A perioperative nurse searching the sterile supply shelves for biopsy forceps often has a choice between a reprocessed single-use device (SUD) or a SUD from the original equipment manufacturer (OEM). Which shall he or she choose? This scenario takes place daily in more than one-third of US hospitals. (1) According to some, this is "medicine's dirty little secret," and the reprocessing and reuse of SUDs are "medical experimentation without patient benefit, written consent, or even patient knowledge." (2)
BACKGROUND
The first SUD was developed in 1948. (3) Before that time, medical devices were intended to be reusable. The practice of reusing SUDs initially was thought to be safe; however, in the late 1950s, a New Jersey dentist reused single-use hypodermic needles, which resulted in nine patients dying from hepatitis. (4) In 1970, a facility in the United Kingdom reprocessed single-use oxygenators used in heart bypass surgery. Patients consequently developed fatal immune reactions from pyrogens that had not been removed properly from the oxygenators. (5)
During the 1970s and 1980s, technology resulted in medical device designs that included plastics. Original equipment manufacturers, aware of the potential harm to patients due to improper reuse, began to label more of their devices as single use only. (6) The pressure from the Balanced Budget Act of 1997, the increasing prevalence of health maintenance organizations, and Medicare caused some hospitals to turn to reprocessing SUDs as a way to reduce costs and create savings. (7) This move created an outside market of third-party reprocessors. Third-party reprocessors reprocess more than one million SUDs per year with a profit of nearly $40 million. (8)
HISTORICAL ANALYSIS
In November 1977, the Compliance Policy Guide (CPG) was issued by the US Food and Drug Administration (FDA). The CPG states that
hospitals that reprocess SUDs assume full liability and responsibility for
their reprocessing actions and should ensure that the products are
adequately cleaned and sterilized and that device safety, effectiveness,
and quality are maintained. (9)
The FDA has not issued regulations that address third-party reprocessors of SUDs.
Under current policy, third-party reprocessors are subject to registration, listing, quality service, labeling, and medical device reports. (10)
The original requirements for labeling medical devices were created in the Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act. This Act was amended by the passage of HR 3095 and S 2783. (11) The FDA Modernization Act of 1997, signed into law by former President Clinton on Nov 21, 1997, created three medical device classes: Class I, II, and III. (12)
On May 5 and 6, 1999, a conference was held by the FDA and the Association for the Advancement of Medical Instruments (AAMI). This provided an opportunity for the FDA to listen to a wide variety of people and organizations directly involved or affected by the practice of reprocessing and reusing SUDs. The main issues were
* the need for equal regulation of OEMs and third-party reprocessors,
* additional guidance and strict rules regarding the reprocessing process, and
* the collection of scientific research to determine the safety of reprocessing. (13)
Armed with this information, in November 1999, the FDA proposed new draft regulations titled "Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme and the Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals." (14) These draft regulations outline the FDA's additional categorization of reprocessed devices as high, moderate, or low risk. The FDA will use these new settings to determine remarket requirements. According to the FDA, high risk SUDs may pose a significant risk to a patient's health after being reprocessed, moderate risk SUDs are not in the low or high risk category, and low risk SUDs pose little or no threat to the safety of the patient after being reprocessed.
The proposed guidelines state that the FDA will enforce stringent requirements on reprocessed medical devices that fall into the high risk category, less for those in the moderate risk category, and even less for the low risk category. All items are listed and can be obtained on the FDA's web site at http://www.fda.gov/cdrh/reuse/1029.html. This proposal will be applicable to third-party reprocessors and hospitals that reprocess instruments. Exempt are permanently implantable pacemakers and opened but unused SUDs. Health care facilities that are not hospitals will be investigated at a later time. The FDA will phase in the enforcement of these new guidelines, which will allow reprocessors and hospitals to acclimate and will not strain the FDA's limited resources.
The requirements set forth in the guidance for third-party and hospital reprocessors include
* registration and listing,
* medical device reporting,
* tracking,
* corrections and removals,
* quality system regulation,
* labeling, and
* premarket requirements.
Labeling has become an important issue for the FDA because this area has not been properly addressed by reprocessors in the past. Reprocessed SUDs are not required to have special identifiers on their labels so that the person who ultimately opens the SUD may not know it has been reprocessed or how many times it has been reprocessed.
Premarket requirements will have the largest impact. According to the draft guidance, unless the classification regulation states the device is exempt, a premarket notification (510[k]) submission must be done for Class I and Class II devices. Class III devices may need a 501(k) or a premarket approval (PMA) application. This depends on the classification regulation for each Class III device. The new categories of high, moderate, and low risk do not relate to the type of submission that may be needed.
When the premarket notification is used,
the applicant assumes the burden to identify the legally marketed predicate
device and to make sufficient comparisons between its device and the
predicate device to establish that they are equivalent with respect to
important safety and effectiveness factors. (15)
The PMA is used when there is a reasonable assurance of safety and effectiveness of a reprocessed device based on valid scientific data. The PMA approval does not require the comparison of the device to a currently legal predicated device.
ISSUES UNDERLYING THE CURRENT POLICY
Recent concern has been raised by many regarding reprocessing SUDs and the impact on patient safety. Safety has become the focus because
* the marketing of this option to hospitals by outside facilities increased significantly,
* reprocessing of complex SUDs has increased, and
* the FDA has not uniformly regulated OEMs, third-party reprocessors, and health care facilities with respect to SUDs. (16)
Concern about patient safety has increased because of sensational front-page news stories throughout the country that highlight horrific details of patients being injured because of reprocessed SUDs. (17) Damaging reports obtained from the FDA and printed by the media include nonsterile sutures that were used on premature babies, reprocessed biopsy forceps that were found to contain hepatitis B residue from a previous patient, and catheters that broke during a routine scan, which resulted in the need for emergency surgery. (18)
The ethical dilemma regarding reprocessing and reusing SUDs is where the heart of this issue lies. One author highlighted the overall ethical theme as "Just because I can do something, does that mean I should do it?" (19) The immediate solution is to identify the dilemmas involved using an ethical guideline. The answer for beneficence is to put concerns for the patient's well-being above any benefit. Distributive and social justice require that an equal distribution of risk and benefit be accomplished for all patients. A patient's autonomy is affected by not being informed of about the use of reprocessed SUDs. The largest concern involves the moral question of how reusing SUDs would look on a television news show segment. (20) Each nurse and organization will identify the dilemmas differently, therefore, varying the solutions. (21)
National concern became apparent when compelling language was included in HR 3148, sec 524, cosponsored by Rep Anna Eshoo (D-Calif) and Rep Fred Upton (R-Mich), and S 1542, which was sponsored by Sen Dick Durbin (D-Ill). These bills cite government findings saying,
The Food and Drug Administration has information indicating that some
reprocessed medical devices labeled for single use have been associated
with serious injury and that reprocessed medical devices labeled for single
use have the potential to cause injury. (22)
STATE AND FEDERAL ACTIONS
Continued from page 1.
Concern about patient safety when reprocessed devices are used was raised in both California and Illinois. (23) On Feb 26, 1999, California assemblyman Thomas Calderon (D-Montebello) introduced AB No 1359, which prohibits the reuse of any SUD, because, "AB 1359 will put a stop to this Russian roulette with medical equipment." (24) The bill was referred to committee where it died on Feb 3, 2000. (25)
The 90th General Assembly for the State of Illinois passed SB 80, which amended the Illinois Food, Drug, and Cosmetic Act prohibiting the "reuse, recycle, or refurbish for reuse, or provide for reuse of a single-use surgical device" (26) On March 9, 1999, Illinois state senator Evelyn Bowles (D-Edwardsville) introduced SB 1217. (27) The bill was assigned to the rules committee, where it died on May 26, 1999.
Federal concern about patient safety in regard to reprocessed and reused SUDs also has been increasing steadily. On Aug 4, 1999, the US Senate approved the amendment introduced by Sen Durbin. This amendment gave an additional $1 million to the FDA to provide additional resources for overseeing reprocessing and reuse of SUDs. (28) On Aug 5, 1999, Sen Durbin introduced S 1542 to amend the Federal Food, Drug, and Cosmetic Act. It established mandatory registration by the FDA of all individuals and organizations that reprocess instruments. It also requires that every individual or organization reprocessing instruments demonstrates the safety and effectiveness of reprocessed SUDs and that they honor the requirements of section 510 and 515, which refer to premarket requirements. The S 1542 amendment died in the Health, Education, Labor, and Pension (HELP) committee and has not been reintroduced in the 107th Congress. (29)
On Oct 26, 1999, Rep Eshoo and Rep Upton introduced HR 3148. This bill amends the Federal Food, Drug, and Cosmetic Act and contains language identical to Sen Durbin's bill (ie, S 1542). House Bill 3148 was assigned to the Commerce and Government Reform Committees. The Subcommittee on Oversight and Investigations held a hearing on Feb 10, 2000. (30) The subcommittee wanted more information on reprocessing and reuse of SUDs to determine whether there is a safety issue for patients and to discover the FDA's plans for overseeing and regulating this practice. The bill died in committee and has not been reintroduced in the 107th Congress.
On June 27, 2000, the HELP Committee held a hearing to gather information regarding the practice of reprocessing and reusing SUDs, and it included the formal release of the Government Accounting Office's (GAO's) findings, which were that the number of facilities and the type of SUDs reprocessed are unavailable and that reprocessing SUDs does pose a health risk; however, clinical evidence has shown selected devices can be reprocessed safety. The GAO also found that there has been a significant cost savings directly related to reprocessing SUDs, the FDA's regulation of SUD reprocessing has not been consistently enforced, and the revised regulation will provide information that will allow the FDA to effectively monitor the reprocessing of SUDs. (31) Rep Eshoo, who was the first witness, stated she would remove the requirement of an informed consent from patients if the FDA adequately oversaw and effectively enforced the reprocessing and reuse of SUDs. This was viewed as a major stride toward a possible bipartisan solution.
POLICY OBJECTIVES
The intention of the FDA's new draft regulations was to increase regulation of medical devices by the FDA, provide assistance to OEMs by establishing the Division of Small Manufacturers Assistance, and create an extension for the FDA to issue its final regulations of the Federal Food, Drug, and Cosmetic Act. The explicit intentions of the draft regulations were to give advance notice of the FDA's proposed guidelines and provide an opportunity for feedback from the medical community and industry before implementing the regulations.
The FDA's draft regulations were meant to quiet concerns being voiced by lobbyists and reduce the mounting anxiety being heard on Capitol Hill. Congress' objective in its introduced legislation and round of hearings was to nudge the FDA to reevaluate, formulate, and implement regulatory changes in areas that Congressional members believed needed to be addressed. Legislation often is introduced to prompt regulatory bodies to make changes internally rather than have Congress pass proposed legislation.
The activity spurned by the passage of these amendments created increased regulations and forced the FDA to take responsibility for implementing and enforcing regulations on reprocessed SUDs. The establishment of the Division of Small Manufacturers Assistance and the extension gave the FDA the reprieve it needed to properly implement its new guidelines of the Federal Food, Drug, and Cosmetic Act. The introduction of HR 3148 and S 1542 was a written stance of Congress' overall concern about the reprocessing and reuse of SUDs. The FDA's draft regulations allowed the FDA and all parties affected to decide on the best course of action and solution to the problem.
PROS AND CONS OF THE POLICY
The proposed policies and finalization of the FDA guidelines will result in the reprocessing of SUDs being considered a legitimate practice and will open doors of opportunity. Consequences of the new regulations proposed by the FDA and Congress vary depending on the individual and organization affected.
Both OEMs and third-party reprocessors will benefit. Original equipment manufacturers will be able to continue to expand and grow as new medical devices are designed and marketed. Third-party reprocessors will be recognized for performing a safe job and for offering an alternative to disposable SUDs. Individual hospitals, however, may be unable to meet the new FDA requirements and may choose not to reprocess. (32)
Patient benefits still are in question. Numerous studies demonstrate the inability to adequately remove and properly resterilized SUDs. (33) Although the GAO failed to find any real evidence of harm, it did find evidence that not all SUDs can be reprocessed safely, and it strongly recommends oversight by the FDA. (34)
The savings from reprocessing have been touted by many. One researcher reports a savings of more than $9 million from reprocessing catheters during the past 20 years. (35) The Association of Medical Device Reprocessors (AMDR) says, "Simply put, medical device reprocessing allows us to provide more quality health care at an affordable price. (36) There are others, however, who are quick to disagree. One researcher discovered there are no published standards to demonstrate savings. (37) The ECRI formula demonstrates that the first time a device is reprocessed saves the greatest amount, and savings decrease significantly thereafter. (38) A cost comparison study found data necessary to determine actual savings were difficult to obtain and yielded too close of an outcome to warrant a decision to reprocess rather than dispose of SUDs. (39)
Another concern is that the money needed by the FDA to process PMA requests by third-party reprocessors will come from the same pool used by OEMs. The fight for resource dollars may interfere with the expedient progression of new medical devices to the market. In addition, the FDA believes that it will be unable to adequately monitor all of the reprocessors, and it has asked the Centers for Medicare and Medicaid Services--formerly the Health Care Financing Administration--and the Joint Commission on Accreditation of Healthcare Organizations for assistance. (40) Currently, these organizations have not offered to assist the FDA in monitoring reprocessors. In addition, there has been talk of creating an outside office that would report directly to the FDA to oversee the process. The introduction of legislation in both the House and Senate, along with hearings by the Commerce Committee and the HELP Committee, have demonstrated Congress' overwhelming concern about patient safety. The general consensus among members of Congress, however, is that they support the FDA's new regulation, implementation, and enforcement of the reprocessing and reuse of SUDs. Bills that have been introduced likely will not proceed further unless there is a concern the FDA is not doing its job.
ADVOCATES FOR OR AGAINST POLICY MODIFICATION
Continued from page 2.
Those in favor of FDA regulation are companies directly affected by reprocessing and reuse of SUDs. The AMDR is in favor of FDA regulation but against implementation of PMAs and the premarket notification. This association believes that the medical devices its members process are safe; therefore, PMAs are unnecessary. (41) The Medical Device Manufacturers are in favor of the new regulation and advocate for research regarding the safety of reprocessed devices. (42) The American Society of Healthcare Central Services Professionals of the American Hospital Association agrees with the FDA's rule and recommended high risk devices reprocessed by commercial reprocessors. (43) Fellows of the American College of Surgeons state that they are unaware of the reuse status of sterilized instruments, but they want the FDA to collect and verify data, create a labeling protocol, and mandate that OEM demonstrate single-use requirements through scientific studies. (44)
Organizations that oppose the promotion, reprocessing, and reuse of SUDs are a mixed group. (45) The Health Industry Manufacturers Association is against the reuse or the promotion of reuse of devices designed or labeled for single use. (46) Medical Devices Canada strongly disapproves of reprocessing SUDs, as does the Society of Gastroenterology Nurses and Associates, Inc. (47) Department of Veteran's Affairs hospitals are the only facilities that have a written policy not to reprocess SUDs. (48)
Organizations that do not have an official position on the practice of reprocessing and reusing SUDs are numerous. (49) AORN did not officially address the practice of reprocessing and reuse of SUDs until May 2001. AORN's position is that the individual health care facility should determine whether to engage in the act of reprocessing or reusing SUDs. (50) The International Association of Healthcare Central Service Materiel Management considers the decision whether to reprocess to be the responsibility of an appointed committee that includes members from administration, risk management, infection control, central service, and other appropriate departments. (51) The Department of Defense Hospitals, unlike the Veteran's Affairs hospitals, do not have a universal or a service-wide policy. Policy decisions on SUDs are left up to individual Department of Defense hospitals. (52) The Association for the Advancement of Medical Instrumentation does not advocate any position regarding the reuse of SUDs. (53)
POLICY MODIFICATION
Some policy modifications that need to be considered include
* increasing research by professionals at facilities that are known for accurate data collection;
* developing and enforcing strict standards for the proper method of reprocessing;
* sterilizing, disinfecting, and recalibrating SUDs; and
* reflecting the savings created by the justification of reprocessing in the fees charged by hospitals.
The requirement for PMAs by the FDA will create clinical trials, which must be performed by an organization best suited for research (eg, the National Institutes of Health). Clinical trials must require the consent of the patient. This will satisfy proposed legislation requiring informed consent and relieve the added burden and concerns of the AMDR. Currently, third-party reprocessors decide which instruments will be reprocessed; however, SUDs should not be reused after being reprocessed without sound clinical data to back up their safe use, along with permission from the FDA.
A search of FDA warning letters to third-party reprocessors yielded seven since December 1997. The concern about strict standards for reprocessing SUDs was highlighted by a certified biomedical equipment technician employed as a medical device service person in Minnesota. (54) He elaborates on unknown requirements when calibrating SUDs, and states that, without directions from the OEMs, reprocessors decide on their own how to calibrate SUDs. With patient safety in question, this no longer can be tolerated. Strict standards must be implemented to guarantee uniformity in reprocessing all SUDS.
Savings created by reprocessing SUDs must be reflected in patient charges. It is considered fraudulent to charge the same price for a SUD from the OEM as a reprocessed SUD. Hospitals must demonstrate equitable sharing of savings for all patients. The Centers for Medicare and Medicaid Services should not reimburse at the same rate for a SUD that has been reused as one that has not been reused. (55)
Even though the proposed change is believed to be the best solution, it may not become a reality. There always is the possibility for an outside disruptive force to directly affect the forward movement of a proposal. The policy process does not happen overnight; patience is the key, and astute individuals or organizations will look for an opportunity for their proposal to arise when the ground is more fertile. According to one author, "Once a solution is carried out, it creates whole new sets of issues, ensuring that no public problem ever really dies." (56) The finalization of the FDA's guidelines for the reprocessing and reuse of SUDs may be an opportunity to implement the new proposed solution. For updates on the status of proposed changes, go to http://www.fda.gov.
POLITICAL ACTION PLAN
A political action plan on reprocessing SUDs would require a rational, comprehensive model of policy (ie, the problem must be clarified and properly identified). (57) This requires gathering additional data through research. Prioritizing change areas is paramount in solving the problem. Constantly re-evaluating the pros and cons, searching for alternatives, or evaluating leaving the proposal as it is must be done on a regular basis. Identifying individuals and organizations directly affected, both favorably and negatively, by the proposal is useful when proposing an effective change because it is important to have a clear understanding of their views and obtain accurate data detailing the exact cost and benefits before moving ahead.
When deciding to proceed with the proposed change, an effective lobbyist should be hired. He or she could be helpful in identifying a potential sponsor and in drafting the bill. Contact and motivation of special interest and advocacy groups, such as those that would benefit the most from the proposal, must be targeted early through telephone calls, letters, and e-mail. Establishing a web site with interactive e-mail capability is a requirement in this day and age. The most important aspect of creating an environment of positive inertia lies in educating patients, hospitals, and health care professionals, especially RNs, surgical technologists, and surgeons, about the positive aspects of the proposed policy. (58) Finally, the media can be used more efficiently by hiring a public relations specialist who can distribute press releases, place
