The goal of each medical device manufacturer is to produce safe and effective products. These manufacturers are responsible for carrying out postmarket surveillance activities to monitor and collect the performance of their products. In the current regulatory environment, companies are under scrutiny for their complaint procedures and their ability to react and respond.
The FDA annually receives hundreds of thousands of medical device reports of serious harm, deaths or malfunctions. These are not only from the manufacturers but also the end users. The regulation provides a means for the FDA to monitor significant issues regarding medical devices.
Reporting Requirements
Manufacturers of finished devices commercially distributed in the U.S. must report issues that include:
Death
Serious injuries - life threatening, permanent impairment or requires medical or surgical intervention.
Malfunctions - a failure of the device to meet its intended use where the result of serious injury or death is not remote. Other malfunctions are not reportable.
The manufacturers must review and evaluate all complaints to determine if the issue represents a reportable event. This is documented on Form FDA 3500A and is required when the manufacturer becomes aware of the issue. Complaint information can be gathered through many avenues and may be collected by various employees. Therefore it is imperative that all personnel are trained to recognize and report complaints in a timely manner. The complaint procedures should specify how complaints are evaluated to determine if the event meets the reportability requirement. Manufacturers must also implement written MDR procedures.
How to Report
The FDA requires 5 types of reports with varying timeframes:
30-day report - within 30 days of the awareness of the event. The clock begins upon receipt of the information that reasonably suggests that a reportable event has occurred.
5-day report - within 5 days of the awareness of an event which requires remedial action to prevent substantial harm to the public or as a result of a request from the FDA. After the 5-day report, the manufacturer should provide additional information as it becomes available on a supplemental report.
Baseline report - this accompanies the 3500A form and is used when the event is reported for the first time.
Supplemental report - as noted above, is used when additional information is acquired after the 5-day or 30-day report.
Annual certification - the manufacturer certifies the number of MDRs in the previous 12 months.
Device users must report suspected medical device related deaths to the FDA and the manufacturer. Serious injuries are reported to the manufacturer or to the FDA if the manufacturer is not known. Both must be reported within 10 days. They are not required to report malfunctions but may voluntarily do so using the MedWatch form.
Quality Obligation
The FDA expects a robust postmarket surveillance program from every device manufacturer. To that end, it is important to have a cohesive process for complaint handling that drives consistent capture throughout the organization and the appropriate evaluation of events. This type of practice supports timely and accurate reporting to ensure necessary actions are taken to protect public safety.