Gao Reprocessed Single-Use Medical Devices

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GAO-08-147 Reprocessed Single-Use Medical …

https://www.gao.gov/assets/gao-08-147.pdf

1Generally, a medical device includes items used for the diagnosis, cure, mitigation, treatment, or prevention of a disease or other condition. 21 U.S.C. § 321(h). Throughout this report, the term device refers to a medical device that is not being regulated as a drug …

Reprocessed Single-Use Medical Devices: FDA …

https://www.gao.gov/products/gao-08-147

This report addresses (1) the SUD reprocessing industry--the number of reprocessing establishments, the types of devices reprocessed, and the extent to …

Medical Devices: Reprocessing and Reuse of Devices …

https://www.gao.gov/products/t-hehs-00-143

Pursuant to a congressional request, GAO discussed the reprocessing and reuse of medical devices marketed for single use, focusing on: (1) the extent of single …

GAO-08-147, Reprocessed Single-Use Medical Devices: …

https://www.gao.gov/assets/a271672.html

This is the accessible text file for GAO report number GAO-08-147 entitled 'Reprocessed Single-Use Medical Devices: FDA Oversight Has Increased, and Available Information …

T-HEHS-00-143 Medical Devices: Reprocessing and …

https://www.gao.gov/pdf/product/108509

1SUDs are also referred to as disposable devices because they are intended to be discarded after one use. 2Single-Use Medical Devices: Little Available Evidence of …

January 2008 REPROCESSED SINGLE-USE …

https://www.gao.gov/assets/gao-08-147-highlights.pdf

What GAO Found United States Government Accountability Office Why GAO Did This Study HighlightsAccountability Integrity Reliability January 2008 REPROCESSED …

Single-Use Medical Devices: Little Available Evidence of …

https://www.gao.gov/products/hehs-00-123

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 …

Some single-use devices can be reprocessed safely, GAO report …

https://www.reliasmedia.com/articles/54862-some-single-use-devices-can-be-reprocessed-safely-gao-report-says

Here are two bits of surprising news that could affect your opinion on reprocessing of single-use devices (SUDs): First, the General Accounting Office …

Summary of the Medical Device User Fee and …

https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/summary-medical-device-user-fee-and-modernization-act-2002

GAO reports. By July 1, 2003, 2004, and 2005, ... Reprocessed Single-Use Medical Devices § 302 of MDUFMA provides new regulatory requirements for …

Reprocessing of Reusable Medical Devices | FDA

https://www.fda.gov/medical-devices/products-and-medical-procedures/reprocessing-reusable-medical-devices

Adequate reprocessing of reusable medical devices is vital to protecting patient safety. Inadequate cleaning between patient uses can result in the retention of …

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