By Stewart Eisenhart, Emergo Group
The US Food and Drug Administration has released final guidance on how manufacturers of reusable medical devices should validate instructions for these products.
The new guidance also lists recommendations for labeling and instructions for use of such devices. Four categories of devices fall under the guidance’s scope:
- Reusable devices supplied sterile to users, who then must reprocess – clean or sterilize – those devices after initial use but before use on patients
- Reusable devices supplied non-sterilized to users who must then reprocess those devices before both initial use and subsequent uses
- Reusable devices intended for reuse by a single patient, but that must be reprocessed before each use
- Single-use devices supplied non-sterilized to users who must process those devices before use
Six criteria for instructions
The guidance lays out six key criteria US regulators highly recommend be met by manufacturers to provide clear reprocessing instructions. Although the guidance does not technically constitute official regulatory requirements, it’s understood that manufacturers had best meet these recommendations in order to satisfy FDA reviewers.
First, a device’s labeling should reflect its intended use, and include reprocessing instructions appropriate for its design, intended use and likely exposure to contaminants.
Second, all reprocessing instructions should recommend “thorough” cleaning of a device. If necessary, device disassembly instructions should be included if taking a product apart is required to thoroughly clean it.
Third, reprocessing instructions should include microbicidal processes necessary for sterilization or disinfection of the device; such processes should reflect up-to-date infection control principles including the Spaulding Classification system, as well.
Fourth, instructions should be technically feasible in the context of their intended locations; any equipment necessary for proper sterilization of the device should be readily available to the product’s intended user.
Fifth, reprocessing instructions should be comprehensive and complete; any special accessories, disassembly and reassembly, and cleaning methods necessary for proper reprocessing should be included.
Sixth, reprocessing instructions should be understandable to intended end users.
QSR requirements for validating reprocessing methods
FDA Quality System Regulation (QSR) requires manufacturers of Class II and III as well as some Class I devices to develop and maintain procedures for process validation in accordance with defined user needs and intended use. For devices affected by the new reprocessing guidance, US regulators expect manufacturers to comply with components of 21 CFR Part 820addressing reprocessing instructions for reusable devices.
Even though there are many reusable devices that are exempt from 510(k) clearance review, these must still comply with QSR requirements for proper labeling instructions for reprocessing, according to the guidance.
Reprocessing instructions and FDA premarket submissions
Manufacturers seeking US registration for their reusable medical devices should complete all validation of reprocessing instructions before submitting their FDA applications, and include instructions with other application materials.
Various FDA market pathways require the following reprocessing instruction and labeling information:
- 510(k) applications should include proposed device labels that cover device description, intended use and instructions for use, including reprocessing instructions. Labeling of the registrant’s device will typically be compared to that of a predicate device already on the US market.
- Premarket Approval (PMA) applications should include protocols and test reports for registrants’ validation of reprocessing instructions; this information should be included in the PMA’s manufacturing and design section.
- Investigational Device Exemption (IDE) applications should provide reports of all previous clinical, preclinical and laboratory device testing – including summaries of validation testing of reprocessing instructions. The FDA recommends that applicants complete validation testing of such instructions before submitting IDE applications.
Ronald Boumans is Senior Global Regulatory Consultant at Emergo and formerly a senior inspector with the Dutch Healthcare Inspectorate. He has been involved in developing risk models for supervision of medical devices.
