Medical Device Injury
What are medical device injuries?
Medical devices are designed to diagnose and treat medical problems. Patients and their health care providers rely on medical devices to work properly. Usually, medical devices work as they should; however, sometimes they do not work correctly and they may injure the patients whom they are supposed to help.
A medical device injury is a personal injury that people suffer because of medical devices that do not work as they are supposed to work. Almost any medical device can cause injuries under certain circumstances. Some of the common types of medical devices that have caused injuries include:
- Blood glucose meters;
- Breast implants;
- Dental sealants;
- Hip replacements;
- Incontinence devices;
- Knee replacements;
- Medical pumps;
- Prosthetic limbs and accessories;
- Da vinci Robots,
- Transvaginal mesh; and
- Other recalled or defective devices.
Sometimes, these devices malfunction due to an oversight when the device is designed or manufactured, resulting in a defective product. Other times, a patient may suffer harm from a device that occurs during a medical procedure. If the medical professionals treating the patient did not take the proper precautions to protect the patient before, during, or after the use of the, medical device, the negligent parties can be held responsible for the patient’s injuries.
Regulation of Medical Devices
The United States Food and Drug Administration (FDA) is the government agency that is responsible for overseeing that medical devices are safe and effective. While the FDA follows procedures to ensure that medical devices receive the proper level of scrutiny, FDA approval is not an absolute guarantee of safety. Nor does FDA approval shield the manufacturer of a medical device from liability.
The law requires manufacturers of medical devices to inform physicians of the health risks involved with a given device. However, it may be the physician’s responsibility to explain those risks to the patient.
The law also requires medical professionals to report to the FDA, the medical device’s manufacturer, and sometimes the medical device’s distributor all deaths, serious injuries, and malfunctions that they suspect may be related to medical devices.
The FDA monitors the reports of problems with medical devices and alerts health professionals and the general public when such alerts are needed to ensure the proper use of medical devices and the safety of patients. Sometimes, the FDA will recall medical devices from the market if the agency receives enough information to indicate that a recall is necessary to protect the public. To find the FDA’s latest information about recalls, visit the agency’s medical device recalls page.
Who may be held responsible for a medical device injury?
The designers and manufacturers of medical devices have the responsibility of creating safe devices. Depending on the circumstances of the patient’s injury, a patient may be able to pursue legal recourse against the following persons or companies:
- The designer of the faulty medical device;
- The manufacturer of the faulty medical device;
- The distributor of the faulty medical device; or
- The doctor who performed a procedure on the patient using the faulty medical device.
Contact a Miami Medical Device Injury Lawyer Today
If you have been injured by a medical device, or believe you may have, please seek appropriate medical treatment immediately. Then please contact us for a free and confidential consultation about your case. You may contact us online or phone us at 305-372-0123 (local) or (866) 769-0123 (toll-free) to arrange your consultation. For no charge, you can tell us about your experience and learn how the legal system may handle your case. We look forward to hearing from you and to working with you on your case.