New AAMI Guidelines

Draft of New AAMI Validation Requirements The FDA first published “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration” on March 17, 2015. According to the FDA , the guidance "provides recommendations for the formulation and scientific validation of reprocessing instructions for reusable medical devices.” For the past several years, AAMI members, along with FDA personnel and individuals from the medical device industry, have been working on updating and revising these FDA reprocessing guidelines. AAMI’s Working Group ST/WG 12 “Instructions for reusable device reprocessing” has been focused on the need for improvements with manufacturers’ reprocessing instructions for reusable medical devices. More specifically, the focus is on the need for manufacturers to test and validate their reprocessing instructions for use (IFUs). The most recent update (October 9, 2018) from AAMI’s Working Group ST/WG 12 includes the following changes and improvements to the FDA’s reprocessing guidelines: 5.1 According to ANSI/AAMI/ISO 17664 and the FDA, the medical device manufacturer shall validate each process that is identified in the information supplied with the medical device. This validation shall demonstrate that each process is suitable for processing of the medical device. 5.2 Both ANSI/AAMI/ISO 17664 and the FDA state that the medical device manufacturer shall have objective evidence available that validation of the processing procedures has been undertaken to confirm that the specific medical device will be clean, disinfected and/or sterilized when processed as directed. 5.4.1 “Device manufacturers should generate and document test data and other information supporting the efficacy of the recommended reprocessing agents and procedures.” 5.5.1 “When developing cleaning instructions and the protocols for validating those instructions, manufacturers should consider all elements of device use and processing, including factors such as clinically relevant test soil, worst-case manipulation and use of devices during simulated use soiling (i.e., the most rigorous manipulation for the maximum duration), and worst-case (least thorough) implementation of each step of the recommended cleaning process.” 5.5.1 (Paragraph 2) “The cleaning procedure developed by the manufacturer must be able to be easily and accurately performed in healthcare facilities.” 5.5.1 (Paragraph 4) “Using scientifically valid methods, the manufacturer should show that the recommended cleaning process is effective in removing the simulated soil from all surfaces of the device that could come into contact with the patient or that are accessible to tissue, blood, body fluids, and other organic material, and that could interfere with subsequent processing steps.” 5.5.1 (Paragraph 4) “Testing should ensure that the process can be easily and accurately performed in the hospital environment.” 7.4.4.3.1 “It is the responsibility of the manufacturer of the reusable device to first validate the reprocessing instructions (see section 5) and then include them in the device labeling.” 8.7 “The processing instructions are based on the results of validation testing (section 5) conducted to determine the efficacy of the processing steps.”¹ So what does all of this mean for you, your facility and most importantly, your patients? It means that the FDA and AAMI realize the patient risks associated with reusable medical devices whose reprocessing IFUs have not been validated to ensure clean, sterile, moisture-free devices after every reprocessing cycle. It means that in the near future, the manufacturers of all reusable devices, including modular and take-apart instruments, will have to validate their reprocessing IFUs to prove that they can be thoroughly cleaned, sterilized and safely returned to surgery. In a 2017 article in Healthcare Purchasing News, Kara Nadeua stated: “It’s the sad reality of what people in CS/SPD face. They are held accountable for returning clean, sterile, moisture free instruments up to the OR and yet they are dealing with instruments whose cleaning IFUs have never been validated and they have to rely on visual inspection, which is not an acceptable technique.”² 1. AAMI’s Working Group ST/WG 12 Interim Report October 9, 2018 2. “Validated? It’s complicated” by Kara Nadeau, HPN, April 2017