Outpatient Surgery Magazine, providing current information on Surgical Services, Surgical Facility Administration, Outpatient Surgery News and Trends, OR Excellence and more.
Issue link: http://outpatientsurgery.uberflip.com/i/726435
Intertek, 1 of 2 U.S. labs that tests AAMI Level 4 gowns. One of the 3 lots failed. That prompted a K-C scientist to instant message the man- ager of the plant in Honduras where the gowns were made. "We need to try and come up with a reason/rationale why only one lot of MicroCool had sleeve seam fails — which would justify testing it again. … [S]omething … anything … so we can re-test and have a rea- son. … Anything you can think of — doesn't have to be a proven rea- son. Just something to hang a re-test on. Know what I mean?" According to the brief, the manager responded, "We do not have that process (sleeve sealing) validated." Despite the results, K-C continued to market the gowns. It would sell more than 50 million between February 2012 and January 2015. Just as the gowns failed in-vitro tests, they started failing in-vivo tests. Surgeons started experiencing "strike-through," meaning that liquid permeated the gown and soaked through to their skin. How many did is a matter of dispute. According to deposition testimony from Bernard Vezeau, K-C's former global strategic marketing director for surgical and infection prevention, during that 3-year period, the company received large numbers of complaints about the gowns, enough to fill a printed spreadsheet hundreds of pages long. That doc- ument remains under seal. However, William Rutala, PhD, MPH, an expert witness for Halyard Health, testified that the company sold 55 million gowns between 2013 and 2015, and received only 45 com- plaints. Dr. Rutala, a renowned expert on infection, cited unpublished K-C data. Rashel Campos, RN, administrator of the Bahamas Surgery Center in Bakersfield, Calif., which is a plaintiff in the case, testified in her deposition that in her center, surgeons experienced strike-through several times. "There were times when our surgeons had removed their gowns, and they were wet or bloody and then (had) to shower S E P T E M B E R 2 0 1 6 • O U T PA T I E N TS U R G E R Y. N E T • 2 5