In May, the FDA published a Draft Guidance for Industry and FDA Staff entitled "Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. When finalised, the document should replace FDA Reviewer Guidance "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities".
The aim of the new Guidance is to inform reviewers - in the premarket application process for medical devices (510k, PMA, HDE processes) and for clinical studies (IDE process) - about the latest developments and support them during the review process. Moreover, the draft deepens the process validation topic in the context of reprocessing.
The extensive document is composed of 35 pages structured in 7 chapters. Five appendixes can be found at the end of the draft. Single use devices (and their reprocessing) are explicitly not subject matter of the guidance, nor are removal or inactivation of transmissible spongiform encephalopathy (TSE) which contaminated medical devices.
After the introduction, background and scope of the document, Chapter 4 deals with Reusable Medical Devices. This chapter presents a process overview for reusable medical devices reprocessing in 3 steps (Point-of-Use Processing, Intensive Cleaning and Disinfection/Sterilisation).
The Technical Information Reports (TIR) of the Association for the Advancement of Medical Instrumentation (AAMI) are referred to as support. Chapter 5 gives an overview over the requirements on labeling for reusable devices. Already at this point, the necessity of cleaning, disinfection and sterilisation validation is stressed as well as validation of reprocessing instructions. Chapter 6 provides a very detailed programme (14 pages!) composed of 7 points ("FDA´s Seven Criteria") for the creation of reprocessing instructions.
Chapter 7 provides information on the importance of validation of methods of reprocessing in accordance with the Quality System Regulation guidelines (QSR, 21 CFR 820). Especially design validation (21 CFR 820.30) and process validation (21 CFR 820.75) related to cleaning and sterilisation are quoted. Chapter 8 focuses on cleaning processes validation and describes FDA's recommendations on that point. A two-step approach is recommended:
The validation plan should include worst-case testing conditions (e.g. dried, clinically relevant soil). Examples for worst-case scenarios are listed in Chapter 8. Validation tests should be statistically relevant. Even the test methods should be validated. To this effect, an AAMI-TIR is quoted to present a selection of test methods. A whole subchapter gives support regarding the content and the form of validation documentation which should have to be submitted to the FDA. Chapter 9 (Validation of Terminal Reprocessing) briefly deals with disinfection and sterilisation and refers to two other FDA documents.
In Appendix A you can find an overview over Reusable Medical Devices Reprocessing. Appendix B lists examples of sterilisation cycles used in health care facilities. Appendix C contains definitions. Appendix D provides a (general) overview over resistance of microorganisms to germicidal chemicals. Eventually, helpful literature sources can be found in Appendix E.
Comments to the draft can be submitted within 90 days.
Conclusion: The draft is surprisingly detailed with regard to the creation of instructions on Reusable Medical Devices Reprocessing. The chapter on Cleaning Validation (7 pages) is very detailed, too, and describes possible worst-case scenarios. These 2 chapters provide important support to the industry regarding Reusable Medical Devices Reprocessing for the US American market.
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
PS. During the ECA Course "Medical Devices Validation Manager" on 18/19 January 2012 you will focus on the process validation topic. In addition, you will have the possibility to pass an exam and, if successful, become Certified Medical Devices Validation Manager.