Healthmark Offers New Vendor Credentialing Program

Healthmark Industries’ clinical affairs team has announced the creation of 13 training programs that will be offered for vendors and manufacturer representatives to satisfy vendor credentialing requirements.

Interim Life in the Age of COVID

An interim director of surgical services is familiar with unpredictability. In a new assignment, the needs of the OR, often disparate, compete for their attention. Prioritizing what to execute first is a delicate balancing act.

Asensus Surgical Announces FDA Clearance in General Surgery

Asensus Surgical Inc. (formerly TransEnterix Inc.) has received an additional FDA clearance for the Senhance Surgical System which allows for indication expansion in general surgery in the United States. A news release states that Asensus Surgical's technology...

Staying Positive During the Pandemic

The good news for patients in need of outpatient surgery is that, across the country, health care providers and policymakers have recognized that elective surgery is not the same thing as optional surgery and are allowing ASCs to remain open to provide this care.

New FDA Actions to Promote the Safe Use of Surgical Staplers and Staples for Internal Use: Proposed Reclassification, Draft Guidance, and Public Panel Meeting

The U.S. Food and Drug Administration (FDA) is concerned by the large number of adverse events associated with surgical staplers and staples specifically for internal use. We are taking multiple actions to help promote patient safety and reduce the risk of adverse events associated with these devices.

Between January 1, 2011 and March 31, 2018, the FDA received over 41,000 medical device reports related to surgical staplers and staples for internal use, including 366 reported deaths, over 9,000 serious injuries, and over 32,000 malfunctions.

As first announced in our March 8, 2019, letter to healthcare providers, the FDA has now issued:

  • A draft guidance, “Surgical Staplers and Staples for Internal Use – Labeling Recommendations,” to help manufacturers develop labeling with information about specific risks, limitations, and directions for use of the device, which is open for public comment through June 24, 2019.
  • A proposed order to reclassify surgical staplers for internal use from Class I to Class II medical devices, which is open for public comment through June 24, 2019.
  • Currently, surgical staplers for internal use are regulated as Class I medical devices, which do not require a premarket submission to the FDA.
  • Classification as a Class II device would allow the FDA to establish mandatory special controls and require premarket notification (510(k)).
  • A Federal Register notice formally announcing an open public meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. On May 30, 2019, the committee will discuss and make recommendations regarding the proposed reclassification of surgical stapler devices for internal use from Class I (general controls) to Class II (special controls).

We invite any interested parties to participate in the public panel meeting, either by attending the meeting, presenting at the meeting, or submitting written comments.



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