Hundreds of medical device-associated serious injuries, malfunctions and deaths are reported in various medical associations worldwide. Medical device malfunction reporting is one of the surveillance strategies that many countries use to keep an eye on the performance of medical devices and to detect potential safety issues associated with the devices. It also offers the benefit and risk assessments for each medical device.
Manufacturers, device users, and importers must submit certain kinds of reports regarding product problems and adverse events associated with medical devices. Other than them, medical professionals, caregivers, patients, and consumers can also submit voluntary reports regarding the problems related to medical devices. We can also file reports regarding quality issues, users, and therapeutic failures of a mobile device.
All these data and information from other sources can offer critical details that, in turn, help improve the patient's safety. Most people do not know how this reporting works and what they should do about it. In the following section of this article, we have gathered a couple of questions and tried to provide answers for them to help you in such a situation.
Who Should File Mandatory Reports of Medical Device-Related Adverse Events?
As we have already mentioned, device manufacturers, distributors, and user facilities importers are responsible for filing such reports. The device user facilities include Ambulatory surgical facilities, hospitals, outpatient departments of diagnostic facilities, Nursing Homes, etc. The health facility reporting such an event can be an independent entity or a part of another medical entity.
When Should You File a Report?
Serious Injury
The medical device report should be filed in case of serious injury. A serious injury is a condition or illness that:
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Is fetal
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Leads to permanent impairment or injury e
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Necessitates surgical or medical intervention
For example, suppose a patient experiences recurrent visual problems after going through a LASIK procedure. In that case, it can be easily controlled that the patient has suffered from some Visual impairment during the procedure. In this case, the Healthcare facility and the professionals should thoroughly investigate whether the patient has been seriously injured during the process or whether this problem stems from something else. If they find that it directly results from serious injury, they should file a report accordingly.
Malfunction
In general terms, malfunction means that the device could not be able to meet its performance specification. Everything that is written on the label of the medical device can be considered as the performance specification. Report a medical device malfunction if you notice any of the following problems.
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If there is a chance of serious injury due to the recording malfunction of the medical device.
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Whether the recording malfunction affects the machine in such a way that it can cause serious injury to the patient.
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If the malfunction stops the device from performing its essential function and compromises the therapeutic effects of the equipment.
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You can report a malfunction for any long-term implants or life support devices.
When Should Medical Device Malfunctioning Report Not Be Filed?
If the manufacturer has the necessary information, a qualified person can conclude reasonably that the device did not create any problem that led to serious injury or death of the patient. If the competent person also concludes that there is little or no relationship between the malfunctioning of the device and the incident that led to the serious injuries. Doctors, nurses, risk managers, and biomedical engineers can be qualified to determine whether the malfunction had anything to do with the accident.
The malfunctioning report should not be filed if the manufacturer finds out that the information they receive is wrong. No device-related adverse events have occurred in any scenario.
You cannot file a malfunctioning device complaint against a company if it has not manufactured the product.
All the manufacturers should save the documentation of false complaints.
How do The Reports help?
All the user disability reports regarding medical device malfunctioning and death are entered into a database. This accumulated information helps the medical personnel of various countries to analyze and review the performance of different medical devices and determine whether they are up to the mark. All this information also helps to notice whether the device is suffering from any manufacturing defects or design-related issues.
There is no doubt that medical device reports help improve the equipment's functions and quality. It also helps to keep things transparent in medical accidents or injuries.