Medical Device Risk Management

摘要

The risk management model for medical device design and manufacture has finally matured. Medical devices include such diverse products as pacemakers, drug-delivery systems, angioplasty catheters, disease-marker diagnostics, robotic surgical devices, devices for testing the domestic blood supply, and recombinant DNA. But fundamentally, they are systems like any others with hardware, software, mechanisms, materials, but also drugs, biologies, and a patient. With cutting-edge technology and the clinical nature of the patient's risks, device manufacturers are still scrambling to completely implement the full life-cycle requirements for risk management. The U.S. Food and Drug administration and the European Notified Bodies both expect manufacturers to comply with ISO/ANSI/AAMI 14971:2000 -Application of risk management to medical devices, in addition, of course, to a quality system similar to ISO 9001. But most companies still have lot to do to comply. Today, medical device designers are required by law to perform risk analysis (and typically FMECA and fault tree), hazard mitigation, software hazard analysis, mitigation verification, and traceability from requirements to validation. In addition, manufacturers are required to perform process validation (which should be risk-based), and field-failure tracking and reporting. For large, mature, corporations, this often manifests as a problem of integrating many diverse systems into one coherent risk-management structure. For small and start-up companies, the problem is typically obtaining funding for what may be viewed as "bureaucratic overhead." In every case, developing medical devices, one of the best export sectors of the U.S. economy, is a challenge. In time, risk management will actually speed time-to-market of a wide variety of devices which will be in great demand with our maturing society.