class action suit on the part of customers, Halyard also faces a possi-
ble shareholder suit over the gowns. The controversy was also the
subject of a 60 Minutes investigation (osmag.net/HtAAf8) that aired
in May.
The company admits no wrongdoing. It says it's cooperating with the
government agencies and "vigorously" contesting the lawsuits. The
company says it was
"profoundly disappoint-
ed" with the 60 Minutes
segment, calling it "inac-
curate and misleading."
A Halyard statement says, "Protecting healthcare workers and
patients is our number one priority."
Not Cool
The revelations stem from a lawsuit filed in 2014 focused on the com-
pany's MicroCool Breathable High Performance gown: Hrayr
Shahinian, MD vs. Kimberly-Clark Corp.
K-C introduced its MicroCool brand in 1998, and in 2012 it unveiled
the MicroCool Breathable High Performance gown. The company
claimed the gown met the requirements for the Association for the
Advancement of Medical Instrumentation's Level 4 designation —
completely impervious throughout the "critical zone" in the front of
the gown. AAMI recommends Level 4 gowns for cases where the sur-
geon's hands are in a body cavity, for orthopedic procedures without
tourniquets, open CV and thoracic procedures, trauma and cesarean
sections.
Questions about whether the gowns actually met those standards
surfaced soon after the product launch. According to a plaintiff's legal
brief, K-C employees sent a batch of gowns — 3 lots of 32 each — to
2 4 • O U T PA T I E N T S U R G E R Y M A G A Z I N E • S E P T E M B E R 2 0 1 6
A lawsuit against Kimberly-Clark says its
MicroCool Breathable High Performance
gowns failed impermeability industry tests,
but K-C continued to claim the product
provided the highest level of protection.
