By Richard A. Marini Washington. Amid increasing public concern, the Food and Drug Administration announced it will develop stricter regulations governing hospitals' growing practice of reusing medical devices intended for single use. Reuse can apply to simple products such as surgical clamps or to complex cardiac catheters, bronchoscopes, and angioplasty balloons. A public meeting to gather comments on these proposals is scheduled for Dec. 14. The makers of disposable medical devices say the products' often delicate material cannot withstand resterilization and reuse.
Proponents counter that the practice saves money and holds down costs.
Most clinical studies of specific devices have found them safe to reuse, according to Larry Kessler, director of the FDA's office of surveillance and biometrics. Opponents of reprocessing say that improperly sterilized devices spread disease and that these items cannot be safely reused. Until you can prove otherwise, these devices are safe and effective for one use. After that, they're garbage.