Navigating Our New World of Reusable Protective Gowns for use by Healthcare Personnel (HCP)
COVID-19 is permanently transforming many practices in our healthcare world. One of these transformations is the dramatic switch from disposable to reusable protective gowns for use by healthcare personnel (HCP). During the last decade, most single-use protective HCP gowns were manufactured overseas. Recently, many of these single use gowns have been plagued by quality issues and supply chain disruptions. Concurrently, demand has skyrocketed due to COVID-19. Consequently, the availability and performance of HCP gowns have become a chronic issue in healthcare settings. Fortunately, reusable HCP protective gowns are coming to the rescue. In addition to clear environmental advantages, reusable gowns offer superior performance and protection as well as more predictable availability. Their cost per use is typically far below single-use gowns and they support local jobs to reprocess in preferably accredited healthcare laundries. Conversely, disposable gowns are discarded in our landfills after one use and typically do not employ local workers in their reprocessing. The following seeks to inform healthcare practitioners on how to navigate the world of reusable protective gowns for use by HCP. We will explain protective gown terminology and regulations; provide guidance on how to align the correct protective gown to its required purpose; identify key areas to investigate before selecting the protective gown; and finally how to care for and maintain the investment to ensure quality and patient safety. Discussion is limited to reusable gowns making liquid barrier protection claims and that are intended for use in health care settings. Other hospital staff apparel such as scrubs, lab coats, masks, and gloves are not included in the discussion, nor are non-healthcare protective gowns.
Definitions, Regulations and Standards
The Food and Drug Administration (FDA) broadly defines two different categories of protective gowns: those claiming minimal or low levels of barrier protection and those claiming moderate to high barrier protection. More specifically, minimal or low barrier protection gowns are broken down into ANSI/AAMI PB70 Levels 1 or 2 protection or equivalent standards. Moderate or high barrier protection gowns are broken down into ANSI/AAMI PB70 Levels 3 or 4 protection or equivalent standards.
The FDA classifies protective gowns as either class I devices or class II devices. Class I devices are typically lower risk and are “exempt” from the rigorous premarket notification procedures. Class II devices are higher risk and require special controls as well as FDA premarket notification procedures. It is best to think of Class I gowns as non-surgical gowns and class II gowns as surgical gowns. Per the FDA, a class I “non-surgical gown” must meet all of the following criteria:
It is labeled as a gown other than a surgical gown (e.g., isolation gown)
It is not described in its labeling as a surgical gown
If it has statements relating to barrier protection, such statements are for only minimal or low barrier protection.
A class II “surgical gown” must meet any of the following criteria:
It is labeled as such
It is described in its labeling as a surgical gown
It has statements relating to moderate or high-level barrier protection
It has statements that it is intended for use during sterile procedures
The FDA must perform a premarket review of all class II gowns before these can be cleared for marketing. FDA premarket reviews will address areas such as:
Performance testing to ensure the gowns resist blood and liquid penetration
Safety testing for biocompatibility, sterilization method validation, flammability, physical strength, and linting
Labeling including barrier level identification and instructions for use
In the United States, ANSI/AAMI PB70 establishes a system of classification for protective apparel (including surgical gowns and isolation gowns) used in healthcare facilities, based on their liquid barrier performance. The ANSI/AAMI PB70 standard was accepted by the FDA in 2004. AAMI addresses fluid protection in the critical zone, the gown area where an OR staff member is most likely to come in direct contact with potentially infectious material. In surgical gowns, it includes much of the sleeves and the front panel. Both fabric and construction (seams) are tested. The back of the gown is typically not protective. ANSI/AAMI PB70 Levels are defined as follows:
ANSI/AAMI PB70 Level 1: ANSI/AAMI PB70 Level 1 gowns offer minimal protection and are intended to protect the wearer from the transfer of microorganisms and body fluids in low or minimal risk patient isolation situations. These can be used for Standard Precautions and Contact Precautions. Patient gowns and non-surgical isolation gowns are classified as ANSI/AAMI PB70 Level 1.
ANSI/AAMI PB70 Level 2: ANSI/AAMI PB70 Level 2 gowns offer minimal to low fluid barrier protection. These are intended only for low-fluid, minimally invasive surgical procedures such as blood draws and suturing. These can also be used for standard precautions and contact precautions. To classify as ANSI/AAMI PB70 Level 2, the gown must undergo impact penetration testing (AATCC 42) as well as hydrostatic pressure testing (AATCC 127). Impact penetration testing must measure <= 1.0 g. The test indicates how the fabric will resist strikethrough when fluids splash or spray onto the fabric. Please see https://www.aatcc.org/impact-penetration-testing-for-textiles/ for the test definition. Hydrostatic Pressure testing must measure >= 20 cm. This test indicates how the fabric will resist strikethrough when water pressure is applied to the surface of the fabric. A higher number indicates better water resistance. Please see https://members.aatcc.org/store/tm127/535 for the test definition.
ANSI/AAMI PB70 Level 3: ANSI/AAMI PB70 Level 3 gowns offer moderate fluid barrier protection and are used for the widest range of surgical procedures, where moderate fluid protection is necessary. Examples include arterial blood draws, IV insertions, ER staff, and trauma staff. To classify as ANSI/AAMI PB70 Level 3 the gown must measure <= 1.0 g for AATCC 42 impact penetration testing and >= 50 cm for Hydrostatic Pressure testing.
ANSI/AAMI PB70 Level 4: ANSI/AAMI PB70 Level 4 gowns offer the highest fluid and microbial barrier protection against bloodborne pathogens in the critical zones. These are used for long fluid intensive procedures or procedures where there is a high likelihood of bloodborne pathogen contamination. Open heart surgeries, C-Sections, and organ transplants are procedures where ANSI/AAMI PB70 Level 4 gowns would be typically required. Only ANSI/AAMI PB70 Level 4 gowns are tested for viral penetration resistance, and therefore only Level 4 gowns are considered impermeable to viral penetration using ASTM F1671 testing. Please see https://www.astm.org/Standards/F1671.htm for the testing definition. To classify as ANSI/AAMI PB70 Level 4, gowns must exhibit no penetration at 2 psi(13.8 kPa) using ASTM F1671 testing.
According to the CDC, the gowns complying with the lower levels (Level 1, 2 and 3) cannot be considered impermeable. However, Level 1–3 gowns can provide increased resistance to liquids. ANSI/AAMI PB70 Level 1, 2, and 3 surgical/isolation gown-testing requirements only use water as a challenge. Because the surface tension of water is much higher than that of blood, blood can penetrate through fabrics more readily than water. Therefore, no correlation can be made between AATCC water resistance tests (AATCC 42 and AATCC 127) and ASTM F1671 viral penetration tests, and consequently, protection provided by Levels 1, 2, 3 gowns and that of Level 4 gowns.
A common misunderstanding among many end-users is that they are protected from blood, body fluids, and other potentially infectious materials (OPIM) when they wear any type of fluid-resistant garment or surgical or isolation gown. Another common misunderstanding is around gown testing versus fabric testing. Many gowns are marketed with Level 2 or 3 fabric. This is vastly different from an actual Level 2 or Level 3 surgical gown. To be classified as a Level 2 or Level 3 surgical gown, the entire gown critical zones, including all seams, must pass rigorous hydrostatic testing and impact testing after the marketed number of uses. They also have thorough labeling requirements. Do not expect a reusable gown with Level 3 fabric to perform the same or cost the same as an FDA-cleared Level 3 surgical gown. Always thoroughly read the labels and understand the instructions for use, including processing and sterilization requirements.
Finding the Right Tool and the Right Processor
Before choosing the right reusable protective gowns, it is important to understand, as thoroughly as possible, the life cycle factors impacting the gown choice. Different gown types must be used for different situations. Gown performance is certainly critical but there is more to consider. For example:
What are the gown use cases?
How many gowns will be needed per day?
What is the current and future availability of the gowns?
Is your laundry processor accredited?
For how many uses are the gown certified?
How much do the gowns cost?
Most important, understand the use case and anticipated level of exposure for the wearer. For example, the need for cover gowns for hospital visitors can usually be met with a standard Level 1 isolation gown. But don’t expect much fluid repellency and never use these in situations where higher protection is required. In certain higher risk non-OR settings, standard Level 2 isolations gowns may be required. In all cases in the OR, FDA cleared surgical gowns are required. Choose the appropriate ANSI/AAMI PB70 level depending on the requirement. Choose Level 4 for long, fluid-intensive procedures with a high likelihood of lengthy exposure, Level 3 for moderate fluid barrier protection, and Level 2 for low to minimal fluid barrier protection. Try samples from reputable vendors and assess comfort, quality, and style.
Anticipate how many of each type of protective gown your facility will require per day and communicate needs to your laundry provider as early as possible. With COVID-19, reusable protective gown supply chains have been stressed but are catching up. Understanding demands and availabilities early will help you and your laundry provider plan. Shortages can be mitigated temporarily with extra deliveries from your laundry provider.
Make sure you have a quality laundry provider that is accredited by HLAC (http://hlacnet.org ). Check that they process reusable protective gowns properly. If they are accredited, they should, but check anyway. Your laundry provider should not use bleach because it can damage gowns. They should not over dry as excessive heat will weaken protective gowns. They should process on standard protective gown wash formulas. They should regularly verify and document gown fluid repellency. Confirm that they purchase high quality gowns from reputable suppliers with FDA clearance (for Class II gowns). Have them demonstrate that they remove gowns from circulation after their certified number of uses. A gown that is damaged from improper processing will not perform as intended and can become an infection risk for the wearer. Ensure that your laundry provider performs post laundering processing of Class II gowns in an accredited segregated pack room. These steps include gown inspection for cleanliness and integrity; marking usage grids; proper gown folding and packaging; and appropriate labeling. It is always a good idea to inspect your laundry processor regularly to verify they are following the highest standards for infection prevention and patient/staff safety.
Reusable protective gowns generally cost less per use than their disposable counterparts. Understand how your laundry provider charges for reusable protective gowns. Do they charge per each (typical) or per pound. Expect to pay a low price per use for Level 1 or Level 2 non-surgical isolation gowns but expect high usage and high loss. Anticipate paying a premium for high quality Level 3 or Level 4 surgical gowns. Remember, these gowns undergo significant manufacturing steps that are not required for Class I protective gowns. They are also more expensive to process and package by the laundry. To save money and protect the environment, realize that expired Level 3 or Level 4 protective gowns can be re-purposed as Level 1 or Level 2 gowns rather than disposing of them.
The many benefits of reusable protective gowns are undisputable. They are more cost effective, more comfortable, leave a smaller environmental footprint and produce better outcomes for patients and clinical practitioners, to name a few. COVID-19 has highlighted many of the risks of relying on fragile supply chains where disposable products are manufactured thousands of miles from the end-user in factories with suspect quality practices. As a result, is easy to understand why an unprecedented number of healthcare organizations have converted to reusable protective gowns.
Gregory Gicewicz is distinguished in the reusable textile industry as a tireless advocate for increasing awareness of the significant role that having high standards in the processing of healthcare laundry plays in broader infection prevention strategy. He is president & CEO of Sterile Surgical Systems, a full service accredited healthcare laundry & reusable sterile surgical textile pack manufacturer. He is past president of the Healthcare Laundry Accreditation Council (HLAC), currently serves as HLAC inspection committee chair, and led a committee that developed the HLAC Laundry Process Monitoring Toolkit.
