Testimony

Reuse of Medical Devices

Testimony
of the
American Hospital Association
before the
Health, Education, Labor and Pensions Committee
of the
United States Senate
on
Reuse of Medical Devices

Tuesday, June 27th 2000

Mr. Chairman, I am John Clough, M.D., chair of health affairs at the Cleveland Clinic Foundation in Cleveland, Ohio. I am here today on behalf of the American Hospital Association's (AHA) nearly 5,000 member hospitals, health systems, networks, and other providers of care. We are pleased to have the opportunity to testify on the long-standing practice of reprocessing medical devices and the recent General Accounting Office (GAO) report on this issue.

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 outpatients and close to 50,000 hospital patients.

I am a practicing rheumatologist with nearly 30 years of experience. As chairman of the Division of Health Affairs, I oversee government relations, community relations, fund-raising, and the volunteer program. I am involved in the institution's initiatives on protecting patient safety and preventing medical errors.

BACKGROUND

Reprocessing, resterilization and reuse were historically the norm in medical practice. For decades, hospitals have been engaged in resterilizing, repackaging and reusing medical devices. Only in the past 20 years have disposable devices been introduced to the market.

The terms "reuse " and "reprocess" can encompass many scenarios, which can occur in multiple locations - 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 medical 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 includes opening devices labeled "for single use," 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 resterilize, inspect and repackage many devices for later use - a practice that does not pose a risk to our patients. The AHA commends the Food and Drug Administration (FDA) on its decision to exclude open-but-unused devices from the agency's proposed guidance on reprocessing devices labeled "for single use."

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 resterilize, inspect and repackage these types of devices.

Probably the most discussed reprocessing scenario is 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. Hospitals that reprocess critical devices do so using carefully designed protocols that ensure patient safety.

REPROCESSING MAKES SENSE

With constrained health care resources and a heightened commitment to the environment, reprocessing makes sense. I need only reiterate 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 support the long-standing practice that hospitals can safely sterilize, inspect, and repackage many devices for later use.

NO EVIDENCE REUSE POSES A HEALTH THREAT

Many medical products can be safely reused as evidenced through decades of hospital experience in reprocessing both reusable devices and those labeled "for single use." The AHA is unaware of any evidence to demonstrate a problem with reprocessing devices labeled "for single use." In fact, the FDA on several occasions has indicated that it does not believe reprocessing presents a risk to public health or safety.

For instance, in an October 6, 1999 letter from David Feigal, MD, MPH, the Director of the Center for Devices and Radiological Health, to Larry Pilot, Esq. of McKenna & Cuneo, denying the Medical Device Manufacturer Association's Citizen's Petition to ban reprocessing, Dr. Feigal wrote, "In fact, FDA has been unable to find clear evidence of adverse patient outcomes associated with the reuse of a single use device from any source." One year earlier, the FDA denied a similar citizen's petition from the Health Industry Manufacturer's Association, citing, among other things, a lack of evidence of adverse outcomes. At that time, the FDA specifically encouraged "trade and scientific organizations, OEMs [original equipment manufacturers], user facilities, and others to provide any data demonstrating adverse patient outcomes from the use of reprocessed 'single use only' devices," but noted that as of that time, the FDA had seen "no documented evidence that the treatment of patients with, or other patient use of, these reprocessed devices has caused adverse clinical outcomes." (Letter to Nancy Singer, Esq., July 13, 1998.)

In his testimony before the Subcommittee on Oversight and Investigations, House Committee on Commerce on February 10, 2000, Dr. Feigal stated that in a review of the Medical Device Reporting reports received by Center for Devices and Radiological Health over the past three years, "we can discern no pattern of failures with reused SUDs [single use devices] that differs from patterns observed with the initial use of SUDs."

The GAO's June 2000 report on medical device reprocessing further confirms that the FDA believes reprocessing does not pose a risk to public health. It states, "FDA has the authority to immediately halt any practice that threatens the public's health and has not done so with SUD reprocessing because it believes there is no evidence that the public health has been threatened."

In its report, GAO also notes that "[h]ospital infection experts at the CDC [Centers for Disease Control and Prevention] told us that the evidence showed that SUD reprocessing posed minimal, if any, public health risk." CDC experts said that they were not aware of patient illness caused by SUD reuse in the last decade and that hospital infection surveillance systems they relied on would have uncovered those infections had they occurred. The GAO also stated that "several of the reports we identified of patient adverse events allegedly related to SUD reprocessing are inaccurate, not relevant to the debate or difficult to interpret."

Hospitals have been reprocessing medical devices for decades. If this practice threatened patient safety, epidemiologists would have identified long ago clusters of infection developing. However, as the FDA and the GAO confirm, there is no evidence to support the notion that reprocessing is a risk to public health.

The GAO study also confirms that the practice of reprocessing reduces costs. For example, hospitals that reprocess report annual savings ranging from $17,000 for pulse oximeter sensors (an externally applied device which measures blood oxygen levels) to $1 million for electrophysiology catheters. Reprocessing also reduces costs for all users, including facilities that do not reprocess. For example, GAO found that manufacturers sometimes offer lower prices on new devices to facilities that agree not to reprocess. In one instance, a manufacturer agreed to match the price of a third-party reprocessor if the hospital agreed to buy new instead of reprocessing the device. GAO also had evidence that the overall prices of some devices labeled "for single use" that are commonly reprocessed appear to have decreased in recent years, some by as much as 20 percent.

RESTORE MEANING TO THE TERM "FOR SINGLE USE"

Original equipment manufacturers have little incentive to label devices as reusable and, in fact, have financial incentives to designate devices as "for single use." Manufacturers appear to use the term "for single use" as part of their labeling without justifying whether, in fact, the device can be safely reprocessed for subsequent use. We understand manufacturers' desire to control which products they place on the market and the warranties they offer. However, the "for single use" label is a misnomer. In the last two years at the Cleveland Clinic, we have observed products, such as saw blades, that have been labeled historically as reusable, arriving with the "for single use" label with no observable change in the product. We believe that the recent proliferation of costly devices labeled "for single use" that have replaced viable reusable products has contributed to the strain on health care resources.

The AHA believes the FDA should take steps to ensure that the label "for single use" is meaningful and not simply an attempt by manufacturers to increase sales. Currently, device manufacturers determine whether a device is labeled "for single use." However, the FDA should have the authority to regulate the use of the "for single use" label and require manufacturers to both justify labeling a device as "for single use" and provide scientific data specifying any resterilization or reprocessing techniques that might compromise the integrity of the device. We find it odd that the FDA intends to encroach upon an area in which it has no background, i.e., hospitals, but the agency declines to take the initiative to seek expansion of its authority over device manufacturers - an industry clearly in its jurisdiction.

As the owners of the data - much of it proprietary - on the functional specifications of their devices, manufacturers know the most about the ability of their devices to hold up to repeated cleanings and sterilizations. In an era of heightened attention to the environment and cost reduction measures, manufacturers should share that information with those of us who use medical devices and be actively involved in developing consensus standards regarding the reuse of such devices. Those devices that can be safely reprocessed and reused should no longer be permitted to carry the label "for single use."

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, which typically consists 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. Naturally, medical professionals and the health care facilities in which they practice have as their primary mission quality patient care. In pursuit of this mission, they have standards, policies and procedures for reprocessing in place.

At the Cleveland Clinic, for example, our cardiology electrophysiology laboratory reprocesses both non-lumen diagnostic electrophysiology catheters and non-lumen radiofrequency ablation catheters, both of which are currently labeled "for single use." Each catheter is used five times or less. It is tested after each use for electrical and mechanical safety and function, then resterilized. Each year, standard operating procedures are reviewed and patient outcomes are assessed. The sterilization practices are also regularly reviewed and staff competency assessed. Since 1993 our lab has had a continuous quality improvement project to identify any infections in patients who have had 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. We are disappointed that the FDA ignored this existing oversight framework when crafting its proposed guidance.

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.

FDA'S STATUTORY AUTHORITY OVER HOSPITAL-BASED REPROCESSING

The AHA has called upon the FDA to articulate its rationale for claiming authority to regulate reprocessing performed at hospitals. We are not suggesting that hospitals not be subject to appropriate oversight of their reprocessing activities. The FDA's area of expertise is regulating manufacturers, not hospitals, and as we said earlier, numerous other agencies and organizations are charged with overseeing hospitals' activities.

However, even assuming the FDA has statutory authority over hospital reprocessing, we believe that the precedent-setting imposition of FDA manufacturing regulations on hospitals through a guidance document, rather than through a formal rulemaking process, is inconsistent with the requirements of the Administrative Procedures Act (APA).

The FDA's assertion of regulatory authority is apparently based on the premise that reprocessing is the legal equivalent of manufacturing. Under the current statutory and regulatory scheme, the FDA is charged with regulating the design, manufacture and commercial sale of medical devices. However, the AHA has not found an FDA statutory provision or any regulation that specifically addresses the issue of reprocessing a single-use medical device for subsequent reuse.

Reprocessing neither affects a device that is in the process of being delivered in an interstate commercial transaction nor results in a new product that is made available in interstate commerce. This calls into question the FDA's jurisdiction over reprocessing activities. In particular, for hospital-based reprocessing of devices, the device has already reached its final user, the physician, and is no longer in interstate commerce. When a product no longer remains in interstate commerce, the authority of the FDA to regulate ceases.

The FDA recognized as much when it established its policy with respect to reprocessing by health care facilities, as expressed in Compliance Policy Guide (CPG) 300.500, which, for over 20 years, has placed responsibility for hospitals' reprocessing and reuse of devices labeled "for single use" with the hospitals, without FDA oversight or affirmative regulatory requirements.

Treating hospitals as manufacturers doesn't make sense and could unnecessarily strain the resources of health care providers. For hospitals, reprocessing has had the historical benefit of allowing the treatment of a greater number of patients and the accrual of cost savings without sacrificing patient safety. At the Cleveland Clinic, we prorate devices that are reprocessed, thereby passing along our savings to payers.

If hospitals are forced to comply with another layer of bureaucratic regulation, many facilities will abandon the practice of reprocessing, which will increase costs. Given that the FDA is unable to cite evidence of a threat to patient safety, such regulation will only add costs to the health care system but do nothing to improve patient outcomes. In fact, as the GAO report states "because the demonstrated health risks from SUD reprocessing are small, [the new FDA framework] may have only a limited impact on public health."

Even assuming that the FDA has statutory authority to regulate hospital reprocessing activities - which we feel has yet to be proven - we believe that the FDA has not followed the requirements of the APA, which are necessary for the promulgation of legally binding regulations or rules. If the agency is issuing interpretative rules, general statements of policy or rules of agency organization, procedure, or practice, the procedures required by the APA do not apply.

In the case of the Enforcement Priorities guidance, the FDA is asserting that it has always had the authority to regulate reprocessing. Even assuming such jurisdiction, the Enforcement Priorities guidance is clearly much more than just interpretive rules or a general statement of policy. It is, in fact, an entirely new application of FDA regulations to hospital-based reprocessing. The Enforcement Priorities guidance imposes substantial and immediate burdens on hospitals, and violations could result in serious civil and criminal penalties and damage to reputations. This being the case, the guidance is regulation, and the FDA has not engaged in rulemaking in its promulgation.

Given this proposed precedent-setting expansion of the FDA's regulatory authority over hospital reprocessing activities, the agency - if it can prove that it has jurisdiction in this area - should suspend issuance of guidance and proceed with a formal rulemaking process in accordance with the APA. Such a rulemaking process affords the public, in this case our member hospitals, with all rights and remedies that apply when a regulation is promulgated. Further, because hospitals are not manufacturers and would have great difficulty complying with certain of the current provisions that apply to OEMs, a rulemaking process would afford the FDA the ability to design a regulatory structure that makes more sense for hospitals. It could also provide an opportunity to limit application of the regulation only to those devices whose characteristics make appropriate reprocessing more challenging.

In the event that such a rulemaking is undertaken, it is critical that any additional regulation include all health care facilities and other providers who engage in reprocessing activities, such as physician offices, group practices and ambulatory surgery centers. The GAO report supports this position: "By at least temporarily excluding ambulatory surgery centers, physicians' practices, and other nonhospital health care institutions from regulation, the proposal maintains the inconsistency of the current policy by exempting some categories of reprocessors from FDA oversight."

CONCLUSION

Mr. Chairman, patient safety is the first and foremost concern of all hospitals and health systems. Appropriate reprocessing poses little or no risk to the public, as evidenced from the findings of the GAO report, the FDA, the CDC, infection control officials, risk managers and quality consultants. It represents responsible waste management and appropriate use of scarce health care resources. In the absence of evidence that reprocessing and reuse of medical devices labeled as "single use," are a threat to patient safety, regulating reprocessing by treating hospitals as manufacturers adds costs without adding the benefits of increased patient safety or improved outcomes.