Medical device failure and injury

On Behalf of | Feb 28, 2018 | Wrongful Death

Injured patients and family members of victims who have died due to malfunctioning medical devices may be able to seek legal action in Hawaii. While there are systems in place to reduce safety concerns in medical devices, there are still many people negatively affected by defective products.

Those who have experienced issues need to take action as quickly as possible, as FindLaw reports there is a statute of limitations for bringing forth a claim. Knowing who to sue is another issue, as it could be the manufacturer or a specific healthcare provider. An attorney skilled in this area can help determine if medical personnel were warned about potential risks of the devices, in which case it would be a medical malpractice claim instead of a product liability claim.

The FDA has set standards and regulations to keep manufacturers in compliance with safety practices. One of the ways the department monitors device safety is through Medical Device Reporting. Manufacturers of medical products, the importers of these devices and device user facilities are required to report any and all adverse reactions to the FDA. While not required, the FDA also encourages consumers, caregivers and healthcare professionals to voluntarily report any issues related to medical device safety.

A manufacturer and importer are required to report on any device malfunctioning and/or of serious injury or death they learn was possibly due to one of their products. A device user facility refers to an ambulatory surgical facility, a hospital, outpatient facility or nursing home. These places must report to both the FDA and manufacturer about any death suspected to be caused by a medical device so steps can be taken to improve safety.