About medical gowns

Medical gowns, often referred to as surgical gowns, isolation gowns or procedure gowns, are a critical piece of personal protective equipment for personnel working in healthcare settings and an essential element of any infection control protocol. Gowns protect the wearer against infection or illness spread through contact with potentially infectious liquid or solid materials and help prevent the wearer from transferring microorganisms to patients.

In 2004, the FDA recognized the consensus standard American National Standards Institute/Association of the Advancement of Medical Instrumentation (ANSI/AAMI) PB70:2003, “Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.”

The standard classifies the barrier protection levels of gowns and other protective apparel intended for use in healthcare facilities according to 4 levels. Because product names are not standardized, it is important for wearer to select their gown by checking individual gown labels for intended use and according to the desired level of protection based on the following risk levels:

  • Level 1: Minimal risk, to be used, for example, during basic care, standard isolation, cover gown for visitors, or in a standard medical unit.
  • Level 2: Low risk, to be used, for example, during blood draw, suturing, in the Intensive Care Unit (ICU), or a pathology lab.
  • Level 3: Moderate risk, to be used, for example, during arterial blood draw, inserting an Intravenous (IV) line, in the Emergency Room, or for trauma cases.
  • Level 4: High risk, to be used, for example, during long, fluid-intense procedures, surgery, when non-airborne pathogen resistance is needed or infectious diseases are suspected.

Types of medical gowns

Surgical Gowns

In the U.S., surgical gowns are regulated by the FDA as Class II medical devices that require a 510(k) premarket notification. In Canada, all medical gowns (both surgical and surgical isolation) are classified as Class I medical devices and subject to medical devices regulations.

A surgical gown is a personal protective garment intended to be worn by healthcare personnel during surgical procedures to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate matter. All surgical gowns must be labeled as such and may be used for any risk level (levels 1-4).

The critical zones on a surgical gown are:

  • Front of the body, from top of shoulders to knees.
  • Arms, from the wrist cuff to above the elbow.

Surgical Isolation Gowns

Surgical isolation gowns are intended for situations where there is a moderate to high risk of contamination and a need for larger critical zones than surgical gowns. Like surgical gowns, surgical isolation gowns are regulated by the FDA as Class II medical devices that requires a 510(k) premarket notification. A surgical isolation gown should cover as much of the body as appropriate for its intended use.

The critical zones on a surgical gown are:

  • All areas of the surgical isolation gown except bindings, cuffs, and hems

Critical zones must meet the highest liquid barrier protection level for which the gown is rated and all seams on the gown must provide the same level of liquid barrier protection as the rest of the gown.

Non-Surgical Gowns

Non-surgical gowns are considered Class I medical devices. As such, they do not require premarket review. Non-surgical gowns are intended to protect wearers against the transfer of microorganisms and body fluids in low or minimal risk patient isolation situations. Non-surgical gowns are not appropriate for use during surgical procedures, invasive procedures or when there is a moderate to high risk of contamination.

Like surgical isolation gowns, non-surgical gowns should cover as much of the body as appropriate for its intended use.
The critical zones on a non-surgical gown are:

  • All areas of the gown except bindings, cuffs, and hems.

Critical zones must meet the highest liquid barrier protection level for which the gown is rated and all seams on the gown must provide the same level of liquid barrier protection as the rest of the gown.

Performance standards

To determine whether a gown is suitable for a particular use, it is important to consult its label to confirm that it has been tested and meets relevant performance standards. However, it is important to note that conforming to the recognized standards described below is voluntary for medical device manufacturers, who may choose to address relevant performance criteria in a different manner.

ASTM standards

The American Society for Testing and Materials (ASTM) standards has established standards regarding the integrity of the material used to make medical gowns, including tear resistance, seam strength, lint generation, evaporative resistance and water vapor transmission. Both the FDA and Health Canada accept conformance with ASTM F2407, which is an umbrella document that covers the following standards:

  • Tensile strength: ASTM D5034, ASTM D1682
  • Tear resistance: ASTM D5587(woven), ASTM D5587 (non-woven), ASTM D1424
  • Seam strength: ASTM D751 (stretch woven or knit)
  • Lint generation (ISO 9073 Part 10)
  • Water vapor transmission (breathability) ASTM F1868 Part B, ASTM D6701 (non-woven), ASTM D737-75

ANSI and AAMI standards

In both the U.S. and Canada, barrier performance with respect to penetration by liquids or liquid-borne pathogens is described by the American National Standards Institute (ANSI) and the Association of the Advancement of Medical Instrumentation (AAMI): ANSI/AAMI PB70:2012 as follows:

Level

  • Level 1
  • Level 2
  • Level 3
  • Level 4

Description

    • Used for minimal-risk situations.
    • Provides a slight barrier to small amounts of fluid penetration.
    • Single test of water impacting the surface of the gown material is conducted to assess barrier protection performance.
    • Used in low-risk situations.
    • Provides a barrier to larger amounts of fluid penetration through splatter and some fluid exposure through soaking.
    • Two tests are conducted to assess barrier protection performance:
      - Water impacting the surface of the gown material.
      - Pressurizing the material.
    • Used in moderate-risk situations.
    • Provides a barrier to larger amounts of fluid penetration through splatter and more fluid exposure through soaking than Level 2.
    • Two tests are conducted to test barrier protection performance:
      - Water impacting the surface of the gown material.
      - Pressurizing the material.
    • Used in high-risk situations.
    • Prevents all fluid penetration for up to 1 hour.
    • May prevent VIRUS penetration for up to 1 hour.
    • In addition to the other tests conducted under levels 1-3, barrier level performance is tested with a simulated blood containing a virus. If no virus is found at the end of the test, the gown passes.

Applicability

  • Basic care, standard hospital medical unit.
  • Blood draw from a vein, suturing, intensive care unit, pathology lab.
  • Arterial blood draw, inserting an IV, emergency room, trauma
  • Pathogen resistance, infectious diseases (non-airborne), large amounts of fluid exposure over long periods.

Level

Description

Applicability

Level 1
  • Used for minimal-risk situations.
  • Provides a slight barrier to small amounts of fluid penetration.
  • Single test of water impacting the surface of the gown material is conducted to assess barrier protection performance.
Basic care, standard hospital medical unit.
Level 2
  • Used in low-risk situations.
  • Provides a barrier to larger amounts of fluid penetration through splatter and some fluid exposure through soaking.
  • Two tests are conducted to assess barrier protection performance:
    - Water impacting the surface of the gown material.
    - Pressurizing the material.
Blood draw from a vein, suturing, intensive care unit, pathology lab.
Level 3
  • Used in moderate-risk situations.
  • Provides a barrier to larger amounts of fluid penetration through splatter and more fluid exposure through soaking than Level 2.
  • Two tests are conducted to test barrier protection performance:
    - Water impacting the surface of the gown material.
    - Pressurizing the material.
Arterial blood draw, inserting an IV, emergency room, trauma
Level 4
  • Used in high-risk situations.
  • Prevents all fluid penetration for up to 1 hour.
  • May prevent VIRUS penetration for up to 1 hour.
  • In addition to the other tests conducted under levels 1-3, barrier level performance is tested with a simulated blood containing a virus. If no virus is found at the end of the test, the gown passes.
Pathogen resistance, infectious diseases (non-airborne), large amounts of fluid exposure over long periods.

It should be noted that Health Canada also recognizes Canadian Standards Association (CSA): CSA Z314 and European Standard EN 13795 with regards to medical gowns.

Choosing the right gown

According to the CDC, there are three key factors to consider when choosing PPE in general:

  1. Type of anticipated exposure: Touch, splashes or sprays or large volumes of blood or body fluids that could penetrate clothing, as well as the category of isolation precautions a patient is on.
  2. Durability and suitability for the task: e.g., does the task require a gown or a vest; if a gown is selected, whether it needs to be fluid resistant, fluid proof or neither.
  3. Fit: PPE must fit the individual user. Employers are responsible for ensuring that all PPE are available in sizes appropriate for their workers.

The CDC recommends the following selection criteria specifically for gowns:

  1. Intended use: Isolation gowns are generally preferred, but for procedures where limited contamination is anticipated, an apron may suffice. However, if contamination of the arms can be anticipated, a gown should be selected. Gowns should fully cover the torso, fit comfortably over the body and have long sleeves that fit snuggly at the wrist.
  2. Material properties of the gown: Isolation gowns are made from either cotton or a spun synthetic material. This determines whether the gown can be laundered and reused or is intended for single use only (disposable). Cotton and spun synthetic isolation gowns also offer varying degrees of fluid resistance, another factor that must be considered in selecting a gown. In situations where fluid penetration is likely, a fluid resistant gown should be used.
  3. Patient risks: Patient risk levels determine whether a sterile gown is required or if a clean gown is sufficient. Clean gowns are generally used for isolation. Sterile gowns are only required for invasive procedures, such as inserting a central line. In this case, a sterile gown would protect both the patient and healthcare personnel.

Why healthcare professionals prefer Medicom gowns

Although many brands comply with industry standards for providing reliable barrier protection, healthcare professionals prefer Medicom gowns for their unique qualities, including:

  • Premium materials that keep the wearer cool and comfortable
  • Unique designs that provide customized fit and ease of movement
  • Special features that ensure secure closure and easy donning and doffing
  • A wide variety of styles, lengths, sizes, colours and fabric weights
  • Consistent quality, durability and fit.

Medicom has you covered from head to toe

Medicom offers a comprehensive selection of protective apparel, including our AssureWear® VersaGown with Flexneck Technology, AAMI PB70:2012 compliant gowns, overhead gowns, impervious gowns, thumb loop gowns and chemotherapy gowns, as well as lab coats and vests, coveralls and sleeve covers, bouffant caps, shoe covers, beard covers and more. Discover the complete portfolio of Medicom protective apparel here.

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