A medical device injury is a personal injury which people suffer because of medical devices that are supposed to alleviate medical issues. These can include medical devices such as:
Medical Devices and the LawThe US Center for Device and Radiological Health (CDRH) is the center within the US Food and Drug Administration (FDA) which is responsible for overseeing that medical devices are safe and effective. The FDA has developed a system of prioritizing to ensure that each device receives the appropriate level of scrutiny, however an FDA approval is not a guarantee of safety and does not shield a manufacturer from liability. The manufacturer typically is required by law to inform the physician of the health risks involved, but it may be the medical staff’s responsibility to explain these risks to the patient. Generally, medical devices are safe and efficient and do not result in a medical device injury, but unfortunately there are cases where people become injured. The experienced attorneys at the Coye Law Firm want to assist anyone who has suffered a personal injury due to a faulty medical device.
Reporting a Faulty Medical DeviceIf you have experienced an injury as a result of a defective medical device, seek appropriate medical attention immediately. Do not risk your health in an emergency. The Safe Medical Device Act of 1990 requires that all deaths, serious injuries, and malfunctions which medical professionals suspect may be related to medical devices must be reported to the FDA and the manufacturer, and sometimes the distributor. It is also recommended that consumers make an individual report as well. You can find additional information about timeframe and forms needed to report a death, injury, illness, or malfunction of a medical device at the FDA’s site or from the Clinical Information Hotline . The attorneys at the Coye Law Firm recommend that you speak with a lawyer prior to filing this report, however because of the time constraints if you must file it first, be sure to speak with an experienced personal injury attorney as soon as possible.
Medical Device RecallsThe FDA monitors reports of problems with medical devices and alerts health professionals and the general public when they need to ensure the proper use of devices and safety of patients. At times, the FDA will recall products from the market if sufficient information is provided substantiating that decision.
To find out about the latest communications about medical device safety and medical device recalls from the FDA, visit their site here .
Contact an Attorney
When you’re injured you need to devote your energy to recovering. You could pursue a personal injury claim against the medical staff, device manufacturer, or the FDA, but you may also be dealing with a dispute from your health insurance, or conflicts with a disability or workers compensation claim. The more complicated your case becomes, the more you may want to consider speaking with an attorney.
The medical device injury lawyers at the Coye Law Firm are here to help you recover from injuries caused by negligence. Contact one of our offices in Tampa, Clermont, Melbourne, Orlando, or Kissimmee to learn about your rights and protect them. It can be difficult to get benefits without the experienced guidance of a medical device injury attorney. Call today .