The Food and Drug Administration (FDA) recently issued draft guidance documents outlining how, for the first time, it will comprehensively regulate hospitals that reprocess and reuse medical devices that are labeled as disposable or “single-use only.” Commonly reprocessed disposable devices include catheters, endoscopes, operating room gowns, and keratome blades. The guidances are in response to charges by Congress and the medical device industry that reprocessing may affect the performance of the device and, if cleaning or sterilization is inadequate, could lead to transmission of disease.
The draft guidances currently only apply to hospitals (and third-party reprocessors). A “hospital” is defined as an “acute health care facility.” However, the Agency is evaluating whether to extend its regulatory reach to reprocessing in other health care settings such as physician offices and nursing homes.
Under FDA’s proposed scheme, hospitals that engage in reprocessing would be subject to the same comprehensive regulatory requirements that currently govern medical device manufacturing, including:
- Registration and Listing;
- Medical Device Reporting;
- Medical Device Tracking;
- Medical Device Corrections and Removals;
- Quality System Regulation;
- Labeling; and
- Premarket Requirements.
“Premarket Requirements” refers to a submission that must be made to FDA before the device may be used. The type and complexity of the premarket submission (e.g. whether clinical data is needed) depends on the type of device. In general, the submission must demonstrate that the reprocessed device is safe and effective.
Hospitals would be required to comply with all of the requirements listed above other than the Premarket Requirements beginning six months after FDA publishes a final guidance document. The Agency has proposed a phased-in enforcement scheme for the Premarket Requirements based on the risks posed by the particular device. For high risk devices (such as biopsy needles and keratome blades), FDA would require a premarket submission within six months of the issuance of a final guidance. For moderate risk devices (such as urethral catheters), a submission would be required within twelve months of the final guidance. For low risk devices (such as endoscopic guidewires), a submission would be required within eighteen months.
FDA is accepting written comments on the draft guidance documents until April 11, 2000.
Another item to note is that a bill has been introduced in Congress to require that patients be notified before certain reprocessed single-use devices are used. FDA, for its part, has thus far taken the position that it does not have the authority to require such notification.
If you would like copies of the draft guidance documents, or if you have any questions, please contact the persons listed in our FDA practice group.