Consider caveats of reprocessing safely
Consider caveats of reprocessing safely
Although the General Accounting Office (GAO) has reported that some devices can be reprocessed safety when proper cleaning and sterilization procedures are followed, the report included some caveats.1
It is difficult to identify sources of infection in individual patients, and it can be particularly difficult to trace infections back to the use of specific medical devices, said Janet Heinrich, associate director of health financing and public health issues for the GAO, in June 27 testimony summarizing the report before the Senate Committee on Health, Education, Labor, and Pensions.2
"Current medical device surveillance systems almost certainly do not detect all infections and injuries resulting from the use of reprocessed SUDs, or from the use of medical devices in general, and there is general agreement that many types of SUDs cannot be effectively cleaned and sterilized," Heinrich said. The report gave an example of a reprocessing firm that only reprocesses 15 "families" of devices, and many of these were opened but unused devices.
Furthermore, procedures for safe reprocessing aren’t always followed, she added.
The FDA has received reports from device manufacturers of damaged, unclean, or nonsterile reprocessed SUDs taken from hospitals that had been reprocessed by third-party reprocessors.
That agency found at least one of the claims had merit, according to Heinrich’s testimony. In March 1999, a manufacturer said six reprocessed GI biopsy forceps at a Florida hospital were not sterile. The devices were labeled for single use and had been reprocessed by a third-party reprocessing company, according to Heinrich.
"Although there is no evidence that these reprocessed devices have harmed patients, this case demonstrates the possibility that some reprocessed SUDs sterilized according to current protocols might not be free of bacterial contamination," she said.
How can same-day surgery centers ensure that SUDs are reprocessed safely? The GAO report spelled it out: ". . . Institutions must be able to clean [the SUD] thoroughly, sterilize it to acceptable standards, and ensure that reprocessing and reuse will not degrade its functioning."
Cleaning is a critical step, the report emphasized: ". . . even measurably sterile devices can harbor biological material from previous uses that may prove a health risk for subsequent patients. Potentially, this biological residue by itself can prove toxic to new patients, and it also can form a crust to shield harmful bacteria from sterilization procedures."
References
1. General Accounting Office. Single-Use Medical Devices — Little Available Evidence of Harm from Reuse, but Oversight Warranted. Washington, DC; 2000.
2. General Accounting Office. Medical devices: Reprocessing and reuse of devices labeled for single use. Statement of Janet Heinrich, associate director, health financing and public health issues; Health, Education, and Human Services Division; before the Committee on Health, Education, Labor, and Pensions, U.S. Senate. Washington, DC; June 27, 2000.
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