A widespread problem in the consumer industry is the underreporting of medical device defects. It’s important for manufacturers, sellers and medical providers in Georgia to report any defect that could cause serious harm to a patient. Preventing injuries and deaths must involve creating protocols for reporting medical device defects.
Requirements for mandatory reporting
Manufacturers, importers and device user facilities are required by law to follow Medical Device Reporting regulations. They must report any form of adverse result that is related to using a product to the FDA.
Manufacturers that create medical devices are required to report any problem that may lead to a severe injury or death. Importers are also required to report any malfunctioning devices to the FDA if it caused a serious injury or death. To qualify as being serious, the devices need to cause product defect injuries that lead to hospitalizations, emergency room visits or near-death experiences.
Device user facilities include medical facilities but exclude doctor’s offices. The providers must report a death that is linked to medical device to the FDA and the manufacturer. They must report a serious injury to the manufacturer or FDA.
Manufacturers are allowed to report defective medical devices in quarterly reports that are part of a Voluntary Malfunction Summary Reporting program. The FDA participates in the program and wants to improve their ability to regulate medical devices.
The value of reporting
Reporting the dangers of using defective products is not inconvenience; it is necessary for the FDA to make medical devices that are safer for all users. Medical device manufacturers, importers and facilities must know the precise regulations that they need to follow to remain within the law.