How to evaluate and select isolation gowns?

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What is an isolation gown?

Four levels under standard

What's on the product label is more important than the product name

How Easy is an Isolation Gown to Put On and Remove?

What is an isolation gown?

The purpose of an isolation gown is to help protect your front-line caregivers and staff from infectious droplets, fluid infiltration and solids, and to help prevent the transfer of microorganisms to vulnerable residents.

There are two main categories of isolation gowns used for healthcare purposes: surgical gowns and non-surgical gowns.

Surgical gowns are a type of personal protective gown for healthcare workers to wear during procedures to protect patients and healthcare workers from the transfer of microorganisms, body fluids and particulate matter.

Non-surgical gowns or isolation gowns are Class I devices (exempt from premarket review) designed to protect the wearer from the transfer of microorganisms and body fluids in low-risk or minimal-risk patient isolation situations. Non-surgical gowns are not worn during surgical procedures, invasive procedures, or when there is a moderate to high risk of contamination.

Understanding Level of Protection Standards

FDA recognizes the American National Standards Institute/Association for the Advancement of Medical Instrumentation (ANSI/AAMI) consensus standard PB70:2003, "Performance and Classification of Liquid Barriers for Protective Gown and Drapes Used in Health Care Facilities.

There are four levels under this standard:

Level 1: Minimal risk, e.g., for use in primary care, standard isolation, covered gowns for visitors, or in standard medical units.

Level 2: Low risk, for example, for use in blood draws, suturing, intensive care units (ICUs), or pathology laboratories.

Level 3: Moderate risk, for example, for use in arterial blood draws, insertion of intravenous (IV) lines, emergency rooms, or trauma cases.

Level 4: High risk, e.g., use during prolonged, fluid-intensive procedures, surgery, when resistance to pathogens is required or when an infectious disease is suspected (non-airborne).

For example, for nursing homes, Level 1 basic fluid resistance is often desirable to prevent the transmission of COVID-19. Since there is no widespread risk of transfer of blood or other body fluids, having a higher level of gown is not important. For more advanced fluid resistance needs, surgical gowns with a higher level of resistance may be considered.

What's on the product label is more important than the product name

For these purposes, we use the term isolation garment. However, you should focus less on the product name (e.g., isolation garment, nursing garment, surgical garment, etc.) and more on the function, intended use and level of protection provided. This will be indicated on the label or packaging.

During a COVID-19 pandemic, the primary goal is to protect frontline nursing home staff from the spread of COVID-19 and to protect against the accidental transfer of COVID-19 to other residents and staff. The basic level 1 fluid resistance of non-surgical isolation gowns is likely sufficient. Having a higher level of surgical gown is not important because there is not a broad risk of transfer of blood or other body fluids.

How Easy is an Isolation Gown to Put On and Remove?

The ease or difficulty with which a gown is put on and removed may affect its effectiveness and the potential for self-contamination, especially during the doffing of a contaminated gown.