More than 24% of all U.S. hospitals reuse single-use medical devices (SUDs), according to the Food and Drug Administration (FDA). According to a recent telephone survey of all hospitals conducted by the FDA, the most commonly reused SUDs are:
- sequential compression device sleeves (15.8% of all hospitals);
- drill bits, saws, blades, or burrs (7.3% of all hospitals);
- biopsy forceps and snares (6.2% of all hospitals).
Nearly half of all hospitals with more than 250 beds reused SUDs, while only 12% of hospitals with fewer than 50 beds reuse them. Of the hospitals reusing SUDs, 84% use third-party reprocessors. The remaining 15.4% of hospitals reprocess at least some in-house. To see the survey results, go to: www.fda.gov/cdrh/Reuse/survey-execsum.html.
CD-ROM offers details
The FDA active enforcement of premarket notification submission requirements for class II SUDs is in effect for hospitals. The FDA is making a CD-ROM set available that explains the regulatory requirements for hospitals that reprocess SUDs. The CD-ROM set, An Overview of the Regulatory Requirements for Reprocessing of Single-Use Devices by Hospitals, covers labeling, medical device tracking, problems with reprocessing, registration and listing, premarket review, and corrections and removals. Free copies of the discs are available at www.fda.gov/cdrh/reuse/reuse-important.shtml.
Facilities that use outside reprocessors should ensure that the reprocessing company is registered with the FDA and meets all the agency’s premarket certification requirements, advises Mark Mayo, executive director of the Illinois Freestanding Surgery Center Association in St. Charles. While only hospitals fall under the federal mandates on reprocessing SUDs, this step also is advisable for surgery centers, Mayo says. "Also, facilities should make sure the company is insured for malpractice and make sure items are properly labeled and coded to keep track of when and how many times they are reprocessed," he says.
More than 24% of all U.S. hospitals reuse single-use medical devices (SUDs), according to the Food and Drug Administration.
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