Regulatory and legal implications of reprocessing and reuse of single-use medical devices

Food and Drug Law Journal

Volumn 56, Issue 1, 2001, Pages 77-98

  Wang, Emil P ^a  

^a Morgan Lewis and Bockius LLP   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

COST BENEFIT ANALYSIS; COST EFFECTIVENESS ANALYSIS; DEVICE; DISPOSABLE EQUIPMENT; FOOD AND DRUG ADMINISTRATION; HEALTH MAINTENANCE ORGANIZATION; INFECTION RISK; LEGAL ASPECT; POLICY; REVIEW;

ALGORITHMS; DISPOSABLE EQUIPMENT; EQUIPMENT REUSE; EQUIPMENT SAFETY; GUIDELINES; HUMANS; LIABILITY, LEGAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0035058988     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (138)

1. Dana Hawkins, News You Can Use: Risky Recycling, 127 (11) U.S. NEWS & WORLD REP., Sept. 20, 1999, at 62 (referring to FDA reports of unsterile, potentially contaminated, and failed devices causing patient injury in hospitals).
2. Id. (stating that the medical device reprocessing industry generates about $20 million per year.) Pamela Furman, Executive Director, Association of Medical Device Reprocessors, claims that $700 million per year could be saved if hospitals took full advantage of this practice. Id.
3. Id.
4. See, e.g., FDA Single-Use Device Reuse Policy Expected to Solidify By Mid-2000, F-D-C REP. ("The Gray Sheet"), Dec. 20, 1999 (reporting how independent consultant Louis Mazzarese argued that results of 19 separate studies submitted to FDA demonstrate that approximately 75% of the reprocessed devices studied failed due to the presence of blood, non-functionality, and defective packaging, causing patient injuries; David Hambrick, Director, GI Lab at Montclair Baptist Medical Center in Birmingham, AL, cited internal results that 14 out of 24 reused SUDs failed sterility tests); Sylvan Plante et al., Reuse of Balloon Catheters for Coronary Angioplasty: A Potential Cost-Saving Strategy?, 24 (6) J. AM. C. CARDIOLOGY, 1475-81 (Nov. 15, 1994) (asserting how reuse strategy was associated with a higher rate of adverse events, prolonged procedure time and increased use of contrast medium, although whether these differences are related to the reuse strategy or to differences in patient groups could not be determined by this observational study); Clarence J. Gibbs et al., Transmission of Creutzfeldt-Jakob Disease to a Chimpanzee by Electrodes Contaminated During Neurosurgery, 57(6) J. NEUROLOGY, NEUROSURGERY, & PSYCHIATRY, 757-58 (June 1994) (reporting how chimpanzees became ill with Creutzfeldt-Jakob Disease (CJD) after stereotactic multicontact electrodes, used more than two years prior in a woman previously implicated in the accidental transmission of CJD to two younger patients, were implanted, despite repeated cleaning and sterilization attempts); E.J. Monti, The Safe Use of Disposable Syringes in Anesthesia: Cost Effective or Costly? 6 (2) CLINICAL F. FOR NURSE ANESTHETISTS 85-90 (May 1995) (reporting how reuse of disposable syringes, needles, and drug vials have resulted in observation of microscopic contamination, raising the risk of hazards of blood-borne disease transmission contaminated multidose vials have been associated with the transmission of hepatitis B and bacterial infections).
5. See, e.g., FDA Single-Use Device Reuse Policy Expected to Solidify By Mid-2000, F-D-C REP. ("The Gray Sheet"), Dec. 20, 1999 (reporting how independent consultant Louis Mazzarese argued that results of 19 separate studies submitted to FDA demonstrate that approximately 75% of the reprocessed devices studied failed due to the presence of blood, non-functionality, and defective packaging, causing patient injuries; David Hambrick, Director, GI Lab at Montclair Baptist Medical Center in Birmingham, AL, cited internal results that 14 out of 24 reused SUDs failed sterility tests); Sylvan Plante et al., Reuse of Balloon Catheters for Coronary Angioplasty: A Potential Cost-Saving Strategy?, 24 (6) J. AM. C. CARDIOLOGY, 1475-81 (Nov. 15, 1994) (asserting how reuse strategy was associated with a higher rate of adverse events, prolonged procedure time and increased use of contrast medium, although whether these differences are related to the reuse strategy or to differences in patient groups could not be determined by this observational study); Clarence J. Gibbs et al., Transmission of Creutzfeldt-Jakob Disease to a Chimpanzee by Electrodes Contaminated During Neurosurgery, 57(6) J. NEUROLOGY, NEUROSURGERY, & PSYCHIATRY, 757-58 (June 1994) (reporting how chimpanzees became ill with Creutzfeldt-Jakob Disease (CJD) after stereotactic multicontact electrodes, used more than two years prior in a woman previously implicated in the accidental transmission of CJD to two younger patients, were implanted, despite repeated cleaning and sterilization attempts); E.J. Monti, The Safe Use of Disposable Syringes in Anesthesia: Cost Effective or Costly? 6 (2) CLINICAL F. FOR NURSE ANESTHETISTS 85-90 (May 1995) (reporting how reuse of disposable syringes, needles, and drug vials have resulted in observation of microscopic contamination, raising the risk of hazards of blood-borne disease transmission contaminated multidose vials have been associated with the transmission of hepatitis B and bacterial infections).
6. See, e.g., FDA Single-Use Device Reuse Policy Expected to Solidify By Mid-2000, F-D-C REP. ("The Gray Sheet"), Dec. 20, 1999 (reporting how independent consultant Louis Mazzarese argued that results of 19 separate studies submitted to FDA demonstrate that approximately 75% of the reprocessed devices studied failed due to the presence of blood, non-functionality, and defective packaging, causing patient injuries; David Hambrick, Director, GI Lab at Montclair Baptist Medical Center in Birmingham, AL, cited internal results that 14 out of 24 reused SUDs failed sterility tests); Sylvan Plante et al., Reuse of Balloon Catheters for Coronary Angioplasty: A Potential Cost-Saving Strategy?, 24 (6) J. AM. C. CARDIOLOGY, 1475-81 (Nov. 15, 1994) (asserting how reuse strategy was associated with a higher rate of adverse events, prolonged procedure time and increased use of contrast medium, although whether these differences are related to the reuse strategy or to differences in patient groups could not be determined by this observational study); Clarence J. Gibbs et al., Transmission of Creutzfeldt-Jakob Disease to a Chimpanzee by Electrodes Contaminated During Neurosurgery, 57(6) J. NEUROLOGY, NEUROSURGERY, & PSYCHIATRY, 757-58 (June 1994) (reporting how chimpanzees became ill with Creutzfeldt-Jakob Disease (CJD) after stereotactic multicontact electrodes, used more than two years prior in a woman previously implicated in the accidental transmission of CJD to two younger patients, were implanted, despite repeated cleaning and sterilization attempts); E.J. Monti, The Safe Use of Disposable Syringes in Anesthesia: Cost Effective or Costly? 6 (2) CLINICAL F. FOR NURSE ANESTHETISTS 85-90 (May 1995) (reporting how reuse of disposable syringes, needles, and drug vials have resulted in observation of microscopic contamination, raising the risk of hazards of blood-borne disease transmission contaminated multidose vials have been associated with the transmission of hepatitis B and bacterial infections).
7. See, e.g., FDA Single-Use Device Reuse Policy Expected to Solidify By Mid-2000, F-D-C REP. ("The Gray Sheet"), Dec. 20, 1999 (reporting how independent consultant Louis Mazzarese argued that results of 19 separate studies submitted to FDA demonstrate that approximately 75% of the reprocessed devices studied failed due to the presence of blood, non-functionality, and defective packaging, causing patient injuries; David Hambrick, Director, GI Lab at Montclair Baptist Medical Center in Birmingham, AL, cited internal results that 14 out of 24 reused SUDs failed sterility tests); Sylvan Plante et al., Reuse of Balloon Catheters for Coronary Angioplasty: A Potential Cost-Saving Strategy?, 24 (6) J. AM. C. CARDIOLOGY, 1475-81 (Nov. 15, 1994) (asserting how reuse strategy was associated with a higher rate of adverse events, prolonged procedure time and increased use of contrast medium, although whether these differences are related to the reuse strategy or to differences in patient groups could not be determined by this observational study); Clarence J. Gibbs et al., Transmission of Creutzfeldt-Jakob Disease to a Chimpanzee by Electrodes Contaminated During Neurosurgery, 57(6) J. NEUROLOGY, NEUROSURGERY, & PSYCHIATRY, 757-58 (June 1994) (reporting how chimpanzees became ill with Creutzfeldt-Jakob Disease (CJD) after stereotactic multicontact electrodes, used more than two years prior in a woman previously implicated in the accidental transmission of CJD to two younger patients, were implanted, despite repeated cleaning and sterilization attempts); E.J. Monti, The Safe Use of Disposable Syringes in Anesthesia: Cost Effective or Costly? 6 (2) CLINICAL F. FOR NURSE ANESTHETISTS 85-90 (May 1995) (reporting how reuse of disposable syringes, needles, and drug vials have resulted in observation of microscopic contamination, raising the risk of hazards of blood-borne disease transmission contaminated multidose vials have been associated with the transmission of hepatitis B and bacterial infections).
8. Testimony by David W. Feigal, M.D., Director, Center for Devices and Radiological Health (CDRH), Before the Subcommittee on Oversight and Investigations, Committee on Commerce, U.S. House of Representatives, Feb. 10, 2000 [hereinafter Feigal Testimony] and presentation by Larry Kessler, Sc.D., FDA/CDRH/OSB to the Global Medical Device Conference on Jan. 2000 entitled "The Reuse of Single-Use Devices, FDA Proposed Strategy: Concept in Development" [hereinafter Kessler Presentation].
9. Premarket Requirements in sections 513 and 515 of the FDCA; 21 C.F.R. §§ 807, 814 (2000).
10. Reprocessors, OEMs Will Operate on "Level Playing Field," Feigal Testifies, F-D-C REP. ("The Gray Sheet"), Feb. 14, 2000 (Robert O'Holla, Vice President Regulatory Affairs, Johnson & Johnson, raised a concern that a "problem area" with the premarket requirements is reprocessing devices that are exempt from premarket requirements when originally manufactured.) Because the premarket requirements for reprocessors of SUDs under PDA's proposed regulatory strategy are identical to those for OEMs, reprocessors [and OEMs] would have to submit a 510(k) under 21 C.F.R. §§ 862-892.9(a) for a new intended use in claiming an SUD as reusable. The classification regulation for a medical device, as provided under 21 C.F.R. §§ 862-892, establishes the class for each type of device and specifies whether it is exempt from premarket requirements.
11. Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended 21 U.S.C. §§ 301 et seq. (1994)).
12. 64 Fed. Reg. 59,782-783 (Nov. 3, 1999).
13. Compliance Policy Guide 300.500 (formerly CPG 7124.16) (Sept. 24, 1987).
14. See Kessler Presentation, supra note 5.
15. See id.
16. See id.
17. See Feigal Testimony, supra note 5.
18. "Dear Colleague" Letter from D. Bruce Burlington, M.D., Director, CDRH, alert regarding a potential infection problem with reusable medical devices (Apr. 17, 1997).
19. Id.
20. GAO Inquiry Into Device Reprocessing, FDA Oversight to Be Sought by Senate, F-D-C REP., ("The Gray Sheet"), July, 26, 1999 [hereinafter GAO Inquiry].
21. S. 1542, 106th Cong. § 2 (1999); H.R. 3148, 106th Cong. § 2 (1999).
22. See S. 1542 proposed amendment by Senator Richard Durbin (D-IL) and H.R. 3148 proposed amendment by U.S. Representative Anna Eshoo (D-CA).
23. Peter Delevett, Reuse of Disposable Medical Devices Raises Concerns, 23 BUS. J., Nov 12, 1999.
24. See supra note 9.
25. See Feigal Testimony, supra note 5.
26. 64 Fed. Reg. 7027-29 (Feb. 11, 2000).
27. Draft Guidance for Industry and for FDA Staff - Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme, Rockville, MD, FDA/CDRH (Feb. 8, 2000).
28. Defined by the Draft SUD RPS Guidance as an acute healthcare facility.
29. See CPG 7124.12, issued on Oct. 1, 1980 and revised in Mar. 1995.
30. E.H. Spaulding, Chemical Disinfection and Antisepsis in the Hospital, J. HOSP. RES. 9, 5-31 (1972) (stating that a device is classified into a critical, semi-critical, or non-critical level, as assessed per the Spaulding criteria, which determines the type of device contact to a patient, user, or healthcare worker).
31. See 21 C.F.R. § 807.87(i)(2) (1999) and described in 21 C.F.R. § 807.94.
32. See id. § 20.61(a), which states that a trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of . . . the end product, and 21 C.F.R. § 20.61(b), which specifies that commercial information (valuable data or information) is privileged or confidential and not available for disclosure to the public.
33. See GAO Inquiry, supra note 17.
34. Id.
35. Biopsy devices are Class II devices requiring 510(k) notification submissions, described under the following FDA regulations: 21 C.F.R. §§ 876.1075, 876,1500, and 876.4300.
36. Draft Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology, Rockville, MD, FDA/CDRH, undated.
37. Draft Guidance for Industry and for FDA Staff-Enforcement Priorities for Single-Use Devices Reprocessed by Third-Parties and Hospitals, Rockville, MD, FDA/CDRH (Feb. 8, 2000).
38. See FDA Single-Use Device Reuse Policy Expected to Solidify, supra note 4 and accompanying text.
39. Final Guidance for Industry and for FDA Staff-Enforcement Priorities for Single-Use Devices Reprocessed by Third-Parties and Hospitals, Rockville, MD, FDA/CDRH (Aug. 14, 2000).
40. See FDA Single-Use Device Reuse Policy Expected to Solidify, supra note 4 and accompanying text.
41. 21 U.S.C §§ 360c, 360e (FDCA §§ 513, 515); 21 C.F.R. §§ 807, 814. Either a premarket notification 510(k)) or a premarket application (PMA) will be required depending upon the device classification scheme. For premarket regulations, evidence must be provided to address the reprocessed SUD's safety and effectiveness. A reprocessor may need to include clinical data in support of a premarket submission. It should be noted that FDA requires a satisfactory inspection of the manufacturing facility [hospital or third-party reprocessor] before a PMA application may be approved, in accordance with the Quality System (QS) regulation.
42. 21 U.S.C. § 360i (FDCA § 510); 21 C.F.R. § 807; Form FDA-2891 ("Initial Registration of Device Establishment"); Form FDA-2892 ("Medical Device Listing"). Establishments who process devices must register their establishment with FDA and provide a list of their devices. A separate Form FDA-2892 must be submitted for each category or type of device that a reprocessor reprocesses.
43. 21 U.S.C. § 360i(a), (b), (c) (FDCA § 519 (a), (b), (c)); 21 C.F.R. § 803 (1999); 65 Fed. Reg. 4112-121 (Jan. 6, 2000). If a serious adverse event involving a reprocessed (or any other) device occurs in a hospital, user facilities and distributors are expected to submit an MDR. FDA also would conduct an investigation and take appropriate action, as necessary.
44. 21 U.S.C. § 360i(f) (FDCA § 520(f)); 21 C.F.R. § 820. QS regulation requirements include design controls (21 C.F.R. § 820.30; see FDA/CDRH, Design Control Guidance for Medical Device Manufacturers (Mar. 11, 1997); corrective and preventive action (21 C.F.R. § 820.100); and process validation requirements (21 C.F.R. § 820.75); see Guideline on General Principles of Process Validation, Rockville, MD, FDA/CDRH (last visited Feb. 1, 2001) www.fda.gov/cdrh/ode/425.pdf. See also "Guide to Inspections of Quality Systems" (last visited Feb. 1, 2001) www.fda.gov/ora/inspect_ref/igs/ qsit/QSITGUIDE.pdf and Medical Device Quality Systems Manual: A Small Entity Compliance Guidance, Rockville, MD, FDA/CDRH (last visited Feb. 1, 2001) www.fda.gov/cdrh/dsma/gmp_man.html.
45. 21 U.S.C. § 360i(f) (FDCA § 520(f)); 21 C.F.R. § 820. QS regulation requirements include design controls (21 C.F.R. § 820.30; see FDA/CDRH, Design Control Guidance for Medical Device Manufacturers (Mar. 11, 1997); corrective and preventive action (21 C.F.R. § 820.100); and process validation requirements (21 C.F.R. § 820.75); see Guideline on General Principles of Process Validation, Rockville, MD, FDA/CDRH (last visited Feb. 1, 2001) www.fda.gov/cdrh/ode/425.pdf. See also "Guide to Inspections of Quality Systems" (last visited Feb. 1, 2001) www.fda.gov/ora/inspect_ref/igs/ qsit/QSITGUIDE.pdf and Medical Device Quality Systems Manual: A Small Entity Compliance Guidance, Rockville, MD, FDA/CDRH (last visited Feb. 1, 2001) www.fda.gov/cdrh/dsma/ gmp_man.html.
46. 21 U.S.C. § 360i(f) (FDCA § 520(f)); 21 C.F.R. § 820. QS regulation requirements include design controls (21 C.F.R. § 820.30; see FDA/CDRH, Design Control Guidance for Medical Device Manufacturers (Mar. 11, 1997); corrective and preventive action (21 C.F.R. § 820.100); and process validation requirements (21 C.F.R. § 820.75); see Guideline on General Principles of Process Validation, Rockville, MD, FDA/CDRH (last visited Feb. 1, 2001) www.fda.gov/cdrh/ode/425.pdf. See also "Guide to Inspections of Quality Systems" (last visited Feb. 1, 2001) www.fda.gov/ora/inspect_ref/igs/ qsit/QSITGUIDE.pdf and Medical Device Quality Systems Manual: A Small Entity Compliance Guidance, Rockville, MD, FDA/CDRH (last visited Feb. 1, 2001) www.fda.gov/cdrh/dsma/ gmp_man.html.
47. 21 U.S.C. § 352 (FDCA § 502); 21 C.F.R. § 801). See Guidance on Labeling Regulatory Requirements for Medical Devices, Rockville, MD, FDA CDRH.
48. 21 U.S.C. § 360i(e) (FDCA § 519(e)); 21 C.F.R. § 821). See Guidance on Medical Device Tracking, Rockville, MD, FDA/CDRH (last visited Jan. 24, 2000) www.fda.gov/cdrh/modact/ tracking.pdf.
49. 21 U.S.C. § 360i(f) (FDCA §519(f)); 21 C.F.R. § 806). For example, the corrections and removal regulation would be applicable requiring a report to FDA if a hospital reprocessed an SUD that results in a patient experiencing an adverse health event and the hospital pulls the remaining devices from the suspect batch or lot off their shelves to reduce the risk to health.
50. See Feigal Testimony, supra note 5 (asserting that a review of Medical Device Reports (MDR) submitted by manufacturers and received by CDRH from August 19, 1996, through December 7, 1999, reveal that 464 reports out of 300,000 adverse events could possibly be attributed to reuse of an SUD). An FDA/CDRH/OSB analysis of voluntary Manufacturers and Users Devices Experience (MAUDE) reports submitted by user facilities and distributors since 1993 through the MedWatch program indicate that 245 total reports were associated with SUD reuse, with 7 deaths, 72 patient injuries, and 147 device malfunctions.
51. GAO Report to the Chairman, Committee on Governmental Affairs, United States Senate, Washington, D.C. GAO; 1986 Dec. 12/9. Report No. GAO/PEMD-87-1 (This report studied the number of device-related accidents and injuries as compared to the number reported to FDA. It was determined that 99% of all problems associated with the selected devices, including those that could or did cause injury, had not been reported to PDA.). See also Delevett, supra note 20 (reporting U.S. Representative Anna Eshoo (D-CA) making a statement that FDA "doesn't have a system to track reprocessing, making it difficult to know how widespread [the problem] is").
52. Pub. L. No. 105-115, 111 Stat. 2296 (1997) (amending 21 U.S.C. §§ 201 et seq. (1994)).
53. Amending 21 U.S.C. § 360i(b).
54. Id.
55. See GAO Inquiry, supra note 17.
56. Id.
57. Id.
58. See Single-Use Device Reprocessing: No Added Regs for Hospitals, AHA Says, F-D-C REP., ("The Gray Sheet"), Nov. 15, 1999, and Feigal Testimony, supra note 5.
59. See Janice M. Hogan & Thomas Colonna, Products Liability Implications of Reprocessing and Reuse of Single-Use Medical Devices, 53 FOOD & DRUG L.J. 385 (1998).
60. Id.
61. Id.
62. Department of Health and Human Services regulations are found at 45 C.F.R. § 46.116(a) (2000); FDA regulations are found at 21 C.F.R. §§ 50.25(a)(5), 812.100; Health Care Financing Administration regulations are found at 42 C.F.R. § 405 (2000).
63. 21 C.F.R. § 50.
64. See supra note 7.
65. Id.
66. Final Guidance for Hemodialyzer Labeling, Rockville, MD, FDA/CDRH (1995).
67. Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance, Rockville, MD, FDA/ODE (Apr. 1996).
68. 21 C.F.R. § 801.
69. See Hogan & Colonna, supra note 54, at 389.
70. Id. at 391 (citing Medtronic v. Lohr, 116 S. Ct. 2240 (1996)). The extent to which FDCA preempts state product liability claims has long been disputed; however, the Supreme Court recently clarified the scope of federal preemption in Medtronic. Medtronic involved the issue of whether section 360k of the FDCA preempts plaintiffs from bringing a common-law state claim. Medtronic, 116 S. Ct. at 2245. The Court held that "[n]othing in [section] 360k denies . . . the right to provide a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements." Id. at 2255. In Medtronic, the Court held that defective design claims are not pre-empted by an FDA determination of "substantial equivalence" through the 510(k) premarket notification process. Id. at 2254. The Court also concluded that the plaintiff's defective labeling claims were not pre-empted by 510(k) clearance. Id. at 2258. The Court did not reach the issue of whether premarket approval by FDA would preempt these types of state law claims.
71. Id.
72. Section 402A provides: (1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if (a) the seller is engaged in the business of selling such a product, and (b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold. (2) the rule stated in subsection (1) applies although (a) the seller has exercised all possible care in the preparation and sale of his product, and (b) the user or consumer has not brought the product from or entered into any contractual relation with the seller. RESTATEMENT (SECOND) OF TORTS § 402A (1965). A new tentative draft of the Restatement has been issued, but is not yet final. RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY, PROPOSED FINAL DRAFT (Apr. 1, 1997). The Proposed Final includes section 6, which specifically covers liability for prescription drugs and medical devices and would significantly modify section 402A.
73. See Linda A, Sharp, Annotation, Liability of Hospital or Medical Practitioner Under Doctrine of Strict Liability in Tort, or Breach of Warranty, for Harm Caused by Drug, Medical Instrument, or Similar Device Used in Treating Patient, 65 A.L.R. 5th 357 (1999).
74. RESTATEMENT (SECOND) § 402A.
75. Id. at Comment A.
76. See Hogan & Colonna, supra note 54, at 392; Violette v. Smith & Nephew Dyonics, 62 F.3d 8 (1st Cir. 1995) (holding design of endoscope used for carpal tunnel syndrome procedure defective), cert. denied, 116 S. Ct 1568 (1996); Airco, Inc. v. Simmons First Nat Bank, 638 S.W.2d 660 (Ark. 1982) (awarding compensatory and punitive damages for design and manufacturing defects of a selector valve, an optional accessory on the ventilator, which caused irreversible brain damage).
77. See Hogan, supra note 54, at 392; Carlin v. Superior Ct., 920 P.2d 1347 (Cal. 1996) (holding failure to provide adequate warnings for prescription drug); Air Shields, Inc. v. Spears, 590 S.W.2d 574 (Tex. 1979) (holding incubator manufacturer liable for failure to furnish appropriate warnings related to the risk of giving supplemental oxygen).
78. See infra note 87, RESTATEMENT (THIRD), section 6, Comment F. 74 See Hogan & Colonna, supra note 54, at 392; Fulton v. Pfizer Hosp. Prods. Group, 872 S.W.2d 908, 912 (Tenn. 1993) (holding doctrine of res ipsa loquitor has application only to law of negligence and does not apply to products liability action based on breach of warranty).
79. See infra note 87, RESTATEMENT (THIRD), section 6, Comment C.
80. Id. at Comment B.
81. See infra notes 105-109 and accompanying text.
82. Id. at Comment G; see Porter v. Pfizer Hosp. Prods. Group, 783 F. Supp. 1466, 1474-75 (D. Me. 1992) (holding hip prosthesis manufacturer had no duty to warn surgeons as to product misuse that was not reasonably foreseeable at the time of sale).
83. Comment K of section 402A states: There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use . . . . Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous . . . . The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known [,] but apparently unreasonable risk. RESTATEMENT (SECOND), supra note 69, § 402A Comment K.
84. See Hogan & Colonna, supra note 54, at 394; Tansy v. Dacomed Corp., 890 P.2d 881, 885 (Okla. 1994) (contending that Comment K affirmative defense can be applied to products liability action against manufacturer of penile implant).
85. See Hogan & Colonna, supra note 54, at 401.
86. Id. at 394; see W. PAGE KEETON ET AL., PROSSER & KEETON ON THE LAW OF TORTS § 102, 711-12 (5th ed. 1984 & Supp. 1988).
87. Id. at 394; see W. PAGE KEETON ET AL., PROSSER & KEETON ON THE LAW OF TORTS § 102, 711-12 (5th ed. 1984 & Supp. 1988).
88. See Hogan & Colonna, supra note 54, at 394.
89. See infra section IV-B on breach of warranty claims.
90. See Sharp, supra note 68; Silverhart v. Mount Zion Hosp., 20 Cal. App. 3d 1022 (1971) (holding that a hospital furnishing a surgical needle as part of the medical services it provides is not a seller engaged in the business of selling such needles, and liability of the hospital or physician would be based on negligence or intentional misconduct in the use of the needle); North Miami Gen. Hosp., Inc. v. Goldberg, 520 So. 2d 650 (Fla. 1998) (holding that strict liability requires that defendant be in the business as a manufacturer, distributor or within the product's distribution chain based on the rationale that those who profit from the sale or distribution of a product should bear the financial burden of undetectable product defects); Easteryly v. HSP of Texas, Inc., 772 S.W.2d 211 (Tex. 1989) (holding that there can be no strict liability for defective services, in which the "sale" of an epidural kit was integrally related to the medical procedure and thus lost its separate character as a good).
91. See Hogan & Colonna, supra note 54, at 394; Fugate v. AAA Mach., 593 F. Supp. 392, 393 (E.D. Tenn. 1984) (noting that the drafters of the Model Uniform Product Liability Act recommended that sellers of used products who rebuilt or remanufactured products should be subject to strict liability); Rollins v. Cherokee Warehouses, Inc., 635 F. Supp. 136, 137-38 (E.D. Tenn. 1986); Richardson v. Gallo Equip. Co., 990 F.2d 330 (7th Cir. 1993). In Richardson, Judge Posner stated, "[A]ny reconstruction or reconditioning [as distinct from a mere repair . . . ] which has the effect of lengthening the useful life of a product beyond what was contemplated when the product was first sold starts the statute of [limitations] running anew . . . . Otherwise, the statute would create an inefficient incentive to reconstruct or recondition old products rather than new ones, in order to reduce expected liability costs; for under such a regime [,] a product rebuilt after ten years would be immunized from liability." Id. at 331.
92. RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY, PROPOSED FINAL DRAFT, Apr. 1, 1997, section 8 (Liability of Commercial Seller or Distributor of Defective Used Products).
93. See, e.g., Cruz v. Midland-Ross Corp., 813 F. Supp. 628, 632 (N.D. Ill. 1993) (holding that evaluation of strict tort or negligence liability for the seller of used products turns on whether the seller is the simple conduit for the transaction or has assumed a more intrusive and affirmative role by either warranting the condition of the product, or inspecting, reconditioning, or rebuilding the product); Whitaker v. T.J. Snow Co., Inc., 953 F. Supp. 1034, 1044-45 (N.D. Ind. 1997).
94. See supra note 67, at Comment H.
95. It is often unclear as to whether a reprocessor is a "seller in the business of selling" the reconditioned product; see Hogan & Colonna, supra note 54 and accompanying text. Similarly, courts have explained that a seller, as part of its commercial, profit-producing activity, is continuously involved in placing a particular product or line of products in the stream of commerce through selling the product to other persons or business entities. See Anderson v. Olmstead Util. Equip., 573 N.E.2d 626, 630-31 (Ohio 1991) (referring to Model Uniform Product Liability Act (U.P.L.A.) §§ 102[B] and 104). An entity is not a "seller" for purposes of the Act where the product is sold only incidentally or in an isolated transaction in an attempt to dispose of it.
96. See Sharp, supra note 68.
97. See Hogan & Colonna, supra note 54, at 395. In Rollins, the court held that a reconditioner must be engaged in the business of the selling the product to be held liable. Rollins, 635 F. Supp. at 138. Furthermore, the court asserted, "This means that the seller, as part of its commercial, profit-producing activity, is continuously involved in placing a particular product or line of products in the stream of commerce through selling the product to other persons or business entities." Id.
98. See Sharp, supra note 68.
99. See PROSSER & KEETON, supra note 82, at 679-81.
100. See, e.g., supra notes 33 and 61-62.
101. See Hogan & Colonna, supra note 54, at 397; Thompson v. Nason Hosp., 591 A.2d 703, 706 (Pa. 1991) (noting that hospital could be subject to corporate liability if it failed to uphold a proper standard of care, had actual or constructive knowledge of defect or procedures which created harm, and its negligence was a substantial factor in bringing about harm to patient); Pedroza v. Bryant, 677 P.2d 166 (Wash. 1984) (stating that the standard of care to which hospitals will be held under corporate-negligence doctrine is that of an average, competent practitioner in the same or similar circumstances); see also W.E. Shipley, Annotation, Hospital's Liability to Patient for Injury Sustained From Defective Equipment Furnished by Hospital for Use in Diagnosis or Treatment of Patient, 14 A.L.R. 3d 1254 (1967) (citing Sough Highlands Infirmary v. Camp, 180 So. 2d 904 (Ala. 1965) (asserting that equipment furnished by a hospital for a patient's use should be reasonably fit for the uses and purposes intended under the circumstances)).
102. See Hogan & Colonna, supra note 54, at 397; Thompson v. Nason Hosp., 591 A.2d 703, 706 (Pa. 1991) (noting that hospital could be subject to corporate liability if it failed to uphold a proper standard of care, had actual or constructive knowledge of defect or procedures which created harm, and its negligence was a substantial factor in bringing about harm to patient); Pedroza v. Bryant, 677 P.2d 166 (Wash. 1984) (stating that the standard of care to which hospitals will be held under corporate-negligence doctrine is that of an average, competent practitioner in the same or similar circumstances); see also W.E. Shipley, Annotation, Hospital's Liability to Patient for Injury Sustained From Defective Equipment Furnished by Hospital for Use in Diagnosis or Treatment of Patient, 14 A.L.R. 3d 1254 (1967) (citing Sough Highlands Infirmary v. Camp, 180 So. 2d 904 (Ala. 1965) (asserting that equipment furnished by a hospital for a patient's use should be reasonably fit for the uses and purposes intended under the circumstances)).
103. Murillo v. Good Samaritan Hosp., 99 Cal. App. 3d 50, 56-57 (1979) (emphasis in original).
104. Thompson, 591 A.2d at 707.
105. See Hogan & Colonna, supra note 54, at 396.
106. Schlotfeldt v. Charter Hosp., 910 P.2d 271 (Nev. 1996) (holding that vicarious liability requires existence of employer-employee relationship).
107. Berel v. HCA Health Serv., Inc., 881 S.W.2d 21 (Tex. App 1994) (holding that if a hospital retains the right to control the details of the work to be performed by a contracting party, a master-servant relationship exists that will authorize the application of the doctrine of respondeat superior) (emphasis added).
108. See, e.g., Sword v. NKC Hosp., Inc., 661 N.E.2d 10 (Ind. App. 1996) (holding that hospitals may be liable for negligence of their apparent agents (independent physician contractors) where a reasonable patient could conclude that the healthcare professional was an employee or agent of the hospital and patient acted in reliance on the conduct of the hospital); Henderson v. Marx, 674 N.Y.S.2d 247 (1998) (holding that hospital may be vicariously liable for a physician's malpractice when the patient sought medical care from the hospital rather than from a particular physician, even where the alleged negligent physician was an independent contractor).
109. See Hogan & Colonna, supra note 54, at 398 (citing, Reeves v. Acromed Corp., 44 F.3d 300 (5th Cir. 1995) (holding physician liable for using metal bone implant for spine rather than labeled use in long bones of upper or lower extremities).
110. Id.
111. Phillip W. Fiscus, Managing Expectations: Building a Strong Offense Against Medical Device Reuse Litigation, MED. DEVICES LITIG. REP. 11 (July 7, 1998).
112. Id.
113. See Hogan & Colonna, supra note 54, at 399 (referencing F. Chu et al., Reuse and Reprocessing of Disposable Medical Devices: Legal Liability Issues, 3 J. HEALTH CARE TECH. 5-11 (1986).
114. See Hogan & Colonna, supra note 54, at 399 (referencing F. Chu et al., Reuse and Reprocessing of Disposable Medical Devices: Legal Liability Issues, 3 J. HEALTH CARE TECH. 5-11 (1986).
115. Id. (citing Porter, 783 F. Supp. at 1466); see also Piper v. Bear Med. Sys. (Ariz. App. 1993) (holding ventilator manufacturer liable for design defect due to reasonably foreseeable misuse by respiratory therapists, who modified expiratory arm by adding parts, including bacterial filters, and that manufacturer was aware of this practice).
116. 21 C.F.R. § 801.4 (2000).
117. See Hogan & Colonna, supra note 54, at 398 (referencing Ronald Lafferty & Allan Giboffsky, Regulatory and Legal Issues in the Reprocessing and Reuse of Hemodialyzers, 9 J. LEGAL MED. 279-311 (1988); see also Ronni P. Solomon, 12(4) ANESTHESIA PATIENT SAFETY FOUND. NEWSLETTER 35-36 (1997-98).
118. See Hogan & Colonna, supra note 54, at 398 (referencing Ronald Lafferty & Allan Giboffsky, Regulatory and Legal Issues in the Reprocessing and Reuse of Hemodialyzers, 9 J. LEGAL MED. 279-311 (1988); see also Ronni P. Solomon, 12(4) ANESTHESIA PATIENT SAFETY FOUND. NEWSLETTER 35-36 (1997-98).
119. See Hogan & Colonna, supra note 54, at 398 (referencing Ronald Lafferty & Allan Giboffsky, Regulatory and Legal Issues in the Reprocessing and Reuse of Hemodialyzers, 9 J. LEGAL MED. 279-311 (1988); see also Ronni P. Solomon, 12(4) ANESTHESIA PATIENT SAFETY FOUND. NEWSLETTER 35-36 (1997-98).
120. See Hogan & Colonna, supra note 54
121. Id.
122. See Hawkins, supra note 1, at 62.
123. See Hogan & Colonna, supra note 54; Sharp, supra note 68 and accompanying text.
124. See Hogan & Colonna, supra note 54, at 400 (citing PROSSER & KEETON ON THE LAW OF TORTS).
125. See Hogan & Colonna, supra note 54, at 400 (citing PROSSER & KEETON ON THE LAW OF TORTS).
126. U.C.C. § 2-314 (1996).
127. Id. § 2-315 (1996).
128. See Sharp, supra note 68 (citing Dorfman v. Austenal, Inc., 3 U.C.C. Rep. Serv. (CBC) 856 (N.Y. Sup. Ct. 1996) (exemplifying how court refused to apply theory of implied warranty of fitness because no seller-and-purchaser relationship existed using the "essence of the transaction" test)); see also Noralyn Harlow, Applicability of Warranty of Fitness Under UCC § 2-315 to Supplies or Equipment Used in Performance of Service Contract, 47 A.L.R. 4th 238 (1986) (citing Redwine v. Baptist General Convention of State of Okl., 681 P.2d 1121 (Okla. Ct. App. 1982) (exemplifying how court refused to apply theories of warranty of fitness and merchantability since healthcare providers are engaged principally in furnishing of professional services, and use of equipment is merely incidental to the provision of medical services. The charge for use of the medical equipment does not constitute a "sale" under the U.C.C.)). Cf. Skelton v. Druid City Hosp. Bd., 459 So. 2d 818 (Ala. 1984) (holding hospital subject to breach of warranty of fitness for a particular purpose where patient was injured when a reusable suturing needle broke and part of the needle was left inside of him, on the theory that hospital impliedly warranted that the needle was fit for its intended purpose, patient sought services and products necessary for service from hospital, patient was injured by the product associated with the services, and the patient relied on the skills and expertise of the hospital in selecting the product; therefore, hospital was a "seller" of goods within meaning of U.C.C. § 2-315).
129. U.C.C. § 2-313 (1996).
130. See Sharp, supra note 68.
131. See Hogan & Colonna, supra note 54, at 400 (citing Tatum v. Cordis Corp., 758 F. Supp. 457) (M.D. Tenn. 1991) (holding general promotional statement (that pacemaker was manufactured to high quality standards) was insufficiently specific to constitute an express warranty)).
132. See, e.g., Mallinckrodt, Inc. v. Medipart, 976 F.2d 800 (Fed. Cir. 1992) (holding that use of patented product beyond scope of patent limitation could constitute infringement where device labeling for "single use only" is a viable condition of sale, and where restriction is within patent's scope or otherwise reasonable); United States Surgical Corp. v. Orris, Inc., 5 F. Supp. 2d 1201 (D. Kan. 1998) (holding that repairing trademarked goods, without a likelihood of confusion between the original trademark and quality of the reconditioned product, does not constitute an improper use of the trademark); Kendall Co. v. Progressive Med. Tech., Inc., 85 F.3d 1570 (Fed. Cir. 1996) (holding an implied license to repair and replace components of a patented product).
133. B. Braun Med., Inc. v. Abbott Labs, 124 F.3d 1419, 1426 (Fed. Cir. 1997).
134. United States Surgical Corp., 5 F. Supp. 2d at 1205-06.
135. Id. at 1206.
136. Kendall, 85 F.3d at 1573.
137. Mallinckrodt, 976 F.2d at 709.
138. Id. at 708 (citing Lummus Indus. v. D.M. & E. Corp., 862 F.2d 267, 272 (Fed. Cir. 1988) and Everpure, Inc. v. Cuno, Inc., 875 F.2d 300 (Fed. Cir.), cert. denied, 493 U.S. 853 (1989)).