FDA ISSUES DETAILED REQUIREMENTS FOR DEVICE REPROCESSORS
Device reprocessors must adhere to new data requirements in their cleaning and sterilization methods, the FDA said in recent guidelines.
The FDA Sept. 25 issued a rule and guidance on reprocessed single-use devices (SUDs).
The rule, published as both a proposed and a direct final rule, updates information on reused devices that require premarket submissions, or 510(k)s.
The guidance details validation data requirements for reprocessed SUDs, which include cleaning, sterilization and functional performance data showing a reprocessed device is "substantially equivalent" to the original device "after the maximum number of times [it] is reprocessed as intended."
The cleaning process includes "all steps to remove, inactivate or contain contamination, beginning immediately after clinical use of the device and all subsequent steps to decontaminate and clean a device" before packaging and prior to the first step of the sterilization process, the guidance says. "This includes all quality control tests."