Public Health Effectiveness of the FDA 510(k) Clearance Process Measuring Postmarket Performance and Other Select Topics: Workshop Report (2011) / Chapter Skim
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Appendix D: Trustworthy Medical Device Software
Appendix D: Trustworthy Medical Device Software
Pages 97-118
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From page 97... ...
This report draws upon material from research in software engineering and trustworthy computing, public FDA data, and accident reports to provide a high-level understanding of the issues surrounding the risks and benefits of medical device software. INTRODUCTION Software plays a significant and increasing role in the critical functions of medical devices.
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, medical devices that depend on software continue to injure or kill patients in preventable ways. Problems in medical device software result largely from a failure to apply well-known systems engineering techniques, especially during specification of requirements and analysis of human factors.
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. Human Factors Infusion pump: Patients Software that did not prevent key injured or killed by drug bounce misinterpreted key presses of overdoses.
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and the adoption of modern software engineering techniques can mitigate many of the risks of medical device software. Such techniques include a technical and managerial mindset that focuses on "design and development of the overall system" (Leveson, 1995)
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However, the methodology used in practice to mitigate risks inherent in software have not kept pace with the deployment of software-based medical devices. For example, using techniques that work well to assure the safety and effectiveness of hardware or mechanical components will not mitigate the risks introduced by software.
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For example, a Networking and Information Technology Research and Development Program (NITRD) report of the High-Confidence Medical Devices, Software, and Systems (HCMDSS)
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TECHNIQUES TO CREATE TRUSTWORTHY MEDICAL DEVICE SOFTWARE While the role of software in medical devices continues to increase in significance, deployment lags for well-known techniques that can mitigate many of the risks introduced by software. The following discussion draws from several technical documents on software engineering for critical systems.
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Leading software engineers believe that many medical device manufacturers have an opportunity to significantly improve specification of requirements. In comparing medical devices to avionics systems, researchers wrote in the NITRD report High-Confidence Medical Devices: Cyber-Physical Systems for 21st Century Health Care (NITRD, 2009)
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for critical systems such as found in medical devices. Under this philosophy, system designers focus on providing direct evidence to support claims about software dependability.
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Because medical devices are no longer isolated devices, an effective strategy for increasing trustworthiness is to follow good systems engineering methodology. Evaluation of medical device software should require independent, third-party review by experts who are not connected with the manufacturer.
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and diminished safety (e.g., overdoses from infusion pumps, radiation therapy, or implantable medical devices)
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Specify Outcome Measures, Not Technology The safety and effectiveness of software-based medical devices could be better regulated in terms of outcome measures rather than in terms of
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could assist in creating outcome measures for trustworthy medical device software. Collect Better Statistics on the Role of Software in Medical Devices Many questions about the trustworthiness of medical device software are difficult to answer because of lack of data and inadequate record keeping.
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Otherwise it will only be possible to point out anecdotal failures rather than confidently point out trends for successful products that epitomize innovation of trustworthy medical device software. Enable Open Research in Software‑Based Medical Devices The highly proprietary nature of the medical device software industry makes it difficult for innovators to build upon techniques of properly built systems.
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If a medical device relies on third party software such as operating systems, who is responsible for maintaining the software? Technology alone is unlikely to mitigate risks that stem from systemlevel interactions of complex software designed by different organizations with different agendas and outcome measures.
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Medical devices can outlast the underlying operating system software. Many medical devices rely on commercial off-the-shelf (COTS)
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Increase FDA Access to Outside Experts in Software Engineering The FDA should increase its ability to maintain safety and effectiveness of medical devices by developing a steady pipeline of human resources with expertise in software engineering for critical systems. Various offices within FDA's CDRH employ a small number of software experts.
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An interesting thought experiment is to ask how the trustworthiness of electronic health records differs from traditional paper records. FDA generally does not consider a paper medical record as a medical device.
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application have experience in software engineering -- even though the majority of medical devices today rely on software. The FDA should expand its access to outside experts for medical device software by creating fellowship programs that target software engineers.
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2009. Reminder from FDA: Cybersecurity for networked medical devices is a shared responsibility [cited 10/29/2010]
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2009. Inside risks, reducing risks of implantable medical devices.
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2009. High confidence medical devices: Cyber-physical systems for 21st century health care.
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