AAMI Gown Protection Standards & FAQ

What is the purpose of an isolation gown?

A medical gown is intended to protect healthcare personnel and patients from the transfer of micro-organisms and particulate material.

I’ve heard other terms used for medical gowns like “hospital gowns,” “disposable gowns,” “surgical gowns ,” “protection gowns,” etc. Are there differences between the terms used for gowns?

Medical gowns, Isolation Gowns, and Hospital gowns

These are all members of the same family of products and offer protection against the transfer of microorganisms and particulate material. Depending on the level of protection of the product, they may be used for anything from janitorial work to being worn by visitors to healthcare providers changing dressings. They have a wide range of applications and styles that can be tailored to the end user’s needs.

Reusable Gowns

These articles are simply ones that are disinfected and cleaned prior to re-wearing. Depending on the specific type of gown and its protection level (e.g. surgical versus isolation versus patient etc.) it may have a limited number of wearing and cleaning cycles before it must be disposed of. These are typically made of woven fabrics like cotton or other synthetic fibers.

Single use gowns

These gowns are disposed of after use. This makes their use and lifecycle significantly more straight forward from a facilities management perspective by avoiding the need to maintain or contract potentially costly laundering services. These as a rule of thumb tend to be made of nonwoven polymers and/or films.

Surgical gowns

In Canada and several other jurisdictions, surgical gowns are generally worn during surgery and are usually supplied as a sterile product. In the United States, the FDA’s approach to the term is one more based on its protection level as opposed to its name. For example, a “Surgical isolation gown” may not be sterile and may be used in areas where a higher degree of, whereas surgical gowns in the traditional sense of the name typically are. For further details, refer to "Requirements Concerning Gowns Intended for Use in Health Care Settings"

Is the fit of an isolation gown important?

Yes, the fit of a medical gown is very important. If a medical gown does not fit properly, it can be hazardous for various reasons:

  • If the isolation gown is too large; it can cause a tripping hazard for the user.

  • If there is excess exposed skin around the neck opening of the isolation gown, it is likely too large.

  • If a gown is too small for the user, they will not be properly protected. A gown that is too tight inhibits the user from moving freely, as well as presents risks of ripping through the gown and being exposed to harmful contaminants.

How do I ensure a good fit of my PRIMAGARD® Medical Gown?

PRIMAGARD® Medical Gowns come in universal and an extra-large sizes. You can check that you have chosen the correct gown size by making sure there is no excess material dragging on the ground and that the gown is comfortable and does not overly restrict your movements.

When should I replace or dispose of a medical gown?

All PRIMAGARD® Medical Gowns are single-use. This means gowns should be disposed of and replaced if any type of fluid has soiled it, an object has penetrated the material, or if there is any any type of abrasion on the gown.

Some of the hospital gowns that I have used feel hot, are there more breathable options?

priMED utilizes the most innovative and highest quality gown materials on the market however in general, as protection levels increase gowns tend to become warmer. This allows the end users to me more comfortable while still maintaining the required levels of protection.

Are thumbloops important to have on a medical gown?

Thumbloops are designed to keep the gown in place under the wearer’s the glove and help minimize the risk of fluid exposure to your wrists during use. Thumbloop gowns are recommended when the probability of fluid contact is high. Refer to the “Instructions for Use ” page for proper donning and doffing instructions.

What level of protection do PRIMAGARD® Medical Gowns offer?

PRIMAGARD® Medical Gowns cover all protection levels from unrated spunbond cover gowns to AAMI 3 rated isolation gowns. priMED also offers an extensive collection of open back gowns manufactured with various levels of protection. For further details, please contact your priMED sales representative.

What is AAMI?

AAMI refers to the Association for the Advancement of Medical Instrumentation. AAMI is an international standards organization that develops and publishes technical standards for the medical device industry.

What testing is required in order to claim a gown is “AAMI rated”?

AAMI PB70:2012 details specific test methods and passing criteria in order to label an isolation gown as AAMI 1, 2, 3, or 4 rated. A summary of the required testing is in the table below.

AAMI Levels and Testing Methods

AAMI Level Test Method Criteria
1

AATCC-42: Water Resistance: Impact Penetration

≤ 4.5g

2

AATCC-42: Water Resistance: Impact Penetration

AATCC-127: Water Resistance: Hydrostatic Pressure

≤ 1.0g

≥ 20cm

3

AATCC-42: Water Resistance: Impact Penetration

AATCC-127: Water Resistance: Hydrostatic Pressure

≤ 1.0g

≥ 50cm

4

ASTM F1671: Viral Penetration

Pass

What is AAMI PB70:2012?

PB70:2012 is a publication by AAMI detailing the liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. It rates gowns in increasing levels of protection from level 1 through to level 4. It has become recognized as the global standard for protection criteria of isolation gowns throughout the world.

What are critical zones?

Critical zones are the areas of the gown that are expected to come into contact with fluid. For example under PB70, a surgical gown’s minimum critical zone includes the front of the gown (chest to knees) and sleeves. Conversely for an isolation gown, the critical zone is the entirety of the gown minus the cuffs, hems and bindings. priMED’s AAMI rated isolation gowns are tested to the applicable standards on the material, at the seams, and on the belt attachment location. This ensures that the entire gown passes the AAMI standards.