Overnight a story by Anderson Cooper (see 60 Minutes investigates medical gear sold during Ebola crisis), has made ripples across the health care industry, as he looked into allegations that a company provided faulty surgical gowns to U.S. hospitals and to the U.S. Strategic National Stockpile.
You can find additional coverage in the Florida Times Union report UF Health Jacksonville surgeons among those reporting defective surgical gowns during Ebola crisis.
Without regard to this specific case - if all of this sounds somewhat familiar - it might be because we looked at the failure rate of isolation gowns almost a year ago in NIOSH Science Blog: Not All Isolation Gowns Tested Met Standards.
While the 60 Minutes piece looked specifically at the manufacturer of one type of gown, last July we saw testing results of 22 disposable models provided by 6 different manufacturers, where 7 (31.8%) of 22 failed to meet the required ANSI/AAMI PB70 liquid barrier performance standard.
According to NIOSH, the gowns for this test were voluntarily submitted by the manufacturers, under the understanding that:
For the purposes of this research, NIOSH agreed not to identify specific results to a particular model or manufacturer, though manufacturers did receive the results to the tests on their own gowns. The testing was conducted according to criteria established by the AAMI, and testing standards developed by the American Association of Textile Chemists and Colorists (AATCC) and ASTM.
Meaning we don't know if the gowns that were the subject of the 60 Minutes piece were among those tested.
Gowns (surgical, isolation, or low-risk `cover’) are the second most common form of barrier protection used by Healthcare workers, exceeded only by disposable gloves. Although they come in many styles and design, the FDA recognizes four main types (see FDA - Medical Gowns)
- Level 1: Minimal risk, to be use used, for example, during basic care, standard isolation, cover gown for visitors, or in a standard medical unit
- Level 2: Low risk, to be use used, for example, during blood draw, suturing, in the Intensive Care Unit (ICU), or a pathology lab
- Level 3: Moderate risk, to be use used, for example, during arterial blood draw, inserting an Intravenous (IV) line, in the Emergency Room, or for trauma cases
- Level 4: High risk, to be use used, for example, during long, fluid intense procedures, surgery, when pathogen resistance is needed or infectious diseases are suspected (non-airborne)
With the recent introductions of Ebola and MERS into the United States, and H5N1 and H7N9 avian flu into Canada, plus the more commonly encountered blood borne pathogens like HIV, HVC & HVB, there is growing interest in the proper use, and design, of PPEs (Personal Protective Equipment) like gloves, gowns, and masks (N95 & surgical).
Despite this renewed focus, there have been numerous challenges, including:
All of which proves that the job of protecting hospital staff and patients is tough enough without adding faulty PPEs into the mix.