Dive Brief:

• FDA is proposing to reclassify surgical staplers from Class I to Class II. The higher-risk Class II category requires a premarket review before marketing.
• The proposed order follows an agency review of the medical device reporting database that found the widely used tools were linked to numerous problems and serious complications, including 366 deaths, over a seven-year period. It also came after a media report that the agency maintained a separate database for adverse events not easily available.
• The Class II category allows FDA to establish special controls and labeling requirements for the devices. The agency detailed a number of stronger controls in the reclassification proposal and issued a separate draft guidance outlining labeling elements to support safe use of the devices.

Dive Insight:

FDA alerted healthcare providers in March to a rise in adverse event reports involving surgical staplers and staples, disclosing that it had received more than 41,000 such reports from Jan. 1, 2011, to March 31, 2018. The reports linked 366 deaths, more than 9,000 serious injuries and more than 32,000 malfunctions to the devices.

The letter to healthcare providers came on the heels of a Kaiser Health News investigation that revealed an alternative database where FDA collected reports of incidents with surgical staplers and other medical devices out of public view.  The story singled out surgical staplers as an example of the disparity between the small number of incident reports included in the widely-known MAUDE database compared to those in the alternative database

A spokesman for leading stapler maker Medtronic in an email to MedTech Dive in March confirmed it stopped using the alternative summary reporting process in July 2017.

Now, FDA has issued a proposed reclassification order that spells out stronger controls to mitigate the risks associated with staplers. FDA said both misuse and malfunction are root causes of adverse events.

FDA said the most common problems in the adverse event reports included an opening of the staple line, malformation of staples, misfiring, difficulty or failure in firing the staple, staples applied to the wrong tissue, and staples of the wrong size applied to tissue.

Of the 366 stapler-related deaths, FDA said the cause was associated with an opening of the staple line or malformation of staples in 159 reports, bleeding during surgery in 53 reports, sepsis in 47 reports, peritonitis in 5 reports, necrosis in 5 reports and air embolism in four reports.

In addition, 195 of those reports included misfiring, difficulty in firing or misapplied staples. Common reasons cited for the problems included mechanical issues such as jams, broken device components, and the device operating differently than the user expected. In 11 of the 366 deaths, use error was determined to be a contributing factor. Many of the same complications that resulted in death were also reported in the serious injury reports.

Surgical staplers can shorten procedure times compared to manual suturing. The devices are used in a wide range of surgical applications, including gastrointestinal, gynecologic and thoracic surgeries, to remove part of an organ, cut through tissues and connect structures.

Special controls for the devices that the agency seeks to establish include: mandatory performance testing of mechanical features, demonstration of usage and labeling comprehension, including assessing healthcare providers' ability to properly select the device, and specific labeling elements supporting safe use of the device.

FDA's draft guidance on labeling recommends manufacturers include information such as relevant hazards, contraindications for use, warnings on what uses to avoid, and instructions for the types of tissues on which the device may be used. The guidance also advises that directions for use clearly explain situations such as how to evaluate staple line formation and integrity, and that the label clearly identify key technical characteristics and performance parameters.

To prevent stapler malfunction, information on which staples are compatible should be provided in the labeling, FDA said. The labeling should provide warnings on how to avoid hazards including obstructions to the creation of a staple line and the unintended stapling of other anatomic structures.

Adequate performance testing should include an evaluation of staple formation characteristics in the maximum and minimum tissue thicknesses for each staple type, measurement of the worst-case deployment pressures on stapler firing force, and a measurement of staple line strength.

FDA said the device should show biocompatibility due to risk of adverse tissue reaction, and testing should demonstrate the sterility of the device. Labeling should include validated methods and instructions for cleaning and sterilization of reusable components. Shelf-life testing should demonstrate that the device maintains its performance characteristics and the packaging of the device maintains its integrity for the duration of the proposed shelf-life, and the label should specify an expiration date.

FDA has set a public meeting of the General and Plastic Surgery Devices Panel of its Medical Devices Advisory Committee on May 30-31 to address whether the current pathway for manufacturers to market surgical staplers is appropriate and to receive expert input on the proposed reclassification and draft guidance. FDA will present a comprehensive analysis of the medical device reports received for surgical staplers and implantable staples at the meeting.