Standards for Isolation Gowns

Standards for Isolation Gowns

The COVID-19 outbreak has increased everyone’s awareness of the importance of personal protective equipment of all types. We know PPE is essential for any kind of contact situation in the current epidemic and that the highest levels of protection are vital for Health Care Workers.

Of critical importance for those working directly with all types of patients is the Isolation Gown, which is designed specifically to give complete protection from infectious liquids and solids and prevent cross-contamination. Gowns are the second most used form of PPE, after gloves, providing increasing levels of defense against infection for both the health care worker and vulnerable patients.

An isolation gown needs to comply with a number of performance requirements, whatever the level of protection it provides:

  • It should fit closely while still providing complete freedom of movement
  • The fabric must withstand pulls and tears
  • It should be easy and quick to put on while ensuring complete protection is established
  • It should protect against body fluids at the appropriate level, while ventilating the wearer’s body heat for comfort

Isolation gowns are regulated by the FDA to ensure they comply with strict standards providing levels of protection suitable for different types of medical work. They are constructed of non-woven synthetic fibers and are usually single use, disposable gowns. Using guidelines from the American National Standards Institute/Association of the Advancement of Medical Instrumentation (ANSI/AAMI) standards have been set for testing the performance of gowns to establish four levels of protection.

What are the Different Standards (Levels) of Isolation Gown?

Level 1 Isolation Gowns: Used for Minimal Risk of exposure to infectious fluids.

Made of lightweight fabric the Level 1 Isolation Gown is used during basic patient care, such as in a standard medical unit, when transporting patients, in standard isolation treatment, or as a cover gown for visitors. These gowns are non-sterile, and designed to provide a “slight” barrier against fluids. These gowns should only be used in routine health care situations where the likelihood of coming into contact with bodily fluids is low.

Level 2 Isolation Gowns: Used where the risk of exposure to fluids is Low.

Level 2 gowns are made of mediumweight fabric. The Level 2 Isolation Gown should be used during blood draws, suturing, in Hyperbaric and Dialysis treatment, in the ICU or a pathology lab. These gowns are suitable for circumstances that do not require a sterile gown, but where the likelihood of coming into contact with bodily fluids is relatively high compared to routine care. Level 2 gowns are effective against splatters and a high degree of soaking.

Level 3: Used for Moderate Risk procedures where contact with bodily fluids is likely.

Level 3 gowns are necessary in invasive procedures such as blood draws from arteries, inserting IV lines, working in the ER and Burn Units, trauma work, and Critical Care. They can be used for work which requires sterile gowns and equipment. Level 3 gowns are made of a heavyweight fabric and are effective against splatters and a high degree of soaking.

Level 4: Used during all types of high-risk procedures.

Level 4 gowns offer the highest levels of protection for the wearer and to prevent contamination. These are suitable in high-risk situations, such as while working in the Operating Room. These heavy-duty gowns are sterile and will provide protection from fluids and viruses for up to an hour of heavy exposure.

How are Isolation Gowns Tested?

Gowns are strictly tested for their ability to protect from fluids within carefully designated protective zones such as the front and arms. Their design must comply with standards of protection designated for each level such as fit of the cuffs, pore size and distribution, construction of seams, and tear and puncture resistance.

Level 4 gowns are tested using blood containing a virus and must provide protection against pathogens and non-airborne viruses. Gowns are labeled to show they have been tested and reach the performance standards required for that level of protection.

Where there is a risk of COVID-19 infection, the choice between different levels of isolation gown is the same. For patients with suspected or confirmed cases, non-sterile, disposable gowns (Level 1 or 2) for routine care are suitable where the risk of bodily fluid exposure is low. For situations with a medium to high risk of contamination via fluids, a Level 3 or 4 sterile gown would be used. It’s important to know the difference between the different levels so you can ensure you, your staff, and those in their care stay safe in all situations as they do vital work.