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Medical Product Manufacturing News, November/December 2015

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M E D I C A L P R O D U C T M A N U F A C T U R I N G N E W S Q M E D . C O M / M P M N 1 0 N O V E M B E R / D E C E M B E R 2 0 1 5 SPECIAL FEATURE: SOFTWARE I t's rare these days to find a medical device that does not rely heavily on software to operate. In many cases, it's the software component within a device that differentiates one company's product from another's. But as medical software grows more sophisticated in terms of both design and functionality, FDA reviewers are forced to increase their level of expertise, as well as the amount of time they spend reviewing many 510(k) submissions. This can impede time to market. Increased software complexity also makes it harder for manufacturers to pinpoint the technical risks that could lead to failure or recall—or worse. In November of 2000, at the National Cancer Institute in Panama, radiation therapy planning software in a Cobalt-60 radiotherapy machine miscalculated the proper dosage of radiation, jolting 28 patients with massive overdoses of gamma rays. Forty months after the incident, it was reported that 21 of the 28 patients had died. 2 More recently, in May of 2015, CareFusion issued a Class I recall of its Alaris Pump caused by a software error that caused the pump to delay an infusion. Days later, CareFusion recalled a line of ventilators, citing a software flaw that could cause suffocation. 3 While there were no fatalities associated with the CareFusion malfunctions, the company has sustained considerable brand and reputation damage. Unique Challenges of Identifying Defective Software Clearly, a software malfunction can be just as deadly as any other device component failure. However, it's harder to identify and quantify the potential effects of defective software. The more complex the component, the more defects it may have, and software programs are the most complex things humans make. Also, many of the standard components used in devices, valves, for example, have established track records with mountains of performance data for engineers to consider. Software, with few exceptions, is proprietary and often device-specific, so performance data is sparse or non-existent. "Medical device software engineers essentially have to reinvent the wheel with each new piece of code," says Matt Lowe, MasterControl executive vice president, global sales and marketing, who has experience launching more than a dozen medical devices. "They don't have the luxury of performing a complaint analysis on a predicate device. The data just isn't there." So, how can manufacturers reap the benefits of software while avoiding the clearance delays, increased safety risks and other setbacks that are often side effects of rapidly advancing technology? As with most things these days, it comes down to risk. Foundational Standards for Medical Devices Risk management is not a new concept for device makers. The FDA's Quality System Regulation requires risk management in their design, manufacturing, and support processes, and ISO 14971, the international risk management standard for medical devices, has been around since 2000. The main standard pertaining to software in medical devices, IEC 62304, also supports a risk-based approach to software development. There are at least a half-dozen additional standards that address the importance of applying risk management principles when designing life- or safety-critical systems and devices. Yet here we are—several years and standards later—still struggling to understand risk management and the vital role it plays in promoting software safety. Perhaps part of the problem is that many device makers assume successful risk management means eliminating risk altogether, or they see it as an isolated regulatory activity, separate from the design process. In reality, risk management is ongoing. Continuous improvement, not risk elimination, is its real goal. "It's impossible to anticipate every potential hazard of your device or its components. This is especially true in the case of software, which is inherently vulnerable," said Walt Murray, director of MasterControl's quality and compliance consulting services, who has more than two decades of risk management expertise. "When assessing software-related risks, you don't ask, 'What risks can occur if the software fails?' You ask, 'What risks can occur when the software fails?'" Understanding Risk-Related Terminology Loosely defined, risk management is a systematic process that can be used to identify hazards; to estimate and evaluate the risk associated with those hazards; and to implement and monitor the effectiveness of risk mitigation measures. Done effectively, it helps a manufacturer produce a safer product that performs as expected and experiences fewer failures in the field. If that sounds remarkably like design control, that's because it is. Risk management as a requirement of design control shares its purpose: to produce safer devices that meet user needs. They should be performed simultaneously. Whether you are applying risk management principles to the software in a device, to the mechanical or electrical components in a device, or to the medical device as a whole, the process is virtually the same. It comprises four phases: risk planning, risk assessment, risk control, and risk review/monitoring. Risk Planning The planning stage is critical. Poor or insufficient planning is a common reason for medical software failure—and one that is easy Medical device recalls nearly doubled from fiscal years 2003 to 2012, according to the FDA. 1 While some attribute the spike to increased reporting on the part of device manufacturers, others blame design failure—in particular, software design failure, which was identified as the most common recall cause. Lisa Weeks How to Cut Software-Related Medical Device Failures and Recalls

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