Hospitals that reuse certain disposable products could be regulated as stringently as device manufacturers, according to a Food and Drug Administration proposal released last week.
The change would reverse an FDA policy that has essentially exempted hospitals from such oversight.
Reprocessing of these devices for reuse has come under increased scrutiny in recent years, and several bills have been introduced in Congress that would restrict the practice.
To save money, many hospitals clean and resterilize devices, such as electrophysiology catheters used to diagnose and treat some common heart conditions and orthopedic drill bits used in surgery. Some employ third-party firms to do so-especially for complex devices.
Figures on the reuse of disposable devices are hard to come by because most hospitals are reluctant to discuss the practice, given possible patient reactions to treatment with previously used devices and potential legal liability. Most observers agree that the practice is increasingly common as cost-conscious hospitals look for ways to stretch every dollar.
The FDA signaled its intent to step into the hazy area of device reprocessing in a white paper floated for public comment. Any regulatory changes would be many months, if not years, away, however.
American Hospital Association President Richard Davidson said in a prepared statement that the FDA's proposal is "a thoughtful approach." He said association member hospitals asked the agency for guidance in the area.
Under its plan, the FDA would divide regulations into three tiers based on the potential risk to patients caused by the reuse of devices. Recyclers of devices that could pose a significant health risk after reprocessing would have to comply with most of the same regulations that manufacturers do. Recyclers would be subject to quality control measures, and the FDA would have to approve devices before they could be sold.
The FDA expects to "exercise discretion" in enforcing regulations for low-risk products and expects reprocessors to comply with technical standards and basic regulatory requirements.
Devices in the middle ground would be subject to a blend of requirements from the high-and low-risk categories.
Independent reprocessors, which would also be more heavily regulated under the proposal, reacted with cautious optimism.
"It takes a risk-based approach that we think makes sense," said Pamela Furman, executive director of the Association of Medical Device Reprocessors, Washington. She emphasized, though, that the FDA should base risk determinations on "credible scientific evidence and not public relations perceptions."
Critics charge that reprocessed products may fail and put patients at risk of injury or that inadequate cleaning or sterilization could cause infection.
But proponents point out that repeated use of medical products was commonplace 20 years ago without ill effects. Many manufacturers unnecessarily label their products for one-time use, but that does not preclude safe and economic reuse, they say.
Last month the FDA supported that position by rejecting a petition filed by a group of device manufacturers to ban reprocessing. In its decision, the FDA wrote that it "has been unable to find clear evidence of adverse patient outcomes associated with the reuse of a single-use device from any source."