The U.S. Food and Drug Administration (FDA) is providing additional recommendations for healthcare providers to help protect patient safety and reduce the risk of adverse events associated with surgical staplers and staples for internal use. In addition, the FDA has announced new actions being taken to help ensure the safe use of these devices.
Surgical staplers for internal use are specialized prescription devices used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses. Surgical staplers and staples for internal use may be indicated for use in a wide range of surgical applications, including but not limited to gastrointestinal, gynecologic, and thoracic surgery. Because of increased use and reliance on surgical staplers and concerns about the increasing number of adverse events associated with surgical staplers and staples for internal use, the FDA issued a letter to healthcare providers in March 2019. These include update to previous recommendations and new FDA actions regarding the safe use of surgical staplers.
The recommendations include:
- 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 clamping the stapler on delicate tissue, as clamping can still cause injury even if no staples are fired.
- Have methods of blood vessel control in place in the event of stapler failure. Where practical, proximal control of blood vessels is recommended prior to stapling.
- Check to ensure that the staples are compatible with the stapler.
- Be aware that there is a risk of increased leak rates when staple lines are crossed, even if there may be clinical circumstances when it is clinically necessary or appropriate to do so.
- Since all unique clinical scenarios cannot be captured through general stapler recommendations, these recommendations are intended to supplement, and not replace, good clinical judgement.
The FDA continues to work with hospitals and professional societies to encourage training and education associated with the use of these devices.