Safe Use of Surgical Staplers and Staples
The U.S. Food and Drug Administration (FDA) has issued a Letter to Health Care Providers alerting them to the increasing number of adverse events associated with surgical staplers and staples for internal use and is providing additional recommendations to help protect patient safety and reduce the risk of adverse events associated with these devices.
Because surgical staplers and staples for internal use are used as a system, the FDA analyzed the medical device reports submitted for both surgical staplers and implantable staples to obtain a comprehensive picture of the safety profile for these devices. The analysis, which is ongoing, found that from January 1, 2011 to March 31, 2018, the FDA received over 41,000 individual medical device reports for surgical staplers and staples for internal use, including:
- 366 deaths,
- over 9,000 serious injuries, and
- over 32,000 malfunctions.
The FDA believes that many of the problems identified in these reports can be primarily attributed to surgical staplers for internal use because proper staple formation is largely contingent on proper function and use of the stapler.
Some of the most commonly reported problems in these adverse event reports include:
- opening of the staple line or malformation of staples,
- difficulty in firing,
- failure of the stapler to fire the staple, and
- misapplied staples (e.g., user applying staples to the wrong tissue or applying staples of the wrong size to the tissue).
Stapler and/or staple malfunctions or misuse may result in prolonged surgical procedures or unplanned, additional surgical interventions, which may lead to other complications, such as:
- Fistula formation
- Tearing of internal tissues and organs
- Increased risk of cancer recurrence
The FDA provides the following recommendations for health care providers:
- Read and carefully follow the stapler manufacturer’s instructions for use.
- Have a range of staple sizes available and select the appropriate size cartridge for the tissue type and thickness.
- If you have difficulty squeezing the handle of the stapler, you may need to select a different size staple.
- Avoid using the stapler on tissue that is too thick or too thin for the selected staple size, as this could result in staple malformation.
- Be aware that different companies may use different color schemes on the cartridges to indicate different staple sizes.
- Consider other options if the patient’s tissue is edematous (swollen with fluid), friable (tissue that readily tears, fragments, or bleeds when gently palpated or manipulated), or necrotic (death of tissue), as the staples may be less likely to securely approximate tissue.
- Be familiar with the structures around the intended staple site.
- Check that unintended structures, such as urinary bladder, or foreign objects, such as clips, are not in the staple line.
- Avoid using on large blood vessels, such as the aorta.
- Avoid clamping the stapler on delicate tissue, as clamping can still cause injury even if no staples are fired.
- If a malfunction of the stapler occurs while applying staples across a blood vessel, then clamp or ligate the vessel before releasing the stapler, while the stapler is still closed on the tissue.
In addition to the above recommendations, the FDA also outlines in the letter new actions they are taking to help ensure the safe use of these devices.
Follow the link below for more information.
Want to read the full alert and receive alert emails?