When it comes to the term medical devices, it can be referred to any object, device, tool or digital machine that are used for human medical health purposes. This means from a small tong to a programmed machine. Medical devices could either be used to prevent a health issue or to treat an already existing health problem. In order for these kinds of devices to be used on humans and to function like it should, it is strictly advices to have medical device reporting done in order to avoid injury or death through fault devices. Which includes both the patient and the medical experts using the device. Since the patient is most probably already weak, it is important that their health condition is not worsened by a faulty medical device.

Food and Drug Administration (FDA)

The FDA make use of diverse methods to monitor the performance of medical devices, to look for possible safety issues with the devices, and assist with risk assessments of these devices. The FDA wants medical experts to give medical device reports on devices that they believe have errors, device quality problems, and any other faults. These types of reports could help improve medical devices for future usage and even improve the healthcare of patients in need of support through these devices. It is also important that manufacturers and importers of medical devices report to the FDA when they know of any injuries or fatal accidents which were caused by their devices.[1]

Medical Device Reporting

The medical device law is a method used by the FDA to monitor the performance of medical devices in order to detect possible faults and dangers caused by these devices. This makes it possible for medical experts to report safety and effectiveness of devices they use after buying it. Any device that could possibly have any errors which could be dangerous to others should be reported to the FDA. These measures should always be built on relevant international standards and the regulations of the relevant country in which the medical devices are planned to be sold and used.[2]

Requirements for Service Reports

It is very important that each technician take the time to carefully review their technical documentation before they submit it to a reported person. Here are important points that should be taken into consideration after an installation of medical devices.

  • The individuals servicing the device: technician name
  • The name of the device serviced
  • The date of service
  • Any device identifications and control numbers for example, article number
  • Information of system workload: hours worked
  • The type of service performed
  • The test and inspection data: setting into service, electrical safety, dependant on repair, repair matrix
  • Device owner, address and phone number and the specific location of the device for example, the ward
  • Mention any unusual environmental conditions, any evidence of damage or misuse
  • Mention if the device failed to meet specifications (according to setting into service)
  • Mention if the device was being used for treatment (was patient connected?) when the failure occurred.
  • Date of last service and service report number, if known.

 

Keywords: Medical Devices, Food and Drug Administration, Medical Device Reporting

 

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Sources:

[1] https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems#overview

[2] https://compliancenavigator.bsigroup.com/en/medicaldeviceblog/medical-device-risk-management-by-iso-14971-top-management/

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