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The legal and economic forces that will shape the international market for cybersurgery
Author(s) -
McLean Thomas R.
Publication year - 2006
Publication title -
the international journal of medical robotics and computer assisted surgery
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.556
H-Index - 53
eISSN - 1478-596X
pISSN - 1478-5951
DOI - 10.1002/rcs.109
Subject(s) - liability , malpractice , business , health care , legal liability , medical malpractice , medical emergency , law , medicine , finance , political science
Background Despite the common use of medical devices most health care providers have little understanding how a device alters medical malpractice litigation. Such knowledge will be increasingly valuable as cybersurgery (i.e. remote robotic surgery) becomes routine. Methods Review of the laws governing products and telecommunication liability. Results Litigation after cybersurgery will be complex. In addition to being able to sue physicians and hospitals, patients who sustain an adverse outcome after cybersurgery will have the potential to sue the robotic manufacturer and telecommunication company. Robotics manufacturers can obtain virtual immunity from liability if they elected to place their devices on the market after obtaining §360 per‐market approval from the FDA. However, because §360 pre‐market approval is expensive and time consuming most medical devices on the market (including the robotic surgical instruments) do not have immunity to products liability. Consequently, after an adverse cybersurgical outcome a manufacturer of a robotic surgical instrument faces liability for failure to warn, design defects, and failure to properly manufacture. As for telecommunication providers, existing law provides them with immunity from liability. Conclusions Litigation following cybersurgery will involve multiple defendants who are likely to use “finger pointing” defenses. Accordingly, there will be liability traps associated with providing cybersurgery. Copyright © 2006 John Wiley & Sons, Ltd.