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.
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.
- 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.
- 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.
Since 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:
- 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.
- 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.
- Clean or sterile – Clean gowns are sufficient for most general uses. For surgical or invasive procedures though, sterile gowns are necessary.
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