Image
Top
Navigation
May 12, 2016

Contamination Control News: It’s the Difference Between Life and Death

575x325_ebola

Ebola. Even that small collection of letters on a page is enough to strike fear into most people. And rightly so. In a recent outbreak of the disease in Liberia, a small West African nation bordered by Sierra Leone and Ivory Coast, ebola killed more than five hundred people. And while that in itself should be newsworthy, it is one additional fact that makes it so.

The five hundred casualties of the virus were all medical personnel, killed by ‘strike-through.’

Let’s back up for a moment and consider the facts.

Ebola is a lethal disease.

Ebola is a lethal disease. A form of hemorrhagic fever, it is transmitted by direct contact with the bodily fluids of an infected person. Blood, saliva, urine or vomit are all vectors of transmission, either directly or via needle-stick injuries. After infection, symptoms including fever, severe headache, vomiting, diarrhea, and hemorrhaging will appear within two to twenty-one days and currently no medicine or vaccine is available to fight the virus directly. Survival depends largely upon a patient receiving IV fluids, balancing electrolytes, and maintaining blood pressure. In other words, there is no magic pill and ebola victims survive only if their bodies can be kept alive long enough for their own immune systems to vanquish the virus.(1)

So the attention of medical personnel is, in this case, literally the only chance ebola victims have for survival. Which makes them even more valuable an asset. One worth protecting, you might think.

Enter Personal Protective Equipment or PPE. PPE is a collective term relating to gowns, body bio-hazard suits, gloves, glove liners, masks – basically any outerwear that prevents the fluid-based transmission of a virus. In an outbreak of ebola, it’s clear that these items must be of the highest possible quality to protect those on the front lines of stemming the outbreak. However, in a 60 Minutes report by Anderson Cooper which aired on May 6th, it is alleged that Halyard Heath – a part of the behemoth Kimberley-Clark Corporation – knowingly supplied sub-standard gowns to those treating the ebola patients in Liberia. According to an industry insider, Bernard Vezeau, who worked as the global strategic Marketing Director for MICROCOOL products, the gowns failed AAMI Level 4 permeability tests. In short, in pressure tests, the gowns would leak.(2)

In medical terms, this kind of leakage is known as ‘strike-through’ and refers to bodily fluids penetrating the protective barrier of gown or gloves and coming into direct contact with the wearer. It is the moment a surgeon removes her gloves to find the patient’s blood on her hands or when a nurse removes his gown to find blood on the inside. In Cooper’s 60 Minutes investigation, it is alleged that in tests on the MICROCOOL gown sleeves, 77% of the test gowns failed, a number that would seem to lend credence to the reports from medical professionals in the domestic market also complaining of experiencing strike-through. Some surgeons at UF Health in Jacksonville, FL, even took photographs of their bloodied arms to prove that the materials were defective.

And furthermore, in addition to strike-through, wearers of MICROCOOL’s gowns also complained that the gowns could literally fall apart. When reports started coming in of sleeves or ties falling off gowns in the middle of a surgical procedure, Vezeau made his fears official by putting them on record with the COO of Halyard Health.

in addition to strike-through, wearers of MICROCOOL’s gowns also complained that the gowns could literally fall apart.

The company’s response? According to Vezeau, the rejoinder was as simple as it was chilling: “Nobody really cares about this. Nobody really cares about surgical gowns.”(3)

And yet perhaps they do. Surgeons presumably do. Front-line providers of medical assistance to those battling ebola in Liberia certainly do. And now so do the FDA and the Department of Justice, which served Halyard Health with a subpoena relating to its own investigation. And, although the company has since denied all allegations leveled in the 60 Minutes report, it seems the market cares too. With Halyard’s stock slipping by almost 1% in premarket trading, it tumbled by a further 11% after a preview of the report was published online. And now Kimberley K Underhill, President of Kimberley-Clark Corporation, seems to care too. According to a filing to the SEC just last week, Underhill disposed of some three thousand shares of his own company.(4) We leave you to draw your own conclusions about this issue.

And on a last note, despite having a full 77% of gowns fail QA testing, Halyard continued to produce MICROCOOL gowns. By early 2015, thousands had already been supplied to the CDC’s Strategic National Stockpile of medical equipment, intended as a reserve in the event of a national catastrophe. Those gowns with their propensity to fall apart and to leak are now no longer heading for a disaster in a remote African nation but are staying close to home as a crucial part of our national emergency stockpile. And of course, this makes them the difference between life and death…on American soil.

Got an opinion or a comment? We’d love to hear from you!

References

  1. http://www.cdc.gov/vhf/ebola/about.html
  2. http://www.cbsnews.com/news/60-minutes-investigates-medical-gear-sold-during-ebola-crisis/
  3. http://www.cbsnews.com/news/60-minutes-investigates-medical-gear-sold-during-ebola-crisis/
  4. http://www.conferencecalltranscripts.org/4/summary2/?id=2728448

Our commitment to quality is second to none.  We will continue to share the latest industry news on our Cleanroom News Blog. Also feel free to visit our parent site for additional information, training, and products.

Share This!

Comments

  1. Francisco Dale

    Hello! Do you use Twitter? I’d like to follow you if that would be ok. I’m absolutely enjoying your blog and look forward to new updates.

Submit a Comment

Categories

FDA

css.php
Show Buttons
Hide Buttons