Medical gowns are personal protective equipment (PPE), commonly used for infection control in hospitals, emergency rooms, pathology labs, and other healthcare settings. They protect the wearer from potentially harmful pathogens, microorganisms, and body fluids.
As new research, health threats, and industry standards emerge, hospitals, labs, and medical facilities must alter PPE policies accordingly. With new pathogens and drug-resistant bacteria, such as COVID-19, healthcare institutions must ensure their staff, patients, and visitors are kept as safe as possible.
What Protection Do Medical Gowns Offer?
There are several types of medical gowns, with different styles designed for specific medical use. When it comes to levels of protection, there are two main areas of focus. These are the critical zones of protection and liquid barrier performance.
Critical zone of protection
Critical zones of protection are the vulnerable parts of the body that are susceptible to disease transmission or the transfer of hazardous pathogens and microorganisms.
For patient and medical professional safety, medical gowns are manufactured with specific critical zones of protection. Depending on the type of gown and it’s intended uses, these zones may differ.
Liquid barrier performance
Liquid barrier performance is a medical gown’s ability to protect the wearer from fluid penetration. Certain bloodborne or liquid pathogens have different penetration power, meaning gowns must be fluid resistant and provide adequate liquid barrier protection to the wearer.
Other critical protective characteristics include tensile strength, tear resistance, seam strength, lint generation, and water vapor transmission (breathability).
Levels of Protection
The American National Standards Institute and the Association for the Advancement of Medical Instrumentation (ANSI/AAMI) set the standards for liquid barrier performance. They categorize different gowns across four levels of protection in the critical zones.
Level 1 medical gowns are designed for minimal risk procedures, where exposure to harmful pathogens is unlikely. They are typically worn by doctors and nurses providing basic care and performing non-invasive procedures.
These gowns can only block small amounts of liquid. Level 1 gowns are often provided as cover gowns for visitors in a standard medical unit.
Level 2 medical gowns protect the wearer in low-risk medical situations like pathology lab work or drawing blood. They offer adequate protection for fluid penetration from splashes and splatters.
Level 3 medical gowns offer protection in moderate-risk situations, including certain invasive procedures (e.g., arterial blood draw or inserting an IV line) and trauma cases. This type of gown can protect the wearer against liquid soakage and splatter.
Level 4 medical gowns are designed for use in high-risk situations and intense fluid procedures, such as surgery. These gowns offer the highest level of protection and are recommended for scenarios where infectious disease is suspected.
All ANSI/AAMI-approved gowns undergo stringent testing to ensure they provide maximum protection to the wearer. All gowns are tested for impact penetration, while level 2, 3, and 4 gowns are also tested for hydrostatic pressure.
Level 1 testing
Level 1 gowns are tested using a single method. The surface of the gown material is sprayed with water, then analyzed to assess resistance and barrier protection performance.
Level 2 testing
Level 2 gowns undergo two tests. The first analyzes its resistance and barrier protection performance against low levels of water spray and penetration. The second tests its water resistance to low levels of liquid exposure and penetration under constant contact with increasing pressure.
Level 3 testing
Level 3 gowns undergo the same tests as level 2 gowns, but they are tested for water resistance to moderate liquid exposure, penetration, and pressure.
Level 4 testing
Level 4 gowns are tested for water resistance and fluid penetration, as with level 2 and 3 gowns. However, they also undergo a separate test using simulated blood containing a virus. The gown is exposed to the blood then analyzed. It can only pass if there is no virus detected following exposure.
All gowns are clearly labeled with their protection level. Be sure to choose the right type of medical gown with an appropriate level of protection for the task.
Types of Gowns
There are three main categories for medical gowns. These are surgical gowns, surgical isolation gowns, and non-surgical gowns.
A surgical gown is an FDA-approved, Class II medical device used in moderate to high-risk situations. A Class II device requires knowledge and special controls to ensure safety and effectiveness. Surgical gowns must also undergo a premarket review, called a 501(k) premarket notification. Manufacturers must submit for approval from the FDA, demonstrating their surgical gowns are safe and effective before being legally marketed.
Surgical gowns are designed for surgical procedures to protect the wearer and the patient from the potential transfer of harmful pathogens, microorganisms, body fluids, and particulate matter.
Surgical gowns are suitable for virtually all medical scenarios, whether the required protection level is 1 or 4. As procedural gowns, these garments must offer comprehensive protection of critical zones.
For standard surgical gowns, critical zones include the entire front area and the arms from the wrists to the elbows. In most cases, the back of the gown is non-protective.
Surgical isolation gowns
Surgical isolation gowns offer maximum levels of protection and are suitable for protecting the wearer in any medical situation, including high-risk surgical procedures. The FDA regulates these isolation garments, which are categorized as Class II medical devices. The main differences between these two gown types are the critical zones of protection.
The entire isolation gown is regarded as a critical zone, meaning every aspect of the device, from the seams to the primary protective material, must meet the highest levels of liquid barrier performance as outlined by the ANSI/AAMI standards. The only materials exempt from meeting these standards are the hems, cuffs, and bindings.
Surgical isolation gowns are often longer than standard surgical gowns to provide complete coverage.
Non-surgical gowns are not used for surgery or invasive procedures. Unlike surgical and surgical isolation gowns, they are categorized by the FDA as Class I medical devices. This means they are suitable for low to moderate risk situations and are subject to the least regulatory control.
Not all isolation gowns are surgical. Isolation gowns that provide protection levels between 1 and 3 are unsuitable for high-risk and fluid intensive procedures like surgery.
However, non-surgical isolation gowns must also cover as much of the body as is necessary for the specific task. All areas of the gown must offer adequate liquid barrier protection for its assigned level.
Important Factors for Choosing the Right Gown
The most important factors for choosing the right gown for maximum protection are the levels of protection and the type of garment. Once you have determined what level of risk, critical zones of protection, and the necessary liquid barrier performance, some other key considerations include:
While there are standard sizes for some PPE, it’s important to use fitted medical gowns where possible. Ill-fitting PPE can be a major safety hazard, restricting the wearer’s movement and causing discomfort. If a surgical gown is too tight, a surgeon may be unable to perform optimally. If an isolation gown is too loose, it may snag on equipment, compromising the wearer’s safety and the patient.
When choosing medical gowns, purchase the right sizes for staff. Consider taking the measurements of workers to ensure a good fit and maximum protection.
Breathability is an important safety factor in certain instances. For example, workers in a stuffy laboratory or vaccination center may require gowns made from more breathable material to work comfortably and safely.
Sterile gowns are most commonly used for invasive procedures or where there is a risk of contamination. Non-sterile, reusable gowns are often sufficient for general patient care or low to moderate risk medical situations.
Reusable or disposable
There are pros and cons to choosing reusable and disposable gowns. Reusable and disposable gowns are available in all four protection levels, meaning they can both be used for surgical procedures, provided they pass the necessary testing.
While disposable medical gowns are often more convenient, a recent NCBI study suggested that reusable gowns may offer increased protection and cost savings because of their durability and sustainability.
Choose ICU Production Inc. for Maximum Protection Medical Gowns
Choosing the right medical gown helps protect healthcare workers, patients, and visitors from disease transmission and harmful pathogens. Whether you need level 4 surgical isolation gowns for surgeons or a fresh batch of non-surgical gowns for trainee nurses, ensure you source quality equipment from a reliable supplier, like ICU Production Inc.
We provide high-quality medical gowns from levels 1 to 4. All of our equipment is FDA regulated and available in a range of sizes. We stock a variety of PPE, including gloves, masks, face shields, hand sanitizer, and kids’ equipment.