The Safe Medical Devices Act requires health care facilities to report to the manufacturers such as Stryker any injuries or illnesses in patients or employees caused by the use of the manufacturers’ medical devices such as an IVC filter. If a patient or employee happens to die as a result of the device being used, the FDA should be contacted as well. This ensures that a manufacturer is made aware of the defect.
Whom Exactly Does this Act Apply to?
This Act states that all healthcare employees who have experienced some incident with a device that has or could have resulted in a detrimental consequence to the patient or the employee, such as surgical robots or transvaginal mesh, must report the incident to the manufacturer. These employees can include:
- Allied health professionals
- Students and volunteers
- All other employees associated with the facility
What is the Duty of the Employee when They Discover a Defect in a Device?
An employee must take the following steps when a medical device has been found to be defective:
- Put the device and all its parts back in its packaging and write down its clinical engineering number or serial number.
- Put some kind of notification on the device or packaging so people are aware it is defective and should not be used.
- If there was a patient involved in the incident, the patient’s physician should be notified. If an employee was involved in the incident, the employee should be referred to Occupational Health.
- Contact Risk Management as soon as possible (must be within 10 days).
- Fill out an incident report and deliver it to Risk Management within 24 hours.
- Notify whichever department is appropriate for handling the device.
Can a Health Care Facility Be Held Liable if they Don’t Report Defects?
If a health care facility knowingly uses a defective medical device, such as a defective duodenoscope or a defective Bair Hugger, without notifying the manufacturer as required by the Safe Medical Devices Act, the facility may be held liable for injuries to its patients.
Do I Need a Lawyer to Hold a Health Care Facility Liable?
If you have been injured by a medical device at a health care facility you should consider hiring an attorney. An experienced defective products lawyer can determine whether the health care facility violated the Safe Medical Devices Act and, if so, whether the facility is liable for your injuries.