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.
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Capital equipment
Beds, bedrails, scales, wheelchairs, IV poles, infusion pumps, lifts, bathtubs. MRI, Cat Scan, radiology equipment
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Disposables and accessories
Needles, syringes, IV tubing, foley catheters, feeding tubes, gloves, ventilator breathing supplies, trocars
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Instruments
Pulse oximetry, glucose machines, surgical staplers
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Implantable
Hip/knee, stents, defibrillators
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Monitoring systems
Cardiac, telemetry, patient call systems
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Computerized medical systems
Hardware, software
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Reagents
Laboratory solutions
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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.
- Recognize, Remove and Report: FDA Educational Materials
- A video production from the FDA/MedSun
Disclaimer
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).
