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Federal Register / Vol. 86, No. 193 / Friday, October 8, 2021 / Rules and Regulations discussed in the proposed order, there have been a large number of adverse events associated with use of both surgical staplers and staples for internal use; both device misuse and device malfunctions are root causes of these adverse events. Therefore, FDA finds it is essential to communicate specific information about the risks, limitations, and directions for use in the labeling for surgical staplers and staples for internal use to lower the risk of occurrence of these adverse events and to promote safe and effective use of these devices.
As discussed separately in the responses to the comments below in section IV, FDA has chosen to remove or revise certain labeling special controls in an effort to allow for physician discretion as discussed with the Panel, but we continue to conclude that other labeling special controls are necessary to provide a reasonable assurance of the safety and effectiveness of these devices.
Comment 11 Some commenters felt that the contraindication that the device should not be used to staple tissues that are necrotic, friable, or have altered integrity should be removed from the stapler labeling as it extends into the realm of surgical practice and involves the application of medical judgement that should be left to trained surgeons.
Response 11 FDA disagrees that the contraindication regarding stapling of tissues that are necrotic, friable, or have altered integrity should be removed from the labeling. FDA notes that application of staples to tissues that are necrotic, friable, or have altered integrity has resulted in complications such as, but not limited to, tissue damage, anastomotic leakage, bleeding, abscess, sepsis, peritonitis, and hemorrhage. To FDAs knowledge, there is no known benefit of applying surgical staples to tissues that are necrotic, friable, or have altered integrity.
Therefore, FDA determines that the risk of stapling tissues that are necrotic, friable, or have altered integrity outweighs any reasonably foreseeable benefit due to known complications.
FDA finds that this contraindication is necessary to mitigate the risks of complications associated with improper device use and to provide a reasonable assurance of the safety and effectiveness of these devices.
Comment 12 One commenter felt that the warning to visually inspect for inclusion of unintended anatomic structures within the staple line should be removed from the stapler labeling as it extends into the realm of surgical practice and involves the application of medical judgement that should be left to trained surgeons.

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Response 12 FDA disagrees that the warning regarding avoidance of obstructions to the creation of the staple line and the unintended stapling of other anatomic structures should be removed from the labeling. As noted in the proposed order, obstructions to the creation of the staple line and unintended stapling of anatomic structures have been associated with known hazards. For example, FDA has received medical device reports where obstructions to the staple line and/or unintended stapling of anatomic structures have resulted in anastomotic leaks and other injuries. Therefore, FDA
finds that this warning is necessary to mitigate the risks of complications associated with improper device use and to provide a reasonable assurance of the safety and effectiveness of these devices.
Comment 13 Similar to the Panel discussion, some commenters felt that the warning to establish and maintain adequate proximal control of blood vessels prior to stapling should be removed from the stapler labeling as it extends into the realm of surgical practice and involves the application of medical judgement that should be left to trained surgeons.
Response 13 FDA disagrees that the warning to establish and maintain adequate proximal control of blood vessels prior to stapling should be removed entirely, as it is important to have methods of blood vessel control in place in the event of stapler failure to prevent the risk of uncontrolled bleeding. However, FDA acknowledges there are situations where it may not be practical to establish proximal control of blood vessels prior to stapling.
Therefore, FDA has revised the labeling special control to include a warning regarding the establishment of proximal control of blood vessels prior to stapling where practical and establishment of methods of blood vessel control in place in the event of stapler failure.
FDA finds that this warning is necessary to mitigate the risks of complications associated with improper device use and to provide a reasonable assurance of the safety and effectiveness of these devices.
Comment 14 One commenter felt that the warning that clamping and unclamping of delicate tissue structures, such as venous structures and bile ducts, may result in damage to tissue irrespective of stapler firing, should be removed from the stapler labeling as it extends into the realm of surgical practice and involves the application of medical judgement that should be left to trained surgeons.

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Response 14 FDA disagrees that the warning regarding avoidance of clamping and unclamping of delicate tissue structures should be removed from the labeling. As discussed in the proposed order, clamping and unclamping of delicate tissue structures have been associated with known hazards such as tissue damage. For example, FDA has received medical device reports where clamping of the stapler has resulted in tissue damage or bleeding. As also noted in FDAs Letter to Health Care Providers, Safe Use of Surgical Staplers and Staples, clamping of staplers on delicate tissue can cause injury even if no staples are fired Ref. 7. Therefore, FDA finds that this warning is necessary to mitigate the risks of complications associated with improper device use and to provide a reasonable assurance of the safety and effectiveness of these devices.
Comment 15 Some commenters felt that the warning regarding measures to take if a stapler malfunction occurs while applying staples across a blood vessel, including clamping or ligating the vessel before releasing the stapler, while the stapler is still closed on the tissue, should be removed from the stapler labeling as it extends into the realm of surgical practice and involves the application of medical judgement that should be left to trained surgeons.
Response 15 FDA agrees that the warning regarding clamping or ligating the vessel before releasing the stapler, while the stapler is still closed on the tissue may be too prescriptive and has removed this from the labeling special controls. Nonetheless, FDA continues to find that it is important to have methods of blood vessel control in place in the event of stapler failure in order to prevent the risk of uncontrolled bleeding. Therefore, FDA has modified the remainder of the labeling special controls to add a warning regarding methods of blood vessel control in the event of stapler failure. FDA finds that this warning is necessary to mitigate the risks of complications associated with improper device use and to provide a reasonable assurance of the safety and effectiveness of these devices.
Comment 16 Consistent with the Panel discussion, commenters requested revision or removal of the warning regarding avoidance of use of the stapler on large blood vessels, such as the aorta. Some commenters felt that the term large blood vessels is vague and recommended revising the statement to warn specifically against stapling the aorta. Some commenters noted that many surgical staplers are contraindicated for use on the aorta and felt that this statement should only be
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