Disposable versus reusable medical gowns

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This research evaluated the performance of disposable versus reusable medical gowns by assessing their ability to provide adequate protection across their expected service lifespan. Level I, II, and III gowns were tested for water resistance and hydrostatic pressure, along with other durability assessments (breaking, tear, and seam strength, pilling resistance, dimensional stability, air permeability, colorfastness, and fabric hand) per standard test methods. Data were collected at new for the disposable gowns and after 1, 25, 50, and 75 industrial launderings for the reusable gowns. Results were compared to the Association for the Advancement of Medical Instrumentation® (AAMI) PB70 performance specifications.

Background

As a result of the COVID-19 pandemic, personal protective equipment (PPE) became a household term as many citizens were made aware of its significance to reduce community spread and protect health care workers (HCWs) on the front lines. PPE is defined as an “item of clothing that is specifically designed and constructed for the purpose of isolating all or part of the body from a potential hazard or isolating the external environment from contamination by the wearer of the clothing.” Protective apparel is worn by HCWs to inhibit the transfer of blood, body fluids, and other potentially infectious materials and to help preserve the integrity of the sterile field. These garments are the HCW's only line of defense from potentially deadly infectious diseases and viruses during patient care. A severe shortage of necessary PPE during the COVID-19 pandemic caused concern for health care providers as they feared being infected by the patients they cared for and, in turn, passing the virus on to their own families.

A key part of health care workers’ PPE is medical gowns, which include both isolation and surgical gowns. Medical gowns have been identified as the second-most commonly used PPE item, following gloves, in health care settings. According to the Association for the Advancement of Medical Instrumentation® (AAMI), an isolation gown is an “item of protective apparel used to protect health care personnel and patients from the transfer of microorganisms and body fluids in patient isolation situations.” Surgical gowns are defined by the United States (US) Food and Drug Administration (FDA) as “devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids.”

AAMI Protection Requirements

Medical gowns are rated according to AAMI standards, which define four levels of protection (Levels 1, 2, 3, and 4). Each protection level must meet specific standard performance requirements for impact penetration and hydrostatic pressure resistance, detailed in the AAMI PB70 standard for isolation and surgical gowns. The level of protection, or classification of barrier performance, is determined by the performance of all critical zone components, including seams. Critical zones are defined by AAMI as areas “where direct contact with blood, body fluids, and other potentially infectious materials is most likely to occur.” For surgical gowns, these zones should comprise the front area of the gown from chest to knees and the sleeves from cuff to elbow. The critical zones of isolation gowns comprise the same areas as surgical gowns but include the entire gown, excluding cuffs, hems, and bindings. Therefore, the required protection testing should be performed in the critical zone areas of the gown.

Regardless of their disposable or reusable nature, Level 1 gowns must have an impact penetration (AATCC 42) ≤4.5 g. Level 2 and Level 3 gowns must have an impact penetration ≤1.0 g, as well as a hydrostatic pressure (AATCC 127) value ≥20 cm for Level 2, and >50 cm for Level 3. It should be noted that Level 1 gowns are not required to be tested for hydrostatic pressure performance per AATCC 127. Both impact penetration and hydrostatic pressure tests are measures of liquid barrier performance with varying levels of force.

The Centers for Disease Control and Prevention (CDC) currently issues recommendations regarding when and what level of PPE should be worn to prevent exposure to infectious diseases. According to the CDC's guideline for Isolation Precautions, isolation gowns should be worn to protect HCWs’ arms and other exposed areas during procedures and patient-care activities when contact with clothing, blood, bodily fluids, secretions, and excretions is anticipated.

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As the COVID-19 pandemic continued, the CDC provided a series of strategies or options to optimize the use of medical gowns in health care settings when supplies were limited, known as “surge capacity.” The CDC defines surge capacity as “the ability to manage a sudden, unexpected increase in patient volume that would otherwise severely challenge or exceed the present capacity of a facility.” In March of 2020, the CDC recommended gown use be shifted toward “cloth gowns,” stating that reusable (i.e., washable) gowns are typically made of polyester or polyester-cotton fabrics, unlike most disposable gowns which are constructed from nonwoven materials. Gowns made of these fabrics can be safely laundered according to routine procedures and are, therefore, reusable.

Disposable versus Reusable Gowns

A major challenge of the CDC's recommendation to adopt reusable gowns during surge capacity is that cloth gowns have a much lower market share than disposable gowns in US health care. Presently, disposable gowns make up at least 80% of the isolation gown market. However, this market share trend is expected to change over time in favor of reusable gowns. Especially as the protection of disposable gowns has been called into question after recent epidemics such as the Ebola crisis of 2014, which claimed the lives of over 11,000 people, including 500 health care personnel. Following this crisis, in 2016, it was found that some medical gowns on the market were defective, allowing fluids to leak through, ultimately infecting surgeons and nurses in contact with infected patients.

Previous research has highlighted the sustainability of reusable gowns noting they are more cost-effective throughout their life cycle in terms of production costs, waste, and carbon footprints. Limited studies, however, have been conducted on the required protective performance and durability of reusable surgical gowns over their useful life, specifically across the wash lifespan. Leonas (1998) assessed the barrier properties of reusable gowns after 50 commercial care cycles and found that laundering reduced the ability of the fabric to prevent the transmission of bacteria. Higher barrier properties were found to correspond with higher degrees of repellency and greater fabric thickness (i.e., 2-layers in some cases). Besides this study, little research has been performed on reusable gowns after multiple commercial launderings, especially regarding serviceability components beyond protection, including comfort, durability, and appearance retention. To the researchers’ knowledge, no study has conducted a comprehensive performance comparison between disposable and reusable gowns across the wash lifespan.

The purpose of this research was to determine the performance of disposable versus reusable medical gowns by assessing their ability to provide adequate protection, durability, and comfort across the product's wash lifespan. First and foremost, the ability of the gowns to meet required protection specifications per AAMI standards was investigated. Commercially available Level 1, 2, and 3 disposable and Level 2 and 3 reusable gowns were evaluated using the American Association of Textile Chemists and Colorists (AATCC) Test Method (TM) 127 and AATCC TM 42. Results were compared to AAMI PB70 and the American Society for Testing and Materials (ASTM) performance requirements. The fabric weight, thickness, breaking strength, tearing strength, seam strength, pilling resistance, dimensional stability, colorfastness, air permeability, and fabric hand of the disposable and reusable gowns were also determined and compared.

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