The US Food and Drug Administration (FDA) is planning to review surgical staplers after it emerged that manufacturers were allowed to ‘hide’ malfunction reports.
Officials say that faulty staplers, which close internal surgical wounds, can lead to bleeding, organ damage, sepsis and even death.
In a letter sent to health care providers, the FDA said it is setting up a committee to update recommendations to hopefully reduce the risk of using the devices.
It comes after a Kaiser Health News investigation found that the FDA allowed the makers of surgical staplers an ‘exemption’ to file malfunction reports in a separate database from the one available to the general public.
The news website found that, in some years, only a couple of hundred of injuries or malfunctions were made publicly available while as many as 10,000 reports were filed in the hidden database.
The US Food and Drug Administration is planning to review thousands of malfunction reports of surgical staplers that were ‘hidden’ from the public database between 2011 and 2018. Pictured: A stapler made by Medtronic, one of the companies that received the ‘exemption’
Surgical staples are used to close both internal and external wounds.
Doctors have turned to using staples over sutures in recent years because they reduce the amount of wound infections, the size of the wound and the time needed for the wound to heal.
The first staplers were made of stainless steel, but today only half of them are, while the rest are disposable and made from plastic.
Records from the FDA show that, over the course of seven years, the agency allowed exemptions to be made on malfunctions of both staplers and staples.
Kaiser Health News found that in 2016, there were 10,000 malfunction reports entered into the internal database, but the public database only showed about 100 malfunctions.
This is a problem because the public database, called MAUDE (Manufacturer and User Facility Device Experience), is used by doctors to track device failures.
The FDA told Kaiser Health News that ‘about 100’ devices received exemptions, but did not reveal the identities of the companies.
The agency also said that it ended the majority of its exemption program in 2017.
Medtronic, which makes staplers, told Kaiser Health News that it used to report malfunctions under exemptions but that it stopped in July 2017.
The news website found that public reports of injuries and malfunctions from Medtronic increased 11-fold from roughly 1,000 in 2015 to 11,000 in 2018.
In the letter sent out by the FDA, officials said that between January 2011 and March 2018, the agency received more than 41,000 medical device reports regarding surgical staplers and staples to be used internally.
Incidents included 366 deaths, more than 9,000 injuries and more than 32,000 malfunctions.
The problems that were most commonly reported include staples being misfired, having difficulty being fired, the stapler failing to fire the staple, the staple line being opened and staples that were either the applied to the wrong tissue or of the wrong size to the tissue.
The letter noted that these malfunctions and misuses can lead to complications such as further surgeries, internal bleeding, sepsis, tissues and organs tearing, and even death.
‘As part of our public health mission, it is important that we communicate with the public when we become aware of issues stemming from the use, or misuse, of medical devices,’ said Dr William Maisel, chief medical officer in the FDA’s Center for Devices and Radiological Health.
‘Improving the safety of surgical staplers and implantable staples is a top priority for the FDA, and we believe our forthcoming draft guidance to industry and planned advisory committee meeting will advance those efforts.’
The FDA also plans to discuss the possibility of reclassifying surgical staplers for internal use.
Currently, staplers used both externally and internally are under Class I, meaning the makers do not need a premarket review.
However, if internal use surgical staplers are moved to Class II, they would need a premarket review and would require regulation to assure consumers of their safety and efficacy.