Originally Published MDDI May 2005

NEWSTRENDS

Erik Swain

FDA and other regulators have stressed the need for risk management a lot in the last few years. Most medical device manufacturers now understand that they must incorporate it into their product design process. Performing risk management for device software, however, has presented its own challenges. And those have not been addressed to any great degree by existing standards.

That should no longer be the case now that the AAMI (Arlington, VA) has issued a report on risk management for medical device software.

Developed by AAMI's medical device software committee, the technical inspection report, TIR32: 2004, is now available .“Medical devices and the software included in them span a wide range of risk,” says Sherman Eagles, cochair of the software committee. “This guidance gives practitioners a tool to help them ensure that they are directing their attention to the areas of software where they can do the most to help reduce risk.”

The report aims to give insight to device software designers about safety considerations. It also attempts to alert those responsible for overall risk management about the risks that software can bring. The subcommittee had noted that those who design software and those who manage risk almost never interact. With the advent of this report, that could change.

Such interaction is increasingly necessary as it becomes common for the clinical functionality of many devices to be controlled by a software system. On the diagnostic and imaging sides, software is increasingly responsible for processing and displaying data. Thus, software-related errors can have disastrous consequences for patients.

The TIR costs $50 for AAMI members and $95 for nonmembers. To order the report, visit www.aami.org or call 800/332-2264, ext. 217.

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