Cardiovascular devices are clearly an important subject of MDR regulation. Over a third of all reports received by FDA involved cardiovascular devices, and over 70% of those reports involved death or serious injury. Heart valves, defibrillator, ventilators and pacemakers accounted for nearly half of all reports involving death and over a third of all reports involving serious injury.
The frequency of reports about a device reflects all risks associated with the device. Device manufacturers often attempt to classify risks according to whether or not they are inherent (unavoidable) or extrinsic (avoidable). However, from the point of view of the individual who suffers the harm, risks due to a manufacturing defect or inadequate labeling are no different from risks due to misuse or risks due to the condition of a patient. Thus, all risks are associated with both inherent and extrinsic factors, and, while no activity can be completely risk free, much of the harm that would otherwise result from a specific risk can be avoided by minimizing the change that the risk will cause the harm.
A better point of view would be to accept risk as an inevitable part of all human activity and to try to minimize it by careful planning and applying lessons learned from past harm. The cost of this planning and these lessons should be borne by users who benefit from the reduced risk.
This suggests that medical device regulation should be as concerned with harm resulting from any cause as it is presently with harm caused by malfunctioning devices. While device regulation naturally focuses on devices, risk minimization requires focus on all sources of injury. To remedy this situation, it is suggested that Congress broaden the regulatory authority of FDA to include heath care providers and other potential sources of patient injury.
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