By Bonnie Johnson, RN, JD, director, Fairview Risk Professional Services

Medical devices can provide important clues to determine whether, how or why they contributed to patient injury. However, we can't learn from the device if it is not available for evaluation or has been altered in any way prior to evaluation.

If you know or suspect that a piece of equipment is even remotely involved in a patient occurrence, preserve that device, whether it is a CT scanner or a glucose meter.

Federal statute defines a "medical device" as almost anything other than medication, including machines, machine parts, implants, tubing, cannulas and other disposables.

Caregivers are responsible to preserve intact for evaluation any device known or suspected to be involved in patient injury. This includes cases requiring an invasive procedure to fix or remove a malfunctioning implanted device, or devices associated with an occurrence involving unexplained patient injury. Preservation of the item includes

initiating a "chain of custody" form, properly labeling the device and leaving unchanged any dials or settings. Fairview's system policy, "Medical Device: Occurrence Known or Possibly Associated With," available on the Fairview intranet, offers guidance through the process.

In the absence of patient injury, caregivers must remove from use non-functioning or malfunctioning medical equipment and notify the proper person for evaluation and follow-up. Fairview's policy offers guidance on the communication and handling processes.

A caregiver's first thought should be to preserve a device until otherwise directed. Risk management staff, in cooperation with the clinical team, will determine what to do with a device after reviewing the circumstances. Our goal is to learn everything we can from the equipment while also preserving evidence when necessary.

For more information about devices involved in patient harm, contact Johnson, 612-672-6927, bjohns25@fairview.org.