Medical gowns are personal protective equipment (PPE) used in the healthcare industry to protect the wearer and those they are in contact with from the spread of infectious diseases and other hazardous materials. Protective gowns play a critical role in medical professional safety as well as patient care. Medical isolation gowns are a particular form of gown regulated by the United States Food & Drug Administration (FDA) designed specifically for high-risk scenarios.
Isolation gowns have been used for many years. However, with increased knowledge about the spread of microorganisms through essentially invisible droplets, healthcare workers and staff at hospitals have growing concerns over the spread of infectious diseases and the safety of their healthcare setting. The emergence of Ebola hemorrhagic fever and COVID-19 has fueled this concern, creating a huge surge in demand for gowns and other PPE products worldwide.
Hospital gowns are the second most used PPE in the healthcare industry. Only gloves are used more frequently in healthcare facilities. However, not all gowns offer the same protection. Some are created with long sleeves to protect the full arm, others are waterproof. While most are disposable, many are reusable. For anyone involved in infection control or working with medical professionals, it’s important to know what gowns are available and which protective medical gowns are most suitable for their needs.
Difference Between Isolation Gowns and Surgical Gowns
Isolation gowns and surgical gowns are two of the most common types of PPE. Although they are similar, they are not identical. Substituting one for the other could put you at a higher risk of infection.
Surgical gowns are FDA regulated and are classified as Class II medical devices. This means they are required to have a 510(k) premarket notification. These medical products are designed for medical personnel to wear during various types of surgery and surgical procedures. The primary focus of these gowns is to protect the wearer and their patients from the transmission of harmful microorganisms, body fluids, and hazardous particulate matter.
All surgical gowns are designed with critical zones. These are the areas where direct contact with bodily fluids, blood, and infectious substances has the highest chance of occurring. The Association for the Advancement of Medical Instrumentation (AAMI) sets the standards for critical zones of protection for FDA-registered gowns. The critical zones range from the top of the shoulders down to the knees and from the wrist to just above the elbow with surgical gowns.
Surgical gowns are recommended for use at any risk level, from 1 to 4. They are specifically labeled with a tag as surgical gowns.
The main difference between surgical gowns and isolation gowns is the critical zones of protection and testing. The back of surgical gowns may not act as a protective barrier. With isolation gowns, they are required to offer protection for the entire back and hold a barrier performance of at least Level 1.
Isolation gowns are mainly used in medical scenarios where the risk of contamination or infectious transmission is medium to high and when there is a need for bigger critical zones of protection. Similar to surgical gowns, they are also regulated by the FDA, are classified as Class II medical devices, and require a 510(k) premarket notification.
All areas of an isolation gown are regarded as critical zones of protection, other than bindings, cuffs, and hems. They must meet the highest possible standards for liquid barrier protection of their given level. The seams must also have the same liquid barrier protection as the other parts of the gown. With isolation gowns, the fabric shouldn’t cover more of the body than needed for the particular procedure.
Types of Isolation Gowns
Isolation gowns are categorized into four different levels of protection. Any isolation gowns regulated by the FDA must meet minimum standards outlined by the American National Standards Institute and the Association of the Advancement of Medical Instrumentation (ANSI / AAMI). These standards outline particular testing and desired results that determine if the isolation gowns offer adequate levels of protection.
The gown levels are mainly focused on the liquid barrier performance of each piece. The gowns must be fluid resistant and protect the wearer from harmful pathogenic microorganisms in the areas where they are most vulnerable (critical zones of protection). As the level of risk increases, so too does the need for protection. Level 1 isolation gowns are for minimal risk fluid barrier protection, while level 4 is for the highest risk level of fluid protection plus viral barrier protection.
- Level 1: for use in minimal-risk scenarios or regular hospital instances, such as basic care. Hospitals often stock these items for visitors. Although these gowns can protect wearers somewhat from fluids, they aren’t suitable for procedures such as drawing blood or in the ICU facility.
- Level 2: for use in low-risk medical scenarios such as drawing blood or to wear in pathology labs and ICUs that don’t require sterile gowns. These items are stringently tested for fluid resistance. Compared to level 1, they are much more effective in protecting against fluid penetration that could take place due to splatter or soaking.
- Level 3: for use in moderate-risk medical situations. For example, drawing blood from arteries, inserting intravenous (IV) lines, or in the Emergency Room (ER) for trauma incidences. Like level 2 gowns, they are comprehensively tested to ensure efficacy against the transmission of fluids and infection from splatter and soaking.
- Level 4: for use in high-risk medical circumstances. These are suitable for use in an operating room for surgery where medical professionals are using sterile equipment and devices. They are created using specially tested fabrics for disease control and can stop fluid and virus penetration for up to one hour.During testing, level 4 gowns are exposed to simulated virus-contaminated blood. Scenarios that they’re used in include fluid intense procedures, surgery, and when pathogen resistance is required for potential infectious diseases.
Within these gowns levels, there are numerous gown types available, such as:
- Disposable isolation gowns
- Latex-free gowns
- Reusable gowns
- Waterproof polyester isolation gown
- Non-surgical gowns
- Procedural gowns
- Cover gowns
Choosing the Right Isolation Gown
The Centers for Disease Control (CDC) recommends that employers, hospital managers, and healthcare professionals consider the following factors before choosing the most suitable gowns for their needs.
The Purpose of the PPE
Determine what the main use of the gown will be, who will wear it, and what they will be doing while wearing it. Some gowns come in a one-size-fits-all or universal size. However, they are also available in different sizes. For maximum protection, gowns should be sized to the wearer if possible.
Different types of gowns are made from various materials. For example, disposable isolation gowns are usually made from polyethylene or polypropylene, while reusable isolation gowns are generally made from synthetic materials or cotton. Depending on the supply of medical equipment in medical facilities and their budget and needs, different options should be made available for staff.
The risk level of the scenario should play a massive role in choosing an isolation gown. If you need the gown for a minimal risk procedure such as basic care, a level 1 gown will suffice. However, if you’re purchasing equipment for intensive surgeries, you’ll need a level 4 gown.
Isolation Gowns for COVID-19
Throughout the COVID-19 pandemic, medical institutions around the world experienced shortages in PPE, including isolation gowns. Coincidingly, PPE has been essential in maintaining the health and safety of medical personnel, patients, and members of the public. In some cases, Emergency Use Authorizations (EUAs) for medical devices were instated to increase the supply.
Level 1 and 2 gowns are usually non-sterile. They may be used for COVID-19 patients and workers if the risk of fluid exposure is minimal to low. Level 3 or 4 gowns are usually sterile and should be used with COVID-19 patients and hospital employees where the risk of transmission of infection through bodily fluids is medium to high.
A synthetic material gown typically performs better than cotton when preventing fluid penetration and minimizing the risk of COVID-19 spreading.
How to Don and Doff an Isolation Gown
PPE such as gowns, face masks, and gloves can become sources of contamination if they aren’t donned (put on) and doffed (removed) correctly. Doctors, nurses, and other medical professionals must learn how to use these items safely. The steps for applying and removing an isolation gown are:
Donning the Gown
- Sanitize your hands
- Choose the right material, type, and size gown for the task
- Hold the gown from the neck
- Let the gown unfold entirely
- Place your arms into the sleeves, one at a time, and place your hands into the thumb loop and elastic cuff
- Pull the gown down over your head
- Tie the gown and ensure your back isn’t exposed
Doffing the Gown
- Open any waist or neckties
- Pull the gown from your neck and shoulder area
- Carefully fold the contaminated side toward the inside until the gown is in a neat bundle
- Make sure the clean part is visible and that the contaminated area is not exposed
- Safely discard the gown
Contact ICU Productions Inc. for Quality Medical Gowns
Determining what PPE you need is challenging, especially during a pandemic. Understanding what medical gowns are used for and what types are suitable for particular medical scenarios helps make the process easier. No matter what type of medical devices and PPE you need, it’s vital to purchase quality materials from a reliable source.
ICU Productions Inc. is a leading provider of FDA and CDC-approved PPE. We provide a variety of medical gowns, from levels 1 to 4. Some of the other important PPE we provide include gloves, masks, face shields, hand sanitizer, and children’s PPE. For more information or if you have any questions about our equipment, give us a call, send us an email, or visit our website today.