McGivney W T
Physician Exec. 1992 Mar-Apr;18(2):54-5.
The author argues that the burden of proof for the safety and efficacy of some medical devices properly lies with the manufacturers of the devices and with the providers who use them. The controversy over breast implants is used as a case for this shift in the burden of proof of safety and effectiveness.
作者认为，某些医疗设备安全性和有效性的举证责任应由设备制造商和使用这些设备的供应商承担。围绕隆胸植入物的争议被用作安全性和有效性举证责任发生这种转变的一个案例。
