What’s New in the Patient Safety World

April 2019

 

FDA Warning on Surgical Staplers Opens a Can of Worms

 

 

Another under-the-radar problem has just popped up. The FDA (FDA 2019), between January 1, 2011 to March 31, 2018, received over 41,000 individual medical device reports for surgical staplers and staples for internal use, including:

·       366 deaths

·       over 9,000 serious injuries

·       over 32,000 malfunctions

 

Common problems noted in those incident reports include:

·       opening of the staple line or malformation of staples,

·       misfiring

·       difficulty in firing

·       failure of the stapler to fire the staple

·       misapplied staples (e.g., user applying staples to the wrong tissue or applying staples of the wrong size to the tissue)

 

Such incidents may result in bleeding, sepsis, fistula formation, tearing of internal tissues and organs, increased risk of cancer recurrence, and death. Such malfunctions or misuse also may result in prolonged surgical procedures or unplanned, additional surgical interventions.

 

The FDA makes a number of recommendations for hospitals and healthcare professionals. It notes that a range of staple sizes should be available to facilitate selection of the appropriate size cartridge for the tissue type and thickness (but keep in mind that different companies may use different color schemes on the cartridges to indicate different staple sizes). Difficulty squeezing the handle of the stapler may indicate the need to select a different size staple. The FDA recommends avoiding use of the stapler on tissue that is too thick or too thin for the selected staple size.

 

It is especially important to consider other options if the patient’s tissue is edematous, friable, or necrotic, because the staples may be less likely to securely approximate tissue. Clamping the stapler on delicate tissue can still cause injury even if no staples are fired.

 

Operators obviously need to be sure that unintended structures, such as urinary bladder, or foreign objects, such as clips, are not in the staple line.

 

The warning specifically cautions about the use of surgical staplers near large blood vessels, such as the aorta. It states that, if a malfunction of the stapler occurs while applying staples across a blood vessel, clamp or ligate the vessel before releasing the stapler, while the stapler is still closed on the tissue.

 

The FDA also plans to develop a draft guidance for public comment, discuss this as a topic at an upcoming advisory committee meeting, and is considering reclassification of surgical staplers as Class II medical devices.

 

The FDA also notes that there are likely many more reported incidents involving surgical staplers submitted as Alternative Summary Reports so it will be analyzing those reports as well as any new ones submitted after the above dates.

 

Stapler malfunction may be particularly problematic in laparoscopic or other minimally invasive procedures. Kwazneski et al. (Kwazneski 2013) found that most minimally invasive surgeons have experienced laparoscopic linear stapler malfunction and 25% have had to significantly alter the planned operative procedure due to the malfunction. They noted difficulty getting helpful feedback from the manufacturers despite contacting them. They noted the lack of clarity for how to report such malfunctions. Note that the current FDA letter to health care providers does spell out how to report such malfunctions.

 

The experience of Kwazneski et al. was also recently highlighted in a Kaiser Health News article discussing that reports of incidents related to many medical devices are hidden from the public because they have been exempted from such reporting (KHN 2019). The article notes that, “since 2016, at least 1.1 million incidents have flowed into the internal “alternative summary reporting” repository, instead of being described individually in the widely scrutinized public database known as MAUDE, which medical experts trust to identify problems that could put patients in jeopardy.” While deaths must still be reported in MAUDE, the “hidden” database has included serious injury and malfunction reports for about 100 medical devices,

 

So, the stapler issue may be just the tip of the iceberg. It’s likely that problems related to multiple other medical devices have evaded scrutiny because they have been “exempted” from reporting to MAUDE or other publicly accessible databases.

 

 

References:

 

 

FDA (US Food and Drug Administration). Safe Use of Surgical Staplers and Staples – Letter to Health Care Providers. March 8, 2019

https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm632938.htm?utm_campaign=Surgical%20Staplers&utm_medium=email&utm_source=Eloqua

 

 

Kwazneski DR, Six CK, Stahlfeld KR. The Unacknowledged Incidence of Laparoscopic Stapler Malfunction. Surg Endosc 2013; 27(1): 86-89

https://link.springer.com/article/10.1007%2Fs00464-012-2417-y

 

 

KHN (Kaiser Health News). Hidden FDA reports detail harm caused by scores of medical devices. Tampa Bay Times 2019; March 7, 2019

https://www.tampabay.com/investigations/2019/03/07/hidden-fda-reports-detail-harm-caused-by-scores-of-medical-devices/

 

 

 

 

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