Anthony D. Watson, BS, MS, MBA, Director, Division of Anesthesiology, FDA
Mr. Chairman, Ranking Member Filner, and Members of the Committee, I am Anthony
D. Watson, Director, Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices, Office of Device Evaluation, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA or the Agency). Thank you for the opportunity to discuss reprocessing of reusable medical devices and the importance of adequate reprocessing to protect patient safety. FDA is committed to working with our partners in industry, government and care settings to ensure patients are not at risk from unacceptable lapses in patient safety practices related to the reprocessing of medical devices. Today, I will provide you with an overview of medical device regulation, discuss the background on reprocessed medical devices, and describe actions FDA is taking to address safety concerns related to reprocessing of reusable medical devices.
Overview of Device Regulation
A medical device, as defined by federal law, encompasses several thousand health products, from simple articles such as tongue depressors and heating pads to cutting-edge and complex devices such as implantable defibrillators and robotic equipment for minimally invasive surgery.
The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) gave FDA specific authority to regulate the safety and effectiveness of medical devices. Medical devices are assigned to one of three regulatory classes based on risk.
Class I, General Controls, is the lowest risk category of devices and includes items such as adhesive bandages. These devices are subject to the General Controls of the Act, which include establishment registration and device listing, compliance with current Good Manufacturing Practice (cGMP) and labeling, recordkeeping, and reporting requirements.
Class II, Special Controls, is the next category of risk and includes devices such as intravenous catheters and powered wheelchairs. They are subject to the General Controls of the Act as well as Special Controls, which may include special labeling requirements, mandatory performance standards, and post-market surveillance, in order to provide reasonable assurance of the safety and effectiveness of the device.
Class III is the highest risk category of device and includes devices such as heart valves and coronary stents. These devices are subject to the General Controls of the Act, plus approval prior to marketing of a premarket approval application containing scientific evidence of the device’s safety and effectiveness.
Adverse Event Reporting
Once a medical device is marketed, FDA monitors reports of adverse events and alerts health professionals and the public when needed to ensure proper use of devices and the health and safety of patients. FDA uses two principal systems to capture device-related adverse event and product problem reports: the Medical Device Reporting regulation (MDR) and the Medical Product Safety Network (MedSun).
MDR is the mechanism by which FDA receives over 300,000 significant medical device adverse events annually from manufacturers, importers, and user facilities, including hospitals. FDA carefully evaluates the reports received to identify safety concerns of public health importance, such as product problems that could potentially cause injury. User facilities are required to report deaths to the manufacturer and FDA and serious injuries to the manufacturer. Manufacturers must report to FDA within 30 days deaths, serious injuries, and malfunctions that could contribute to a death or serious injury. FDA also receives voluntary reports from many different sources including consumers and health care professionals.
The limitations inherent in passive reporting systems such as MDR, include underreporting of adverse events, the submission of incomplete or difficult-to-understand reports, and insufficient information to accurately identify the product in question. Recognizing the limitations of passive reporting systems, FDA launched MedSun in 2002. MedSun is an “active” adverse event reporting program that allows FDA to work collaboratively with the clinical community to identify, understand, and solve problems with the use of medical devices. Over 350 health care facilities, primarily hospitals, participate in the MedSun Network.
Facilities participating in the MedSun Network use an Internet-based system to report adverse medical device events to FDA. MedSun facility reporting differs from the other (mandatory) user facility reporting because MedSun participants not only report medical device problems that result in serious injury or death, but they also are encouraged to voluntarily report problems with devices, such as “close-calls,” potential for harm, and other safety concerns.
In general, FDA may become aware of device-related or associated adverse events that occur in hospitals through the following mechanisms:
- the hospital submits an MDR directly to FDA (as described above);
- a voluntary report from a clinician or patient associated with the hospital and/or the event;
- a report to the MedSun program (if the hospital is in the program, as described above);
- the hospital submits information regarding the event to the manufacturer, who then reports an MDR to FDA as part of their MDR reporting obligation; and
- through the Centers for Disease Control and Prevention (CDC) when it undertakes a possible outbreak investigation at the request of a state health department.
Reprocessing of Reusable Medical Equipment
Reusable medical devices are devices that are designed and labeled for use on multiple patients and are made of materials that can withstand repeated reprocessing, including manual brushing and the use of chemicals. Some examples of reusable medical devices are surgical instruments, such as clamps and forceps; endoscopes, used to visualize areas inside the body; and accessories to endoscopes, such as arthroscopic shavers; and laparoscopic surgery accessories, such as graspers and scissors.
All reusable medical devices can be grouped into one of three categories according to the degree of risk of infection associated with their use:
- Critical devices, such as surgical forceps that come in contact with the bloodstream or normally sterile tissue.
- Semi-critical devices, such as certain endoscopes that come in contact with mucus membranes.
- Non-critical devices, such as stethoscopes that come in contact with intact skin.
Description of reprocessing process
Adequate reprocessing of reusable medical devices is a critically important step in protecting patient safety. Reprocessing is intended to remove blood, tissue, and other debris and to inactivate infectious microbes to ensure that devices are safe for the next patient use. Reprocessing can be both labor-intensive and time-consuming, because most reusable medical devices require a specific reprocessing regimen.
In general, reprocessing reusable medical devices involves three steps: initial decontamination and cleaning at the point of use; transfer to the reprocessing work area where the device is thoroughly cleaned; and, either low/intermediate disinfection, high-level disinfection, or sterilization, depending on the intended use of the device, its risk of infection transmission, and the materials from which it is made. The device is then stored or routed back into use.
Many factors contribute to reprocessing difficulties, including device complexity, absence of best practices, user error, and poor instructions on how to reprocess. Manufacturers, health care facilities, health care professionals, and FDA share responsibility for reducing the risk of health care-associated infections (HAIs) from inadequately reprocessed reusable medical devices. HAIs are infections caused by a wide variety of common and unusual bacteria, fungi, and viruses during the course of receiving medical care.
Under FDA labeling regulations, 21 CFR Part 801, a device must have adequate directions for use. This includes instructions on how to reprocess (i.e., clean and disinfect or sterilize) a reusable device to ensure that it is effectively prepared for its clinical use. FDA applies its unique position and expertise to reduce the risk of infection from reusable medical devices by evaluating devices prior to marketing, identifying device designs that facilitate proper reprocessing, assuring that manufacturer instructions are clear, and promoting collaboration among all stakeholders. FDA also works with manufacturers to correct product problems associated with reprocessed medical devices.
Manufacturers should design their devices to minimize debris retention, so they can be easily and effectively cleaned. Instructions for reprocessing, included in product labeling, should be complete, detailed, practical, and easy to understand. FDA expects manufacturers to validate their reprocessing protocols using clinically relevant soil, considering the internal components of the device, and using an actual marker(s) (a measured component of the soil, such as protein, inorganic carbon, etc.) for clean under- simulated use conditions and worst-case scenarios.
Health care facility and provider roles
Health care institutions and staff and medical personnel share responsibility for preventing problems associated with reprocessing. Facilities should periodically assess infection control practices in clinical areas using audit tools. Facilities should also ensure that those responsible for reprocessing understand the importance of the job, are given the necessary training to perform it properly, and maintain proficiency in performing reprocessing for each type of device they reprocess. Reprocessing staff should understand that pre-cleaning, cleaning, high-level disinfection, and/or sterilization are distinct and separate steps of reprocessing and that they should follow reprocessing instructions provided by device manufacturers.
Physicians and nurses should consider that reprocessing plays a role in device performance and follow-up with the appropriate chain of accountability. They can do this by reporting adverse events that may be related to inadequate reprocessing, following guidelines established by professional societies, and communicating with manufacturers regarding labeling issues and ease of reprocessing.
Based on adverse event reports received, FDA has identified several safety concerns with reprocessed medical equipment. For example, in a review of adverse event reports on endoscopes filed with the Agency from January 1, 2007, to May 11, 2010, FDA identified 80 reports of inadequate reprocessing and 28 reports of infection that may have occurred from inadequate reprocessing. Endoscopes are long thin tubes with a camera or a light that are threaded into the lungs, the blood vessels, or other cavities to visualize areas within the body. The designs of endoscopes are intricate and complex, making optimal cleaning, high-level disinfection, or sterilization difficult. It is important to note, however, that endoscopes are used in over 10 million medical procedures per year. While it appears that the risk of acquiring such an infection is relatively low and that the benefits of these important devices outweigh their risks, we continue to work with industry, provider and government partners to further reduce risks to patients.
Additional challenges to adequate reprocessing of reusable devices include the detailed, labor-intensive, and time-consuming nature of the necessary processes and the fact that each reusable medical device requires specific reprocessing steps or techniques appropriate for that device. While manufacturers are required to validate their reprocessing instructions by documenting that the recommended cleaning, disinfection, or sterilization process consistently results in an adequately reprocessed device, many manufacturers do not use a clinically relevant test soil in the validation testing of their cleaning instructions for use, nor do they use an adequate marker for the removal of soil. Finally, facility reprocessing challenges, such as inadequate staff training and failure to consistently follow reprocessing procedures, have been noted.
FDA's work with the VA and CDC
The VA and FDA have a Memorandum of Understanding in place which allows for timely information sharing to enhance knowledge and efficiency between the federal partners. Within FDA, CDRH has designated a liaison that the VA may contact at any time regarding questions or concerns on any topic. With regard to reprocessing, beginning in 2008, the VA and FDA have collaborated to address concerns regarding reprocessing of reusable medical devices and cross-contamination of endoscopes during reprocessing. The Agency has provided labeling and general information on FDA regulations and participated in the VA conference entitled “Reprocessing of Reusable Medical Equipment: Using a Team Approach Towards a Strategic Plan,” December 9 11, 2009.
Further, on November 19, 2009, the VA, CDC, and FDA issued a joint safety communication regarding endoscope reprocessing, cautioning health care facilities, including hospitals, ambulatory care facilities, and private practices, about the risks to patients of improperly processed flexible endoscopes and their accessories and recommended steps to reduce these risks.
The VA has developed and shares with FDA information from its national electronic Cardiovascular Assessment Reporting and Tracking System (CART-CL), a network of approximately 70 cardiac catheterization labs. FDA staff reviews this information with VA on a monthly basis, and triages for appropriate further actions. Ongoing communication benefits both parties, with FDA learning of unexpected lab-based experiences, and CART-CL learning about FDA recalls and public health communications.
CDC and FDA communicate quite frequently on matters related to general infection control and to coordinate on the approval of some respiratory devices. FDA has an ex-officio member on CDC's Healthcare Infection Control Practices Advisory Committee. CDC has an official liaison stationed at FDA, and there are regular interagency teleconferences with CDC, FDA and EPA to discuss liquid chemical germicides, high- level disinfectants and various aspects of reprocessing of mutual interest to all three agencies.
Actions FDA is Taking
Adequately reprocessing reusable medical devices is a critically important step in protecting patient safety. FDA is taking a collaborative approach toward improving the reprocessing of reusable medical devices. On April 29, 2011, FDA launched the Reusable Medical Devices Improvement Initiative to reduce the risk of HAIs from inadequately reprocessed medical devices. FDA’s approach to addressing reprocessing problems focuses on collaborating with other government agencies, manufacturers, health care facilities, and health care professionals to strengthen all steps in reusable device reprocessing by fostering improved, innovative device designs to reduce debris retention, strengthening the science of cleaning and high-level disinfection or sterilization of medical devices, and ensuring that health care facilities properly perform cleaning, disinfecting, and sterilization.
Specifically, FDA has issued revised draft guidance that updates and clarifies the recommended content of, and review procedures for, medical device applications concerning the labeling instructions for reprocessing reusable medical devices. In addition, this draft document provides more detail about FDA’s recommendations for the validation of processes intended to support reprocessing. We have also announced a public meeting to be held on June 8-9, 2011, to discuss factors affecting the reprocessing of reusable medical devices and FDA’s plans to address the identified issues. Finally, FDA has developed a webpage that provides general outreach about reprocessing of reusable medical devices, the challenges of reprocessing, actions FDA is taking to improve safety and effectiveness, and steps consumers and health care professionals can take to learn more about reprocessing reusable medical devices and reporting problems to FDA.
Goals of these actions
The Reusable Medical Devices Improvement Initiative focuses on improvements in device design, reprocessing procedures and protocols, and health care facility quality assurance practices. This initiative will promote innovation in next-generation reusable medical device design that will make medical devices easier to clean, disinfect, and sterilize, advance the science of cleaning and cleaning validation methods, foster health care facility reprocessing quality assurance programs, and share best practices.
The Public Meeting will bring together key stakeholders—including industry, user facilities, standards organizations, health care accreditation organizations, government agencies, and professional societies—the first in a series of conversations between FDA and reusable medical device stakeholders.
Reducing the risk of infection from reusable medical devices is a shared responsibility, and one that the FDA takes very seriously. By using its unique vantage point, FDA is helping address unacceptable patient safety problems with reprocessed devices while facilitating improvements in innovative design of the next generation of these devices. Mr. Chairman, this concludes my formal statement. I will be happy to address any questions you may have.