MEDICAL DEVICES: Recycled Single-Use Equipment on the Rise
Millions of disposable medical devices intended for single use are being legally reused by financially squeezed hospitals, which reprocess them or shuttle them to third-party reprocessors -- often away from the watchful eye of the FDA, the Los Angeles Times reports. Under pressure from device manufacturers, the FDA is poised to crack down on the "largely unregulated practice" of reprocessing, even though it claims that incidents of contamination or malfunctioning devices are "rare." Government files on reprocessed instruments point to cardiac catheters with tips that break off inside patients' hearts or infections caused by high levels of bacterial toxins. "These devices are intricate, they have sharp points or tightly coiled wires, and they're often made of materials not used to withstanding mechanical or biochemical aspects of reprocessing," said Dr. Philip Grossman, a manufacturing consultant and Miami-based gastroenterologist. The debate pits manufacturers, who want to sell as many single-use devices as possible, against the third-party reprocessors, who "cater to hospitals striving to save health care dollars." The problem is fueled by managed care companies, whose hospital reimbursements often "are not sufficient to cover the cost of new devices." The Los Angeles Times reports, for example, that two cardiac catheters used during a single electrophysiology procedure cost $2,000, or nearly 60% to 80% of the entire reimbursement for the procedure. Reprocessors can sterilize the device and trim 30% to 50% from the price tag for buying new devices.
For its part, the FDA has long turned a blind eye toward reprocessing and "does not require reprocessors to demonstrate that a device is safe after it has been reprocessed." But that might change, the Los Angeles Times reports. In a recent letter it sent to the Association of Medical Device Reprocessors, the FDA stated that "third-party reprocessing of devices labeled for single use is unlawful" unless the reprocessors document that the devices are safe after withstanding the process. "The problem all along, and the reason why we have not exercised any regulatory discretion, is because we have not had really good data with which to project that a certain amount of harm was occurring to the public," said the FDA's Larry Spears. There is no follow-up on patients on whom reprocessed devices are used, tracking of the devices is virtually nonexistent and independent studies of the devices are scarce. Manufacturers protest that only seven out of 23 third-party reprocessors are registered with the FDA and that they are not required to submit documentation indicating that a single-use device has become reusable, although manufactures are required to notify the FDA if they make such a change. The FDA said it hopes to issue an official position by October. Sen. Richard Durbin (D-IL) is preparing legislation that would impose stricter requirements on reprocessing, and has asked the GAO to investigate the practice. At the same time, the American Hospital Association claims that patients' health care is at risk if the government cracks down on reprocessing and already pinched hospitals will sink further into the red. In the meantime, patients are caught in the middle, said Lynn Sehulster of the CDC. "It is only a matter of time until the public becomes aware in large measure. ... Will they tolerate this practice?" (Pagan Westphal, 8/2).