On August 1, 2011, AMDR submitted comments to FDA’s docket established to seek input on the agency’s Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.
AMDR commends FDA for issuing this guidance, underscoring the agency’s commitment to advancing patient safety with regard to reprocessed medical devices. While our comments as FDA-regulated reprocessors of “single-use” devices (SUDs), would, at first blush, appear to be beyond the scope of the Draft Guidance for reusable devices, our members’ experience with validated methods for reprocessing SUDs is applicable to FDA’s current effort to address validation and labeling issues associated with reprocessing reusable devices.
AMDR shares the agency’s commitment to ensuring that all reprocessed medical devices are safe and effective. Patients and clinicians expect medical devices to be processed/reprocessed properly, meaning no increased risks to patients. We view this Draft Guidance for manufacturers of reusable devices as reaffirming the agency’s commitment to ensuring that all processed/reprocessed devices are safe and effective.
AMDR believes that all reprocessors/manufacturers should be held to high standards when reprocessing or providing instructions for reprocessing medical devices – regardless of how the device is labeled (e.g., reusable, single-use, etc.). AMDR commends FDA for working to improve manufacturer validations for reusable device processing/reprocessing via this guidance and provides the following input and comments for consideration.
For AMDR’s full comments, click here.