FDA Update: Administration Announces Initiative to Improve Reusable Medical Device Reprocessing and Conducts Two Day Workshop

Health care providers routinely reuse medical devices for the diagnosis and treatment of multiple patients. The process for preparing a reusable medical device for use on or by a patient is referred to as “reprocessing.” It is critical that the processes, procedures, and materials used for reprocessing be adequate to ensure that the reprocessed device is safe for use on the patient. It is equally important that the medical device be designed so that it can be adequately reprocessed.

The FDA divides reusable medical devices into three categories according to the degree of risk of infection associated with the use of the device:

• Critical devices, such as surgical forceps, which come in contact with blood or normally sterile tissue.
• Semi-critical devices, such as endoscopes, which come in contact with mucus membranes.
• Non-critical devices, such as stethoscopes, which come in contact with unbroken skin.

The FDA is focusing this new initiative on critical and semi-critical medical devices that are intended for reuse after reprocessing. However, MDCI believes that non-critical devices will be expected to comply with the spirit of the new initiative even if all of FDA’s recommendations will not be applicable.

The FDA’s initial guidance for reprocessing reusable medical devices was released on February 27, 1996. In the intervening years, innovation in the medical device industry has increased the number and complexity of reusable medical devices on the market. However, a complex design often makes adequate reprocessing difficult to achieve, and the science of reprocessing has not kept pace with the speed of design innovation.

The FDA has become concerned with the number of well-publicized incidences of patient infection attributed to faulty reprocessing. In a statement made to before the Committee on Veteran’s Affairs, United States House of Representatives on May 3, 2011, Anthony D. Watson, BS, MS, MBA (Director, Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation) pointed to 80 adverse event reports involving inadequate reprocessing and 28 reports of infection that may have resulted from inadequate reprocessing that were filed with the Agency from January 1, 2007, to May 11, 2010.

FDA Launches Reusable Medical Device Reprocessing Improvement Initiative

On April 29, 2011 the FDA launched the reusable medical device reprocessing improvement initiative and announced a public workshop to collaborate with representatives from other stakeholders, government agencies, manufacturers, and health care providers on future device design and scientific advances in reprocessing. In advance of the workshop, the FDA released an updated guidance document, Draft Guidance for Industry and FDA Staff – Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (issued May 2, 2011). This document provides recommendations for developing appropriate reuse instructions to be developed for reusable medical device labeling, and also outlines the validation of these instructions. Areas of particular interest in the guidance include the following:

• Step by step instructions for disassembly and reassembly.
• Identify and address known post-market human factors issues with the reprocessing of your device or similar devices. This requires a search of a number of resources including internal complaints, published clinical literature, and the FDA MAUDE database.
• Validation of reprocessing instructions to ensure that end users can understand and follow them. This is not a validation of the capacity of your reprocessing instructions to successfully clean and sterilize the device. This is a human factors assessment that is used for validation of the usability of the instructions.
• Inclusion of reprocessing risks in risk analysis.
• Addition of reprocessing items to design inputs.
• Addition of validation of reprocessing instructions to design outputs.

The new guidance contains a flowchart that includes an overview of the steps involved in reusable medical devices, and it also reproduces FDA-accepted steam sterilization cycle parameters and provides a thorough list of useful references.

Highlights of Public Workshop

At the reprocessing reusable medical devices workshop, the FDA provided a historical perspective on the issues involving inadequate reprocessing, explained the rationale behind the new initiative, and reviewed the draft guidance point by point. One of the most thought-provoking presentations was given by Linda Condon of Johns Hopkins University Hospital. She brought home the challenges healthcare facilities encounter on a daily basis – specifically, the need to effectively reprocess a vast number of medical devices from different manufacturers in the face of outdated, impractical reprocessing instructions, inadequate personnel and facilities, and tremendous time pressures. Other presentations focused on how to properly integrate effective reprocessing into a manufacturer’s quality system, techniques for monitoring reprocessing of complex instruments, and tips for ensuring the efficacy of reprocessing procedures.

Next Steps

On October 11-12, 2011, the FDA and AAMI will co-host a summit on reprocessing. The FDA intends to continue to engage with stakeholders on this issue, and the Administration recognizes that while they can provide guidance documents on device design and the development of effective reprocessing instruction, medical device manufacturers must take the lead and actually implement these recommendations in order to make substantial progress toward the goal of improving medical device reprocessing.

MDCI is uniquely positioned to support medical device manufacturers in the development and validation of reprocessing instructions. MDCI has a broad product experience with reusable non-critical, semi-critical, and critical medical devices. In addition, MDCI has extensive experience with infection control devices (sterilization wraps, process indicators and sterilization technologies) that are required for reprocessing reusable medical devices. Finally, MDCI has developed partnerships with commercial testing facilities and human factors firms with expertise in the procedures involved for the analytical and usability elements of validation of reprocessing instructions.

Lisa King
Cindy Nolte
Suzanne Goodman
MDCI Blogging Team