Going 90 in a 55 M.P.H. speed zone: Reprocessing of used single-use medical devices and the Food and Drug Administration's non-enforcement of the Food, Drug, and Cosmetic Act

Food and Drug Law Journal

Volumn 56, Issue 1, 2001, Pages 57-76

  Karst, Kurt R ^a  

^a Phelps and McNamara   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DEVICE; DISPOSABLE EQUIPMENT; ECONOMIC ASPECT; FOOD AND DRUG ADMINISTRATION; INSTRUMENT STERILIZATION; LAW; POLICY; REVIEW; SAFETY; TECHNOLOGY;

DISPOSABLE EQUIPMENT; EQUIPMENT REUSE; EQUIPMENT SAFETY; GUIDELINES; HISTORY, 20TH CENTURY; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0035059755     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (145)

1. Throughout this article, the terms "disposable device," "single-use device," and "used single-use device" are used synonymously.
2. The terms "reprocessor" and "third-party reprocessor" are used synonymously throughout this article to refer to manufacturers of reprocessed used s ingle-use devices.
3. FDA suggests the following definitions for the terms reprocessing and reuse: Reuse: The repeated use or multiple use of any medical device including devices intended for reuse or single-use, with reprocessing (cleaning, disinfection or sterilization) between uses. Reprocessing: Reprocessing includes all the steps performed to make a contaminated reusable or single-use device patient-ready. The steps may include cleaning, functional testing, repackaging, relabeling, disinfection, or sterilization. Guidance for Industry and for FDA Staff: Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals, OC, Division of Enforcement III, Center for Devices and Radiological Health (CDRH), FDA. (Aug. 14, 2000) [hereinafter Enforcement - Final]. The final guidance was noticed in the Federal Register. See 65 Fed. Reg. 49,583 (Aug. 14, 2000). The term reprocessed is used throughout this article to refer to the process through which reprocessed used single-use devices are manufactured. The term reuse is used throughout this article to refer to the practice of using reprocessed used single-use devices.
4. OEM refers to the original manufacturers of single-use devices.
5. The scope of this article is limited to reprocessed used single-use medical devices that are reprocessed by third-party reprocessing companies or hospitals or other healthcare facilities. Specifically excluded from analysis in this article are single-use devices that are opened but unused and which may be reprocessed subsequently.
6. Reprocessors use various cleaning agents and methods to reprocess single-use devices. These agents and methods include Ethylene Oxide (EtO), peracetic acid, and high temperature/pressure steam. See generally 43 Fed. Reg. 27,474 (June 23, 1978) (discussing the use of EtO to sterilize medical devices and proposing to establish residue and exposure limits for EtO); Velvi W. Greene, Disinfection & Sterilization: Reuse of Disposable Devices, HOSP. EPIDEMIOLOGY & INFECTION CONTROL, 1996, at 947-48 (discussing the development of steam autoclaving).
7. Reprocessors use various cleaning agents and methods to reprocess single-use devices. These agents and methods include Ethylene Oxide (EtO), peracetic acid, and high temperature/pressure steam. See generally 43 Fed. Reg. 27,474 (June 23, 1978) (discussing the use of EtO to sterilize medical devices and proposing to establish residue and exposure limits for EtO); Velvi W. Greene, Disinfection & Sterilization: Reuse of Disposable Devices, HOSP. EPIDEMIOLOGY & INFECTION CONTROL, 1996, at 947-48 (discussing the development of steam autoclaving).
8. Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301 et seq. (1994)).
9. 21 U.S.C. §§ 351, 352 (FDCA §§ 501, 502).
10. See id. § 360e (FDCA § 515).
11. See id. § 360(k) (FDCA § 510(k)). FDA and its expert panels, however, have exempted certain new devices from 510(k) and PMA requirements because these requirements were not deemed necessary to ensure the safety of the devices.
12. See Guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device, Office of Device Evaluation (ODE), CDRH, FDA, at 9-11 (Jan. 10, 1997).
13. See Letter from Larry Spears, Director, Division of Enforcement III, Office of Compliance (OC), CDRH, FDA, to Stephen Terman, Esq., Olsson, Frank & Weeda, P.C. (July 9, 1999) [hereinafter Spears Letter] ("Third-party reprocessing of devices labeled for single use is unlawful unless those engaged in this practice comply with all regulatory requirements for manufacturers, including premarket notification requirements. FDA has exercised and will continue to exercise regulatory discretion for all premarket notification requirements.").
14. Several case reports of patient injuries due to reprocessed single-use devices have been reported. See Dietrich Hallermann, M.D. & Gurinder Singh, M.D., Iatrogenic Central Retinal Artery Embolization: A Complication of Cardiac Catheterization, 16 ANNALS OF OPHTHALMOLOGY 1025 (Nov. 1984) (reporting an incident whereby the tip of a reprocessed single-use catheter broke off and lodged in the central retinal artery of the right eye of the patient); Susanna C. Bahne et al., Parental Report of Pediatric Tracheostomy Care, 79 ARCH. PHYS. MED. REHABIL. 1367 (Nov. 1998) (reporting on the occurrence of pneumonia among pediatric patients from the use of reprocessed single-use tracheostomy tubes);
15. Several case reports of patient injuries due to reprocessed single-use devices have been reported. See Dietrich Hallermann, M.D. & Gurinder Singh, M.D., Iatrogenic Central Retinal Artery Embolization: A Complication of Cardiac Catheterization, 16 ANNALS OF OPHTHALMOLOGY 1025 (Nov. 1984) (reporting an incident whereby the tip of a reprocessed single-use catheter broke off and lodged in the central retinal artery of the right eye of the patient); Susanna C. Bahne et al., Parental Report of Pediatric Tracheostomy Care, 79 ARCH. PHYS. MED. REHABIL. 1367 (Nov. 1998) (reporting on the occurrence of pneumonia among pediatric patients from the use of reprocessed single-use tracheostomy tubes);
16. see also Arlington Mem'l Hosp. Found., Inc. v. Baird, 991 S.W.2d (Tex. 1999) (involving injury to the eye of a patient from possible reuse of a single-use phacoemulsification tip).
17. See, e.g., Greene, supra note 6, at 952 (criticizing the assumption that reprocessing is economically efficient), But cf, Pamela J. Furman, Third-Party Reprocessing: Conserving Health-Care Resources, 20 MED. DEVICE & DIAGNOSTIC INDUSTRY 26, 28 (Oct. 1998) (arguing that the economic incentive for hospitals to contract with third-party reprocessing companies is significant).
18. See, e.g., Greene, supra note 6, at 952 (criticizing the assumption that reprocessing is economically efficient), But cf, Pamela J. Furman, Third-Party Reprocessing: Conserving Health-Care Resources, 20 MED. DEVICE & DIAGNOSTIC INDUSTRY 26, 28 (Oct. 1998) (arguing that the economic incentive for hospitals to contract with third-party reprocessing companies is significant).
19. See, e.g., Janet K. Schultz, Ethical Considerations for Reusing Single-Use Medical Devices, 4 SURGICAL SERVICES MGMT. 11 (July 1998) (discussing the ethical aspects of using reprocessed used single-use devices in patients without patient consent).
20. See, e.g., Janice M. Hogan & Thomas E. Colonna, Products Liability Implications of Reprocessing and Reuse of Single-Use Medical Devices, 53 FOOD & DRUG L.J. 385 (1998) (discussing the potential products liability issues that arise as a result of device failure and patient infection from reprocessed single-use devices).
21. See, e.g., ECRI, Special Report: Reuse of Single-Use Medical Devices: Making Informed Decisions, at 5 (1997) ("The reuse of single-use medical devices has the potential both to reduce healthcare costs and to harm patients.").
22. Pub. L. No. 79-404, 60 Stat 237 (1946) (codified at 5 U.S.C. §§ et seq. (1994)).
23. See infra notes 84 to 117 and accompanying text.
24. See infra notes 118 to 128 and accompanying text.
25. See infra note 130 and accompanying text.
26. See International Conference on the Reuse of Disposable Medical Devices in the 1980's, March 29-30, 1984, at 95 [hereinafter Reuse in the 80s] (statement of A.K. DasGupta, Ph.D., Director, Bureau of Medical Devices, Department of Health and Welfare, Canada); Jonathan S. Kahan & Jeffrey N. Gibbs, Reuse of Disposable Medical Devices: Regulatory and Liability Issues, 2 HEALTHSPAN 12 (1985) [hereinafter Kahan/Gibbs]. In the United States alone, the market for disposable medical devices is expected to exceed $55 billion by the year 2004. See News in Brief: Disposables Market to Reach $55 Billion by 2004, CLINICA, Apr. 3, 2000, at 2.
27. See International Conference on the Reuse of Disposable Medical Devices in the 1980's, March 29-30, 1984, at 95 [hereinafter Reuse in the 80s] (statement of A.K. DasGupta, Ph.D., Director, Bureau of Medical Devices, Department of Health and Welfare, Canada); Jonathan S. Kahan & Jeffrey N. Gibbs, Reuse of Disposable Medical Devices: Regulatory and Liability Issues, 2 HEALTHSPAN 12 (1985) [hereinafter Kahan/Gibbs]. In the United States alone, the market for disposable medical devices is expected to exceed $55 billion by the year 2004. See News in Brief: Disposables Market to Reach $55 Billion by 2004, CLINICA, Apr. 3, 2000, at 2.
28. See International Conference on the Reuse of Disposable Medical Devices in the 1980's, March 29-30, 1984, at 95 [hereinafter Reuse in the 80s] (statement of A.K. DasGupta, Ph.D., Director, Bureau of Medical Devices, Department of Health and Welfare, Canada); Jonathan S. Kahan & Jeffrey N. Gibbs, Reuse of Disposable Medical Devices: Regulatory and Liability Issues, 2 HEALTHSPAN 12 (1985) [hereinafter Kahan/Gibbs]. In the United States alone, the market for disposable medical devices is expected to exceed $55 billion by the year 2004. See News in Brief: Disposables Market to Reach $55 Billion by 2004, CLINICA, Apr. 3, 2000, at 2.
29. See Pharmaceutical Research and Manufacturers of America, PHARMACEUTICAL INDUSTRY PROFILE 1999, at 41 (citing Organization for Economic Cooperation and Development, Health Data 1998).
30. ECRI, Special Report: Reuse of Single-Use Medical Devices: Making Informed Decisions, at 1 (1997) ("[T]he economic pressure to cut costs [] is behind today's decisions to reuse . . . single-use medical devices.").
31. See Reuse in the 80s, supra note 22, at 107 (statement of Edward R. Duffie, Jr., M.D., Vice President, Medical Affairs, Becton Dickinson and Co.).
32. Letter from David Feigal, Jr., M.D., M.P.H., Director, CDRH, FDA, to Larry Pilot, McKenna and Cuneo, L.L.P. at 1 (Oct. 6, 1999) (FDA Docket No. 99P-1516) (responding to a citizen petition from the Medical Device Manufacturers of America requesting FDA to ban reprocessed single-use devices, FDA stated that it need not take action on reprocessed single-use devices until there is "clear evidence that reprocessing presents an unreasonable and substantial risk of illness or injury").
33. See Reuse in the 80s, supra note 22, at 108 (statement of Edward R. Duffie, Jr., M.D., Vice President, Medical Affairs, Becton Dickinson and Co.); Kahan & Gibbs, supra note 22, at 12.
34. See Reuse in the 80s, supra note 22, at 108 (statement of Edward R. Duffie, Jr., M.D., Vice President, Medical Affairs, Becton Dickinson and Co.); Kahan & Gibbs, supra note 22, at 12.
35. See FDA's Proposed Strategy on Reuse, CDRH, FDA (Nov. 3, 1999), at 2 [hereinafter Proposed Strategy] ("Because most of the reusable devices were fabricated from glass, rubber, or metal, early reprocessing of reusable products . . . involved little more than hand-wiping, dipping, and soaking and disinfection solutions. . . ."). This document was noticed in the Federal Register at 64 Fed. Reg. 59, 782 (Nov. 3, 1999).
36. See id.
37. Reuse in the 80s, supra note 22, at 108 (statement of Edward R. Duffie, Jr., M.D., Vice President, Medical Affairs, Becton Dickinson and Co.).
38. This very logic is inherent in the term "for single-use only." By their very nature, devices labeled "for single-use only" have not been proven safe and effective for multiple-use. Rather, the devices were designed, constructed, and tested for use in a single patient with no thought as to the effects of reprocessing on sterility and functionality.
39. The precise number of hospitals that use reprocessed single-use devices is uncertain, however, several surveys suggest that the number is significant. See United States General Accounting Office, Single-Use Medical Devices: Little Available Evidence of Harm From Reuse, but Oversight Warranted (June 2000), available at (last visited Mar. 5, 2000) www.gao.gov (stating that "accurate and comprehensive information about the number of facilities that use reprocessed [single-use devices] and the types of [single-use devices] that are reprocessed is not available, Surveys by professional organizations and other groups have found that approximately 20 to 30% of U.S. hospitals reported that they reuse at least one type of [single-use device and that at least one-third of the hospitals that do so contract with third-party reprocessing companies."); Survey: ORs are Split on Reuse of Single-Use Items, OR MANAGER, at 11 (Sept. 1999) (citing 26% with 36% providing no answer); see also Kahan & Gibbs, supra note 22, at 12 (citing 90%).
40. The precise number of hospitals that use reprocessed single-use devices is uncertain, however, several surveys suggest that the number is significant. See United States General Accounting Office, Single-Use Medical Devices: Little Available Evidence of Harm From Reuse, but Oversight Warranted (June 2000), available at (last visited Mar. 5, 2000) www.gao.gov (stating that "accurate and comprehensive information about the number of facilities that use reprocessed [single-use devices] and the types of [single-use devices] that are reprocessed is not available, Surveys by professional organizations and other groups have found that approximately 20 to 30% of U.S. hospitals reported that they reuse at least one type of [single-use device and that at least one-third of the hospitals that do so contract with third-party reprocessing companies."); Survey: ORs are Split on Reuse of Single-Use Items, OR MANAGER, at 11 (Sept. 1999) (citing 26% with 36% providing no answer); see also Kahan & Gibbs, supra note 22, at 12 (citing 90%).
41. The precise number of hospitals that use reprocessed single-use devices is uncertain, however, several surveys suggest that the number is significant. See United States General Accounting Office, Single-Use Medical Devices: Little Available Evidence of Harm From Reuse, but Oversight Warranted (June 2000), available at (last visited Mar. 5, 2000) www.gao.gov (stating that "accurate and comprehensive information about the number of facilities that use reprocessed [single-use devices] and the types of [single-use devices] that are reprocessed is not available, Surveys by professional organizations and other groups have found that approximately 20 to 30% of U.S. hospitals reported that they reuse at least one type of [single-use device and that at least one-third of the hospitals that do so contract with third-party reprocessing companies."); Survey: ORs are Split on Reuse of Single-Use Items, OR MANAGER, at 11 (Sept. 1999) (citing 26% with 36% providing no answer); see also Kahan & Gibbs, supra note 22, at 12 (citing 90%).
42. Reuse in the 80s, supra note 22, at 93 (statement of John C. Villforth, Director, CDRH, FDA); Kahan & Gibbs, supra note 22, at 12.
43. Reuse in the 80s, supra note 22, at 93 (statement of John C. Villforth, Director, CDRH, FDA); Kahan & Gibbs, supra note 22, at 12.
44. Reuse of Single-Use Medical Devices: Hearing Before the Subcomm. on Oversight & Investigations of the House Comm. on Commerce, 106-89, 106th Cong. (2000) [hereinafter Reuse Hearing] (statement of John H. Fielder, Ph.D., Villanova Univ.) ("[Reuse] is an unethical experiment because patients a) receive no benefits from being treated with a reprocessed device instead of a new one, b) are not told that they are being treated with a reprocessed device . . . and c) are not asked to give consent to the treatment.").
45. The members of one reprocessing advocacy group collectively claim to have reprocessed more than nine million devices labeled for single-use. See Reuse Hearing, supra note 34 (testimony of Vern Feltner, President, Alliance Medical Corp.).
46. See (21 U.S.C § 396) (FDCA § 906) (prohibiting FDA from interfering with the authority of Healthcare practitioners in the prescribing or administration of products under the jurisdiction of FDA); see also Letter from Rick Pollack, Executive Vice President, American Hospital Association, to FDA Dockets Management Branch (Apr. 11, 2000) (FDA Docket No. 00D-0053) (discussing FDA's authority over hospital-based reprocessing).
47. See 61 Fed. Reg. 52,602, 52,610 (Oct. 7, 1996) (including in the term "manufacturer" "any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use").
48. See Reuse in the 80s, supra note 22, at 94 (statement of John C. Villforth, Director, CDRH, FDA); Transcript of Dec. 14, 1999 FDA Public Meeting: PDA's Proposed Strategy on Reuse of Single Use Devices at 236-37 (Statement of Larry Kessler Sc.D., Director, Office of Surveillance and Biometrics (OSB), CDRH, FDA).
49. See Reuse in the 80s, supra note 22, at 94 (statement of John C. Villforth, Director, CDRH, FDA); Transcript of Dec. 14, 1999 FDA Public Meeting: PDA's Proposed Strategy on Reuse of Single Use Devices at 236-37 (Statement of Larry Kessler Sc.D., Director, Office of Surveillance and Biometrics (OSB), CDRH, FDA).
50. See Enforcement-Final, supra note 3, at 13.
51. See 21 U.S.C. § 360 (FDCA § 510); 21 C.F.R. Part 807 (2000).
52. See 21 U.S.C. §§ 360c, 360e (FDCA § 513, 515); 21 C.F.R. Parts 807, 814.
53. See 21 U.S.C. § 360i(a)-(c) (FDCA § 519(a)-(c)); 21 C.F.R. Part 803.
54. See 21 U.S.C § 360j (FDCA § 520(f)); 21 C.F.R. Part 820.
55. See 21 U.S.C. § 352 (FDCA § 502); 21 C.F.R. Part 801.
56. See 21 U.S.C. § 360i(e) (FDCA §519(e)); 21 C.F.R. Part 821.
57. See 21 U.S.C. § 360i(f) (FDCA § 519(f)); 21 C.F.R. Part 806.
58. Reuse in the 80s, supra note 22, at 93 (statement of John C. Villforth, Director, CDRH, FDA) (citing FDA Compliance Program Evaluation Report 7324.1 (May 17, 1976)).
59. See id.
60. FDA Compliance Policy Guide 7124,16, § 300.500, "Reuse of Medical Disposable Devices" (1987). This CPG subsequently was reissued in 1980 and 1981, and was revised in September 1987.
61. Id.
62. Id.
63. See id.
64. ACHE is an international professional society of nearly 30,000 healthcare executives that advocates for improving the health status of society by advancing healthcare management excellence. See ACHE (last visited Dec. 1, 2000) www.ache.org.
65. Letter from Lillian Gill, Director, OC, CDRH, FDA, to the ACHE, at 1 (Dec. 27, 1995).
66. Id.
67. HIMA is a medical technology trade association. Recently, the trade association changed its name to AdvaMed. The association's membership includes more than 800 medical device, diagnostic products, and health information systems manufacturers. AdvaMed's goal is to "promote a legal, regulatory and economic climate that advances healthcare by assuring worldwide patient access to the benefits of medical technology." AdvaMed (last visited Dec. 1, 2000) www.htmanet.com.
68. See HIMA Citizen Petition, at 1-2 (FDA Docket No. 97P-0377) (Sept. 5, 1997) (requesting FDA to apply "all applicable FDA regulations governing medical device manufacturing" to commercial reprocessors of disposable medical devices).
69. See Letter from Bruce Burlington, M.D., Director, CDRH, FDA, to Nancy Singer, Esq., Special Counsel, HIMA, at 2 (July 15, 1998) (FDA Docket No. 97P-0377).
70. See id. ("[R]eprocessors are also subject to medical device reporting, registration, and listing requirements.").
71. Id. at 2.
72. See id. ("FDA notes the current general absence of evidence of adverse patient outcomes attributed to the reuse of single-use devices.").
73. See Letter from Josephine Torrente, Esq., Hyman, Phelps & McNamara PC, to Lillian Gill, Director, OC, CDRH, FDA (Feb. 4, 1999) (informing FDA of reprocessors' use of published articles to educate others about the agency's position regarding reprocessing single-use devices).
74. AMDR is a trade organization that represents third-party reprocessors of single-use medical devices. AMDR's member companies perform approximately 80% of third-party reprocessing in the United States. See AMDR (last visited May 1, 2000) www.amdr.org.
75. Spears Letter, supra note 12, at 1 (emphasis added).
76. Id.
77. Id.
78. See S. 1542, 106th Cong., 1st Sess. (1999); H.R. 3148, 106th Cong., 1st Sess. (1999).
79. See S. 1233, 106th Cong., 1st Sess. (1999) (appropriating $1,000,000 to FDA for enforcement and oversight related to reprocessing single-use devices).
80. See Assembly Bill 1359, 1999-2000 Sess. (Cal. 1999); Senate Bill 80, 90th Leg., 1st Sess. (Ill. 1998).
81. E.g., from May 5-6, 1999, in Washington, D.C., FDA and the Association for the Advancement of Medical Instrumentation held a conference titled "Conference on the Reuse of Single-Use Devices." On November 10, 1999, FDA held an interactive teleconference titled, "Proposed FDA Strategy for Reuse of Single-Use Medical Devices." On December 14, 1999, FDA held a meeting in Gaithersburg, MD, titled "Open Meeting: FDA's Proposed Strategy on Reuse of Single-Use Devices."
82. Guidance for Industry and for FDA Reviewers: Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme, ODE, Division of Dental, Infection Control, and General Hospital Devices, CDRH, FDA (Feb. 8, 2000) [hereinafter RPS]. The RPS was noticed in the Federal Register. See 65 Fed. Reg. 7027 (Feb. 11, 2000).
83. Guidance for Industry and for FDA Staff: Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals, OC, Division of Enforcement III, CDRH, FDA, 65 Fed. Reg. 7027 (Feb. 11, 2000) [hereinafter Enforcement]. The Enforcement guidance was noticed in the Federal Register. See 65 Fed. Reg, 7027 (Feb. 11, 2000).
84. See Enforcement, supra note 72, at 2 (noting that "[t]he RPS assigns an overall risk to each SUD by addressing the risk of infection and the risk of inadequate performance following reprocessing").
85. Class I devices are defined as those devices 1) for which general controls, such as the prohibitions on adulteration and misbranding, are sufficient to provide reasonable assurance of safety and effectiveness; or 2) if such assurance is not available, those devices that are not represented for use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, and which do not present a potential unreasonable risk of illness or injury. See 21 U.S.C. § 360c(a)(1)(A) (FDCA § 513(a)(1)(A)).
86. Class II devices are defined as those devices for which the general controls used for Class I devices are insufficient to provide reasonable assurance of safety and effectiveness, and for which there is sufficient information to establish special controls, such as performance standards and postmarket surveillance, that will provide such assurance. See id. at § 360c(a)(1)(B) (FDCA § 513(a)(1)(B)).
87. See Enforcement, supra note 72, at 2 and 9. Section 206 of FDAMA added section 510(1) to the FDCA, which directs FDA to exempt certain Class I and Class II devices from premarket notification requirements. Section 510(1) provides that pursuant to a decision from FDA, certain Class I or II devices may be exempted from the premarket notification requirements. FDA may grant an exemption unless a device is intended for a use which is of substantial importance in preventing impairment of human health or it presents a potential unreasonable risk of illness or injury. See 21 U.S.C. § 360(1) (FDCA § 510(1)).
88. RPS, supra note 71, at 15 ("[T]he agency may continue to exercise its discretion to not actively enforce FDA requirements for longer periods of time than described below when there may be shortages of medically necessary devices or for other compelling reasons.").
89. Enforcement - Final, supra note 3.
90. In addition to the change from a risk-based to a class-based approach for determining the timing of the submission of 510(k)s or PMAs, FDA also established a one-year phase-in for active enforcement of non-premarket requirements for hospitals. The only non-premarket requirement that FDA immediately will enforce against hospitals is the MDR requirement. See Enforcement - Final, supra note 3 at 31.
91. See id. at 6 ("At a later date, FDA intends to examine on a case-by-case basis, the need to revoke exemptions from premarket requirements for class I and II exempt products based upon the risks that may exist due to reprocessing.").
92. See id. at 26 (explaining the conditions under which FDA will continue to use enforcement discretion).
93. In addition to the documents noted in this section, there were numerous miscellaneous FDA pronouncements that implied a changing agency policy on reprocessed used single-use devices. See, e.g., Warning Letter from Roger Lowell, District Director, Seattle District Office, FDA, to Timothy Cooke, President, The Electrode Store, Inc., at 2 (June 21, 1999) (warning the The Electrode Store that "[w]ith regard to the reusable monopolar and concentric needle electrodes . . . [it markets], CDRH has determined that a 510(k) is necessary because the indications have been changed from single-use to multiple-use"); Warning Letter from Lillian Gill, Director, OC, CDRH, FDA, to Robert Chester, Breath of Life, at 2 (May 9, 1997) (warning the manufacturer of a kit that was distributed with its emergency manual resuscitator for failing to submit a 510(k) for a change from single-use to reusable); see also Warning Letter from Edward R. Atkins, Acting Director, Florida District Office, FDA, to Louis L. Rudt, President, Visions in Endosurgery, Inc. (Jan. 6, 2000) (warning for failure to test EtO residues and device degradation); Warning Letter from Douglas Tolen, Director, Florida District Office, FDA, to Charles Masek, Jr., President and CEO, Vanguard Medical Concepts, Inc. (Oct. 14, 1999) (noting Vanguard's failure to appropriately adhere to the QSR by validating the sterilization process, recording data on various processes, and by incompletely sterilizing devices); Warning Letter from Douglas Tolen, Director, Florida District Office, FDA, to Rick Ferreira, CEO, Alliance Medical Corp. (Dec. 23, 1999) (finding numerous violations, including failure to maintain device history records, failure to monitor the production process, and inadequately trained personnel).
94. See infra 87.
95. See H.R. REP. No. 94-853, 94th Cong., 2d Sess. 12 (1976) ("[The MDA] . . . would prohibit . . . the marketing of a new device until the safety and effectiveness of the device has been established . . . . [The MDA] reflects the need to develop innovative new devices, consistent with the need to protect the subjects of device research.").
96. See infra notes 111-17 (arguing that FDA's discretionary non-enforcement of the premarket submission requirements against reprocessors and concurrent full enforcement against OEMs hold these similarly situated parties to different regulatory demands).
97. Pub. L. No. 94-295, 90 Stat 539 (codified at 15 U.S.C § 55; 21 U.S.C. §§ 301, 331, 334, 351, 352, 358, 360, 360c-360-k, 374, 379, 379a, 381 (1994)).
98. See H.R. REP. No. 94-853, 94th Cong., 2d Sess. 12 (1976) (noting that the purpose of requiring premarket review was to address congressional concern that post-marketing regulation of medical devices was inadequate to protect public health).
99. See 21 C.F.R. § 814.39 (stating that PMA supplements are required for new indications of use if they affect the safety or effectiveness of the device); 21 C.F.R. § 807.81(a)(3)(ii) (stating that premarket notifications are required for "[a] major change or modification in the intended use of the device").
100. See infra note 96 and accompanying text.
101. See Draft Guidance: Reprocessing and Reuse of Single Use Devices: Risk Categorization Scheme at 13, ODE, CDRH, FDA (Dec. 9, 1999) [hereinafter FDA Draft Proposed Strategy].
102. See infra note 101 and accompanying text.
103. Pub. L. No. 105-115, 111 Stat. at 2296 (amending 21 U.S.C. § 201 et. seq. (1994)).
104. See Reuse in the 80s, supra note 22, at 107-09 (statement of Edward R. Duffie, Jr., M.D., Vice President, Medical Affairs, Becton Dickinson and Co.).
105. See Letter from Josephine Torrente, Hyman, Phelps & McNamara, P.C., on behalf of the ADDM, to FDA Dockets Management Branch, at 12-14 (Feb. 1, 2000) (FDA Docket No. 99N-4491) (citing various examples of functional failures and infections from reprocessed devices). ADDM is a trade organization of OEMs that advocates for the equal enforcement of premarket submission requirements against reprocessors of used single-use devices.
106. See 21 C.F.R. § 807.81(a)(3)(ii).
107. See Guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device, ODE, CDRH, FDA, at 10-11 (Jan. 10, 1997) ("[A] common change[] that impact[s] intended use and usually would require submission of a 510(k) [is]: [] reuse of devices previously labeled 'single use only' . . . ."); Questions and Answers for the FDA Reviewer Guidance: Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities, CDRH, FDA, at 6 (Sept. 3, 1996) ("Question]; I have a device which is cleared for single use. If I want to market it as reusable what is required? A[nswer]: In order to market a single use device as reusable, a new 510(k) is required since there is a potential impact on the safety and effectiveness of the device."); see also Warning Letter from Roger Lowell, District Director, Seattle District Office, FDA, to Timothy Cooke, President, The Electrode Store, Inc., at 2 (June 21, 1999) (warning the The Electrode Store that "[w]ith regard to the reusable monopolar and concentric needle electrodes . . . [it markets], CDRH has determined that a 510(k) is necessary because the indications have been changed from single use to multiple use").
108. See Guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device, ODE, CDRH, FDA, at 10-11 (Jan. 10, 1997) ("[A] common change[] that impact[s] intended use and usually would require submission of a 510(k) [is]: [] reuse of devices previously labeled 'single use only' . . . ."); Questions and Answers for the FDA Reviewer Guidance: Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities, CDRH, FDA, at 6 (Sept. 3, 1996) ("Question]; I have a device which is cleared for single use. If I want to market it as reusable what is required? A[nswer]: In order to market a single use device as reusable, a new 510(k) is required since there is a potential impact on the safety and effectiveness of the device."); see also Warning Letter from Roger Lowell, District Director, Seattle District Office, FDA, to Timothy Cooke, President, The Electrode Store, Inc., at 2 (June 21, 1999) (warning the The Electrode Store that "[w]ith regard to the reusable monopolar and concentric needle electrodes . . . [it markets], CDRH has determined that a 510(k) is necessary because the indications have been changed from single use to multiple use").
109. See Guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device, ODE, CDRH, FDA, at 10-11 (Jan. 10, 1997) ("[A] common change[] that impact[s] intended use and usually would require submission of a 510(k) [is]: [] reuse of devices previously labeled 'single use only' . . . ."); Questions and Answers for the FDA Reviewer Guidance: Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities, CDRH, FDA, at 6 (Sept. 3, 1996) ("Question]; I have a device which is cleared for single use. If I want to market it as reusable what is required? A[nswer]: In order to market a single use device as reusable, a new 510(k) is required since there is a potential impact on the safety and effectiveness of the device."); see also Warning Letter from Roger Lowell, District Director, Seattle District Office, FDA, to Timothy Cooke, President, The Electrode Store, Inc., at 2 (June 21, 1999) (warning the The Electrode Store that "[w]ith regard to the reusable monopolar and concentric needle electrodes . . . [it markets], CDRH has determined that a 510(k) is necessary because the indications have been changed from single use to multiple use").
110. FDA Proposed Strategy, supra note 28, at 13 (stating that "[o]ne option the agency is considering is requesting OEMs to label their devices 'single-use' to provide, as part of the devices labeling, any information of which they are aware regarding the potential risks associated with reusing their [single-use devices]").
111. 21 U.S.C. § 352(a) (FDCA § 502(a)).
112. Id. § 352(f) (FDCA § 502(f)).
113. FDA Reviewer Guidance: Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities, CDRH, FDA, at 2 (April 1996).
114. See Janice M. Hogan & Thomas E. Colonna, Products Liability Implications of Reprocessing and Reuse of Single-Use Medical Devices, 53 FOOD & DRUG L.J. 385, 389 (1998) ("Although [Section 205 of FDAMA] appears to preclude FDA from requiring proof of "substantial equivalence" for off-label uses, the agency can require labeling for reuse and support testing. FDA, however, may require the original manufacturer, rather than the reprocessor, to provide this labeling if FDA determines that reuse is reasonably likely.").
115. A new 510(k) is required for "[a] major change or modification in the intended use of the device." 21 C.F.R. § 807.81(a)(3)(ii).
116. See Blue Book #k86-3: Determination of Intended Use for 510(k) Devices - Guidance for Industry and CDRH Staff, ODE, CDRH, FDA at 1 (Jan. 30, 1998) ("[T]he intended use of a device shall be determined by an evaluation of the proposed labeling for the device as submitted in the 510(k).").
117. 21 U.S.C. § 360c(i)(1)(E)(i)(I)-(II) (FDCA § 513(i)(1)(E)(i)(I)-(II)).
118. Determination of Intended Use for 510(k) Devices - Guidance for Industry and CDRH Staff, supra note 103, at 2.
119. Spears Letter, supra note 12, at 1 (emphasis added).
120. See Statement of Larry Kessler, Sc.D., Director, Office of Surveillance and Biometrics (OSB), CDRH, FDA, at the FDA Satellite Videoconference on the Proposed FDA Strategy for Reuse of Single Use Devices (Panel I) (Nov. 10, 1999) ("Some reports we have in that system suggest some problems associated with products that might have been reprocessed; so we might see cracking of some catheters, but I need to remind people who look to that system that it's an excellent system for signaling potential problems, but it's not great for cause and effect. It's not the same as systematic science to prove a problem. So we have some suggestions of some problems but they're limited and it's not clear or documented scientific evidence that we can count on.").
121. See, e.g., Reuse Hearing, supra note 34 (testimony of Vern Feltner, President, Alliance Medical Corp.).
122. During FDA Satellite Videoconference on the Proposed FDA Strategy for Reuse of Single-Use Devices (Nov. 10, 1999), one panel member/physician commented that if a reprocessed single-use device fails during a procedure, he simply discards the device. He made no mention of filing an MDR. See Statements of Douglas B. Nelson, M.D., Veterans Affairs Medical Center, Minneapolis, MN and Assistant Professor of Medicine, University of Minneapolis, at the FDA Satellite Videoconference on the Proposed FDA Strategy for Reuse of Single-Use Devices (Panel III) (Nov. 10, 1999).
123. There is also a disincentive to report reprocessed device failures due to physician and hospital liability. See FDA Compliance Policy Guide 7124.16, § 300.500, "Reuse of Medical Disposable Devices" (1987) ("[A]ny institution or practitioner who resterilizes and/or reuses a disposable medical device must bear full responsibility for its safety and effectiveness.").
124. FDA acknowledges that it "has not regulated OEMs, third-party reprocessors, and healthcare facilities in the same manner with respect to their [single-use devices]." FDA Draft Proposed Strategy, supra note 90, at 4.
125. 5 U.S.C. § 706(A)(2) (1994).
126. Id.
127. 806 F.2d 1081, 1089 (D.C. Cir. 1986) (citation omitted).
128. 963 F. Supp. 20, 28 (D.D.C. 1997) (citation omitted); see also United States v. Diapulse Corp. of Am., 748 F.2d 56, 62 (2d Cir. 1984) (holding that FDA must act "evenhandedly" and may "not 'grant to one person the right to do that which it denies to another similarly situated.'"); Willapoint Oysters, Inc. v. Ewing, 174 F.2d 676, 697 (9th Cir.), cert. denied, 338 U.S. 860 (1949).
129. See Guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device, ODE, CDRH, FDA, at 9-11 (Jan. 10, 1997).
130. See infra notes 127 to 128 and accompanying text.
131. RPS, supra note 71.
132. Enforcement, supra note 72.
133. Enforcement - Final, supra note 3.
134. In order to determine the level of risk of infection or device failure, FDA proposed a series of questions presented in two different flow charts. Based on the answers to the various questions, a reprocessed device will be "high," "moderate," or "low" risk. See RPS, supra note 71, at 23-24.
135. Class III devices are devices that cannot be classified as either Class I or Class II devices because insufficient information exists to determine if the application of general or special controls will provide reasonable assurance of safety and effectiveness, and which are purported for use in supporting or sustaining life or for a use of substantial importance in preventing impairment of human health, or which prevent an unreasonable risk of injury. See 21 U.S.C. § 360c(a)(1)(C) (FDCA § 513(a)(1)(C)).
136. Enforcement, supra note 72, at 9-10.
137. FDA indicated in the draft guidance that it might propose classification amendments that would result in a requirement for premarket notification for any reprocessed single-use device that is Class I-exempt or Class II-exempt and that FDA identifies as "moderate" or "high" risk. Until classification amendments are proposed and adopted, however, Class I-and Class II-exempt devices that are identified as "moderate" or "high" risk could be marketed without a 510(k). See Enforcement, supra note 72, at 2-3.
138. See, e.g., Letter from Sally L. Maher, Esq., Director, Regulatory Affairs/Clinical Research, Smith & Nephew, Inc., Endoscopy Division, to FDA Dockets Management Branch (June 1, 2000) (FDA Docket No. 00D-0053) (arguing that the current device classification system should be used to determine the timing of FDA's enforcement of premarket submission requirements).
139. See Enforcement - Final, supra note 3.
140. See Reuse Hearing, supra note 34 (statement of David W. Feigal, M.D., Director, CDRH, FDA). 128 21 U.S.C. § 360(m)(2) (FDCA § 510(m)(2)).
141. FDA could determine that a reprocessed single-use device is exempt from premarket requirements; however, the exemption must be granted under the normal process on a device-by-device basis rather than under the blanket exemption in FDA's final guidance document.
142. See generally Letter from Josephine Torrente, Hyman, Phelps & McNamara P.C., on behalf of the ADDM, to FDA Dockets Management Branch (Apr. 10, 2000) (FDA Docket No. 00D-0053) (criticizing the RPS and Enforcement draft guidances for their exclusion of premarket notification requirements for reprocessed devices that are exempt as single-use devices).
143. Moreover, the language used in FDA's August 2000 guidance document is unclear as to who bears the responsibility for maintaining the exemption on a particular device. The final guidance document states "At a later date, FDA intends to examine on a case-by-case basis, the need to revoke exemptions from premarket requirements for Class I and II exempt products based upon the risks that may exist due to reprocessing." Enforcement - Final, supra note 3, at 6. Whether this means an OEM must fight to maintain the exemption for their original device or whether a reprocess or must petition FDA to maintain the exemption for their reprocessed device is unclear. See SUD Reprocessing Guidance Retains Premarket Exemptions For Now, F-D-C Rep. "The Gray Sheet" (Aug. 7, 2000 at 5), ("FDA has not yet clarified whether it would remove the exemption for an originally made [single-use device] if it were to remove an exemption for reprocessors.").
144. Future Reuse Guidances Likely, Says FDA's Kessler in Exclusive Interview, DEVICE & DIAGNOSTICS LETTER at 2 (Aug. 11, 2000) (noting that FDA likely will issue future guidance documents on a review standard, open-but-unused single-use devices, and compliance visits).
145. In a recent article commissioned by ADDM and submitted to FDA titled "Scientific & Regulatory Considerations for the Review and Approval of Reprocessed Single Use Device Premarket Submissions," the authors suggest several factors FDA reviewers must consider in evaluating premarket submissions for reprocessed single-use devices. The article focuses on five key areas: 1) product physical integrity; 2) sterilization and cleaning; 3) biocompatability; 4) shelf life and packaging; and 5) labeling, and addresses the effects of reprocessing on each key area. Further, the article suggests the quantity and quality of data necessary in a premarket submission to prove the safety and effectiveness of a reprocessed single-use device.