It is hard to know who is right because no one has regulated the practice. Now, following years of complaints about the uncertainty, federal rules to ensure recycling is done safely are kicking in. Food and Drug Administration inspections of hospitals are set to start any day, to see who is recycling and ensure that quality standards are followed.
More restrictions come next year.
Recyclers will have to prove that nooks and crannies in numerous other devices, such as cardiac catheters, can be adequately resterilized without damaging delicate parts, to keep recycling them. The rules are causing rancor. When several companies failed to finish studies proving the safety of recycled heart catheters they have been selling, the FDA gave them six more months to comply instead of stopping sales. Recyclers argue that the FDA is requiring too much safety proof on short notice. They say it is no more risky to resterilize a disposable device than to clean similar products intended to be reused.