Quotes About the Safety of Reprocessing

"FDA believes that reprocessed SUDs that meet FDA’s regulatory requirements are as safe and effective as a new device.

Daniel Schultz, M.D., Director CDRH (FDA’s Center for Devices & Radiological Health)

"FDA officials have concluded ... that the available data… does not indicate that reprocessed SUDs present an elevated health risk. FDA has analyzed its data on reported adverse events related to reprocessed SUDs and has concluded that there are no patterns that point to these devices creating such risks."

January, 2008
Randall B. Williamson
Acting Director, Health Care
United States Government Accounting Office

"In January, after reviewing eight years of FDA data, the Government Accountability Office weighed in with a report concluding there is no evidence that reprocessed single -use devices create an elevated health risk for patients."

The Wall Street Journal
March 19, 2008
"Hospitals Reuse Medical Devices to Lower Costs"
By Laura Landro

"If you’re searching for ways to reduce expenses without compromising quality, chances are you’ve at least considered the possibility of reprocessing single-use medical devices (SUDs)..."

Debra Dunn, RN, MVA, CNOR
Outpatient Surgery Magazine Article

"None of the representatives of MedSun hospitals who participated in the FDA focus groups reported being aware of any infections related to the use of reprocessed SUDs" furthermore, participants stated: "that there were actually fewer performance problems with reprocessed SUDs than with new SUDs. According to FDA, all participants believed that reprocessing establishments are more stringently regulated by FDA than are the manufacturers of the original devices, and this provided them a sense of confidence in the reprocessing process."

2005 Medical Product Safety
Network Study (MedSun)
GAO Report, January, 2008

"The reuse of medical devices that are labeled for singleuse only is a well-established and safe practice regulated by the FDA and utilized by most of the top-ranked hospitals in the country."

Kenneth Kizer
Former Undersecretary for Health,
US Dept. of Veterans Affairs