AAMI is the standard in surgical gown manufacturing. It is based on objective tests that measure barrier effectiveness against penetration from blood, bodily fluids and other potentially infectious materials. Each gown should have a label attached identifying its AAMI level. Labels on packaging, while an important part of inventory management, are seldom seen by end users. The FDA discourages the use of words such as “impervious” or “impermeable” because these terms are vague, easily misinterpreted and potentially misleading.9 Yet, even today, labeling issues continue to complicate surgical gown purchasing decisions. For example, a gown marketed as a “Breathable Film Surgical Gown” containing material meeting a particular material standard may fail to qualify as an AAMI level 4 gown because protection is poor in crucial areas.
In addition to AAMI’s safety levels, purchasing managers must consider other selection criteria contained in AAMI Technical Information Report 11 (TIR11).10 TIR11 considers comfort, drapeability, flammability, lint generation, resistance to tears and other factors. For example, all surgical gowns, no matter what the material, are flammable under the right circumstances, especially in the oxygen-enriched environment of a hospital operating room.11 Also, some end-users consider AAMI level 4 gowns less comfortable than less protective surgical garments, although innovations in microfibers have reduced comfort concerns in the most protective gowns.
In sum, material managers must educate themselves on which gowns should be used in different circumstances. “All surgical gowns are not created equal; this is an important consideration when trying to decide what level of gown is needed for a surgical or invasive procedure. The AAMI standard addresses the barrier effectiveness of surgical gowns, but OR directors, infection preventionists, safety officers, material managers, and other product committee members should consider many other attributes related to the safety and efficacy of surgical gowns, as well as other protective apparel, when choosing these products.”12