ANSI/AAMI PB70: Closing the Gap

ANSI/AAMI PB70:2012 states that any protective apparel for healthcare settings with liquid or liquid microbial claims should be tested using the methods outlined in PB70. Although this statement exists, the only products that are specifically outlined in the current standard are surgical drapes and surgical and isolation gowns. These products are defined, have diagrams that show the critical areas to test, and include barrier level requirements. For example, a surgical gown is “worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate matter.” Surgical gowns should be sterile, level 4 barrier, and the critical areas to test are front (chest to knees) and sleeves (cuff to elbow including seams). It is thought that because other products are not specifically outlined and defined within the standard that a gap has formed between the liquid barrier claims for some products and the required tests and critical areas to support those claims.

To close the gap, the committee is defining these products similar to how they are defined for surgical gowns and will include barrier and critical area requirements. The products currently under consideration to define further in the standard are decontamination garments; open back gowns; procedure gowns; hoods and toga ensembles; and protective sleeves, aprons, and boot covers. Task groups were formed to develop definitions, purpose, critical areas, and liquid barrier level requirements, and the revised standard with this new information was sent to committee members for comments. Comments were discussed during the AAMI meeting on October 16, 2017.

One notable discussion item involved the proper selection and use of decontamination garments. Detergents are used when healthcare workers are decontaminating instruments used in procedures such as surgery or endoscopy. Detergents decrease the surface tension of water, and a decreased surface tension is more penetrating. In addition, there is a high risk of exposure to liquids for the healthcare worker in this setting. The end use of a decontamination garment would suggest that a requirement should be at least level 3 or 4. A level 4 garment requires the most stringent barrier level test, viral penetration, and is required for surgical gowns. Products that pass this test usually need a film to prevent penetration. Since these healthcare workers are cleaning instruments that may have potentially infectious materials and have a high risk of exposure, adding a definition and barrier level/critical area requirements for decontamination garments is important for the safety of healthcare workers and aids healthcare facilities in proper selection and use.

Another notable change underway is expanding the scope of PB70, which currently includes surgical drapes and accessories and all types of protective apparel with liquid or liquid microbial barrier claims, such as isolation gowns, surgical gowns, decontamination garments, and aprons. It currently excludes products such as gloves, shoe and boot covers, and facial apparel such as hoods, caps, face shields, and masks. One major addition being proposed is to include facial apparel and shoe and boot covers that are designed to provide liquid barrier protection. Discussion during the recent AAMI meeting included the use of correct wording for these products. For example, there was general consensus to include head and boot covers, which are meant to provide liquid barrier protection, and to exclude head caps meant to contain hair and foot covers meant to keep the environment free of contamination.

After the October 16 AAMI meeting, the task groups will be working on better clarifying the purpose, definitions, barrier level requirements, and critical areas throughout the entire document. Many agreed diagrams for each product type should be included in the informative section similar to the diagram that already exists for surgical and isolations gowns. In addition, AAMI TIR11:2005/(R)2015 “Selection and use of protective apparel and surgical drapes in health care facilities” will soon be under revision to guide healthcare personnel on the appropriate selection and use of the products added to PB70. The revision of PB70 and TIR 11 should publish around the same time. Since the standard is currently under revision and has not gone through the balloting process, the information presented here may change once the standard revises.