January 19, 2023

AAMI updates PPE standard

By: Judy Mathias

Editor's Note

The Association for the Advancement of Medical Instrumentation (AAMI) on January 18 released a revised American National Standard that includes new information for manufacturers and users of personal protective equipment (PPE).

The new edition of “ANSI/AAMI PB70:2022, Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities” specifies requirements for surgical gowns, isolation gowns, other gowns and protective apparel, surgical drapes, and drape accessories designed to protect healthcare workers during surgery and other healthcare procedures.

The previous edition only included barrier claims for surgical gowns, surgical drapes, and isolation gowns.

Additional protective apparel categories that were added include:

  • Surgical gown-e, which provides extended protection of critical zones where direct contact with blood, bodily fluids, and other potentially infectious material is most likely to happen
  • Nonsurgical protective gowns, including procedure and decontamination gowns
  • Protective hoods and togas along with a general category of other protective apparel, such as aprons, footwear covers, and sleeves.

Labeling requirements also were added for nonsurgical gowns, stating that the gown packaging should inform users of the areas of protection--full coverage, nonprotective back, and open back gowns. The standard does not cover medical gloves, surgical masks, goggles, or gown-to-glove interface.


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