The Risk Factors Involved In The Reuse Of Single Use Medical Devices
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The Risk Factors Involved In The Reuse Of Single Use Medical Devices
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Author : National Standards Authority of Ireland
language : en
Publisher:
Release Date : 1989
The Risk Factors Involved In The Reuse Of Single Use Medical Devices written by National Standards Authority of Ireland and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1989 with Biomedical engineering categories.
The Safety Of Reprocessed Medical Devices Marketed For Single Use
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Author :
language : en
Publisher:
Release Date : 2010
The Safety Of Reprocessed Medical Devices Marketed For Single Use written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010 with categories.
One of the Directives regulating the placing on the market of medical devices in the EU is Directive 93/42/EEC on medical devices. This Directive distinguishes between those devices that are intended by the manufacturer to be reused and those which are intended for single-use. Both types of devices must comply with the essential requirements of this Directive. The use of single-use medical devices (SUDs) has considerably increased for a variety of reasons. However, some medical devices have continued to be reprocessed despite the fact that they were intended for single-use. The use of reprocessed SUDs may not be without risk. In this opinion the possible risks involved in the reprocessing and reuse of single-use medical devices have been evaluated. Several potential hazards have been identified that may eventually lead to a risk for patients on whom a reprocessed SUD would be used.^As is the case for medical devices intended for re-use, the major hazard arises from the inadequate cleaning, disinfection and/or sterilization that may result in persistence of either a chemical or a microbiological contamination, the former resulting in a risk of toxic reactions, the latter in a risk of microbiological infection. Of specific concern is the hazard of the potential contamination with agents causing transmissible spongiform encephalopathies (TSEs). In addition, the interaction with the chemicals used during the various procedures may result in changes in the material characteristics which can affect the performance of the device. Other factors that may increase the risk for the patient when using a reprocessed SUD include poor traceability of a reprocessed device, and inadequate educational and training aspects for complex medical procedures. Data to quantify the risks are however scarce.^Some simulation studies have shown that improper cleaning, disinfection and/or sterilization may leave a bioburden on the reprocessed SUD. There is a lack of data specifically dealing with clinical outcomes for patients treated with reprocessed SUDs. There are a few case reports showing persistence of chemical residues of cleaning agents and disinfectants, persistence of infectious agents and modifications in physical-chemical characteristics. Despite the absence of data, a number of situations in which an increased risk from using a reprocessed SUD may occur have been identified; an increased risk may be present in particular with the use of a re-processed SUD in invasive medical procedures (designated critical use), and with the use of a reprocessed SUD with certain design features that make it unsuitable for reprocessing and re-use. Some recommendations are made.
Reprocessing Of Single Use Medical Devices
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Author : United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
language : en
Publisher:
Release Date : 2000
Reprocessing Of Single Use Medical Devices written by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000 with Medical categories.
Single Use Medical Devices
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Author : U S Government Accountability Office (G
language : en
Publisher: BiblioGov
Release Date : 2013-06
Single Use Medical Devices written by U S Government Accountability Office (G and has been published by BiblioGov this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-06 with categories.
Pursuant to a congressional request, GAO reviewed the practice of single-use device (SUD) reprocessing in the United States, focusing on the: (1) extent of SUD reprocessing; (2) health risks associated SUD with reprocessing; (3) cost savings from reprocessing; and (4) Food and Drug Administration's (FDA) oversight of SUD reprocessing. GAO noted that: (1) while some health care institutions have chosen to reprocess and reuse some kinds of SUDs, accurate and comprehensive information about the number of facilities that use reprocessed SUDs and the types of SUDs that are reprocessed is not available; (2) surveys by professional associations and other groups have found that approximately 20 to 30 percent of American hospitals reported that they reuse at least one type of SUD and that at least one-third of the hospitals that do so contract with third-party reprocessing companies; (3) most hospitals using reprocessed SUDs reuse only a few types of devices; (4) it is likely that some hospitals do not report their use of reprocessed SUDs, and the estimates do not fully include ambulatory surgery centers or physicians' practices that also may reuse SUDs; (5) although SUD reprocessing does pose theoretical health risks, clinical evidence shows that certain devices can be reprocessed safely; (6) some infection control experts told GAO that the careful reprocessing of appropriate SUDs has not been demonstrated to be a public health risk; (7) GAO found that several reports of patient adverse events allegedly due to SUD reprocessing that GAO identified were inaccurate or not relevant to the debate; (8) however, this does not mean that SUD reprocessing is always safe; (9) current surveillance systems almost certainly do not detect all infections and injuries resulting from the use of reprocessed SUDs; (10) FDA, device manufacturers, and third-party reprocessors generally agree that many types of SUDs cannot be safely cleaned and sterilized, and even for devices that usually can be reprocessed, some models are impossible to clean and sterilize effectively; (11) substantial cost savings can be achieved by reprocessing SUDs; (12) independent reprocessing firms charge hospitals approximately one-half the price of a new device for a reprocessed device, while the in-house cost of reprocessing some devices can be less than 10 percent of the price of a new device; (13) under FDA's revised framework for SUD reprocessing, independent reprocessing firms and hospitals will have to obtain FDA's approval before they can reprocess many devices labelled for single-use; and (14) the revised regulatory framework will give FDA more information about SUD reprocessing and strengthen its oversight of reprocessing.
Reuse Of Single Use Medical Devices
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Author : United States. Congress. House. Committee on Commerce. Subcommittee on Oversight and Investigations
language : en
Publisher:
Release Date : 2000
Reuse Of Single Use Medical Devices written by United States. Congress. House. Committee on Commerce. Subcommittee on Oversight and Investigations and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000 with Medical categories.
The Reuse Of Single Use Medical Devices
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Author : Health Industry Manufacturers Association
language : en
Publisher:
Release Date : 1984
The Reuse Of Single Use Medical Devices written by Health Industry Manufacturers Association and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1984 with categories.
Medical Device Regulations
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Author : Michael Cheng
language : en
Publisher: World Health Organization
Release Date : 2003-09-16
Medical Device Regulations written by Michael Cheng and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-09-16 with Medical categories.
The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.
Singleuse Medical Devices Little Available Evidence Of Harm From Reuse But Oversight Warranted Report To Congressional Requesters
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Author :
language : en
Publisher: DIANE Publishing
Release Date : 2000
Singleuse Medical Devices Little Available Evidence Of Harm From Reuse But Oversight Warranted Report To Congressional Requesters written by and has been published by DIANE Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000 with Medical instruments and apparatus categories.
Medical Device Safety
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Author : United States. Congress. House. Committee on Government Reform
language : en
Publisher:
Release Date : 2006
Medical Device Safety written by United States. Congress. House. Committee on Government Reform and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006 with Medical categories.
Single Use Medical Devices
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Author : Medical Devices Agency
language : en
Publisher:
Release Date : 2000
Single Use Medical Devices written by Medical Devices Agency and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000 with categories.