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53 Food & Drug L.J. 385 (1998)
Products Liability Implications of Reprocessing and Reuse of Single-Use Medical Devices

handle is hein.journals/foodlj53 and id is 421 raw text is: Products Liability Implications of Reprocessing and Reuse of Single-Use Medical Devices JANICE M. HOGAN * THOMAS E. COLONNA, PH.D. ** I. INTRODUCTION The practice of reprocessing and reusing devices that are intended for single use' presents potential products liability exposure due to the risk of device impairment through inappropriate or inadequate reprocessing techniques.2 The Federal Food, Drug, and Cosmetic Act (FDCA)3 does not provide a private right of action for patients injured by medical devices or drugs. Moreover, the Food and Drug Administration (FDA) does not presently regulate reprocessing entities as device manufacturers for most purposes.4 Nonetheless, reprocessors face potential liability in tort law under negligence or strict liability theories, or in contract law under breach of warranty theories. Furthermore, hospitals or other end-user facilities may be liable for negli- gent reprocessing or reuse of disposable devices by their employees or vicariously liable for these actions by agents, including third-party reprocessors. In addition, al- though individual physicians generally are not held liable under strict liability or breach of warranty theories because they are providers of medical services and not merchants of medical products,' they may be held liable, however, for negligent reuse of reprocessed devices. This review provides: 1) an overview of the economic forces fueling single-use device reprocessing and reuse; 2) a description of health risks associated with device reprocessing and reuse; 3) a summary of FDA's current policies regarding device reprocessing and reuse as they relate to reprocessors' potential liability; 4) an over- view of the legal framework for assessing products liability for industrial equipment reprocessors generally; and 5) an analysis of these general principles as applied to reprocessing of single-use medical devices. The review concludes with recommenda- tions to minimize potential liability by the outsourcing of disposable device reprocess- ing, the establishment of validation standards, and adequate training and communi- cation with employees. 'Ms. Hogan is an Associate in the law firm of Hogan & Hartson L.L.P., Washington, D.C. - Dr. Colonna is a Medical Device Specialist with the law firm of Hogan & Hartson L.L.P., Washington, D.C. The terms single use and disposable are used synonymously. 2While beyond the scope of this discussion, intellectual property rights claims have asserted that the repro- cessing (cleaning and resterilization) of a single-use device violates the original manufacturer's trademark and patent rights. E.g., Mallinckrodt, Inc. v. Medipart, Inc., 976 F.2d 700 (Fed. Cir. 1992) (holding manufacturer may prohibit buyer from reusing device under patent law if manufacturer's restriction was reasonably within patent grant); Kendall Co. v. Progressive Med. Tech., Inc., 85 F.3d 1570 (Fed. Cir. 1996) (holding supplier not liable for contributory infringement without direct infringement by device purchasers). 3 Federal Food, Drug, and Cosmetic Act, Pub. L. No. 75-717,52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301 et seq. (1994)). See infra discussion in section II1. See infra discussion in section IV.A.2.a. 385

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