Mr. Chairman, I am Walter Maurer, M.D., director of quality management at the Cleveland Clinic Foundation in Cleveland, Ohio. I am here today on behalf of the American Hospital Association's (AHA) nearly 5,000 hospital, health system, network, and other health care provider members. We are pleased to have the opportunity to testify on the long-standing practice of reprocessing medical devices.

The Cleveland Clinic Foundation, founded in 1921, integrates clinical and hospital care with research and education in a private, non-profit group practice. Last year at the Cleveland Clinic and Cleveland Clinic Florida, more than 850 physicians representing 100 medical specialties and subspecialties provided care for more than 1 million outpatient visits and close to 50,000 hospital admissions.

I have spent most of my career as a private practice internal medicine specialist and anesthesiologist at the Cleveland Clinic with a focus on outpatient, pediatric, and ear, nose and throat anesthesia. I also have been involved in resident education, quality assurance and preoperative testing. Currently, I serve as the medical director of the Office of Quality Management. The role encompasses the hospital, its ambulatory settings including community health centers, and a long-term care facility. With approximately 50,000 surgeries and more than 1.5 million outpatient visits yearly, it is my responsibility to guide and direct our quality management team in ensuring the highest level of patient care is provided. I also chair the Quality Council, the Safety Coordinating Committee and the Joint Commission Preparation Team.

BACKGROUND

The term "reuse " and "reprocess" can encompass numerous scenarios, and they take place in multiple locations, in hospitals, ambulatory surgical centers and physician offices. Some hospitals utilize the services of third-party reprocessors while others reprocess within their own facilities. In some cases, the device never touches a patient. For example, almost every day at the Cleveland Clinic we have a surgery cancelled or postponed, sometimes after the operating room has been prepped for the procedure. That preparation may include assembling customized procedure trays that contain many open single-use devices (SUDs), such as needles, scalpels, sponges and syringes. What becomes of these devices when the surgery is cancelled? Most of it would be unfortunately wasted as "medical trash", but because of increased environmental concerns and cost reduction initiatives, we have found that we can safely sterilize, inspect and repackage many devices for later use.

In another scenario, often a manufacturer will ship SUDs to hospitals with separate sterilization instructions, if the manufacturer is experiencing a period of high demand and has not had time to sterilize the SUDs prior to shipment. Hospitals sterilize, inspect and repackage these devices too.

Another common scenario is the reuse of a non-critical device -- one that does not penetrate a sterile tissue plane or mucus membrane during use, but may contact the patient's skin. For instance, a sequential compression device, which is used on the patient's leg to promote circulation and avoid deep vein thrombosis, is comprised largely of plastics and fits like a sleeve over a patient's leg. Hospitals routinely sterilize, inspect and repackage these types of devices.

Ironically, the most discussed reprocessing practice is probably the least common for hospitals: that of cleaning, sterilizing and repackaging a single-use, critical device after it has been used on a patient so it can be used again on another patient.

REPROCESSING MAKES SENSE

Many medical products can be safely reused. The AHA is unaware of any evidence to demonstrate a problem with reprocessed SUDs. With constrained health care resources and a heightened commitment to the environment, reprocessing makes sense. I need only reiterated the slogans we now teach our children - that's the three R's - reduce, reuse, and recycle. AHA members are committed to being better stewards of the environment by pledging to reduce, not increase waste. In 1998, the AHA and the Environmental Protection Agency initiated a joint-partnership to reduce hospitals' total waste volume by 50 percent by 2010. Responsible waste

management and recent cost reduction initiatives have resulted in the discovery that hospitals can safely sterilize, inspect, and repackage many devices for later use.

The AHA is encouraged by the Food and Drug Administration's (FDA) decision to provide guidance in this area to ensure and enhance patient safety, which is the first and foremost concern of AHA members. AHA members have a great deal of experience with reprocessed medical devices and have been working closely with the FDA as it refines its strategy. We believe that the agency's Proposed Strategy represents a thoughtful approach to a complex issue; it both echoes and furthers the goals of patient safety, which we share.

The potential for device malfunctions, patient injuries, or infections related to the reprocessing and reuse of single-use devices is a matter of great concern to hospitals and health systems. The AHA strongly supports the FDA's plan to develop a research program to help bridge the data gap between the perceived and actual safety risks associated with reuse of SUDs. Such research should be directed at the more complex or high-risk devices and be peer reviewed and published for credibility. This will provide device-specific scientific evidence regarding patient safety.

The AHA also is encouraged by the FDA's proposal to categorize SUDs into risk categories, and we agree that the level of regulation for a device correspond to the level of risk to a patient.

Furthermore, the AHA applauds the FDA's plan to develop consensus standards for the reprocessing of SUDs. These kinds of standards would go a long way toward addressing the safety, and effectiveness of reprocessing. The FDA should use a "community best practices" approach for low-risk devices and a more formal FDA interdisciplinary advisory panel for high-risk devices. The FDA should include all stakeholders - manufacturers, third-party reprocessors, health care facilities, physicians and members of the public - in developing the consensus standards.

OVERSIGHT OF REPROCESSING

Hospitals are subject to significant regulatory and accreditation oversight by entities such as the Health Care Financing Administration, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), state licensing authorities, and other county and city agencies, particularly with respect to patient safety and quality of care. By contrast, only one outside source - the FDA, regulates manufacturers and third-party reprocessors.

Hospital reprocessing activities are marked by a high degree of physician involvement, supervision and control. In many cases, a multi-disciplinary committee, such as the infection control committee, consisting of clinical staff (physicians and nurses) and operational staff (sterile processing, risk management, and materials management) oversees the reprocessing activities of health care facilities. This committee monitors reprocessing quality assurance and improvement activities, recommends strategies for improving performance, and reports such findings and recommendations to the facility's performance improvement oversight committee, medical staff and governing body.

Through its membership, activities and reporting structure, this type of multi-disciplinary committee meets the requirements of numerous JCAHO standards, including those for surveillance, prevention and control of infection, etc. Naturally, medical professionals and the

health care facilities in which they practice have as their primary mission quality patient care, and have in place standards, policies and procedures for reprocessing.

At the Cleveland Clinic, for example, our cardiology electrophysiology laboratory reprocesses both non-lumen diagnostic electrophysiology catheters and non-lumen radiofrequency ablation catheters. Each catheter is used five times or less. It is tested after each use for electrical and mechanical safety and function, and then resterilized. Each year, standard operating procedures are reviewed and patient outcomes are assessed. The sterilization practices are regularly reviewed and staff competency assessed. Since 1993 our lab has had a continuous quality improvement project on any infections caused by any procedures done in the lab. Infection cases are then reviewed with the Infectious Disease Department.

Reprocessing standards, policies and procedures, in conjunction with the quality improvement program, are designed specifically to protect the well-being of hospital patients. Existing non-FDA regulatory oversight, which the AHA believes includes the components necessary to address and satisfy the FDA's concerns in this area, has resulted in the development of these processes.

For instance, JCAHO, during its announced and unannounced surveys, focuses heavily on patient safety. In addition to visiting patient care and reprocessing areas to observe infection control practices, JCAHO reviews the minutes of the infection control committee, the medical staff executive committee, the performance improvement oversight committee and the governing body. The inspectors look for evidence of sufficient reporting of performance improvement information and for action on performance improvement recommendations. Failure to adequately demonstrate compliance in these areas would result in substantial findings of non-compliance for the facility.

RESTORE MEANING TO THE TERM "SINGLE USE"

Original equipment manufacturers have little incentive to label devices as reusable, and, in fact, have financial incentives to self-designate devices as "single use." Manufacturers appear to use the term "single use only" as part of their labeling without justifying whether, in fact, the device can be safely reprocessed for subsequent use. In the last two years, we have observed products that have been historically labeled as reusable, arriving with the "single use only" label with no observable change in the product.

We must ensure that the label "single use only" is meaningful and not simply an attempt to increase device sales. Currently, device manufacturers determine whether a device is labeled "single use." However, the FDA should begin to regulate the use of the "single use only" label and require manufacturers to both justify labeling a device as "single use" and provide scientific data specifying any resterilization or reprocessing techniques that compromise the integrity of the device. Manufacturers are the repository for data on the functional specifications of their devices and know the most about the ability of their devices to hold up to repeated cleanings and sterilizations. They should share that information with those of us who use the devices, and be actively involved in developing consensus standards.

OPENED BUT UNUSED DEVICES DESERVE SPECIAL TREATMENT

As discussed earlier, it is common practice for hospitals to reprocess open, but unused, SUDs. Many SUDs are routinely opened prior to use and are assembled as part of customized procedure trays that contain several devices. Sterile processing professionals assemble, wrap and sterilize these trays, which may consist of single-use and disposable items. It is essential that hospitals be permitted to open single-use devices, combine them with other devices as needed for each medical procedure, and resterilize the entire tray. The creation of these trays in advance of surgeries and other procedures is designed to avoid delays in the surgical suite, create efficiencies, and prevent subsequent infection during the procedure. Treating this process as a "reprocessing" activity impedes these efforts.

As I stated earlier, any regulation should reflect the relative risk of the device involved. Reprocessed devices that have been opened, but not used on a patient, do not need to be part of the FDA's guidance. Resterilization and repackaging of such devices pose virtually no risk for patients.

There are three general areas of risk associated with reprocessing:

1. contamination of the device, if it is not properly cleaned and sterilized, could lead to infection;

2. the cleaning and/or sterilization process could harm the integrity of the device; and

3. the repeated use of the device in subsequent procedures could harm the integrity of the device.

With respect to unused devices, the third risk is eliminated entirely. A major component of the first risk, patient cross-contamination, is also eliminated. The only possible risks, therefore, are whether the device can be adequately resterilized and if the process of resterilization somehow harms the device. Hospitals have a great deal of experience in sterilization of medical devices as sterilization is routinely performed on many types of devices. In fact, as mentioned earlier, it is not uncommon for manufacturers to ship SUDs to hospitals with separate sterilization instructions. Therefore, many providers suspect that the "single use only" label and "do not resterilize" instructions are not based on reliable scientific evidence.

CONCLUSION

Mr. Chairman, as we have already noted, patient safety is the first and foremost concern of all hospitals and health systems. The AHA believes that the FDA's proposed strategy on the reuse of SUDs represents a thoughtful approach to a complex issue, and we are pleased that the FDA has been consulting with front-line caregivers and other experts in its effort to make the standards even more meaningful. This is an important step towards the goal of assuring patient safety. For the sake of all concerned, we commend the FDA's efforts to move forward, with all deliberate speed, to finalize its strategy. We further believe that additional legislation is unnecessary at this time and would only undermine the progress that FDA has already made towards developing a balanced and reasonable regulatory structure. We welcome the opportunity to work with the FDA to ensure best practices are universally used.

This hearing document was last edited by the Committee on Commerce on 02/11/2000 01:43:24 PM EST