The U.S. Food and Drug Administration (FDA) has issued a proposed strategy on the reuse of single-use devices (SUDs). The proposed strategy applies only to remanufacturing activities related to the reuse of SUDs. It does not apply to other types of remarketing or remanufacturing activities.
FDA's Current Policy Regarding Reprocessing SUDs
May 1999 FDA and AAMI Conference on Reuse
FDA's Proposed Strategy on Reuse of SUDs
FDA's Current Policy Regarding Reprocessing SUDs
Establishments that engage in manufacturing activities, including reprocessing of SUDs for reuse, may be subject to all requirements of the Federal Food, Drug, and Cosmetic Act including: registration and listing (21 CFR Part 807); premarket notification and approval requirements (21 CFR Parts 807 and 814); submission of adverse event reports under the Medical Device Reporting (MDR) regulation (21 CFR Part 803); manufacturing requirements under the Quality Systems (QS) regulation (21 CFR Part 820); Labeling requirements (21 CFR Part 801); Medical Device Tracking (21 CFR Part 821); and Medical Device Corrections and Removals (21 CFR Part 806).
The FDA has not regulated OEMs, third-party reprocessors, and healthcare facilities in the same manner with respect to SUDs.
OEMs have been subject to all the requirements described above. The agency described the current regulatory responsibilities of hospitals that engage in reprocessing in Compliance Policy Guide (CPG) 300.500 (issued on November 11, 1977). This 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.
FDA has not issued a CPG that addresses third-party reprocessors of SUDs, although the agency has issued statements in response to specific inquiries. Under current agency policy, third-party reprocessors are subject to registration, listing, QS, labeling, and MDR reporting requirements. A recent letter from the Director, Division of Enforcement III, Office of Compliance, stated that third-party reprocessors are subject to premarket requirements. FDA notes, however, that many devices that are commonly reprocessed are exempt, by regulation, from premarket requirements. Over the years, the agency has issued Warning Letters to third-party reprocessors for a variety of violations: failure to comply with quality systems requirements, including failure to validate sterilization procedures (21 CFR Part 820); failure to carry labeling statements that a device has been reprocessed (21 CFR Part 801.1); and failure to bear adequate directions for use (21 USC 352(f)(1)). While the regulations may require third-party reprocessors who engage in certain manufacturing activities to comply with premarket requirements, the FDA, in its enforcement discretion, has not taken action against third-party reprocessors on the basis of noncompliance with premarket notification requirements.
Until FDA completes its examination of the SUD policy and issues a final policy, the agency does not intend to change its policy with respect to third-party reprocessors or healthcare facilities that reprocess. This does not preclude FDA from taking any appropriate regulatory action should a reprocessed medical device present a significant risk to the public health.
May 1999 FDA and AAMI Conference on Reuse
May 5-6, 1999, FDA and the Association for the Advancement of Medical Instrumentation (AAMI) cosponsored a conference at Crystal City, VA, on the practice of reprocessing and reusing SUDs. Among conference attendees and participants were representatives of healthcare facilities, firms that reprocess devices, OEMs, national oversight organizations, state governments, academia, medical ethicists, and standards organizations. This provided FDA the opportunity to hear a wide range of views and concerns from individuals and organizations involved in or affected by this practice. Highlights of the issues discussed are summarized below.
Regulation. FDA received divergent opinions on how reprocessing and reuse of SUDs should be regulated. Some participants believed that reprocessors should be regulated in the same manner as OEMs and that 510(k)s or Premarket Approval applications (PMAs) demonstrating the safety and effectiveness of the reprocessed device should be required. Others felt that OEMs should be required to provide instructions on how to reprocess their devices unless they can demonstrate that the device cannot be reprocessed.
Guidance and Standards. Participants identified the need for additional guidance on reprocessing. Among the suggestions were: standards to assure that cleaning, disinfection, and sterilization processes are validated and that reprocessing may be performed properly; a determination of what types of devices can and cannot be reprocessed; a classification scheme establishing critical, semi-critical, and non-critical categories for reprocessed devices; and clearer definitions for the terms "reuse," "reprocessing," and "resterilization".
Obtaining data on reprocessing and reuse. Participants suggested that clinical data and experience on reuse could be obtained through: hospitals' existing surveillance activities; long-term clinical studies; the establishment of a clearinghouse for data; the dedication of National Institutes of Health funds to study reprocessing; and research to be conducted by professional societies with funding provided by OEMs and reprocessors.
FDA's Proposed Strategy on Reuse of SUDs
The agency's proposed strategy is divided into eight sections:
1. Reconsider the agency's current policy on establishments that reprocess SUDs.
FDA is reconsidering its current policy for establishments that reprocess SUDs. Based on concerns about the practice of reprocessing, the agency is considering a strategy to regulate third-party reprocessors and healthcare facilities that engage in reprocessing in the same manner that the agency has regulated OEMs.
FDA recognizes that a decision to regulate healthcare facilities that reprocess in the same manner as other reprocessors will have a significant impact on the agency's resources, particularly for conducting inspections of these facilities. Therefore, if the agency proceeded to regulate healthcare facilities in the same manner as OEMs, FDA would consider collaborating with accredited third-party organizations or other federal agencies to inspect these facilities to ensure that reprocessing operations are being performed in accordance with the agency's requirements.
2. Explore the development of a device categorization system based on the level of risk presented by reprocessing and reusing SUDs and an enforcement strategy based on the level of risk.
FDA intends to explore the development of a risk-based categorization system to assist the agency in developing an enforcement strategy for reused SUDs. Under this approach, the agency's application of its authority would depend on the level of risk associated with the reprocessing and reuse of a particular SUD.
FDA is seeking input from stakeholders and interested parties on factors that should be considered when evaluating a reprocessed SUD's risk to patients and users, as well as how its enforcement policy should be applied to these devices. The agency believes that the categorization system would be a three-tiered system ("low-risk", "moderate-risk", or "high-risk"). Single-use products that are reprocessed because sterility was breached by means other than patient contact would also be included in this risk categorization scheme. FDA plans to develop a prototype categorization scheme and to circulate it to OEMs, third-party reprocessors, healthcare professionals, and other interested parties for comment.
Factors that FDA is considering that could determine an SUD's risk category include: the complexity of procedures associated with reprocessing the device; the actual and potential risk for infection should the reprocessed device be reused; and the quality and extent of published data on reprocessing for the specific device.
"High-Risk" Reprocessed SUDs:
The agency would consider "high-risk" SUDs to be products that may pose significant public health risk to patients and users after reprocessing. FDA believes that products in this category should be removed from the market within a short time frame if they have not complied with applicable premarket requirements. For this "high-risk" category, FDA is considering enforcing all of the agency's regulatory requirements, including premarket requirements, within six months after a final agency policy on reuse is issued. Considering the type and regulatory class of SUDs that may be included in this category, it is likely that the premarket data that will be reviewed by the FDA for "high-risk" products will be submitted through the premarket approval process.
"Low-Risk" Reprocessed SUDs:
The agency anticipates that the "low-risk" category would include SUDs that pose little or no potential public health risk to patients or users after reprocessing. The agency believes that some of the devices in this category will be Class I and Class II exempt, and some Class I and II non-exempt.
FDA expects that establishment inspections for entities that reprocess "low-risk" SUDs to assure compliance with Good Manufacturing Practices (GMP) would be a low priority for the agency. In addition, FDA plans to exercise enforcement discretion not to enforce 510(k) submission requirements, if applicable, for non-exempt products in this category, provided that the reprocessors have validated reuse procedures or declare conformity to a recognized consensus standard that is applicable to the reprocessed SUD. The agency also plans to enforce all other requirements for products in the "low-risk" category, including registration and listing requirements. The agency anticipates that it would not enforce registration and listing requirements for these products for a six month period after FDA announces its final reuse policy.
"Moderate-Risk" Reprocessed SUDs:
FDA would enforce applicable premarket requirements for products in this category to ensure that the reprocessed device remains as safe and effective as a never-used SUD. This might be accomplished by allowing reprocessors to make declarations of conformity to recognized consensus standards to comply with premarket requirements.
The agency would plan to utilize its enforcement discretion to not enforce premarket requirements for "moderate-risk" SUDs for a period of two years provided reprocessors collect, retain, and maintain postmarket data to document the safety, effectiveness, and performance of reprocessed SUDs in this risk category. The agency is soliciting comments on the type of postmarket data reprocessors should collect during the two-year enforcement discretion period.
The agency also would require reprocessors of devices in the "moderate-risk" category to comply with registration and listing, labeling, corrections and removals, quality systems, and tracking. As with "low-risk" products, FDA would not plan to enforce registration and listing requirements for a period of six months after the agency finalizes its reuse policy.
FDA acknowledges that an SUD's reuse category under this system should not be a permanent designation. The agency recognizes that the categorization system must provide flexibility in allowing SUDs to be moved from one category to another, as more data become available on the risks associated with reprocessing and reusing the device. In particular, the agency views the "moderate-risk" category as one that would contain many devices that are in transition. As data are collected on these products, some public health concerns may emerge and place certain products in the "high-risk" category, while other products may move into the "low-risk" category.
In order to support its premarket decisions on reusing SUDs, the agency anticipates that the reprocessor would submit valid scientific evidence showing that SUDs can be reprocessed by the methods utilized by the reprocessor for a limited or specified number of times and still be safe and effective for their intended uses. Comments and input on this issue are welcome.
3. Solicit comments on FDA's draft "List of Frequently Reprocessed SUDs".
FDA is soliciting comments on its proposed list of "Frequently Reprocessed SUDs." The devices, CFR regulation number, and classification are as follows:
- Surgical Saw Blades – 21 CFR 878.4820, Class I Exempt
- Saw Blades – 21 CFR 878.4800, Class I Exempt
- Surgical Cutting Accessories – 21 CFR 878.4800, Class I Exempt
- Surgical Drills – 21 CFR 878.4820, Class I Exempt
- Surgical Mesh – 21 CFR 878.3300, Class II
- Drill Bits – 21 CFR 878.4540, Class I Exempt
- Laparoscopy Scissors – 21 CFR 876.1500, Class I Exempt
- Endoscopic Carpal Tunnel Blades – 21 CFR 888.4540, Class I Exempt
- Orthodontic (metal) Braces – 21 CFR 872.4510, Class I Exempt
- Orthodontic (plastic) Braces – 21 CFR 872.5470, Class II
- Electrophysiology Catheters – 21 CFR 870.1220, Class II
- Electrosurgical Electrodes and Pencils – 21 CFR 878.4400, Class II
- Cardiac Catheters and Guidewires – Class II and III, 510(k) and PMA; unclassified
- Respiratory Therapy and Anesthesia Breathing Circuits – 21 CFR 868.5240, Class I Exempt
- Biopsy Needles – 21 CFR 878.4800, Class I Exempt; 21 CFR 876.1075, Class II
- Endotracheal Tubes – 21 CFR 868.5730, Class II
- Syringes – 21 CFR 880.5860, Class II
- Sutures – Class II and III, 510(k) and PMA, unclassified
- Staplers – 21 CFR 878.4800, Class I Exempt
- Balloon Angioplasty (PTCA) Catheters – Class II, PMA
- Biopsy Forceps – 21 CFR 876.1075, Class I Exempt, 21 CFR 874.4680, Class II
- Trocars – 21 CFR 874.4420, Class I Exempt, 21 CFR 870.1390, Class II
4. Consider requesting OEMs to provide information on their labels about risks associated with reuse of SUDs.
FDA is considering whether labeling information affecting reuse of SUDs should be provided by OEMs to healthcare providers and consumers. Existing statutes and regulations already require that devices bear adequate directions for use (Section 502(f)), and that the labeling not be false and misleading (Section 502(a)). One option the agency is considering is requesting OEMs who label their devices "single-use" to provide, as part of the device's labeling, any information of which they are aware regarding the potential risks associated with reusing their SUDs. This information would serve as a caution to users and reprocessors who might attempt to reprocess these SUDs.
5. Examine the need to create working definitions for the terms "single-use device", "reuse", "reprocessing", and "resterilization";
During the May 1999 FDA/AAMI conference, several participants voiced the need to define commonly used terms associated with reuse. The definitions listed below are working definitions the agency is considering. The agency is interested in obtaining comments on the following:
Single-use disposable:a single-use device that is intended to be used on one patient during a single procedure. It is not intended to be reprocessed (cleaned and disinfected/sterilized) and used on another patient. The labeling identifies the device as disposable and does not include instructions for reprocessing. Some single-use, disposable devices are marketed as non-sterile and include appropriate pre-use sterilization or processing instructions to make the device patient-ready.
Opened but unused single-use device: a disposable single-use device whose sterility has been breached or whose sterile package was opened but the device has not been used on a patient.
Reuse: the repeated use or multiple uses of any medical device, including reusable and single-use medical devices, on the same patient or on different patients, with applicable reprocessing (cleaning and disinfection/sterilization) between uses.
Reprocessing: includes all operations performed to render a contaminated reusable or single-use device patient-ready or to allow an unused product that has been opened to be made patient-ready. The steps may include cleaning and disinfection/sterilization. The manufacturer of reusable devices and single-use devices that are marketed as non-sterile should provide validated reprocessing instructions in the labeling.
Resterilization: the repeated application of a terminal process designed to remove or destroy all viable forms of microbial life, including bacterial spores, to an acceptable sterility assurance level.
6. Explore how recognized consensus standards can be applied to reprocessing SUDs (e.g., to verify and validate cleaning, disinfection and/or sterilization of SUDs) and explore the development of additional consensus standards to address the safety, effectiveness, and performance of reprocessed SUDs.
FDA is interested in facilitating and, to whatever extent possible, participating in the evaluation of recognized consensus standards to determine their utility in reprocessing SUDs and identifying and developing device-specific standards for reprocessed SUDs. One possibility is to allow reprocessors the option to declare conformity to a recognized standard to ensure that the device remains safe and effective for its intended use. The agency acknowledges that declarations of conformity to consensus standards are voluntary. Moreover, FDA recognizes that there are a limited number of device-specific performance standards currently available for SUDs. Therefore, the agency will need to rely heavily on the cooperation and support of stakeholders and would expect interested parties to assume primary responsibility for the development of these standards.
7. Consider developing a research program on reuse of SUDs and explore avenues to publish and disseminate research and other information on reuse.
FDA is interested in pursuing discussion on the need to develop a research program with a specific focus on reuse of SUDs. The agency has conducted several in vitro studies on reused SUDs and is considering, if resources permit, expanding these efforts for the purpose of increasing its scientific knowledge on how reprocessing effects SUDs. FDA believes that the expansion of its research efforts may facilitate collaboration with stakeholders and interested parties to conduct more in vivo and in vitro studies. In addition, the agency plans to publish the results of the scientific studies that it has conducted to date on reprocessed SUDs.
To ensure that the healthcare community, the manufacturer/reprocessor community, patients, and the public in general are fully aware of the current issues involving the reprocessing and reuse of SUDs, FDA is considering an outreach program to disseminate information on its activities. Some avenues that FDA is exploring include posting of talk papers, public health notifications, and lay articles for consumers on FDA's Web site. FDA also may sponsor satellite teleconferences on this subject. The first satellite teleconference on reuse is tentatively scheduled for November 10, 1999.
8. Convene an open meeting on December 14, 1999 to discuss FDA's proposed strategy.
FDA plans to convene an open meeting in Rockville, Maryland on December 14, 1999, to gather comments on its proposed strategy on reuse of SUDs. At this meeting, the agency hopes to solicit offers of assistance from all stakeholders and interested parties to address the reuse issue expeditiously and effectively.
Written comments and suggestions regarding this document should be submitted to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5603 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. For more information, contact Larry D. Spears, Center for Devices and Radiological Health (HFZ-340), Food and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850; Tel: (301) 594-4646.
To voice your opinion about FDA's proposed strategy, visit the Medical Design Online Discussion Forum at http://www.medicaldesignonline.com/content/forums/discussion_home.asp.