As people age, they tend to rely more heavily on medications and medical devices. The average nursing home is well-stocked with everything from over-the-counter medications like aspirin and talcum powder to medical devices like bed lifts and sleep apnea machines. Occasionally, one of these products will be found to be defective and recalled by the manufacturer. What happens if the nursing home continues to use a product that is known to be defective and it ends up hurting a resident?
Nursing Homes Have Mandatory Medical Device Reporting Requirements
The Food And Drug Administration (FDA) has created a Medical Device Reporting (MDR) regulation that defines nursing homes as device user facilities. Under this regulation, nursing homes are required to report any death that may be device related to the FDA and the device manufacturer. Nursing homes are also required to report any serious injury that may be device related to the manufacturer, or to the FDA if the manufacturer cannot be determined.
Under this regulation, nursing homes are expected to be one of the first lines of defense against defective medical products. When they fail to live up to this expectation and continue to use a defective product that ultimately causes harm to a resident, they may have some accountability. However, the product’s manufacturer is typically the target of these product liability claims.
For example, there is currently a recall of many sleep apnea machines that are commonly used in nursing homes. The recall was initiated by Philips Respironics on a number of its CPAP machines, BiPAP machines and ventilators. Users who have been harmed by these machines may be eligible for compensation from the manufacturer and should speak to an attorney immediately.
Ultimately, it is not the responsibility of the nursing home resident or their family to determine who was at fault. A lawyer can ascertain who the negligent party was and take appropriate action.