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______________________________________________________________________________ TECHNOLOGY STATUS EVALUATION


MAY 1998 INTRODUCTION In order to promote the appropriate use of new or emerging endoscopic technologies which impact on endoscopic practice, the ASGE Technology Committee has developed a series of Status evaluation papers. By this process, relevant information about these technologies may be presented to practicing physicians for the education and care of their patients. In many cases, data from randomized controlled trials is lacking and only preliminary studies are available. Practitioners should continue to monitor the medical literature for subsequent data about the efficacy, safety and socioeconomic aspects of these technologies. BACKGROUND Disposable endoscopic medical accessories were developed for convenience, reliability and fear of transmission of infection [1,2,3,4]. There is increasing interest in the use of reusable accessories and reprocessed single use items because of concerns over health care cost, cost-effectiveness, and environmental contamination[5,6,7,8]. Single-use medical devices sold in the United States have been reused in many countries in Europe, Asia and Canada[9,10]. Devices labeled as reusable have been shown by the manufacturer to retain their safety and efficacy following reprocessing. Although this has not been demonstrated by the manufacturer for devices labeled single-use only, these devices may retain their efficacy and safety after reprocessing[11,12,13,14]. In 1987, the FDA issued a revised compliance policy guide regarding use of disposable medical devices. The FDA . . . finds that there is a lack of data to support the general reuse of disposable medical devices . . . The fact that devices are labeled disposable is indicative of this lack of data. In order for a device to be considered reusable, it
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must be capable of withstanding necessary cleaning and resterilization techniques and methods, and continue to be safe and reliable in its intended use. Since disposable or single-use labeled devices are not intended by the manufacturer or distributor for reuse, any institution or practitioner who resterilizes and/or reuses a disposable medical device must bear full responsibility for its safety and effectiveness[15, 16]. Proper reprocessing is necessary to ensure the sterility of the reused items. Issues such as mechanical safety, risk of disease transmission, proper functioning, patient preference, and legal liability have made it difficult for individual users to reprocess and reuse single-use items. Reprocessing companies have been established to provide these services. DEVICE REPROCESSING COMPANIES What is a device reprocessing company? A reprocessing company provides cleaning, testing, reconditioning, resterilization, and repackaging of reusable and single-use accessories for the intended purpose of reuse on patients. This applies to unopened items that have passed the expiration date, items opened but not used, and items that have been used on patients. They also provide warranty on the reprocessed products and indemnify the medical facility for product liability[3,15]. What is the expected standard of service? The reprocessing industry is not FDA regulated and registration with the FDA is not required. Currently, some of the companies are registered with the FDA and operate under the standard of Good Manufacturing Practices (GMP) (Table 1)[2,17]



TABLE 1 Good Manufacturing Practices

Adequate organizational structure and sufficient personnel Formally established and written quality assurance program Quality review of all production records, manufacturing materials, in-process materials, packaging materials, labeling, and finished devices Verification that quality problems are identified, documented, and corrected Planned and periodic audits of the quality system with documented reports reviewed by management Maintenance of files of written and oral complaints about device performance, quality, safety, durability or effectiveness and records of resolution of each complaints

What is the current position of regulatory agencies and professional organization on reprocessing companies?[3,16,18,19,20,21] FDA - The Food and Drug Administration does not require reprocessors to be registered, however, voluntary registration is accepted. With registration comes the obligation to be in compliance with the current GMPs, as would any device manufacturing company. The FDA has not inspected all reprocessors in the country. Of those that have been inspected, the results are a matter of public record (form 483 and/or warning letters). AMDR - The Association of Medical Devices Reprocessors is working with the FDA to establish additional standards specifically for the reprocessing industry. AAMI - The Association for Advancement of Medical Instrumentation provides standards for sterilization in this industry. The AAMI also distributes The Reuse of Single-Use Medical Devices Guidelines for Healthcare Facilities, originally published by the Canadian Healthcare Association. The AAMI recognizes the topic and has made a publication available for informational purposes. The book sets forth the issues to consider and provides a framework for implementation of a reuse program. APIC - The Association for Professionals in Infection Control and Epidemiology has a Principles and Practice manual. Chapter 129 on Reuse of Singleuse Devices gives an outline for hospitals to follow if implementing a reuse/reprocessing program in the hospital. AHA - The American Hospital Association issued a technical advisory bulletin in 1990 which states that all reprocessing should conform to established reuse policies. It then identifies steps to follow in assessing whether a device can be reprocessed/reused. AORN - The Association of Operating Room Nurses has an informal position statement published in March 1995 and 1997 in the AORN journal. It is similar to the AHA document. Reprocessing is recommended if the manufacturer provides instructions, or if the reprocessor can demonstrate and doc718 GASTROINTESTINAL ENDOSCOPY

ument that the effectiveness and integrity of the medical device is not compromised. It then outlines the same steps to follow in a reprocessing program. JCAHO - Joint Commission on Accreditation of Healthcare Organizations removed the standard that prohibited reprocessing disposable medical devices in 1995. However, written hospital policy needs to reflect this practice. ECRI - a non-profit healthcare research agency has published a book in 1997, Reuse of Single-Use Medical Devices: Making Informed Decisions. The book states ECRI does not formally approve of the reuse of any type or model of single-use device. Nevertheless, we acknowledge that the practice may be accomplished safely and effectively, provided the specific devices are known to be suitable candidates for reuse. CDC - The Center for Disease Control and Prevention states the recommendation against reprocessing and reusing single-use items has been removed. Legislation - The State of Illinois passed a bill that allows hospitals to reprocess devices provided the reprocessing company is FDA registered. The State of Connecticut proposed a bill that would prohibit reprocessing/reuse, which was unanimously defeated. What are the legal liability and responsibilities of the user/medical facility in terms of reuse? The legal liability of the user of a reprocessed device is unclear. The initial product is guaranteed by the manufacturer for its safety and effectiveness. Manufacturers may limit their liability by labeling the product single-use. Reuse of single-use items may put the user/medical facility at risk for claims of lower quality or increased risk of infection [15,16]. The 1987 FDAs compliance policy guide, chapter 24, addresses reuse and emphasizes the responsibility of the institution or manufacturer who resterilizes or reuses a device for the safety and effectiveness of the procedure. It sets forth three criteria that an institution should meet when reusing: (1) the device can be adequately cleaned and sterilized; (2) the physical characteristics and quality of the device will not be adversely affected; and (3) the device
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TABLE 2 Suggested protocol for reuse program [5] Components

1. Establish feasibility What materials are used in the construction of the device? Can the device be effectively reprocessed? At what point should the product be discarded because of material or functional degradation? How can the number of reuses be controlled? Testing Development Training Projected volume Labor for each employee involved in reprocessing (including cost of employee benefit) Administering costs for developing and maintaining protocol and procedure, and quality assurance program Training costs Processing costs Equipment costs Laboratory testing costs Care and handling of the device after use Transportation to central processing Inspection Performance testing Cleaning Sequential marking Preparation for sterilization Sterilization Aeration Packaging Delivery to user department Storage Validate the effectiveness of the recommended sterilization exposure time to kill all microorganisms Validate the effectiveness of the recommended aeration time to remove all toxic residues from the device Validate the effectiveness of the cleaning procedure to remove all protein soil on the device Validate the effectiveness of packaging to maintain sterility Validate the effectiveness of entire reprocessing to maintain product integrity

2. Assessment of new technology for reprocessing 3. Preliminary cost analysis

4. Development of processing procedures

5. Validation of effectiveness of the processing procedures

6. Employee training program 7. Quality assurance program

remains safe and effective for its intended use[16]. The current JCAHO infection control standards state that there shall be written guidelines for the selection, storage, handling, use and disposition of disposable items[21]. It is the expectation of the FDA and JCAHO that these criteria be met. It may be advisable for the user or medical facility to set up a reuse committee to monitor in-house reprocessing or activities of the reprocessing company (Table 2), and to develop a quality assurance program to insure the reprocessed devices are safe to be reused (Table 3). If an outside reprocessing company is used it is up to the hospital reuse committee to select a competent company, monitor its performance, and ensure that the reprocessed devices meet expectations. The committee may conduct site visits, scrutinize the reprocessing companys protocols and ensure that they meet the hospitals requirements. To help monitor the quality of the reprocessed items,
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reprocessing companies should randomly select reprocessed devices to be tested by an independent laboratory periodically and the results of these tests should be routinely provided to the hospital. FINANCIAL CONSIDERATIONS Many single-use items are marketed at a lower price than comparable reusable accessories. The literature on the cost effectiveness of reprocessing single-use accessories is limited. A recent report by Kozarek et al showed that there is a substantial cost saving in the reuse of disposable sphincterotomes [22]. Most reprocessing companies charge a reprocessing fee of 50% of the original purchase price for the single-use item. This is often significantly higher than the cost of in-house reprocessing because it includes all charges such as shipping and independent laboratory testing fees. However, calculations based on a saving of $60 per case for a unit that handles 200 cases a month still show an estiGASTROINTESTINAL ENDOSCOPY 719

TABLE 3 Proposed quality assurance program to monitor reprocessed devices [2] Components
1. Sterility Is the resterilized device as safe, from an infection control point of view, as the original device supplied by the manufacturer? Is the packaging as reliable? What are the maximum number of resterilizations permitted?

2. Free of any toxic chemical residues and pyrogens? 3. Functional reliability 4. Biocompatibility 5. Legal and liability issues

6. Economics

7. Workplace hazards

8. Ethics

What tests/standards were used to ascertain biocompatibility of devices that are implanted in or which have significant contact with body tissues and fluids? Does the hospital carry liability insurance for reused items? Does reuse violate any federal or state or accreditation laws or regulations? If problems arise, who in the hospital is liable? Will the hospital subject itself to the regulations of the Bureau of Medical Devices? Does the hospital actually save money by reprocessing? (Is there a break even point?) Should the hospital pocket the savings or return them to the patient (or the insurer)? Should the patient be charged the same for a reprocessed device as a new one? Will such cost savings be negated by reduced third-party payments? Is the hospital equipped to prevent infection and chemical hazards that are associated with reprocessing? Will there be restrictions on the reuse of items previously used on patients with certain infections or diseases? Who will get the reprocessed device and who will get the new one? Should patients be informed that they are being treated with reused items? While the hospitals are gathering the information on safety and effectiveness, will the hospital inform the patients that they are part of a clinical trial? Will this be a randomized, controlled trial? Will all patients have an equal opportunity to participate, or withdraw? Will the manufacturer be informed that its product is being tested?

mated yearly cost saving of $144,000 if a reprocessing program is used [23]. Furthermore, reuse decreases the environmental impact of medical waste on land fill. COMPARISON TO AVAILABLE TECHNOLOGY What are the potential advantages offered by reprocessing companies over in-house reprocessing? Establishing an effective reprocessing service at the point of use is often confounded by problems such as limited resources, manpower, training, facilities and lack of information to reprocess different accessories. Reprocessing companies have resources including expensive equipment to meet the high standard of sterilization. They are more focused and can process a large number of selected items safely and efficiently. Many reprocessing companies have liability insurance policies that indemnify the customers for legal claims arising from company services based on an occurrence based policy. Typically, they provide industry standard product liability coverage and a single use warranty for the reprocessed items similar to the original manufacturer. The limits of Commercial

General Liability is usually 1 million for each occurrence and 10 million for aggregate or excess liability. What endoscopic accessories are being reprocessed? The majority of items reprocessed are disposable medical devices or surgical equipment. Some companies reprocess endoscopic accessories but the total number of endoscopic items are still very few (Table 4) [23]. SUMMARY Reprocessing of endoscopic accessories has been carried out in many medical facilities, however, there is no information comparing in-house reprocessing with the use of an outside reprocessing company. Although shifting the reprocessing to a reprocessing company reduces the workload, it does not relieve the user/medical facility of its responsibility. In the absence of an industry standard, consistent regulatory enforcement, and established quality control criteria, the reprocessing service should be selected carefully and subsequently monitored. The reprocessing of single-use items remains controVOLUME 48, NO. 6, 1998

TABLE 4 OJI Surgical

GI lab Instruments Contact FDA/GMP FDA Number Warranty Turn-around time Manual cleaning Ultrasound cleaner Eth oxide/H2O2 Pressure chamber Dosimeter Chemical Bacterial spore test Recycle impllants Items for recycle Yes 800-609-9465 Yes 1834002 Yes 10-12 working days Yes Yes Yes No Yes Yes No Biopsy forceps Cannula Endoscopic grasper Endoscopic scissor Laser fiber

Applied Med Tech

Yes 888-888-3433 Yes 1822513 Yes

Anew Med Enterpri

Yes 801-634-9359 Yes pending Yes

Paragon/SRS Vanguard
Yes 800-548-9547 Yes 1643155 Yes Yes 941-683-8680 Yes 1056126 Yes

Yes 510-687-1900 Yes 1648562 Yes

Yes Yes Yes Yes ? ? No Biopsy forceps Snares

Yes Yes Yes No Yes Yes No Biopsy forceps

Yes Yes Yes No Yes Yes No Biopsy forceps Biliary stents ERCP catheter Guidewire

Yes Yes Yes No Yes Yes No Biopsy forceps Biliary catheters

Yes Yes Yes Yes Yes Yes No Snare Biopsy forceps Retrieval basket Gastroenteric tube

Glidewire Bipolar forceps Laser probe Endoscopic cautery Variject Flexiflo CL biliary stent Soehendra stent retr Phoenix AZ 5,000,000 sent St. George, UT 1,000,000 pickup Houston TX 5,000,000 pickup Lakeland FL 1,000,000 sent Houston TX 1,000,000 pickup

Based in Liability $ Collection

Portland OR 1,000,000 pickup

versial and the position of the FDA is awaited. Further studies evaluating the safety and cost effectiveness of reprocessing of single-use items are necessary.
1. Sullivan P. Speakers offers vastly different views on disposable healthcare products. Can Med Assoc 1990;143:1342-5. 2. Greene VW. Reuse of disposable medical devices: historical and current aspects. Am Infect Control 1986;7:508-13. 3. English N. Reprocessing disposables: one strategy to balance cost reduction and quality patient care. Today Surg Nurse 1996:July/Aug:23-6. 4. Kozarek RA. Coming clean on reuse of endoscopic equipment. Gut 1998; 42:155-6. 5. Reichert M. Reuse of single-use devices - a program model. Nurs Clin Am 1993;28:697-709. 6. Raltz S, Kozarek RA, Pethigal PA, Moorhouse MA, Merriam LD. Reusable biopsy forceps: a cost effective measure for the endoscopy suite. Gastroenterol Nurs 1995;18:167-70. 7. Radany MH, Perry S, McCallum D. Is it safe to reuse disposables? Am Nurs 1987;35-9. VOLUME 48, NO. 6, 1998

8. Crow S. The slings and arrows of outrageous fortune. Am Infec Control 1986;7:561-3. 9. Campbell BA, Wells GA, Palmer WN, Martin DL. Reuse of disposable medical devices in Canadian hospitals. Am Infect Control. 1987;15:196-200. 10. Wilkinson M, Simmons N, Bramble M, Leicester R, DSilva J, Boys R, et. al. Report of the Working Party of the Endoscopy Committee of the British Society of Gastroenterology on the reuse of endoscopic accessories. Gut 1988;42:304-6. 11. Kozarek RA. Raltz SL, Merriam D, Sumida SE. Disposable versus reusable biopsy forceps: a prospective evaluation of cost. Gastrointest Endosc 1996;43:10-3. 12. Kimmey MB, Al-Kawas FH, Gannan RM, Saeed ZA, CarrLocke DL, Edmundowicz SA, et al. Disposable endoscopic accessories. Gastrointest Endosc 1995;42:618-9. 13. Kozarek RA, Sumida SE, Raltz SL, Meriam LD, Irizarry DC. In vitro evaluation of wire integrity and ability to reprocess single-use sphincterotomes. Gastrointest Endosc 1997; 45:117-21. 14. Cohen J, Haber GB, Kortan P, Dorais AL, Scheider DM, Cirocco M, et al. A prospective study of the repeated use of sterilized papillotomes and retrieval baskets for ERCP: quality and cost analysis. Gastrointest Endosc 1997;45:122-7. GASTROINTESTINAL ENDOSCOPY 721

15. The reuse of single-use medical devices: guidelines for healthcare facilities. Canadian Healthcare Association. Ottawa, Ontario; CHA Press:1996. 16. Special report: third party reprocessing companies. ECRI chapter 10. 1997. p.75-81. 17. Riordan J, Cotliar W. Complying with FDA Good Manufacturing Practice Requirements. Association for the Advancement of Medical Instrumentation Arlington, VA:1992. 18. Technical advisory bulletin: reuse of disposable medical devices. American Hospital Association; Chicago: 1986. 19. Bisson C, McRae G, Shaner H. An ounce of prevention: waste reduction strategies for healthcare facilities. American Society for Healthcare Environmental Services Chicago: 1993. 20. Clinical issues. Assoc Oper Room Nurs 1995;61:561-82. 21. Joint Commission on the Accreditation of Healthcare Organizations Standards, scoring guidelines and aggregation rules. Surveillance, prevention and control of infection standards. 1996:453-66. 22. Kozarek RA, Raltz SL, Ball TJ, Patterson DJ, Brandabur JJ. One year prospective study reusing disposable sphincterotomes for diagnostic and therapeutic ERCP. Gastrointest Endosc. In press.

23. Reference materials from the following reprocessing companies: 1. Applied Medical Technologies, Phoenix, AZ. 2. Anew Medical Enterprises, Inc., St. George, UT. 3. OJI Surgical Inc., Portland, OR. 4. ORRIS Company, Houston, TX. 5. Sterile Reprocessing Services, Inc., Houston, TX. 6. Van Guard Medical Concepts, Inc., Lakeland, FL.

Prepared by: Technology Assessment Committee David L. Carr-Locke, MD, Chair MitchellI. I. Conn, MD Douglas O. Faigel, MD Karen Laing, RN, CGRN Joseph W. Leung, MD Michael R. Mills, MD Douglas B. Nelson, MD Paul R. Tarnasky, MD Irving Waxman, MD



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