Controversy erupts over reuse of “single use” medical devices

Hospital and clinic instruments are being reused despite their “single-use” designation. Vanguard Medical Concepts of Lakeland, Florida claims to have cleaned and resterilized instruments such as biopsy forceps and wires and balloons used for coronary or cardiac procedures.

Charles Masek, president of Vanguard Medical Concepts, said that his company has reprocessed more than 2.5 million devices—ranging from coronary angioplasty balloon catheters and orthopedic blades, burrs and bits to deep vein thrombosis sleeves and laparoscopic instruments. Vanguard is a founding member of the Washington-based Association of Medical Device Reprocessors.

The manufacturers of medical devices have said that hospitals are putting patients at grave risk to save money. “The real issue is patient safety,” said Josephine Torrente, president of the Association of Disposable Device Manufacturers. “Until you prove otherwise, these devices are safe and effective for one use. After that, they're garbage.”

Larry Kessler, director of the office of surveillance and biometrics at the Food and Drug Administration, said: “There are no products where we have significant evidence that there is immediate harm to the public health.” His view is shared by William Jarvis, head of the infections and prevention branch of the hospitals' infection program, at the Centers for Disease Control and Prevention.

Despite this reassurance, many hospitals remain wary. “Given the fairly convincing evidence that high temperatures and caustic chemicals change the nature of materials, I'd be leery of using redisposables,” said J P Abenstein, chairman of the equipment subcommittee at the Mayo Clinic in Rochester, Minnesota.

The Food and Drug Administration has proposed a strategy designed to protect the public health by assuring that the practice of reprocessing and reusing single use products is based on good science. The administration would thus consider regulating third party processors of single use devices the same way as it has regulated the manufacturers of equipment.

Figure 1.

Reprocessing single use instruments: is regulation needed?