A key member of the U.S. Congress called on Monday for more rigorous federal monitoring of reuse of single-use instruments.
The Food and Drug Administration (FDA) has been monitoring the industry -- called reprocessing -- but significant gaps remain, according to Rep. Rosa L. DeLauro (D-Conn.), the ranking Democrat on the House Appropriations subcommittee that oversees the FDA.
AdvertisementReprocessing is a growing industry believed to serve hospitals in all 50 states and at least eight medical facilities in the Washington area.
Device manufacturers refuse to guarantee the safety of their reconditioned single-use devices, but reprocessors deny any credible evidence that use of their refurbished devices carry a higher risk than new ones. They also say no surgery is without risk.
Many hospitals which reuse processed equipment cite the practice's safety and cost savings.
DeLauro, however, expressed concerns about the FDA's role. She wants the FDA to increase the number of inspectors assigned to reprocessors; now, there is no set number. She also said she plans to address the issue in an appropriations bill next year and possibly call for a hearing on the matter.
FDA relies on doctors to voluntarily report problems with faulty medical devices, and medical facilities are required to report to the FDA deaths, but not device malfunctions.
Naomi Halpern, an attorney for the Association of Medical Device Reprocessors, said the group "looks forward to working with Congresswoman DeLauro as she develops legislation affecting the regulation of the medical device industry."
The FDA said that prior to 2000 it did little to oversee reprocessors other than inspect their facilities and require them to follow good manufacturing practices.
Now, it requires reprocessors to submit data to validate that their work produces safe devices. In a statement, the FDA said it "provides stringent regulatory oversight" and "will act swiftly" if reprocessors do not comply with its requirements.
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