Posted by Bill Sandweg on 02 November 2020.
The surgical stapler is an important tool. Rather than spend substantial time sewing body parts together during abdominal, thoracic or bowel surgeries, surgeons can use a stapler to close up wounds and attach body parts. Removable staples are also used to pull together scalp wounds or other skin wounds under tension. On the other hand, if the stapler malfunctions, it can cause grave damage to the patient up to and including death.
For many, many years the Food and Drug Administration (FDA) has maintained a public database of reports of problems with medical devices. The database is called Manufacturer and User Facility Device Experience (MAUDE). Manufacturers, importers and device-using facilities are required to report device malfunctions to the FDA. Physicians and others can make voluntary reports and are encouraged to do so. The MAUDE database is a vital tool for hospitals, physicians, manufacturers and regulators in their efforts to ensure that the devices they use are safe and to identify and fix problems. Patients who are injured by a device can see if it is an isolated incident or part of a larger problem.
Until recently, the system was thought to work well. Specifically with regard to surgical staplers, there were few reports of malfunctions and the devices were thought to be safe. However, some surgeons were experiencing problems with staplers. Sometimes they would jam and not work at all. If a patient had an open wound that was actively bleeding, the failure of the stapler to work might cause the patient to bleed to death. Some other surgeons experienced a different problem with staplers; they fired on their own. Sometimes this caused significant injury to the patient, including death and brain damage.
When these surgeons reported the problems to the FDA and examined the MAUDE database for stapler complaints, they were surprised to see very few. Some of the surgeons began asking questions of their colleagues and found that many of them were having similar stapler problems. Stapler problems were actually quite widespread. What was going on? Why were significant stapler malfunctions not recorded in the MAUDE database.
After a lengthy investigation by Kaiser Health News, it was discovered that the FDA for almost 20 years had been granting secret reporting exemptions to manufacturers who requested them. These exemptions allowed the manufacturers to have their malfunction reports go into an “alternative summary reporting” database, which was not available to the public or to the medical profession. It made their products look far safer than they were and prevented the public and the medical profession from demanding safety changes, where they were needed.
The number of devices covered by the alternative reporting system was large. There were thousands of them. The number of secret reports was therefore also large. Since 2016, over a million reports were made to the secret database. In 2017 alone, there were 480,000 reports of patient injuries or device malfunctions that were hidden from public view.
In 2016, for example, there were only 84 public reports of stapler malfunctions or patient injuries made to the public MAUDE database. In the same year, there were nearly 10,000 malfunction reports made to the secret database. This is a scandal and an outrage. The FDA has since mostly ended the special exemption program and publicly-available device malfunction reports have soared.
According to the FDA, the exemption program began innocently enough as a way of reducing duplicative reports of malfunctions which were overwhelming staff at the FDA. The program required manufacturers to continue to publicly report deaths but other injuries could be reported in a spreadsheet format on a quarterly basis. The public and the medical profession were never told about this alternative reporting database.
Although the FDA has ended the program for most devices, it refuses to identify the 100 or so devices that were granted the special exemption. Apparently, the alternative reporting program remains in place for pacemaker electrodes and implantable defibrillators.
Although some progress has been made, there is lots of room for improvement of the FDA’s management of device safety. I have blogged on a number of occasions about problems with reusable endoscopes and the FDA’s changing guidance. Medical devices are becoming more complicated and more important to patient care. We need to demand more transparency on the part of the FDA and greater Congressional oversight to make sure this important task is given the priority and resources it deserves.