Medical gowns are a type of personal protective equipment (PPE) used in the health care industry to prevent the spread of infection. Medical gowns are categorized from level 1 to 4, depending on the amount of protection they provide. The low-level gowns are ideal for minimal risk medical encounters such as a patient visit, while the high-level equipment is for professionals with a high risk of exposure to bodily fluids, like invasive surgery.
Gowns are the second most used form of PPE. The Centers for Disease Control and Prevention (CDC) recommend that healthcare workers cover their arms and exposed body areas when dealing with patients and participating in procedures. Gowns should also be worn in anticipation of contact with blood, bodily fluids, secretions, and excretions.
To maintain high national standards, the American National Standards Institute/Association of the Advancement of Medical Instrumentation (ANSI/AAMI) defines the requirements for medical gowns. It uses test results to ensure safety levels are upheld. Quality medical gowns help reduce the risk of health and safety issues in the workplace.
Types of Gowns
Depending on their work environment and exposure level, a patient or medical professional requires a specific type of gown. There are several different gown designs, including surgical and patient gowns. According to the FDA, all quality medical gowns are categorized between levels 1 and 4.
This type of gown is for minimal risk medical situations, such as patient visits, isolation, and basic care. They are lightweight, breathable, and comfortable, so you can wear them for long periods.
These gowns are designed for relatively low-risk scenarios, such as taking blood, suturing, and in a pathology lab or an intensive care unit (ICU). They offer more protection than level 1 gowns through fluid resistance. Two tests are carried out to ensure the gown prevents penetration and soakage.
These are gowns for medical scenarios with moderate levels of risk, like putting in an intravenous (IV) line or drawing arterial blood. Some of these hospital gowns have reinforced fabric for additional protection.
As the best protective gown available, level 4 medical gowns are for high-risk situations such as surgery. They are most resistant to bacterial spread and infection.
While these garments are available in different materials and colors, the design has been standard for some time. These gowns are short-sleeved and go as far as the thigh. The back is open, and it is usually held together using twill tape.
However, fashion designer Diane Von Furstenberg has worked alongside the Cleveland Clinic to create a new design over the past two decades. The design is similar to the Von Furstenberg signature wrap dress, allowing wearers to close it to the back or the front.
Surgical gowns are designed to help protect patients and healthcare workers during surgical procedures. The FDA regulates this type of garment and classifies it as a medical device that needs a 501(k) premarket notification.
The primary purpose of a surgical gown is to stop bacteria, microorganisms, or bodily fluids from transferring between individuals. They must protect the critical zones of the body, including the arms, shoulders, knees, and wrists. No matter what the risk level, surgical gowns are critical.
As the outermost item of clothing used during surgery, these gowns must be of high quality to minimize the risk of infection or other potential issues. They are usually lightweight for maximum comfort.
Isolation gowns are essential for medium to high risk of contamination. They’re needed when procedures involve large critical zones. Like traditional gowns, they comply with FDA regulations and are Class II medical devices, meaning they require a 501(k) premarket notification.
The gown’s seams must provide the same level of liquid protection as the rest of the garment. Isolation gowns are generally lightweight and breathable, making them suitable for surgeons to wear during lengthy procedures. These gowns are made using polypropylene to keep them resistant to soakage.
The materials used to make an isolation gown result in varying levels of resistance to blood and other bodily fluids encountered during medical procedures. Isolation gowns are linked to lower infection rates in hospitals.
These gowns are similar to surgical and isolation gowns, but they’re not intended for use during medical procedures. They are identified as Class I medical devices. This means that they don’t require a premarket review. Non-surgical gowns serve the same purpose as regular gowns, but they provide less protection.
Non-surgical gowns are ideal for non-invasive procedures and low-risk medical scenarios where the chances of contamination are minimal. Although they are used frequently in the medical field, non-surgical gowns are often worn in laboratories and clinical settings.
In certain circumstances, doctors or other medical professionals must take extreme precautions to prevent disease transmission. Diseases like Hepatitis, HIV, AIDS, and Ebola can be transmitted through biological fluids that surgeons may come in contact with during a procedure.
A coverall gown gives wearers more comprehensive coverage, preventing their bodies from coming into direct contact with these fluids. Coveralls are generally made from plastic or a type of waterproof fabric.
In the United States, the FDA regulates medical clothing. Gowns are essential for the health and safety of staff and patients, so there are strict guidelines surrounding the suitability of each type.
Bacteria and harmful viruses can survive for long periods on PPE. Depending on the material, humidity levels, and type of virus, bacteria can last for several months. Studies have shown that the type of material used to make clothing affects the chain of infection due to bacteria and viruses. The materials and quality of textiles used to produce medical gowns have a significant impact on their effectiveness. Therefore, healthcare professionals and equipment manufacturers focus on textiles and their maintenance recommendations to control bacterial or viral transmission.
Before hitting the market, manufacturers must test their gowns. Then they label the garment to prove to users that it meets safety standards. The American Society for Testing and Materials (ASTM) created a document called F2407 that describes testing methods. The most important factors for product quality are tear resistance, lint generation, the strength of seams, resistance to water, and resistance to other liquids.
These tests are specific to the level the surgical gown needs to qualify for. Level 1 gowns undergo a simple test for barrier protection performance based on water impacting the gown’s surface. In addition to this, level 2 and 3 gowns also undergo a test pressurizing the gown’s material. Level 4 gowns receive the most strenuous testing. They complete all methods for levels 1 to 3, and they go through a pathogen resistance test whereby simulated blood containing a virus is put on the gown. If there is no trace of the virus getting through, the gown meets level 4 standards.
The FDA determines whether gowns or other medical equipment are suitable for medical use. Medical-based equipment is marketed as such. Gowns that aren’t for medical use don’t have the same FDA device marketing authorization. As part of the evaluation process, the FDA considers whether the gowns are labeled for use by a medical professional, for use in a medical facility or environment, and whether they contain drugs, biologics, or antiviral agents.
The FDA works continuously to ensure that all gowns are of high quality. These safety standards are maintained strictly to ensure a minimal health risk to medical staff and that the patient experience is as comfortable as possible.
Sourcing High-Quality Medical Gowns
If you need PPE, you must buy it from a reliable source to guarantee top quality. Medical gowns should be FDA approved, and you must always ensure they are a suitable medical grade for the tasks you’re carrying out. Using the wrong level of gown increases the risk of injury and disease transmission.
At ICU Production Inc., we provide high-quality PPE. We stock level 1 to 4 gowns as well as whole-body coveralls. Visit our website or contact us today for more information on our products or for help addressing your PPE needs.