Isolation gowns 101

Isolation Gowns 101: How to Evaluate and Select Isolation Gowns

Equipping your facility with isolation gowns can be a daunting task, here are some key questions and considerations.

What are gowns?

According to the FDA, gowns are a piece of personal protective equipment used to protect the wearer from coming into contact with potentially infectious liquid and solid material.  Gowns are identified as the second-most-used piece of PPE, following gloves, in the healthcare setting and are a crucial part of an overall infection-control strategy.

Gowns are classified into three main categories

Surgical gowns – A surgical gown is a personal protective garment intended to protect both the patient and health care personnel from the transfer of microorganisms, body fluids, and particulate matter during surgical procedures.  A surgical gown is regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification.

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

Surgical isolation gowns – Surgical isolation gowns are used in situations of medium to high risk of contamination, and when there is a need for larger critical zones than traditional surgical gowns.  Like surgical gowns, surgical isolation gowns are regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification. 

Gowns vs. Isolations gowns

The difference between traditional gowns and isolation gowns are the critical zones that they protect.  Isolation gowns simply protect larger critical zones than traditional gowns.

gown critical zone

Critical Zones for Traditional gowns:

  • The entire front of the gown material (areas A, B and C) is required to have a barrier performance of at least level 1. See table 1.
  • The critical zone comprises at least areas A and B.
  • The back of the surgical gown (area D) may be nonprotective material.
isolation gown critical zone
 
Critical Zones for Isolation Gowns:
  • The entire gown (areas A, B, and C), including seams but excluding cuff, hems, and bindings, is required to have a barrier performance of at least Level 1.
 
Levels of protection standards
  • Level 1: Minimal risk

Ex: During basic care, standard isolation, cover gown for visitors, or in a standard medical unit.

  • Level 2: Low risk

Ex: During blood draw, suturing, in the ICU, or a pathology lab.

  • Level 3: Moderate risk

Ex: During arterial blood draw, inserting an IV line, in the ER, or for trauma cases.

  • Level 4: High risk

Ex: During long, fluid intense procedures, surgery, when pathogen resistance is needed, or infectious diseases are suspected.

 

Key takeaway


Isolation gowns for saleSince product names are not standardized (Ex: isolation gown, nursing gown, procedural gown, etc.), it is important that gowns are chosen based on their level of protection and intended use. 

 

The CDC recommends that buyers consider the following 3 factors when choosing gowns for healthcare settings:

  1. Purpose of use – In the midst of the current pandemic, the primary objectives are to protect wears from the spread of COVID-19. Choosing the level of protection based on the level of anticipated contamination is crucial.
  2. Material – Isolation gowns are made either of cotton or a spun synthetic material that dictate whether they can be washed and reused or must be disposed. Another factor that must be considered is the variation in fluid resistance of cotton and spun synthetic isolation gowns.  If fluid penetration is likely, a fluid resistant gown should be used.
  3. Clean or sterile – Clean gowns are sufficient for most general uses. For surgical or invasive procedures though, sterile gowns are necessary.

Who are we?

AegisPPE is an FDA registered supplier of medical devices and personal protective equipment.  We are a family-owned and operated business, using a combination of modern technology, policies, and procedures that allow us to rival the larger corporations in this industry.

Equipping your facility with medical equipment can be a daunting task.  Let us help you make strategic and well-informed purchasing decisions.  Our team is eager to help you build a reliable, cost-effective procurement plan that is specifically tailored to your individual needs.  Contact us today at 561-418-3076 or click the button below!

 

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