clinvue is medical device innovation consultancy specializing in Insight Informed Innovation in the medical industry. Paul and Brandon are also lecturers in innovation for the 'Center for Bioengineering, Innovation & Design' Masters course in Bioengineering Innovation & Design at the Johns Hopkins University, and guest lecturers at Rice University and Virginia Tech. Copyright © 2016 Elsevier Inc. All rights reserved.

Drugs and Medical Devices: Adverse Events and the Impact on Women's Health.

PubMed

Carey, Jennifer L; Nader, Nathalie; Chai, Peter R; Carreiro, Stephanie; Griswold, Matthew K; Boyle, Katherine L

2017-01-01

A large number of medications and medical devices removed from the market by the US Food and Drug Administration over the past 4 decades specifically posed greater health risks to women. This article reviews the historical background of sex and gender in clinical research policy and describes several approved drugs and devices targeted for use in women that have caused major morbidity and mortality. The intended population for the medications and devices, population affected, approval process, and the basic and legal actions taken against the medication/drug company are also discussed. It is recognized that women are still at risk for harm from unsafe medications and devices, and continued improvements in legislation that promotes inclusion of sex and gender into the design and analysis of research will improve safety for both men and women. Copyright © 2017 Elsevier HS Journals, Inc. All rights reserved.

How much do physician-entrepreneurs contribute to new medical devices?

PubMed

Smith, Sheryl Winston; Sfekas, Andrew

2013-05-01

As recent public and private initiatives have sought to increase the transparency of physician-industry financial relationships (including calls for restricting collaboration), it is important to understand the extent of physicians' contributions to new medical devices. We quantify the contribution of information from physician-founded startup companies to 170 premarket approval (PMA) applications filed by 4 large incumbent medical device manufacturers over the period 1978-2007. We ask: Are incumbents more likely to incorporate information from physician-founded firms than nonphysician-founded firms? We matched the text in 4 incumbent medical device firms' PMAs (Medtronic, Johnson & Johnson, Boston Scientific, and Guidant) to the text in patent applications of 118 startup companies that received investment from these incumbents between 1978 and 2007. We use a text-matching algorithm to quantify the information contribution from physician and nonphysician-founded startups to incumbent firms' PMAs. We analyze correlates of backward citations and degree of overlap between incumbents' PMAs and startups' patents using negative binomial and tobit regressions. On average, physician-founded companies account for 11% of the information in PMAs, compared with 4% from nonphysician-founded companies. Regression results show that incumbents are significantly more likely to cite physician-founded companies' patents and to incorporate them into new devices. Physicians are an important source of medical device innovation. The results suggest that restrictions on financial relationships between providers and industry, while potentially improving patients' trust, may result in reduced medical innovation if physicians found fewer startups or if incumbent firms reduce investments in physician-founded startups.

76 FR 48169 - Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-08

...] Advancing Regulatory Science for Highly Multiplexed Microbiology/ Medical Countermeasure Devices; Public... Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices.'' The purpose of the public meeting is to discuss performance evaluation of highly multiplexed microbiology/medical...

Health technology assessment of medical devices: a survey of non-European union agencies.

PubMed

Ciani, Oriana; Wilcher, Britni; Blankart, Carl Rudolf; Hatz, Maximilian; Rupel, Valentina Prevolnik; Erker, Renata Slabe; Varabyova, Yauheniya; Taylor, Rod S

2015-01-01

The aim of this study was to review and compare current health technology assessment (HTA) activities for medical devices across non-European Union HTA agencies. HTA activities for medical devices were evaluated from three perspectives: organizational structure, processes, and methods. Agencies were primarily selected upon membership of existing HTA networks. The data collection was performed in two stages: stage 1-agency Web-site assessment using a standardized questionnaire, followed by review and validation of the collected data by a representative of the agency; and stage 2-semi-structured telephone interviews with key informants of a sub-sample of agencies. In total, thirty-six HTA agencies across twenty non-EU countries assessing medical devices were included. Twenty-seven of thirty-six (75 percent) agencies were judged at stage 1 to have adopted HTA-specific approaches for medical devices (MD-specific agencies) that were largely organizational or procedural. There appeared to be few differences in the organization, process and methods between MD-specific and non-MD-specific agencies. Although the majority (69 percent) of both categories of agency had specific methods guidance or policy for evidence submission, only one MD-specific agency had developed methodological guidelines specific to medical devices. In stage 2, many MD-specific agencies cited insufficient resources (budget, skilled employees), lack of coordination (between regulator and reimbursement bodies), and the inability to generalize findings from evidence synthesis to be key challenges in the HTA of medical devices. The lack of evidence for differentiation in scientific methods for HTA of devices raises the question of whether HTA needs to develop new methods for medical devices but rather adapt existing methodological approaches. In contrast, organizational and/or procedural adaptation of existing HTA agency frameworks to accommodate medical devices appear relatively commonplace.

Adhoc electromagnetic compatibility testing of non-implantable medical devices and radio frequency identification

PubMed Central

2013-01-01

Background The use of radiofrequency identification (RFID) in healthcare is increasing and concerns for electromagnetic compatibility (EMC) pose one of the biggest obstacles for widespread adoption. Numerous studies have documented that RFID can interfere with medical devices. The majority of past studies have concentrated on implantable medical devices such as implantable pacemakers and implantable cardioverter defibrillators (ICDs). This study examined EMC between RFID systems and non-implantable medical devices. Methods Medical devices were exposed to 19 different RFID readers and one RFID active tag. The RFID systems used covered 5 different frequency bands: 125–134 kHz (low frequency (LF)); 13.56 MHz (high frequency (HF)); 433 MHz; 915 MHz (ultra high frequency (UHF])) and 2.4 GHz. We tested three syringe pumps, three infusion pumps, four automatic external defibrillators (AEDs), and one ventilator. The testing procedure is modified from American National Standards Institute (ANSI) C63.18, Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Radiated Electromagnetic Immunity of Medical Devices to Specific Radio-Frequency Transmitters. Results For syringe pumps, we observed electromagnetic interference (EMI) during 13 of 60 experiments (22%) at a maximum distance of 59 cm. For infusion pumps, we observed EMI during 10 of 60 experiments (17%) at a maximum distance of 136 cm. For AEDs, we observed EMI during 18 of 75 experiments (24%) at a maximum distance of 51 cm. The majority of the EMI observed was classified as probably clinically significant or left the device inoperable. No EMI was observed for all medical devices tested during exposure to 433 MHz (two readers, one active tag) or 2.4 GHz RFID (two readers). Conclusion Testing confirms that RFID has the ability to interfere with critical medical equipment. Hospital staff should be aware of the potential for medical device EMI caused by RFID systems and should be encouraged to

Adhoc electromagnetic compatibility testing of non-implantable medical devices and radio frequency identification.

PubMed

Seidman, Seth J; Guag, Joshua W

2013-07-11

The use of radiofrequency identification (RFID) in healthcare is increasing and concerns for electromagnetic compatibility (EMC) pose one of the biggest obstacles for widespread adoption. Numerous studies have documented that RFID can interfere with medical devices. The majority of past studies have concentrated on implantable medical devices such as implantable pacemakers and implantable cardioverter defibrillators (ICDs). This study examined EMC between RFID systems and non-implantable medical devices. Medical devices were exposed to 19 different RFID readers and one RFID active tag. The RFID systems used covered 5 different frequency bands: 125-134 kHz (low frequency (LF)); 13.56 MHz (high frequency (HF)); 433 MHz; 915 MHz (ultra high frequency (UHF])) and 2.4 GHz. We tested three syringe pumps, three infusion pumps, four automatic external defibrillators (AEDs), and one ventilator. The testing procedure is modified from American National Standards Institute (ANSI) C63.18, Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Radiated Electromagnetic Immunity of Medical Devices to Specific Radio-Frequency Transmitters. For syringe pumps, we observed electromagnetic interference (EMI) during 13 of 60 experiments (22%) at a maximum distance of 59 cm. For infusion pumps, we observed EMI during 10 of 60 experiments (17%) at a maximum distance of 136 cm. For AEDs, we observed EMI during 18 of 75 experiments (24%) at a maximum distance of 51 cm. The majority of the EMI observed was classified as probably clinically significant or left the device inoperable. No EMI was observed for all medical devices tested during exposure to 433 MHz (two readers, one active tag) or 2.4 GHz RFID (two readers). Testing confirms that RFID has the ability to interfere with critical medical equipment. Hospital staff should be aware of the potential for medical device EMI caused by RFID systems and should be encouraged to perform on-site RF immunity tests prior

Guidance for the emergency use of unapproved medical devices; availability--FDA. Notice.

PubMed

1985-10-22

The Food and Drug Administration (FDA) is announcing guidance, developed by FDA's Center for Devices and Radiological Health (CDRH), with respect to those emergency situations in which the agency would not object to a physician's using a potentially life-saving medical device for a use for which the device ordinarily is required to have, but does not have, an approved application for premarket approval or an investigational device exemption. The guidance is contained in a document entitled "guidance for the Emergency Use of Unapproved Medical Devices."

Medical devices in dermatology using DLP technology from Texas Instruments

NASA Astrophysics Data System (ADS)

Kock, M.; Lüllau, F.

2012-03-01

The market of medical devices is growing continuously worldwide. With the DLP™ technology from Texas Instruments Lüllau Engineering GmbH in Germany has realized different applications in the medical discipline of dermatology. Especially a new digital phototherapy device named skintrek™ PT5 is revolutionizing the treatment of skin diseases like psoriasis , Vitiligo and other Eczema. The functions of the new phototherapy device can only be realized through DLP™ technology which is not only be used for the selective irradiation process. In combination with other optical systems DLP™ technology undertakes also other functionalities like 3D-topology calculation und patient movement compensation.

Views of patients and professionals about electronic multicompartment medication devices: a qualitative study

PubMed Central

Hall, Jill; Bond, Christine; Kinnear, Moira; McKinstry, Brian

2016-01-01

Objectives To explore the perceived acceptability, advantages and disadvantages of electronic multicompartment medication devices. Design Qualitative study using 8 focus groups and 10 individual semistructured interviews. Recordings were transcribed and analysed thematically. Strategies were employed to ensure the findings were credible and trustworthy. Participants and setting Community pharmacists (n=11), general practitioners (n=9), community nurses (n=12) and social care managers (n=8) were recruited from the National Health Service (NHS) and local authority services. Patients (n=15) who were current conventional or electronic multicompartment medication device users or had medication adherence problems were recruited from community pharmacies. 3 informal carers participated. Results Electronic multicompartment medication devices which prompt the patient to take medication may be beneficial for selected individuals, particularly those with cognitive impairment, but who are not seriously impaired, provided they have a good level of dexterity. They may also assist individuals where it is important that medication is taken at fixed time intervals. These are likely to be people who are being supported to live alone. No single device suited everybody; smaller/lighter devices were preferred but their usefulness was limited by the small number/size of storage compartments. Removing medications was often challenging. Transportability was an important factor for patients and carers. A carer's alert if medication is not taken was problematic with multiple barriers to implementation and no consensus as to who should receive the alert. There was a lack of enthusiasm among professionals, particularly among pharmacists, due to concerns about responsibility and funding for devices as well as ensuring devices met regulatory standards for storage and labelling. Conclusions This study provides indicators of which patients might benefit from an electronic multicompartment

Views of patients and professionals about electronic multicompartment medication devices: a qualitative study.

PubMed

Hall, Jill; Bond, Christine; Kinnear, Moira; McKinstry, Brian

2016-10-17

To explore the perceived acceptability, advantages and disadvantages of electronic multicompartment medication devices. Qualitative study using 8 focus groups and 10 individual semistructured interviews. Recordings were transcribed and analysed thematically. Strategies were employed to ensure the findings were credible and trustworthy. Community pharmacists (n=11), general practitioners (n=9), community nurses (n=12) and social care managers (n=8) were recruited from the National Health Service (NHS) and local authority services. Patients (n=15) who were current conventional or electronic multicompartment medication device users or had medication adherence problems were recruited from community pharmacies. 3 informal carers participated. Electronic multicompartment medication devices which prompt the patient to take medication may be beneficial for selected individuals, particularly those with cognitive impairment, but who are not seriously impaired, provided they have a good level of dexterity. They may also assist individuals where it is important that medication is taken at fixed time intervals. These are likely to be people who are being supported to live alone. No single device suited everybody; smaller/lighter devices were preferred but their usefulness was limited by the small number/size of storage compartments. Removing medications was often challenging. Transportability was an important factor for patients and carers. A carer's alert if medication is not taken was problematic with multiple barriers to implementation and no consensus as to who should receive the alert. There was a lack of enthusiasm among professionals, particularly among pharmacists, due to concerns about responsibility and funding for devices as well as ensuring devices met regulatory standards for storage and labelling. This study provides indicators of which patients might benefit from an electronic multicompartment medication device as well as the kinds of features to consider when

Left to their own devices: medical learners' use of mobile technologies.

PubMed

Ellaway, Rachel H; Fink, Patricia; Graves, Lisa; Campbell, Alanna

2014-02-01

Although many medical learners and teachers are using mobile technologies within medical education, there has been little evidence presented describing how they use mobile devices across a whole curriculum. The Northern Ontario School of Medicine (NOSM) introduced a new mobile device program in 2010. Incoming undergraduate medical learners received a laptop and an iPad and learners entering year three of the four-year program received a laptop and an iPhone. A survey was sent to all learners to gather information on their use of and attitudes toward these devices. A combination of quantitative and qualitative methods was used to analyze the data and to generate a series of themes that synthesized student behaviors, perceptions and attitudes. Context and learner autonomy were found to be important factors with learners using multiple devices for different purposes and adopting strategic approaches to learning using these devices. The expectation that school-issued devices would be regularly and enthusiastically used to replace more traditional study media was not reflected in practice. Learners' approaches to using mobile devices are heterogeneous as is the extent to which they use them. Learners adapt their use of mobile devices to the learning cultures and contexts they find themselves in.

Advancing medical device innovation through collaboration and coordination of structured data capture pilots: Report from the Medical Device Epidemiology Network (MDEpiNet) Specific, Measurable, Achievable, Results-Oriented, Time Bound (SMART) Think Tank.

PubMed

Reed, Terrie L; Drozda, Joseph P; Baskin, Kevin M; Tcheng, James; Conway, Karen; Wilson, Natalia; Marinac-Dabic, Danica; Heise, Theodore; Krucoff, Mitchell W

2017-12-01

The Medical Device Epidemiology Network (MDEpiNet) is a public private partnership (PPP) that provides a platform for collaboration on medical device evaluation and depth of expertise for supporting pilots to capture, exchange and use device information for improving device safety and protecting public health. The MDEpiNet SMART Think Tank, held in February, 2013, sought to engage expert stakeholders who were committed to improving the capture of device data, including Unique Device Identification (UDI), in key electronic health information. Prior to the Think Tank there was limited collaboration among stakeholders beyond a few single health care organizations engaged in electronic capture and exchange of device data. The Think Tank resulted in what has become two sustainable multi-stakeholder device data capture initiatives, BUILD and VANGUARD. These initiatives continue to mature within the MDEpiNet PPP structure and are well aligned with the goals outlined in recent FDA-initiated National Medical Device Planning Board and Medical Device Registry Task Force white papers as well as the vision for the National Evaluation System for health Technology.%. Published by Elsevier Inc.

PVC and phthalates in medical devices: a never ending story.

PubMed

Hansen, O Grøndahl

2006-04-01

Phthalate-plasticised poly (vinyl chloride) (PVC) medical devices have been subject to critical attention for 15 years. This article reviews latest developments. It addresses whether hospitals have achieved their goal of phasing out PVC and phthalates and if it is a certainty that a medical device is better with regard to health and the environment just because it does not contain PVC and phthalates. European risk assessments are also reported.

26 CFR 1.668(a)-1 - Amounts treated as received in prior taxable years; inclusion in gross income.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 26 Internal Revenue 8 2014-04-01 2014-04-01 false Amounts treated as received in prior taxable years; inclusion in gross income. 1.668(a)-1 Section 1.668(a)-1 Internal Revenue INTERNAL REVENUE....668(a)-1 Amounts treated as received in prior taxable years; inclusion in gross income. (a) Section...

26 CFR 1.668(a)-1 - Amounts treated as received in prior taxable years; inclusion in gross income.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 26 Internal Revenue 8 2013-04-01 2013-04-01 false Amounts treated as received in prior taxable years; inclusion in gross income. 1.668(a)-1 Section 1.668(a)-1 Internal Revenue INTERNAL REVENUE....668(a)-1 Amounts treated as received in prior taxable years; inclusion in gross income. (a) Section...

26 CFR 1.668(a)-1 - Amounts treated as received in prior taxable years; inclusion in gross income.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 26 Internal Revenue 8 2012-04-01 2012-04-01 false Amounts treated as received in prior taxable years; inclusion in gross income. 1.668(a)-1 Section 1.668(a)-1 Internal Revenue INTERNAL REVENUE....668(a)-1 Amounts treated as received in prior taxable years; inclusion in gross income. (a) Section...

26 CFR 1.668(a)-1 - Amounts treated as received in prior taxable years; inclusion in gross income.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 26 Internal Revenue 8 2011-04-01 2011-04-01 false Amounts treated as received in prior taxable years; inclusion in gross income. 1.668(a)-1 Section 1.668(a)-1 Internal Revenue INTERNAL REVENUE....668(a)-1 Amounts treated as received in prior taxable years; inclusion in gross income. (a) Section...

26 CFR 1.668(a)-1 - Amounts treated as received in prior taxable years; inclusion in gross income.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 8 2010-04-01 2010-04-01 false Amounts treated as received in prior taxable years; inclusion in gross income. 1.668(a)-1 Section 1.668(a)-1 Internal Revenue INTERNAL REVENUE... treated as received in prior taxable years; inclusion in gross income. (a) Section 668(a) provides that...

Reporting of Cardiovascular Medical Device Adverse Events to Pharmaceuticals and Medical Devices Agency, Japan☆

PubMed Central

Handa, Nobuhiro; Ishii, Kensuke; Matsui, Yutaka; Ando, Yuki

2015-01-01

Background Marketing authorization holders (MAHs) are obligated to report adverse events (AEs) within 15 days (some cases 30 days) to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. Methods To analyze the timeliness of AE reporting to the PMDA, 6610 reports for five categories of cardiovascular devices were retrieved. Two durations were calculated: (1) time from the date the AE occurred to that when the MAH captured it (DOC: days); and (2) time from the date of MAH capture to that of MAH report (DCR: days). Number of DOC > 15 days (DOC15) and delayed reports (DCR > 15 or 30 days) were also calculated. Results AEs included 9.2% deaths and 7.5% non-recoveries. DOC15 and delayed reports were 51.0% and 10.9%, respectively. By multivariate analysis, DOC15 was associated with foreign AE, device category, MAH, patient outcome, event category, and AE that had to be reported within 15 or 30 days (AE15/30). Delayed report was associated with device category, MAH, patient outcome, event category, and AE15/30. Comments Although Japanese MAHs complied with the obligation to report AEs, they often failed to share AEs with healthcare providers. Registry may be a potential solution, although the cooperation of healthcare providers to input data is essential. PMID:26501120

Third-year medical students' knowledge of privacy and security issues concerning mobile devices.

PubMed

Whipple, Elizabeth C; Allgood, Kacy L; Larue, Elizabeth M

2012-01-01

The use of mobile devices are ubiquitous in medical-care professional settings, but information on privacy and security concerns of mobile devices for medical students is scarce. To gain baseline information about third-year medical students' mobile device use and knowledge of privacy and security issues concerning mobile devices. We surveyed 67 third-year medical students at a Midwestern university on their use of mobile devices and knowledge of how to protect information available through mobile devices. Students were also presented with clinical scenarios to rate their level of concern in regards to privacy and security of information. The most used features of mobile devices were: voice-to-voice (100%), text messaging (SMS) (94%), Internet (76.9%), and email (69.3%). For locking of one's personal mobile phone, 54.1% never physically lock their phone, and 58% never electronically lock their personal PDA. Scenarios considering definitely privacy concerns include emailing patient information intact (66.7%), and posting de-identified information on YouTube (45.2%) or Facebook (42.2%). As the ease of sharing data increases with the use of mobile devices, students need more education and training on possible privacy and security risks posed with mobile devices.

Low power signal processing electronics for wearable medical devices.

PubMed

Casson, Alexander J; Rodriguez-Villegas, Esther

2010-01-01

Custom designed microchips, known as Application Specific Integrated Circuits (ASICs), offer the lowest possible power consumption electronics. However, this comes at the cost of a longer, more complex and more costly design process compared to one using generic, off-the-shelf components. Nevertheless, their use is essential in future truly wearable medical devices that must operate for long periods of time from physically small, energy limited batteries. This presentation will demonstrate the state-of-the-art in ASIC technology for providing online signal processing for use in these wearable medical devices.

78 FR 19717 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee: Notice of Change of Meeting Schedule AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction...

Ethics considerations for medical device R&D.

PubMed

Citron, Paul

2012-01-01

Medical devices have emerged as an important clinical option to treat certain serious diseases for which there are no equivalently effective surgical or pharmaceutical alternatives. Although all clinical activities impose high ethical standards of comportment to protect patients, medical device R&D and product application have a number of relatively unique aspects that distinguish them from other technologies such as pharmaceuticals. These include the following: R&D project selection; regulatory requirements, and their intended and unintended effects; when is a new product design sufficiently safe and effective for routine use in patients; and, physician-industry relationships in the innovation process in the context of real or perceived conflict of interest (COI). Each of these factors has implications for the delivery of care, health care leadership, and patient well-being. Copyright © 2012 Elsevier Inc. All rights reserved.

Marketing medical devices in Japan.

PubMed

Ohashi, J

1998-01-01

The control of medical devices in Japan has recently undergone significant changes as the country brings its systems into line with those of the United States and Europe. This article discusses pre-market approval, quality system requirements and post-market surveillance. Many technical issues have been harmonized but language is likely to continue to be a barrier to trade. Details of information services that are available to foreign manufacturers and importers are supplied.

Stakeholder challenges in purchasing medical devices for patient safety.

PubMed

Hinrichs, Saba; Dickerson, Terry; Clarkson, John

2013-03-01

This study identifies the stakeholders who have a role in medical device purchasing within the wider system of health-care delivery and reports on their particular challenges to promote patient safety during purchasing decisions. Data was collected through observational work, participatory workshops, and semi-structured qualitative interviews, which were analyzed and coded. The study takes a systems-based and engineering design approach to the study. Five hospitals took part in this study, and the participants included maintenance, training, clinical end-users, finance, and risk departments. The main stakeholders for purchasing were identified to be staff from clinical engineering (Maintenance), device users (Clinical), device trainers (Training), and clinical governance for analyzing incidents involving devices (Risk). These stakeholders display varied characteristics in terms of interpretation of their own roles, competencies for selecting devices, awareness and use of resources for purchasing devices, and attitudes toward the purchasing process. The role of "clinical engineering" is seen by these stakeholders to be critical in mediating between training, technical, and financial stakeholders but not always recognized in practice. The findings show that many device purchasing decisions are tackled in isolation, which is not optimal for decisions requiring knowledge that is currently distributed among different people within different departments. The challenges expressed relate to the wider system of care and equipment management, calling for a more systemic view of purchasing for medical devices.

Using off-the-shelf medical devices for biomedical signal monitoring in a telemedicine system for emergency medical services.

PubMed

Thelen, Sebastian; Czaplik, Michael; Meisen, Philipp; Schilberg, Daniel; Jeschke, Sabina

2015-01-01

In order to study new methods of telemedicine usage in the context of emergency medical services, researchers need to prototype integrated telemedicine systems. To conduct a one-year trial phase-intended to study a new application of telemedicine in German emergency medical services-we used off-the-shelf medical devices and software to realize real-time patient monitoring within an integrated telemedicine system prototype. We demonstrate its feasibility by presenting the integrated real-time patient monitoring solution, by studying signal delay and transmission robustness regarding changing communication channel characteristics, and by evaluating issues reported by the physicians during the trial phase. Where standards like HL7 and the IEEE 11073 family are intended to enable interoperability of product grade medical devices, we show that research prototypes benefit from the use of web technologies and simple device interfaces, as they simplify product development for a manufacturer and ease integration efforts for research teams. Embracing this approach for the development of new medical devices eases the constraint to use off-the-shelf products for research trials investigating innovative use of telemedicine.

76 FR 14028 - Center for Devices and Radiological Health 510(k) Implementation: Online Repository of Medical...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-15

...] Center for Devices and Radiological Health 510(k) Implementation: Online Repository of Medical Device... public meeting entitled ``510(k) Implementation: Discussion of an Online Repository of Medical Device... establish an online public repository of medical device labeling and strategies for displaying device...

26 CFR 55.4981-1 - Imposition of excise tax on certain real estate investment trust taxable income not distributed...

Code of Federal Regulations, 2014 CFR

2014-04-01

... TREASURY (CONTINUED) MISCELLANEOUS EXCISE TAXES (CONTINUED) EXCISE TAX ON REAL ESTATE INVESTMENT TRUSTS AND REGULATED INVESTMENT COMPANIES Excise Tax on Real Estate Investment Trusts § 55.4981-1 Imposition of excise tax on certain real estate investment trust taxable income not distributed during the taxable year...

26 CFR 55.4981-1 - Imposition of excise tax on certain real estate investment trust taxable income not distributed...

Code of Federal Regulations, 2011 CFR

2011-04-01

... TREASURY (CONTINUED) MISCELLANEOUS EXCISE TAXES (CONTINUED) EXCISE TAX ON REAL ESTATE INVESTMENT TRUSTS AND REGULATED INVESTMENT COMPANIES Excise Tax on Real Estate Investment Trusts § 55.4981-1 Imposition of excise tax on certain real estate investment trust taxable income not distributed during the taxable year...

26 CFR 55.4981-1 - Imposition of excise tax on certain real estate investment trust taxable income not distributed...

Code of Federal Regulations, 2010 CFR

2010-04-01

... TREASURY (CONTINUED) MISCELLANEOUS EXCISE TAXES (CONTINUED) EXCISE TAX ON REAL ESTATE INVESTMENT TRUSTS AND REGULATED INVESTMENT COMPANIES Excise Tax on Real Estate Investment Trusts § 55.4981-1 Imposition of excise tax on certain real estate investment trust taxable income not distributed during the taxable year...

26 CFR 55.4981-1 - Imposition of excise tax on certain real estate investment trust taxable income not distributed...

Code of Federal Regulations, 2013 CFR

2013-04-01

... TREASURY (CONTINUED) MISCELLANEOUS EXCISE TAXES (CONTINUED) EXCISE TAX ON REAL ESTATE INVESTMENT TRUSTS AND REGULATED INVESTMENT COMPANIES Excise Tax on Real Estate Investment Trusts § 55.4981-1 Imposition of excise tax on certain real estate investment trust taxable income not distributed during the taxable year...

26 CFR 55.4981-1 - Imposition of excise tax on certain real estate investment trust taxable income not distributed...

Code of Federal Regulations, 2012 CFR

2012-04-01

... TREASURY (CONTINUED) MISCELLANEOUS EXCISE TAXES (CONTINUED) EXCISE TAX ON REAL ESTATE INVESTMENT TRUSTS AND REGULATED INVESTMENT COMPANIES Excise Tax on Real Estate Investment Trusts § 55.4981-1 Imposition of excise tax on certain real estate investment trust taxable income not distributed during the taxable year...

Improving medical device regulation: the United States and Europe in perspective.

PubMed

Sorenson, Corinna; Drummond, Michael

2014-03-01

Recent debates and events have brought into question the effectiveness of existing regulatory frameworks for medical devices in the United States and Europe to ensure their performance, safety, and quality. This article provides a comparative analysis of medical device regulation in the two jurisdictions, explores current reforms to improve the existing systems, and discusses additional actions that should be considered to fully meet this aim. Medical device regulation must be improved to safeguard public health and ensure that high-quality and effective technologies reach patients. We explored and analyzed medical device regulatory systems in the United States and Europe in accordance with the available gray and peer-reviewed literature and legislative documents. The two regulatory systems differ in their mandate and orientation, organization, pre- and postmarket evidence requirements, and transparency of process. Despite these differences, both jurisdictions face similar challenges for ensuring that only safe and effective devices reach the market, monitoring real-world use, and exchanging pertinent information on devices with key users such as clinicians and patients. To address these issues, reforms have recently been introduced or debated in the United States and Europe that are principally focused on strengthening regulatory processes, enhancing postmarket regulation through more robust surveillance systems, and improving the traceability and monitoring of devices. Some changes in premarket requirements for devices are being considered. Although the current reforms address some of the outstanding challenges in device regulation, additional steps are needed to improve existing policy. We examine a number of actions to be considered, such as requiring high-quality evidence of benefit for medium- and high-risk devices; moving toward greater centralization and coordination of regulatory approval in Europe; creating links between device identifier systems and

Improving Medical Device Regulation: The United States and Europe in Perspective

PubMed Central

SORENSON, CORINNA; DRUMMOND, MICHAEL

2014-01-01

Context: Recent debates and events have brought into question the effectiveness of existing regulatory frameworks for medical devices in the United States and Europe to ensure their performance, safety, and quality. This article provides a comparative analysis of medical device regulation in the two jurisdictions, explores current reforms to improve the existing systems, and discusses additional actions that should be considered to fully meet this aim. Medical device regulation must be improved to safeguard public health and ensure that high-quality and effective technologies reach patients. Methods: We explored and analyzed medical device regulatory systems in the United States and Europe in accordance with the available gray and peer-reviewed literature and legislative documents. Findings: The two regulatory systems differ in their mandate and orientation, organization, pre-and postmarket evidence requirements, and transparency of process. Despite these differences, both jurisdictions face similar challenges for ensuring that only safe and effective devices reach the market, monitoring real-world use, and exchanging pertinent information on devices with key users such as clinicians and patients. To address these issues, reforms have recently been introduced or debated in the United States and Europe that are principally focused on strengthening regulatory processes, enhancing postmarket regulation through more robust surveillance systems, and improving the traceability and monitoring of devices. Some changes in premarket requirements for devices are being considered. Conclusions: Although the current reforms address some of the outstanding challenges in device regulation, additional steps are needed to improve existing policy. We examine a number of actions to be considered, such as requiring high-quality evidence of benefit for medium-and high-risk devices; moving toward greater centralization and coordination of regulatory approval in Europe; creating

[Software as medical devices/medical apps : Tasks, requirements, and experiences from the point of view of a competent authority].

PubMed

Terhechte, Arno

2018-03-01

Software can be classified as a medical device according to the Medical Device Directive 93/42/EEC. The number of software products and medical apps is continuously increasing and so too is the use in health institutions (e. g., in hospitals and doctors' surgeries) for diagnosis and therapy.Different aspects of standalone software and medical apps from the perspective of the authority responsible are presented. The quality system implemented to establish a risk-based systematic inspection and supervision of manufacturers is discussed. The legal framework, as well as additional standards that are the basis for inspection, are outlined. The article highlights special aspects that occur during inspection like verification of software and interfaces, and the clinical evaluation of software. The Bezirksregierung, as the local government authority responsible in North Rhine-Westphalia, is also in charge of inspection of health institutions. Therefore this article is not limited to the manufacturers placing the software on the market, but in addition it describes the management and use of software as a medical device in hospitals.The future legal framework, the Medical Device Regulation, will strengthen the requirements and engage notified bodies more than today in the conformity assessment of software as a medical device.Manufacturers, health institutions, notified bodies and the authorities responsible are in charge of intensifying their efforts towards software as a medical device. Mutual information, improvement of skills, and inspections will lead to compliance with regulatory requirements.

FDA adverse Event Problem Codes: standardizing the classification of device and patient problems associated with medical device use.

PubMed

Reed, Terrie L; Kaufman-Rivi, Diana

2010-01-01

The broad array of medical devices and the potential for device failures, malfunctions, and other adverse events associated with each device creates a challenge for public health device surveillance programs. Coding reported events by type of device problem provides one method for identifying a potential signal of a larger device issue. The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) Event Problem Codes that are used to report adverse events previously lacked a structured set of controls for code development and maintenance. Over time this led to inconsistent, ambiguous, and duplicative concepts being added to the code set on an ad-hoc basis. Recognizing the limitation of its coding system the FDA set out to update the system to improve its usefulness within FDA and as a basis of a global standard to identify important patient and device outcomes throughout the medical community. In 2004, FDA and the National Cancer Institute (NCI) signed a Memorandum of Understanding (MOU) whereby NCI agreed to provide terminology development and maintenance services to all FDA Centers. Under this MOU, CDRH's Office of Surveillance and Biometrics (OSB) convened a cross-Center workgroup and collaborated with staff at NCI Enterprise Vocabulary Service (EVS) to streamline the Patient and Device Problem Codes and integrate them into the NCI Thesaurus and Meta-Thesaurus. This initiative included many enhancements to the Event Problem Codes aimed at improving code selection as well as improving adverse event report analysis. LIMITATIONS & RECOMMENDATIONS: Staff resources, database concerns, and limited collaboration with external groups in the initial phases of the project are discussed. Adverse events associated with medical device use can be better understood when they are reported using a consistent and well-defined code set. This FDA initiative was an attempt to improve the structure and add control mechanisms to an existing code set

[Data transparency regarding medical devices - the position of the medical device industry].

PubMed

Soskuty, Gabriela

2011-01-01

The medical device industry, strongly dominated by medium-sized firms, has significant growth potential and a high number of job opportunities with 170,000 employees in more than 11,000 companies. Approximately one third of the business volume is achieved with innovative products that are less than three years old. The safety, quality and efficiency of the products is tested and approved by CE certification. Due to the heterogeneous field of devices, however, evidence requirements must be differentiated according to the type of device in question. Transparency is as important as the type of evidence, and industry is well aware of the significance of transparency for credibility in the market. Industry believes that all the stakeholders affected must collaborate to define the evidence requirements and decide which data are necessary to assess the benefits of a technology. Before a consistent level of transparency can be achieved, however, it is crucial to jointly develop a framework of requirements including invasiveness, risk potential, patient-relevant endpoints and intended use of the technology, as well as the data source. Transparency is a process that can only be achieved if all stakeholders cooperate successfully. Also, it is important to keep in mind that the development of study designs and reliable evidence needs time. In the interest of all patients it is essential to maintain an innovation-friendly climate in Germany. Copyright © 2011. Published by Elsevier GmbH.

21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical devices; Spanish-language version of....16 Medical devices; Spanish-language version of certain required statements. If devices restricted to... Spanish is the predominant language, such labeling is authorized under § 801.15(c). ...

76 FR 14414 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA-2011-N-0002] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Microbiology...

The Effect of Recent Tax Changes on Taxable Income: Evidence from a New Panel of Tax Returns

ERIC Educational Resources Information Center

Heim, Bradley T.

2009-01-01

This paper estimates the elasticity of taxable income to the net-of-tax share using a panel of tax returns that follows a random sample of taxpayers from 1999 to 2005, spanning the EGTRRA 2001 and JGTRRA 2003 tax changes. Results suggest that the elasticity of taxable income to the current year's net-of-tax share lies between 0.3 and 0.4 overall,…

26 CFR 48.4041-7 - Dual use of taxable liquid fuel.

Code of Federal Regulations, 2011 CFR

2011-04-01

... operates special equipment by means of a power take-off or power transfer, tax applies to all taxable... truck if the mixing unit is operated by means of a power take-off from the motor of the vehicle...

An investigation into the feasibility of locating portable medical devices using radio frequency identification devices and technology.

PubMed

Britton, J

2007-01-01

Portable medical devices represent an important resource for assisting healthcare delivery. The movement of portable devices often results in them being unavailable when needed. Tracking equipment using radiofrequency identification technology/devices (RFID) may provide a promising solution to the problems encountered in locating portable equipment. An RFID technology trial was undertaken at Royal Alexandra Hospital, Paisley. This involved the temporary installation of three active readers and attaching actively transmitting radio frequency tags to different portable medical devices. The active readers and computer system were linked using a bespoke data network. Tags and readers from two separate manufacturers were tested. Reliability difficulties were encountered when testing the technology from the first manufacturer, probably due to the casing of the medical device interfering with the signal from the tag. Improved results were obtained when using equipment from the second manufacturer with an overall error rate of 12.3%. Tags from this manufacturer were specifically designed to overcome problems observed with the first system tested. Findings from this proof of concept trial suggest that RFID technology could be used to track the location of equipment in a hospital.

Scientific evaluation and pricing of medical devices and associated procedures in France.

PubMed

Gilard, Martine; Debroucker, Frederique; Dubray, Claude; Allioux, Yves; Aper, Eliane; Barat-Leonhardt, Valérie; Brami, Michèle; Carbonneil, Cédric; Chartier-Kastler, Emmanuel; Coqueblin, Claire; Fare, Sandrine; Giri, Isabelle; Goehrs, Jean-Marie; Levesque, Karine; Maugendre, Philippe; Parquin, François; Sales, Jean-Patrick; Szwarcensztein, Karine

2013-01-01

Medical devices are many and various, ranging from tongue spatulas to implantable or invasive devices and imaging machines; their lifetimes are short, between 18 months and 5 years, due to incessant incremental innovation; and they are operator-dependent: in general, the clinical user performs a fitting procedure (hip implant or pacemaker), a therapeutic procedure using a non-implantable invasive device (arrhythmic site ablation probe, angioplasty balloon, extension spondyloplasty system, etc.) or follow-up of an active implanted device (long-term follow-up of an implanted cardiac defibrillator or of a deep brain stimulator in Parkinson's patients). A round-table held during the XXVIII(th) Giens Workshops meeting focused on the methodology of scientific evaluation of medical devices and the associated procedures with a view to their pricing and financing by the French National Health Insurance system. The working hypothesis was that the available data-set was sufficient for and compatible with scientific evaluation with clinical benefit. Post-registration studies, although contributing to the continuity of assessment, were not dealt with. Moreover, the focus was restricted to devices used in health establishments, where the association between devices and technical medical procedures is optimally representative. An update of the multiple regulatory protocols governing medical devices and procedures is provided. Issues more specifically related to procedures as such, to non-implantable devices and to innovative devices are then dealt with, and the proposals and discussion points raised at the round-table for each of these three areas are presented. © 2013 Société Française de Pharmacologie et de Thérapeutique.

21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; Spanish-language version of....16 Medical devices; Spanish-language version of certain required statements. If devices restricted to prescription use only are labeled solely in Spanish for distribution in the Commonwealth of Puerto Rico where...

76 FR 17657 - Medical Device Epidemiology Network 2011: Second Annual Public Workshop

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-30

...] Medical Device Epidemiology Network 2011: Second Annual Public Workshop AGENCY: Food and Drug... public workshop entitled ``Medical Device Epidemiology Network (MDEpiNet) 2011: Second Annual Public... and solicit feedback on the establishment of a network that works with FDA experts to determine the...

Drugs and Medical Devices: Adverse Events and the Impact on Women’s Health

PubMed Central

Carey, Jennifer L.; Nader, Nathalie; Chai, Peter R.; Carreiro, Stephanie; Griswold, Matthew K.; Boyle, Katherine L.

2018-01-01

A large number of medications and medical devices removed from the market by the US Food and Drug Administration over the past 4 decades specifically posed greater health risks to women. This article reviews the historical background of sex and gender in clinical research policy and describes several approved drugs and devices targeted for use in women that have caused major morbidity and mortality. The intended population for the medications and devices, population affected, approval process, and the basic and legal actions taken against the medication/drug company are also discussed. It is recognized that women are still at risk for harm from unsafe medications and devices, and continued improvements in legislation that promotes inclusion of sex and gender into the design and analysis of research will improve safety for both men and women. PMID:28069260

77 FR 26769 - Educational Forum on Medical Device Reporting, Complaint Files, and Recalls, Corrections, and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-07

...] Educational Forum on Medical Device Reporting, Complaint Files, and Recalls, Corrections, and Removals; Public...), in collaboration with the FDA Medical Device Industry Coalition (FMDIC), is announcing a public workshop entitled ``Educational Forum on Medical Device Reporting, Complaint Files, and Recalls...

75 FR 29560 - Identifying Unmet Public Health Needs and Facilitating Innovation in Medical Device Development...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-26

...] Identifying Unmet Public Health Needs and Facilitating Innovation in Medical Device Development; Notice of... entitled ``Identifying Unmet Public Health Needs and Facilitating Innovation in Medical Device Development... an initiative to proactively facilitate medical device innovation to address unmet public health...

Emergency department visits for medical device-associated adverse events among children.

PubMed

Wang, Cunlin; Hefflin, Brock; Cope, Judith U; Gross, Thomas P; Ritchie, Mary Beth; Qi, Youlin; Chu, Jianxiong

2010-08-01

The purposes of this study were to provide national estimates of emergency department (ED) visits for medical device-associated adverse events (MDAEs) in the pediatric population and to characterize these events further. ED medical record reports from the National Electronic Injury Surveillance System All Injury Program database from January 1, 2004, through December 21, 2005, were reviewed. MDAEs among pediatric patients were identified, and data were abstracted. National estimates for pediatric MDAEs were determined according to medical specialty, device category and class, injury diagnosis, and patient characteristics and outcome. The total estimated number of pediatric MDAEs during the 24-month period was 144,799 (95% confidence interval: 113,051-183,903), involving devices from 13 medical specialties. Contact lenses accounted for most MDAEs (23%), followed by hypodermic needles (8%). The distribution of MDAEs according to medical specialty varied according to age subgroup. The most-prevalent types of injuries included contusions/abrasions, foreign-body intrusions, punctures, lacerations, and infections. The most-frequently affected body parts were the eyeball, pubic region, finger, face, and ear. The majority of pediatric MDAEs involved class II (moderate-risk) devices. The incidence of pediatric MDAEs decreased with increasing age from early to late childhood and then spiked after 10 years of age. More girls than boys were affected at older ages (16-21 years) and more boys than girls at younger ages (< or =10 years). Hospitalizations were more likely to involve invasive or implanted devices. This study provides national estimates of pediatric MDAEs resulting in ED visits and highlights the need to develop interventions to prevent pediatric device-related injuries.

Management information system of medical equipment using mobile devices

NASA Astrophysics Data System (ADS)

Núñez, C.; Castro, D.

2011-09-01

The large numbers of technologies currently incorporated into mobile devices transform them into excellent tools for capture and to manage the information, because of the increasing computing power and storage that allow to add many miscellaneous applications. In order to obtain benefits of these technologies, in the biomedical engineering field, it was developed a mobile information system for medical equipment management. The central platform for the system it's a mobile phone, which by a connection with a web server, it's capable to send and receive information relative to any medical equipment. Decoding a type of barcodes, known as QR-Codes, the management process is simplified and improved. These barcodes identified the medical equipments in a database, when these codes are photographed and decoded with the mobile device, you can access to relevant information about the medical equipment in question. This Project in it's actual state is a basic support tool for the maintenance of medical equipment. It is also a modern alternative, competitive and economic in the actual market.

Regulatory Science in Practice (Pharmaceuticals and Medical Devices Agency).

PubMed

Hojo, Taisuke

2017-01-01

Review, safety, and relief services of the Pharmaceuticals and Medical Devices Agency are primarily focused on scientifically evaluating pharmaceuticals, medical devices, and cellular and tissue-based products referring to their quality, efficacy, and safety, which requires a variety of scientific knowledge and methods. Pharmaceutical regulation should be established based on the most advanced scientific expertise at all times. In order to evaluate products that use cutting-edge technology such as induced pluripotent stem cells and information and communication technology adequately, since fiscal year 2012 the Science Committee has been established as a platform to exchange opinions among members from top-ranking domestic and international academia and to enhance personnel exchanges through the Initiative to Facilitate Development of Innovative Drugs. In addition, the Regulatory Science Center will be established in 2018 to increase the integrity of our services for product reviews and safety measures. In particular, requiring electronic data submissions for clinical trial applications followed by an advanced approach to analysis should not only enhance the quality of reviews of individual products but should also support the development of pharmaceuticals and medical devices by providing pharmaceutical affairs consultations on research and development strategies with various guidelines based on new insights resulting from product-bridging data analysis. Moreover, a database including electronic health records with comprehensive medical information collected mainly from 10 cooperating medical institutions will be developed with the aim of developing safety measures in a more timely manner using methods of pharmacoepidemiological analysis.

26 CFR 1.822-5 - Mutual insurance company taxable income.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 26 Internal Revenue 8 2013-04-01 2013-04-01 false Mutual insurance company taxable income. 1.822-5... TAX (CONTINUED) INCOME TAXES (CONTINUED) Mutual Insurance Companies (other Than Life and Certain Marine Insurance Companies and Other Than Fire Or Flood Insurance Companies Which Operate on Basis of...

26 CFR 1.822-5 - Mutual insurance company taxable income.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 26 Internal Revenue 8 2012-04-01 2012-04-01 false Mutual insurance company taxable income. 1.822-5... TAX (CONTINUED) INCOME TAXES (CONTINUED) Mutual Insurance Companies (other Than Life and Certain Marine Insurance Companies and Other Than Fire Or Flood Insurance Companies Which Operate on Basis of...

26 CFR 1.822-5 - Mutual insurance company taxable income.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 26 Internal Revenue 8 2014-04-01 2014-04-01 false Mutual insurance company taxable income. 1.822-5... TAX (CONTINUED) INCOME TAXES (CONTINUED) Mutual Insurance Companies (other Than Life and Certain Marine Insurance Companies and Other Than Fire Or Flood Insurance Companies Which Operate on Basis of...

26 CFR 1.822-5 - Mutual insurance company taxable income.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 26 Internal Revenue 8 2011-04-01 2011-04-01 false Mutual insurance company taxable income. 1.822-5... TAX (CONTINUED) INCOME TAXES (CONTINUED) Mutual Insurance Companies (other Than Life and Certain Marine Insurance Companies and Other Than Fire Or Flood Insurance Companies Which Operate on Basis of...

31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false In-kind donations of medicine...-kind donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of medicine...

Pricing and reimbursement of drugs and medical devices in Hungary.

PubMed

Gulácsi, L; Dávid, T; Dózsa, Cs

2002-01-01

Similarly to other countries of Central and Eastern Europe, Hungary has witnessed massive diffusion of healthcare technology such as drugs and medical devices since 1990. While substantial new pharmaceuticals, medical devices, and procedures have been liberalized, there has been no proper evaluation or training in their use. Healthcare providers have come to find themselves as entrepreneurs in private practice, while patients are acquiring an increasing awareness as customers of healthcare,demanding services in return for their taxes and contributions. This has led to extremely irrational patterns of investment in technology, with most an obvious waste of resources, while leaving basic needs unmet. Both the National Health Insurance Fund and the Ministry of Finance believe that the current pharmaceutical and medical device bill is too high. However, introducing a more transparent and flexible pricing and reimbursement framework may enable a more efficient allocation of the limited resources to be achieved.

75 FR 1395 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-11

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0606] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice...) is announcing an amendment to the notice of a meeting of the General and Plastic Surgery Devices...

78 FR 13350 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug... of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee...

Towards automated assistance for operating home medical devices.

PubMed

Gao, Zan; Detyniecki, Marcin; Chen, Ming-Yu; Wu, Wen; Hauptmann, Alexander G; Wactlar, Howard D

2010-01-01

To detect errors when subjects operate a home medical device, we observe them with multiple cameras. We then perform action recognition with a robust approach to recognize action information based on explicitly encoding motion information. This algorithm detects interest points and encodes not only their local appearance but also explicitly models local motion. Our goal is to recognize individual human actions in the operations of a home medical device to see if the patient has correctly performed the required actions in the prescribed sequence. Using a specific infusion pump as a test case, requiring 22 operation steps from 6 action classes, our best classifier selects high likelihood action estimates from 4 available cameras, to obtain an average class recognition rate of 69%.

Recent advances in medical device triage technologies for chemical, biological, radiological, and nuclear events.

PubMed

Lansdowne, Krystal; Scully, Christopher G; Galeotti, Loriano; Schwartz, Suzanne; Marcozzi, David; Strauss, David G

2015-06-01

In 2010, the US Food and Drug Administration (Silver Spring, Maryland USA) created the Medical Countermeasures Initiative with the mission of development and promoting medical countermeasures that would be needed to protect the nation from identified, high-priority chemical, biological, radiological, or nuclear (CBRN) threats and emerging infectious diseases. The aim of this review was to promote regulatory science research of medical devices and to analyze how the devices can be employed in different CBRN scenarios. Triage in CBRN scenarios presents unique challenges for first responders because the effects of CBRN agents and the clinical presentations of casualties at each triage stage can vary. The uniqueness of a CBRN event can render standard patient monitoring medical device and conventional triage algorithms ineffective. Despite the challenges, there have been recent advances in CBRN triage technology that include: novel technologies; mobile medical applications ("medical apps") for CBRN disasters; electronic triage tags, such as eTriage; diagnostic field devices, such as the Joint Biological Agent Identification System; and decision support systems, such as the Chemical Hazards Emergency Medical Management Intelligent Syndromes Tool (CHEMM-IST). Further research and medical device validation can help to advance prehospital triage technology for CBRN events.

31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false In-kind donations of medicine....515 In-kind donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of medicine...

Sterilization and reprocessing of materials and medical devices--reusability.

PubMed

Jayabalan, M

1995-07-01

Problems associated with reprocessing of disposable medical devices such as hemodialysers with resterilization for reuse and changes in material properties with resterilization of polymeric (PVC, polypropylene, polyester, polycarbonate) materials intended for development of disposable devices are reviewed. Reprocessing of hospital supplies, polystyrene microtiter plate and angiographic catheter for reuse is also discussed.

26 CFR 1.822-5 - Mutual insurance company taxable income.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 8 2010-04-01 2010-04-01 false Mutual insurance company taxable income. 1.822-5... TAX (CONTINUED) INCOME TAXES Mutual Insurance Companies (other Than Life and Certain Marine Insurance Companies and Other Than Fire Or Flood Insurance Companies Which Operate on Basis of Perpetual Policies Or...

26 CFR 1.6654-3 - Short taxable years of individuals.

Code of Federal Regulations, 2010 CFR

2010-04-01

... TAX (CONTINUED) INCOME TAXES Additions to the Tax, Additional Amounts, and Assessable Penalties § 1... short taxable year due to a change in annual accounting periods, in determining the tax: (i) Shown on... manner described in the last sentence thereof). If the tax rates or the taxpayer's status with respect to...

27 CFR 70.21 - Canvass for taxable persons and objects.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2011-04-01 2011-04-01 false Canvass for taxable persons and objects. 70.21 Section 70.21 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX... ADMINISTRATION Discovery of Liability and Enforcement of Laws Examination and Inspection § 70.21 Canvass for...

Medical-device risk management and public safety: using cost-benefit as a measurement of effectiveness

NASA Astrophysics Data System (ADS)

Hughes, Allen A.

1994-12-01

Public safety can be enhanced through the development of a comprehensive medical device risk management. This can be accomplished through case studies using a framework that incorporates cost-benefit analysis in the evaluation of risk management attributes. This paper presents a framework for evaluating the risk management system for regulatory Class III medical devices. The framework consists of the following sixteen attributes of a comprehensive medical device risk management system: fault/failure analysis, premarket testing/clinical trials, post-approval studies, manufacturer sponsored hospital studies, product labeling, establishment inspections, problem reporting program, mandatory hospital reporting, medical literature surveillance, device/patient registries, device performance monitoring, returned product analysis, autopsy program, emergency treatment funds/interim compensation, product liability, and alternative compensation mechanisms. Review of performance histories for several medical devices can reveal the value of information for many attributes, and also the inter-dependencies of the attributes in generating risk information flow. Such an information flow network is presented as a starting point for enhancing medical device risk management by focusing on attributes with high net benefit values and potential to spur information dissemination.