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Journal of Long-Term Effects of Medical Implants

ISSN Print: 1050-6934
ISSN Online: 1940-4379

Journal of Long-Term Effects of Medical Implants

DOI: 10.1615/JLongTermEffMedImplants.v18.i1.120
14 pages

Abstract of "Medical Devices−Research, Development, and Clinical Use Ethical Issues"

Vijay V. Rasquinha
Department of Orthopaedics Surgery and Rehabilitation Medicine, SUNY Downstate Medical Center 450 Clarkson Ave, Brooklyn, NY 11203

ABSTRACT

The practice of modern-day medicine is based on collaboration between the device manufacturing industry and physicians/surgeons. This symbiotic relationship has recognized ethical boundaries that protect patients on the one hand and benefit future patients on the other. Recent scrutiny of the physician-industry relationship dictates that physicians stay abreast of evolving regulations, guidance, and professional ethical codes. The key principles of compliance include honesty, transparency, disclosure, and accurate and detailed documentation. Current regulations include the Anti-Kickback Statute; False Claims Act; Food, Drug, and Cosmetic Act; and Stark II. In addition, there are professional society ethical codes such as AdvaMed, the American Medical Association, and specialty organizations such as the AAOS (American Academy of Orthopaedic Surgeons). Guidance to physician researchers is also provided by organizations such as the OIG, CMS, FDA, and ACCME.The spectrum of issues include gifts, meal invitations, investing in medical technology companies, relatives working for device manufacturers, reselling devices with a markup, consulting and advisory agreements, research grants, dinner presentations, royalties, disclosures, and informed consent. It is imperative that physician researchers avoid problems by appropriate education, being aware of questions that need to be asked of themselves, assessing fair market value, and providing bona fide services. Current rules are often conflicting and open to interpretation and may not always be consistent. It is critical that when there is doubt, physician researchers should seek advice from institutional compliance officers and legal counsel in order to protect ideas and develop innovative devices that will benefit patients in the future.