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Recognize, remove and report: medical device safety

By Joan M. Porcaro | May 22, 2023

Monitoring the safe utilization and effectiveness of medical devices is one of many ways to ensure a safe environment for both patients and staff.

Healthcare organizations strive to provide patients with a safe environment. Monitoring medical devices goes hand-in-hand with improving safe practice. It is essential to increase awareness of incidents that potentially involve a medical device or technology and to encourage staff to report the events quickly. Often, staff are not aware that almost all the equipment used with patients are considered a medical device – even a bandage.

Identifying potential problems before serious injuries occur

Healthcare organizations are guided by The Safe Medical Devices Act (SMDA) in monitoring medical device concerns and are required to report medical device problems that result in serious illness, injury, or death. They can voluntarily report problems with devices, such as ‘close-calls,’ potential for harm and other safety concerns. By monitoring reports about problems and concerns before a more serious event occurs, the FDA, manufacturers, and clinicians may work together proactively to prevent serious injuries and death.

Medical devices

The following table provides a sampling of what has been deemed a medical device by the FDA.

  1. Capital equipment

    Beds, bedrails, scales, wheelchairs, IV poles, infusion pumps, lifts, bathtubs. MRI, Cat Scan, radiology equipment

  2. Disposables and accessories

    Needles, syringes, IV tubing, foley catheters, feeding tubes, gloves, ventilator breathing supplies, trocars

  3. Instruments

    Pulse oximetry, glucose machines, surgical staplers

  4. Implantable

    Hip/knee, stents, defibrillators

  5. Monitoring systems

    Cardiac, telemetry, patient call systems

  6. Computerized medical systems

    Hardware, software

  7. Reagents

    Laboratory solutions

  8. Soft goods

    Bandages, q-tips, towels

More than just the equipment

We know of the interface between devices and patients, but it is important to consider the device and its many interfaces as well.

When an adverse event occurs, it is importance to consider all the following:

  • Environment – such as the power source, lighting, and other devices
  • People involved, who may be the patient, device operator or visitors
  • Accessories and disposables: attached such as filters, valves, ports, tubing, etc.

Any, or many, of these aspects of the adverse event or potential events may be the reason or a contributing factor and warrants further investigation.

What types of problems should I look for?

  • Defects
  • Instructions, packaging, or labeling concerns
  • Software problems
  • Failure to work as intended/malfunction
  • Interactions with other devices
  • Use errors
  • Combinations of the above

What is meant by “potential for harm?”

  • Events that are caught before anything harmful has occurred
  • Important observations of a chronic problem with a device
  • Problems which lead staff to develop “work-a-rounds”
  • “Out of the box” problems that are identified before use on a patient

What do you do if you encounter a problematic device?

For medical device equipment:

  • Attach an out of service tag (tag out) on equipment and remove the device from service
  • Contact your biomed department team
  • Call your facilities team for non-medical devices
  • Complete an event report online/paper
  • Advise your manager
  • Notify risk management
  • Comfort and care for the patient

For all other equipment:

  • Call materials management
  • Notify risk management
  • Save the device and packaging and place in a clear plastic bag
  • Complete an event report online/paper
  • Advise your manager
  • Comfort and care for the patient

Additional resources:

The following materials have been produced by the FDA and are a great resource for your team.


Willis Towers Watson hopes you found the general information provided in this publication informative and helpful. The information contained herein is not intended to constitute legal or other professional advice and should not be relied upon in lieu of consultation with your own legal advisors. In the event you would like more information regarding your insurance coverage, please do not hesitate to reach out to us. In North America, Willis Towers Watson offers insurance products through licensed entities, including Willis Towers Watson Northeast, Inc. (in the United States) and Willis Canada Inc. (in Canada).


Director, Client Relationship Management

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