RECYCLED DEVICES: FDA Issues ‘Highly Anticipated’ Regs
Unknown to many Americans, the recycling of disposable medical devices has become a popular practice among hospitals trying to cut costs. Hospitals send used devices -- surgical clamps, cardiac catheters and angioplasty balloons meant to be used once and thrown away -- to resterilizing companies called "reprocessors." Critics argue that recycled products put patients at risk, despite conflicting reports from the CDC stating that potential problems are "rare." In response to a Congressional urge to "crack down" on unregulated reprocessing, the FDA announced Monday that it will take the "first step" towards regulation. Under the proposed strategy, disposable medical devices would be categorized into three groups:
- High-risk: The FDA will stop the sale of these products that will not work after repeated resterilizations or show potential safety hazards;
- Moderate-risk: Products that raise concern, but lack actual evidence of harm will have safety standards established as additional data is collected by reprocessors;
- Extremely low-risk: The FDA will permit sales to continue and require hospitals that reuse products to register for continued monitoring.