Medical devices are a crucial part of the healthcare industry. They help healthcare professionals diagnose diseases and conditions. They cure, alleviate, treat, or prevent disease. Medical devices save lives and improve patient care.
However, like other tools, medical devices can sometimes malfunction or break down. When this happens, it’s important to know how to spot defective medical devices and steps to take.
Medical Devices and How They Become Defective
Medical devices are a broad category of helpful tools in healthcare. Section 201(h) of the Food, Drug, and Cosmetic Act defines a medical device as, “An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is . . . intended to affect the structure or any function of the body . . . .”
It might be easiest to think of medical devices as non-drug objects used in patient care. Because this is a broad category, there are a lot of possible ways for a medical device to become defective. Defects might be from the design of the device, poor maintenance, or damage sustained from distribution methods.
How To Spot Problems
Medical devices, including implants, surgical tools, electrical equipment, and prosthetics, can have many defects. For example, electrical failures can create programming issues, leading to a device delivering medicine at incorrect dosages or intervals. Electrical wires can also shock providers or patients.
For another example, problems with diagnostic machines, such as CT and PET scanners, can misdiagnose patients or fail to find problems. This can result in serious injury or death.
These are possible signs that a medical device is defective:
- It doesn’t work the way it should.
- It breaks easily.
- The display is hard to read.
- There are loose wires or parts.
- It produces strange sounds or smells.
- It doesn’t last as long as it’s supposed to or doesn’t hold a charge.
- It causes pain or injury, including bleeding, pain, and reduced mobility
What To Do With the Defective Device
Now that you know how to spot defective medical devices, you must learn the steps to take. If you know or suspect a device is defective, take it out of service so that it does not injure or harm patients.
If it has electronic memory, keep it plugged in to retain data, but make sure no one uses it. Follow your facility’s procedures for faulty devices. For example, you might need to fill out a defective equipment form.
If a defective device injures a patient, assess and treat the patient’s injuries. Report the incident to the patient’s primary care provider and alert your facility risk manager. Document the incident in the medical record, including the date and time, why you suspect a device malfunction or defect, and a description of the event. Include your interventions.
Document in the medical record the people you’ve notified, dates of notifications, and the actions they took after receiving your information. Complete an incident report.
Keep the device and its packaging. This will help when the manufacturer inspects the device.
Report to the Manufacturer
If you spot problems with a medical device, report the issues to the manufacturer. They will investigate the situation and determine a solution, which might include fixing the device or replacing it. If the device is still under warranty, they might be able to replace the device for free. In some cases, they may recall a defective device.
The manufacturer might have questions for the healthcare professional involved. If you are not satisfied with the manufacturer’s response, you can file a complaint with the FDA. Regardless of the manufacturer’s response, you should report adverse events to the FDA.
Report Adverse Effects to the FDA
Unfortunately, defective devices can cause severe injury and even death. Recognizing the importance of monitoring and limiting these adverse effects, the FDA uses the Medical Device Reporting (MDR) regulation.
The MDR relies on information from manufacturers, importers, and user facilities to detect and correct problems. User facilities include hospitals, nursing homes, surgical facilities, outpatient diagnostic facilities, and outpatient treatment facilities.
If you work in a hospital or medical center, the risk manager, hospital materials manager, or biomedical engineering department will file the FDA report. If you’re an independent practitioner in a small clinic, you’ll probably file it on your own.
The Safe Medical Devices Act (SMDA) outlines that user facilities should report:
- Device-related deaths to the FDA and device manufacturer, if known, within 10 working days.
- Device-related serious injuries to the manufacturer or to the FDA if the manufacturer is unknown, within 10 working days.
- Submit an annual summary to the FDA of all device-related deaths and serious injury reports submitted in the past year.
Other regulations outline the reporting requirements for device manufacturers. These regulations help the FDA correct defective devices and prevent more damage by issuing product recalls and alerting the public.
The following are critical pieces of information needed to report defective devices.
- Device trade, brand, or proprietary name.
- Common name of the device.
- Manufacturer’s name and address.
- The type of person handling the device when it failed, e.g., a nurse.
- Details about the device, such as:
- Expiration date.
- Product information numbers, e.g., the serial number.
Report a Faulty Device to the FDA
A user facility is not required to report a device malfunction to the FDA. But health professionals, consumers, and patients can voluntarily report these issues if they wish. Simply fill out the MedWatch form, which is also available online. If you fill out the form online, you have three days to complete the report from when you start it.
What Happens to the Defective Device
Your facility will follow its own procedures regarding the defective device. Procedures vary based on the device type and the extent of the problem.
In many places, after you pull the device from service and complete your facility’s defective equipment form, the designated repair department works on the equipment. Repair personnel can inspect and repair the device. They can certify it for return. But if the malfunction resulted in death or serious injury, the equipment will likely not be repaired. Instead, it will stay in its current state for the investigations.
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