By Jacob Howard
In the waning days of the Trump administration, a final push was made to fundamentally weaken regulation of medical devices.
Lambasted as a “full frontal assault on public health” by U.S. Food and Drug Administration (FDA) officials, key policy changes include proposed emergency exemptions to bring a multitude of devices to market without the necessary scientific backing. Justified as a strategy to expedite the delivery of life-saving products, this speed comes at a risk to millions of patients.
As the third most prevalent cause of death in the U.S., medical error continues to be a critical issue that is exacerbated by weakening integrity of the regulatory process. This issue is further compounded by the fact that past regulatory failures in the medical device sphere have not been adequately addressed. The surgical stapler offers an illustrative example.
For over a decade, the FDA allowed manufacturers of surgical staplers—among other medical devices—to file injury reports as “alternative summary reports” to avoid registration in the public Manufacturer and User Facility Device Experience (MAUDE) database. Until 2019, most surgical staplers’ contributions to injury statistics were largely hidden in the FDA’s nonpublic databases.
In 2016, only 100 stapler related injuries were disclosed in MAUDE, while 10,000 reports were classified as “alternative summary reports,” hidden from the public and medical professionals. It was only after significant backlash and litigation from the surgical community that these injury reports were finally disclosed by the FDA in 2019.
From 2011 to 2018, the uncovered reports revealed 56,000 hidden injuries, which included over 400 deaths related to the “malformation of staples, misfiring, difficulty in firing, failure of the stapler to fire the staple, and misapplied staples.”
In response to this data, the FDA convened a panel of experts. An executive summary was released promptly, detailing an urgent need to change regulation strategies for surgical staplers.
But, despite FDA and healthcare providers both publicly declaring concern for the risks associated with surgical stapler use, safety standards and classification for surgical staplers have not changed.
FDA medical device classification
The FDA utilizes a three-tiered approach to medical device classification:
Classification 1: Lowest risk medical devices such as examination gloves and tongue depressors. These do not require premarket approval, or any special manufacturing controls.
Classification 2: Riskier medical devices such as syringes, medical lasers, ablation systems, and endoscopes. These can require premarket approval and special controls.
Classification 3: “Greatest Risk” medical devices such as breast implants, dermal fillers, and dry heat sterilizers. These always require premarket approval and special controls.
Since their initial approval by the FDA in 1988, surgical staplers have been classified as “lowest risk” medical devices. This categorization has not changed even after the surfacing of thousands of surgical stapler injury reports. The same category that houses tongue depressors and gauze provides the framework to regulate and stipulate the design and manufacturing of surgical staplers.
As a tool devised to simultaneously cut and ligate tissue, surgical staplers likely fit under Classification 2, rather than Classification 1. There is a growing consensus that surgical staplers should be reclassified in response to uncovered injury reports.
How did we get here?
When the FDA assumed the mantle of medical device regulation in the 1980s, it faced the awkward task of governing devices that were already widely used, trusted, and available on the market. Surgical staplers had been in use for decades and fell under the general grouping of “manual surgical instrument for general use.”
Due to the perceived safety of these already available medical devices, the FDA opted not to enact new regulations. In fact, the FDA felt additional regulation of surgical staplers and other manual surgical instruments would “not advance [the FDA’s] public health mission.” The agency provided no clear timeline for reevaluation of this policy.
That being said, the process of reclassifying a medical device is relatively straightforward and well-outlined. The FDA Commissioner can change device classifications with the federal register at any point by administrative order as long as a classification panel convenes and provides a recommendation in support of reclassification.
However, even though recommendations to reclassify surgical staplers have been made by a classification panel, they have not been reclassified. At this point, two years after the hidden trove of injury reports were revealed, and amid a flurry of deregulation from the departing Trump administration, it seems less likely than ever that the issue will be addressed.
A wake-up call
The irresponsible classification of surgical staplers should signal a wake-up call. We must scrutinize the current approach to classifying medical devices and demand increased transparency. Medical device classification and regulatory transparency not only provide information on how safe a medical device is, but also vital information pertinent to deciding how and when to use a device.
The Trump administration’s policy would allow manufacturers to obtain exemptions to avoid controls and approval requirements within the current medical device classification system. Diana Zuckerman from the National Center for Health Research warns providing exemptions without scientific consensus is an act “companies will appreciate but will put millions of patients and consumers at risk.”
Surgical staplers alone have caused thousands of injuries and hundreds of deaths over the past few decades. It is easy to imagine how providing emergency exemptions to over 80 medical devices, as outlined by the recently departed administration, could multiply the damage to public health. Policy crafted by the Biden administration will have to contend with this recent damage to the regulatory process, as well as long-standing shortcomings.