As hospitals are under increasing budgetary pressure, finding affordable medical devices and equipment can take buyers overseas to one of many trusted manufacturers. The problem that has riddled the American healthcare system is the import of medical devices that meet preliminary standards at the time of purchase, but are not vetted through years of service to determine long-term performance.
Given the number of new medical devices that are innovated and introduced to the market on an annual basis, tracking, testing, and approving the medical equipment and devices has proven to be a large task for American safety regulators.
An excellent recent example of a tested, but failed medical product is the vaginal mesh device, which is currently involved in several class action lawsuits against international manufacturers. The device has reportedly not sustained its structural integrity once implanted, and has resulted in subsequent medical injuries and procedures to remove them.
The FDA Makes Medical Device Reporting (MDR) Easier
Per the Food and Drug Administration (FDA) division of the U.S. Department of Health and Human Services (HHS), the FDA receives several hundred thousand reports per annum, relating to injuries and death caused by medical device malfunctions. The FDA has an expectation that everyone from consumers to nurses to clinical doctors and caregivers in long-term care facilities will accurately and promptly report “errors, product quality issues, and therapeutic failures,” to help preserve patient safety and reduce injuries and fatalities.
In an October, 2016 article in Government Technology Magazine, “New FDA Website Accepts Reports of Misconduct, Medical Device Malfunction,” an FDA spokesperson indicated that a new website had been set up to facilitate faster reporting of medical device malfunctions. While consumer reports to the website would be filed as allegations for investigation, it is an effort to bridge the gap between reports of device issues and action by the FDA. It’s a prompt response that is aimed at preventing injuries and saving lives, through which consumers and healthcare providers can report their observations or findings directly by email, telephone, or in written report summary for investigation.
In addition to recruiting consumers and healthcare providers to be more vigilant with regard to reporting malfunctioning medical devices, there are regulations that outline the mandatory reporting of malfunctions through manufacturers, distributors, and device facility (medical professional) users.
The new measures were planned after the HHS Office of Inspector General (OIG) issued a report in 2009 titled “Adverse Event Reporting for Medical Devices,” which suggested that the previous system in place for reporting and follow up was a “waste of industry and FDA resources.” In the report, it was revealed that there were 72,866 medical device-adverse event reports in 2003, and statistically, five-day reports (which are prompt to prevent injuries or further fatalities) accounted for only one percent of the total device failure records. While manufacturers at that time were adhering to the mandatory five-day deadline for reporting, care facilities, practitioners, and distributors were not.
The most concerning revelation in the report was that the Center for Devices and Radiological Health (CDRH), a branch of the FDA responsible for the approval of all medical devices prior to sale, was not able to link adverse health effects and fatalities to malfunction events. Additionally, the report revealed that the CDRH did not (at the time) document onsite inspections of manufacturers in MAUDE, the adverse event database.
Legal Reporting Requirements
Businesses that manufacture or distribute medical devices are legally required by regulation (21 CFR 803) to provide full reporting of any malfunction, or suspected malfunction that may have contributed to injury or death. Medical device companies are required to report promptly to the FDA for investigation of the incident, and review of “next steps” for recall orders and advisories.
Manufacturer Reporting Requirements
- Are required to report to the Food and Drug Administration when they have been advised by a customer or consumer that a device may have malfunctioned, and contributed to loss, including illness, death, or injury.
- Are required to report when a model that is in service or has malfunctioned, and provide information on the probability of similar models presenting a risk to patients or medical professionals.
Importer Reporting Requirements
- Companies that import, distribute, and sell medical devices are required to both report to the Food and Drug Administration, as well as the manufacturer, when they become aware of a design flaw or malfunction that poses a risk to patients.
- Importers are also required to report any replacement parts that are faulty for devices that are repaired and maintained through after-market parts and service.
Device User Facilities (Clinics and Hospitals)
- The facility that has purchased and used the medical device to deliver patient care is required by law to report any death or injury which may be attributed to a malfunctioning medical device.Hospitals, emergency clinics, private practices, and outpatient facilities are required to also notify the manufacturer.
- User facilities have the lowest rate of report of incidents, even though they are charged with patient care. Many experts believe that downward pressure from administration, combined with investigation and replacement costs, significantly hinder healthcare professionals from reporting adverse incidents.
Class action law suits can be filed any time there is a medical device that has caused injury to an individual or multiple patients. The impetus is on the manufacturer to demonstrate that the specific flaw in the device did not contribute as the cause of injury; however, given medical malpractice liability and costs, class action suits are researched before being filed, to determine the presence of a qualifying technical flaw in a device pursuant to litigation.
By making it easier for consumers and healthcare professionals to report medical device malfunctions (anonymously if they wish), the FDA has taken an important step to minimize fatalities and injuries caused by faulty devices. The new website is a positive step forward that reduces reporting time, and a tool that makes it easier for medical professionals to report without fear of punitive measures by employers wishing to circumvent safety and costs.