MDDI_Medical Device & Diagnostic Industry

MDDI, August 2013

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Risk Management Use, Misuse, and Abuse of the Device Failure Modes Effects Analysis The inductive risk analysis tool addresses design-related risks to users. G.M. SAMARAS Medical Device Risk Management During the late 1990s, there was a recognized need to codify engineering best practices for risk management, so they were available to the largest possible medical device engineering audience. The first comprehensive international consensus standard for risk management of medical devices (ISO 14971) was published in 2000 and amended in 2003. A second edition was published in 2007. ISO 14971 has been an FDA-recognized risk management consensus standard since 2001.4 In 2005, the Global Harmonization Task Force (GHTF), a voluntary international group of representatives from 78 | August 2013 magenta cyan yellow black medical device regulatory authorities and trade associations from Europe, the United States, Canada, Japan, and Australia, issued its final guidance on implementation of risk management within a medical device quality management system.5 Both of these documents provide medical device manufacturers with a structured, systematic approach to risk management. Medical device risk management is a necessary, although not sufficient, component of medical device design control.6, 7 Envision risk management as consisting of iterative risk analyses, followed by evaluation of the overall residual risks and generation of a risk management report. Risk analysis proceeds iteratively (Figure 1) as the medical device design evolves. It consists of the following: ■ Risk identification. Is a potential source of harm known or fore- seen? (Foreseeable risks include those associated with expected use, unexpected use, misuse, and abuse. They include the full range of use activities from acquisition through disposal.) ■ Risk evaluation. Do I really care? ■ Risk mitigation. Can I adequately control the targeted risk? Once the design is frozen, the acceptability of the overall residual risks is determined to evaluate whether the product is viable. A variety of tools can be used for risk analysis (Figure 2, p. 80). The tool chosen depends on two critical factors. First, will the risk analysis be inductive (bottom-up) or deductive (top-down)? Second, what Image courtesy of BLACKRED/istOCKPHOtO.COM T hose of us who work with medical device software are well aware of the radiation therapy software disaster in the mid1980s, in which patients received 100 times the intended dose of radiation due to a software defect. The incident prompted FDAregulation of medical device software.1 It is well established that even the simplest software can have complex and unpredictable behavior, even when it is developed in the structured, systematic manner prescribed by the principles and practices of modern software engineering. Risks creep into the best designs. Your best defense is a robust risk management process with valid decision making.2, 3 Complete and correct risk analysis is the basis of risk management for medical device design. It always has been, and will continue to be, crucial to the safety and effectiveness of medical devices, as long as we continue to develop new or modified products ES294499_MD1308_078.pgs 08.02.2013 02:09 UBM

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