Singleuse Medical Devices Little Available Evidence Of Harm From Reuse But Oversight Warranted Report To Congressional Requesters PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Singleuse Medical Devices Little Available Evidence Of Harm From Reuse But Oversight Warranted Report To Congressional Requesters PDF full book. Access full book title Singleuse Medical Devices Little Available Evidence Of Harm From Reuse But Oversight Warranted Report To Congressional Requesters.
Author | : |
Publisher | : DIANE Publishing |
Total Pages | : 37 |
Release | : 2000 |
Genre | : Medical instruments and apparatus |
ISBN | : 1428972781 |
Download Singleuse medical devices : little available evidence of harm from reuse, but oversight warranted : report to congressional requesters Book in PDF, ePub and Kindle
Author | : United States. General Accounting Office |
Publisher | : |
Total Pages | : 42 |
Release | : 2000 |
Genre | : Medical instruments and apparatus |
ISBN | : |
Download Single-use Medical Devices Book in PDF, ePub and Kindle
Author | : U S Government Accountability Office (G |
Publisher | : BiblioGov |
Total Pages | : 40 |
Release | : 2013-06 |
Genre | : |
ISBN | : 9781289001452 |
Download Single-Use Medical Devices Book in PDF, ePub and Kindle
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.
Author | : United States Accounting Office |
Publisher | : Createspace Independent Publishing Platform |
Total Pages | : 38 |
Release | : 2018-02-13 |
Genre | : |
ISBN | : 9781985285118 |
Download Single-Use Medical Devices Book in PDF, ePub and Kindle
HEHS-00-123 Single-Use Medical Devices: Little Available Evidence of Harm From Reuse, but Oversight Warranted
Author | : United States. Congress. House. Committee on Commerce. Subcommittee on Oversight and Investigations |
Publisher | : |
Total Pages | : 194 |
Release | : 2000 |
Genre | : Medical |
ISBN | : |
Download Reuse of Single-use Medical Devices Book in PDF, ePub and Kindle
Author | : United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions |
Publisher | : |
Total Pages | : 238 |
Release | : 2000 |
Genre | : Medical |
ISBN | : |
Download Reprocessing of Single-use Medical Devices Book in PDF, ePub and Kindle
Author | : |
Publisher | : |
Total Pages | : 0 |
Release | : 2008 |
Genre | : Disposable medical devices |
ISBN | : |
Download Reprocessed Single-use Medical Devices Book in PDF, ePub and Kindle
Author | : United States. Government Accountability Office |
Publisher | : |
Total Pages | : 37 |
Release | : 2008 |
Genre | : Disposable medical devices |
ISBN | : |
Download Reprocessed Single-use Medical Devices Book in PDF, ePub and Kindle
Author | : United States Government Accountability Office |
Publisher | : Createspace Independent Publishing Platform |
Total Pages | : 42 |
Release | : 2018-01-16 |
Genre | : |
ISBN | : 9781983884757 |
Download Reprocessed Single-Use Medical Devices Book in PDF, ePub and Kindle
Reprocessed Single-Use Medical Devices: FDA Oversight Has Increased, and Available Information Does Not Indicate That Use Presents an Elevated Health Risk
Author | : |
Publisher | : |
Total Pages | : 51 |
Release | : 2011 |
Genre | : Medical instruments and apparatus |
ISBN | : |
Download Medical Devices Book in PDF, ePub and Kindle
Recalls are an important tool to mitigate serious health consequences associated with defective or unsafe medical devices. Typically, a recall is voluntarily initiated by the firm that manufactured the device. The Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), oversees implementation of the recall. FDA classifies recalls based on health risks of using the recalled device--class I recalls present the highest risk (including death), followed by class II and class III. FDA also determines whether a firm has effectively implemented a recall, and when a recall can be terminated. This report identifies (1) the numbers and characteristics of medical device recalls and FDA's use of this information to aid its oversight, and (2) the extent to which the process ensures the effective implementation and termination of the highest-risk recalls. GAO interviewed FDA officials and examined information on medical device recalls initiated and reported from 2005 through 2009, and reviewed FDA's documentation for a sample of 53 (40 percent) of class I recalls initiated during this period. To aid its oversight of the medical device recall process, FDA should routinely assess information on device recalls, develop enhanced procedures and criteria for assessing the effectiveness of recalls, and document the agency's basis for terminating individual recalls. HHS agreed with GAO's recommendations.