One of greatest benefits of technology in the medical realm is the creation of devices meant to replace, support or enhance, missing or damaged biological structures to restore or improve a patient’s condition. Not all medical devices work as effectively or safely as these were intended to, however, as some are found to be causing more harm than relief after these have been implanted.
There are many different kinds of medical devices that have already been introduced and used in patients, but which have been proven defective and the causes of harmful effects. A few of these defective medical devices that have already been reported to the US Food and Drug Administration are transvaginal mesh (including Johnson & Johnson vaginal mesh kit and Alloderm mesh), Stryker ABG II Modular-Neck Hip Implant System, Stryker Rejuvenate modular-neck stems, Depuy hip implant, Zimmer NexGen knee replacements, and automated external defibrillator (AED) heart device.
Once a medical device has been approved by the FDA for treatment use, this same agency turns to medical device reporting (MDR), its post-market surveillance tool, to monitor the device’s performance, discover potential safety issues and consider the device’s benefits and risks.MDR is mandatory for importers, manufacturers and device user facilities (such as an outpatient treatment or diagnostic facility, a nursing home, an ambulatory surgical facility or a hospital), while voluntary for consumers, caregivers, patients, doctors and other health care professionals. Besides problems and serious adverse effects linked to medical devices, the FDA also encourages voluntary reporters to share information on any therapeutic failure, poor quality issue, or erroneous use of these devices – all for the purpose of improving and ensuring overall safety of the patient.
With regard to mandatory reporting, the following are asked of the reporters:
- For device manufacturers: the FDA obliges them to report any incidence of device malfunction or their device as being linked to serious injury or death as soon as they learn of it.
- For importers: in the event of a malfunction of an imported device, which may lead to serious injury or death of a patient, an importer must submit a report to the product’s manufacturer. If the importer, however, learns that its device has been linked to a patient’s death or serious injury, then its report should be forwarded to both manufacturer and the FDA.
- For device user facilities: any death linked to a device should be reported by the facility (which has become aware of this incidence) to both manufacturer and the FDA; where serious injury is concerned, the report must be forwarded to the manufacturer. If the manufacturer is not known, then the report will have to be submitted to the FDA.
Hundreds of medical device failures are submitted to the FDA every year, and these are just one type of the many different medical mistakes committed in the US and around the world. Keeping silent will only cause many more severe harm and/or deaths if reports are not made and submitted immediately to those concerned. Thus, reports are both the moral and legal obligation of all who know or who have been affected by a malfunctioning device; this means that acting legally and morally should only be the direction of a reporter’s act.
If you have been hurt because of a medical device failure, contact a New Hampshire Medical Malpractice Attorney today to learn more about how to pursue a medical malpractice lawsuit in the best, most effective way.Read More