By Allyson B. Mullen –
On March 17, 2015, CDRH released the final guidance entitled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.” The draft guidance was issued in May 2011 and is now being finalized on the heels of highly publicized outbreaks of hospital acquired infections associated with Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes. In a safety alert from last month, FDA indicated that “the complex design of duodenoscopes . . . causes challenges for cleaning and high-level disinfection [such that] effective cleaning of all areas of the duodenoscope may not be possible.” Finalizing this guidance is one of the steps FDA is taking in order “to reduce the risk of infection from reprocessed reusable devices.”
This guidance applies to those devices that are intended to be reprocessed (cleaned, disinfected and/or sterilized) in health care facilities or by patients prior to first use and/or prior to subsequent uses. This guidance does not apply to, among other things, reprocessing of single use devices. Also, the guidance notes that this guidance does not apply to any processes intending to remove or inactivate transmissible spongiform encephalopathy (TSE) agents because as of the date of this guidance, CDRH has not approved or cleared medical devices for this specific intended use.
This guidance provides helpful recommendations for manufacturers manufacturing devices within the scope of the guidance. We discuss a few of the more interesting points in the guidance below.
Focus on Labeling Comprehension. The guidance provides a great deal of detail around labeling content. However, the guidance makes it clear that the reprocessing instructions in the labeling must not only meet the content requirements, but users must be able to understand and follow the instructions. The guidance recommends that manufacturers consider using standardized reprocessing instructions (format, methods, cycles) to make the process easier for users to follow. The guidance goes on to indicate that for devices subject to design controls, the manufacturer should validate the reprocessing instructions. This testing is essentially described as a human factors study for the reprocessing instructions. The manufacturer should perform a study with actual users performing actual or simulated reprocessing of the device following the draft reprocessing instructions and solicit feedback regarding the instructions. This appears to be a new requirement for reprocessed devices. It is unclear if this information will be reviewed as part of the premarket submissions for reprocessed devices or reviewed as part of the design history file during inspections. Either way, it will be interesting to see how CDRH implements and enforces this aspect of the guidance.
Validation Guidance. The guidance also provides numerous recommendations for manufacturers to follow when validating its reprocessing methods. None of these recommendations appear to be new, and manufacturers in this space are likely already familiar with them. For example, cleaning should be validated under worst case conditions, artificial soils should be clinically meaningful, and validation process parameters use the shortest time, lowest temperature and weakest dilutions. This guidance should serve as a good resource when drafting reprocessing validation protocols to ensure that all factors have been appropriately considered.
Premarket Submission Content. All premarket submissions need to contain adequate labeling describing the reprocessing instructions. In addition, the guidance states that PMAs, HDEs, De Novos and IDES will all need to contain protocols and full test reports demonstrating that the reprocessing instructions have been validated. As noted above, it is unclear if this means that the reprocessing cycle described in the instructions has been validated or that the instructions themselves have been validated through the human-factor like test discussed above.
With regard to 510(k) submissions, most reprocessed device 510(k)s will not need to include protocols and full test reports demonstrating that the reprocessing instructions have been validated. This approach is consistent with the 510(k) Refuse-To-Accept Checklist (the RTA Checklist), which states that only a summary of the sterilization validation is needed, if a device is end-user sterilized. The guidance goes on to note that CDRH may request such data during the 510(k) review process.
For a subset of 510(k) devices (those identified in Appendix E of the guidance), CDRH has determined that the risks of microbial transmission and infection are high enough to warrant requesting protocols and full test reports demonstrating that the reprocessing instructions have been validated in the 510(k) submissions. The list of devices in Appendix E generally include various types of scopes and accessories that are inherently difficult to clean because of their design (e.g., they include lumens, channels and/or hinges). This list is not surprising given the recent activities that prompted finalization of this guidance.
Moreover, we understand that it has been industry practice to include this information as part of 510(k) submissions for a number of the devices listed in Appendix E to date. Therefore, we do not expect this requirement to come as a surprise to industry. However, since this new requirement appears to conflict with the current RTA Checklist, we are curious to see if it will prompt FDA to update its checklist.
In sum, the final guidance document provides a consolidated list of the labeling, validation and premarket submission information for reprocessed reusable devices.