Gowns are common personal protective equipment (PPE) used in the health care industry. According to the National Center for Biotechnology Information (NCBI), they are the second-most-used type of PPE in health care. Also referred to as hospital gowns, these garments are worn to protect the wearer and reduce disease or infection spread. Their secondary function is to reduce the transmission of harmful microorganisms from coming in contact with patients.
Different gowns vary in their levels of protection, with each type designated for a specific environment, usually based on the risk of exposure to bodily fluids. While each type of gown is manufactured using different materials, they all serve a similar purpose. They protect the wearer from the penetration of microorganisms and infectious fluids, minimizing the spread of disease. Gowns act as a barrier between the health care personnel who wear them and pathogens or viruses.
Most people became hyper-aware of PPE throughout the COVID-19 pandemic as the masses were encouraged to wear protective masks, use respirators, and sanitize their hands regularly. However, PPE plays a critical role in hospitals and surgery rooms year-round. Protective gowns help keep medical professionals and patients safe while contributing to the sanitation of health care facilities. Whether there’s a pandemic or not, hospitals must be adequately stocked with quality PPE at all times.
Types of Medical Gowns
Hospitals and other health care facilities are responsible for providing quality PPE for their workers to ensure they are kept safe and at minimal risk as they work. There are several different types of medical gowns and protective clothing for doctors and medical personnel. Here are some of the most common types of PPE gowns.
Surgical Gowns
Surgical gowns are labeled as Class II medical devices and are required to receive a 501(k) premarket notification. As they are regulated by the U.S. Food and Drug Administration (FDA), these protective medical gowns are held to an extremely high standard in terms of quality. They are designed to be worn by any health care worker involved in a surgical procedure to protect themselves and the patient from the transfer of harmful microorganisms, bodily fluids, and other potentially hazardous materials.
In a surgical setting, you must determine critical zones of protection to maximize safety and sanitation levels. Critical zones include the front of the body, ranging from the shoulders to the knees and from the wrists to right above the elbow. These gowns are suitable for use at all risk levels, from 1 to 4. They are carefully labeled as “surgical gowns” for clarity in critical medical circumstances.
Non-surgical Gowns
Non-surgical gowns are unsuitable for use during invasive procedures such as surgery or settings with a medium to high risk of contamination. They are categorized as Class I medical devices and do not need to receive a premarket review. Their primary use is to protect the wearer from the transfer of fluids or microorganisms in minimal to low-risk medical environments, such as a routine physical examination.
These gowns can be similar in appearance to those designed for surgery. They protect the critical zones and are required to meet the highest standards of liquid barrier performance in their classification.
Apart from the bindings, cuffs, and hems of the gown, all other areas are critical protection zones. The seams should have the same level of liquid barrier protection as the gown.
Isolation Gowns
Surgical isolation gowns can be worn during invasive medical procedures but are specifically designed for medium to high-risk situations. There is a need for a larger critical zone of protection under circumstances where the chances of contamination are higher. Regular surgical gowns are suitable for all medical scenarios. These gowns must receive a 501(k) premarket notification, like surgical gowns.
Hospitals use a mixture of reusable and disposable isolation gowns. However, 80% of the gowns used in hospitals are disposable. Single-use gowns are typically manufactured using raw materials such as synthetic fibers like polyester, polypropylene, and polyethylene. Reusable gowns must be laundered after each use. Multi-use isolation gowns are made from either 100% cotton, 100% polyester, or a blend of the two.
Gown Levels
In 2004, the FDA adopted the standards outlined by the American National Standards Institute/Association of the Advancement of Medical Instrumentation (ANSI/AAMI) to classify the protection level of PPE. Since then, medical institutions have used specific terminology to describe the barrier protection levels of gowns and other protective items. All items are tested to ensure they comply with federal regulations. Medical gowns fall into one of four categories:
- Level 1: are used for minimal risk level situations. For example, during a standard check-up procedure or as a cover gown for hospital or patient visitors.
- Level 2: these gowns offer more protection and are suitable for low-risk medical situations, such as drawing blood, suturing, or for use in an intensive care unit (ICU).
- Level 3: this type of PPE is for procedures that carry a moderate risk. For example, when nurses or doctors insert an intravenous line (IV) in an emergency room (ER) or a trauma case.
- Level 4: these are specialist gowns used in high-risk medical environments such as surgery or fluid intense operations. They are also used if there is a risk of infectious disease.
How to Correctly Put On and Dispose of a Medical Gown
One of the main limitations of PPE is that it doesn’t provide adequate protection if the user wears it incorrectly. The wearing of PPE is referred to as donning. Donning a medical gown correctly is crucial for health care workers as part of an overall infection-control strategy. Whether they’re putting on reusable isolation gowns or disposable medical gowns, workers must be trained to don them properly.
A medical gown should be put on using the following five steps:
Prepare the Gown
After washing or sanitizing your hands thoroughly, grip the gown from the neck area. A gown has an apron-style neck.
Let the Gown Unfold
Most medical aprons are designed to naturally fall and open for easy access. If it doesn’t, maintain your grip on the neck area and use a fast, downward snapping action to open it fully.
Insert Your Arms
Slip your arms into the gown sleeves and place your hands into the thumb loop elastic cuffs.
Fix the Gown into Place
Pull the gown over your head and ensure the size fits snugly. Make sure it’s long enough, covering the torso and arms adequately.
Secure the Gown
Disposable gowns, patient gowns, and other types of medical gowns are usually open at the back. Secure the gown by tying the back at the waist.
Medical gowns are open at the back so that medical professionals can don them quickly and easily with minimal risk of contamination. Patient gowns are open at the back to give doctors, nurses, or surgeons easier access to specific areas of a patient’s body.
Removing a medical gown is known as doffing. Doffing correctly is also important to minimize the risk of spreading infection. It is particularly important for medical professionals as they are most vulnerable at this stage. For example, the transmission of the COVID-19 virus occurs through respiratory droplets, which may be present on a gown. The wearer must avoid contact with body fluids and infectious materials to reduce the risk of spread.
A medical gown should be doffed using the following five steps:
Sanitize Your Hands
Scrub your hands thoroughly to ensure contaminants are removed. Medical workers often wear gloves when removing their gowns.
Break the Neck Closure
Pull the shoulders down to break the neck closure and loosen the gown around your upper torso.
Untie at the Waist
Release the waist ties and free the gown around the sides of your body.
Roll the Gown
One arm at a time, pull them away from the sleeve until the arms of the apron are bunched at the wrists. From here, roll the exposed and potentially contaminated side of the apron inward until it forms into a ball. Ensure the fluids and contaminants don’t leak or escape. You can then remove your hands and gather the apron for disposal.
Dispose of the Gown
Depending on the facility, there may be a specific method for disposing of medical gowns. For reusable equipment, the hospital should have a protocol in place for laundering.
Who Sets Safety Standards For Medical Gowns?
The FDA recognizes the American Society for Testing and Materials (ASTM), American National Standards Institute (ANSI), and Association of the Advancement of Medical Instrumentation (AAMI) as setting the standard for medical gowns. They use various test methods to determine tear resistance, seam strength, water resistance, lint generation, and more. The products are subsequently labeled to demonstrate they meet the national performance and quality standards for use in health care facilities.
For sterile devices, the FDA advises sponsors to provide sterility information outlined in the “Submission and Review of Sterility Information in Premarket Notification (501(k)) Submissions for Devices Labeled as Sterile“. This document includes the requirements for any product labeled as sterile.
Role of Medical Gowns During the COVID-19 Pandemic
Throughout the COVID-19 pandemic, there were global shortages of medical gowns. To slow the spread of COVID-19 and prevent a more severe outbreak, the U.S. authorized the emergency use of gowns and other apparel in May 2020, citing them as a barrier method.
The CDC outlined contingency plans for medical gowns to deal with potential shortages. The capacity of gowns is declared as conventional, contingency, or crisis, and there are conservation strategies for each of these scenarios to manage the supply chain effectively. In early 2021, the U.S. declared a contingency state, with health facilities adequately managing supplies.
Importance of Using Quality PPE
When purchasing PPE, it’s crucial to invest in quality products. This keeps employees, patients, visitors, and other hospital workers as safe as possible. At ICU Productions Inc., we provide high-quality PPE, including medical gowns, respirators, face masks, gloves, and hand sanitizer. All our items are FDA and CDC-approved, ensuring quality standards are met.
Visit our website to view our full range of products. For more information, contact us online or give us a call today.