Device-related litigation & clinical engineering.
The investigation of patient-related incidents often must include consideration of the role of the associated medical devices. In addition to being good practice from quality review perspectives, federally mandated MDR requirements generally need to include clinical engineering input. Medical devices also play a significant role in patient litigation aimed at medical providers, hospitals and device manufacturers. Clinical engineering has an important role to play in supporting and tracking litigation as it relates to medical equipment. This role requires an understanding of the litigation process and active participation as a claim progresses. It also should include careful evaluation of the assertions and defenses raised by the various parties both during and at the conclusion of litigation.
Hyman
W A
WA
Texas A&M University, Bioengineering Program, College Station 77843.
Neigut
J S
JS
D001698:Biomedical Engineering / Q000331:legislation & jurisprudence* / Q000458:organization & administration; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004282:Documentation; D004869:Equipment Safety; D006801:Humans; D007221:Industry / Q000331:legislation & jurisprudence; D016365:Liability, Legal; D008284:Maintenance and Engineering, Hospital / Q000331:legislation & jurisprudence; D010934:Planning Techniques; D012308:Risk Management / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration