Recent research performed at the NIOSH National Personal Protective Technology Laboratory (NPPTL), with support from Nelson Laboratories, suggests that some isolation gowns do not meet the performance standards established by the American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI).
Isolation gowns are the second-most-used piece of personal protective equipment (PPE) in hospitals, following gloves (Holguin, 2011). Hospital isolation gowns are worn to protect healthcare workers during procedures and patient-care activities when anticipating contact with blood, bodily fluids, secretions and excretions (Siegel, 2007). The threat of emerging infectious diseases, such as Ebola virus disease and pandemic influenza, has highlighted the need for effective PPE to protect both healthcare workers and their patients.
ASTM International, formerly known as the American Society for Testing and Materials (ASTM), plans to use the NIOSH findings to assist with the development of a new standard specification for non-sterile isolation gowns intended for use in healthcare settings. The ASTM standard will then be used by manufacturers to develop gowns with improved protection and comfort for healthcare workers, allowing infection preventionists and safety professionals to select the most appropriate gown.
In response to a NIOSH Federal Register Notice and invitation letters sent to manufacturers of isolation gowns[i], NIOSH evaluated twenty-two different models of disposable isolation gowns (provided by six different manufacturers). 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.
Our research revealed that seven of the 22 tested disposable models did not meet ANSI/AAMI PB70 liquid barrier performance standard for protective apparel and drapes. When tested for fabric’s resistance to tearing and breaking and seam resistance to breaking, the 22 models showed a wide range of performance. While some gowns met the performance requirements of the standard, seams and ties on some gowns were not constructed adequately to keep liquids and/or viruses from penetrating at these particular points of the isolation gowns. The findings were limited to the types of gown models tested and variability of the test methods used[ii] and may not be generally representative across all isolation gown products. Within those limitations, the results suggest that isolation gowns on the market should be evaluated periodically to determine if they meet performance requirements for barrier protection. These preliminary findings were presented to the ASTM F23.40 Isolation Gown working group and presented as a poster at the 2015 Association for Professionals in Infection Control Conference[iii]. Additionally, NIOSH/NPPTL shared these results with other federal partners and the International Safety Equipment Association (ISEA).
NIOSH is working with manufacturers to identify issues and determine necessary corrective action to assure that products on the market are providing the expected level of protection to the end user. NIOSH continues to work with the ASTM committee to identify other research gaps where the institute’s expertise can lead the nation to identify appropriate PPE performance requirements for worker safety.
The past ten years has seen an increased emphasis on research for the healthcare community as healthcare worker exposures evidence the need for PPE to keep them safe. NIOSH is well renowned for its work in respiratory protective device research, certification, and standards development. Since 2011, NIOSH has increased its emphasis on protective clothing where research gaps were evident.
Selcen Kilinc-Balci, PhD, MBA and Maryann D’Alessandro, PhD
Dr. Kilinc-Balci is a physical scientist for NIOSH’s National Personal Protective Technology Laboratory.
Dr. D’Alessandro is the Director of the NIOSH National Personal Protective Technology Laboratory.
- Siegel JD, Rhinehart E, Jackson M, Chiarello L.. 2007 Guideline for isolation precautions: preventing transmission of infectious agents in health care settings. American Journal of Infection Control 2007; 35(10): S65-S164.
- Holguin M., “Standard Precautions for Healthcare Workers and the Role of Isolation Gowns, Education & Training, http://healthvie.com Jan 2011.
- Kilinc-Balci F. S . A Review of Isolation Gowns in Healthcare: Fabric and Gown Properties. J Eng Fiber Fabr [in press].
- Kilinc-Balci S . How well do you think you are protected? Understanding proper use and disposal of protective gowns for healthcare workers. NIOSH Science Blog. National Institute for Occupational Safety and Health.
- Shaffer, R Fighting Ebola: A Grand Challenge for Development – How NIOSH is Helping Design Improved Personal Protective Equipment for Healthcare Workers NIOSH Science Blog. National Institute for Occupational Safety and Health.
- Considerations for Selecting Protective Clothing used in Healthcare for Protection against Microorganisms in Blood and Body Fluids. NIOSH/The National Personal Protective Technology Laboratory Topic Page.
- Kilinc-Balci, F. S., Nwoko, J., & Hillam, T. . Evaluation of the Performance of Isolation Gowns. American Journal of Infection Control, 43(6), S44.
[i] Isolation gowns submitted for inclusion in the research program met the following criteria: (1) The gowns must be identified (labeled) as “isolation gowns” and have full coverage in the back to provide protection for the health care worker and the patient; (2) A minimum of 100 units for each code (model) of disposable (single use) gown submitted.
[ii] E.g., ASTM F1671 viral penetration test: screen type and surface tension of the carrier fluid
[iii] Association for Professionals in Infection Control Conference, Nashville, TN, June 27-29, 2015.