Ask HRC: Risk Ranking for Health Devices

April 24, 2006 | Healthcare Risk, Quality, & Safety Guidance

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A patient safety officer recently contacted HRC asking about tools to assign risk levels to health devices as part of an overall inspection and preventive maintenance (IPM) program. As part of our response, HRC shared some resources that are now available in the Sample Policies section of the HRC Members' Web site.

Suggested risk levels are provided in the Typical Device Risk Levels table for several high-, medium-, and low-risk devices. The assigned risk level depends primarily on the device's function, such as life support or critical monitoring. Although risk level is an important indicator, it alone does not define a device's support requirements. A high-risk device may require limited IPM if the risk is associated with user error. A low-risk device may require substantial support because of frequent failures. Similarly, the risk level may...

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