New Regulations for Device Reprocessors
BY LAUREN UZDIENSKI, OCTOBER 17, 2006
Last July, we covered the debate between third-party reprocessors and original equipment manufacturers (OEMs.)
Last month, the FDA issued new regulations for reprocessing of single-use devices (SUDs). The FDA now requires reprocessed devices to be marked "prominently and conspicuously," a change from a former system that could keep both surgeons and patients in the dark about the status of devices.
The labeling change should encourage proper reporting of adverse effects.
Additionally, new rules were added clarifying the submission of validation materials, which must include cleaning, sterilization and functional performance data.
The FDA and CDRH are currently developing standard cleaning techniques for reprocessed devices and continue their commitment to the accessibility of validation data, inspection of reprocessor facilities and keeping their reuse website and validation requirements up-to-date.
