Exposure to biological fluids poses a very real danger to our health workers. As we continue putting up a brave fight against the Corona virus pandemic, we have all learned firsthand the importance of putting on medical protective clothing.
Other common diseases that are spread through microorganisms present in biological fluids are Hepatitis B virus, Hepatitis C virus, Ebola virus as well as HIV. Contrary to popular opinion, simply having a fluid-resistant garment may not be enough.
Most Personal Protective Equipment/ PPE medical gowns appropriate for our health workers are disposable. Some protective medical gowns are surgical gowns, medical isolation gowns, non-surgical gowns, procedural gowns, and operating room gowns and coveralls, to name a few.
This ensures protection to both the healthcare workers and the patients with whom they come into contact with.
Disposable isolation gown
Levels of Protection
The FDA recognized consensus in 2004, outlines the correct liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. This new terminology was put in place to ensure verification and validation of protective wear that is intended for use by health care personnel.
There are specific standard test methods to determine the protection levels of the gowns and other protective wear. The standard levels of risk are as follows;
Level 1- Minimal risk
These PPEs are designed to be used when providing basic care in a standard medical facility like isolation procedures or cover gowns worn by hospital visitors.
Level 2: Low risk
They are PPE designed for use in medical procedures such as drawing blood, in a pathology lab, when suturing, or in the Intensive Care Unit (ICU)
Level 3: Moderate risk
They are PPEs designed for use during procedures such as arterial blood draw, when inserting an intravenous (IV) line, or handling trauma cases in the Emergency Room.
Level 4: High risk
These PPE have been specifically designed for use during prolonged fluid intense procedures, during surgery, where pathogen resistance is required, or where infectious non-airborne diseases are suspected.
Types of Medical Protective Gowns
The name provided on the label does not necessarily describe the desired level of protection; for instance, an isolation gown labeled as such may not be suitable for the specific intended use. Always be sure to check the labeling to see if the safety level is appropriate.
Product names provided by medical suppliers are not really standardized. To help you understand better, here are some standard descriptions.
Surgical Gowns
A surgical gown is a class II personal protective garment required to be worn by health care personnel during surgical procedures. They protect both the patient and the personnel from transferring microorganisms, particulate matter, and body fluids.
Due to the level of exposure during procedures, critical zones on the body should be protected. This refers to the front of the body from top to shoulders and knees and arms from the wrist cuff above the elbow. All surgical gowns should be labeled as such and can be used for any risk level (1-4)
Surgical Isolation Gowns
A surgical isolation gown is for use where there is a medium to high risk of contamination or where a surgical gown is not enough to cover all critical zones.
The entire surgical isolation gown must meet the highest liquid protection level, with the exception of the cuffs, bindings, and hems. The fabric should cover the body as described, and all the seams should have the same liquid barrier protection level as the gown itself.
Non-Surgical Gowns
A non-surgical gown is a class I protective device worn to prevent the transfer of microorganisms or body fluids in low-risk situations. They should not be worn during invasive procedures, surgery, or areas where the risk of contamination is medium to high.
Non-surgical gowns should be able to cover the body well, depending on the procedure. The gown must meet the highest liquid barrier protection level (as it has been rated) in all critical zones and seams, with the exception of the bindings, cuffs, and hems.
In the current market, medical office gowns are breathable and made using non-woven polypropylene spun-bond fabric, which is also used in hospitals.
The fabric is soft, lightweight, and comfortable without compromising durability and fluid (water and blood) resistance. Other applications can be in food processing plants, hotels, supermarkets, and areas exposed to painting.
Understanding Critical Zones on the Body
For surgical gowns, the front of the gown top to bottom (areas A, B, and C) must have a level 1 barrier performance or higher.
The critical zone refers to areas A and B, while the back (area D) does not need to be protective.
For surgical isolation gowns and non-surgical gowns, barrier performance levels should be level 1 or higher in the entire gown (areas A, B, and C), inclusive of seams. Cuffs, hems, and bindings are exempted.
Recognized Standards for Medical Gowns
When selecting a particular gown, the only way to tell if its performance has been tested to suit your needs is by the information on the label.
The American Society for Testing and Materials (ASTM) F2407 is the official recognized document that describes testing for surgical gowns. It includes tear resistance of the fabric, seam strength, lint generation, evaporative resistance as well as water vapor transmission.
The standard recognized ASTM F2407 by the FDA include;
- Tensile Strength: ASTM D5034, ASTM D1682
- Tear resistance: ASTM D5587(woven), ASTM D5587 (nonwoven), ASTM D1424
- Seam Strength: ASTM D751 (stretch woven or knit)
- Lint Generation (ISO 9073 Part 10)
- Water vapor transmission (breathability) ASTM F1868 Part B, ASTM D6701 (nonwoven), ASTM D737-75
On the other hand, the American National Standards Institute (ANSI) and the Association of the Advancement of Medical Instrumentation (AAMI) have certified protective wear according to their liquid barrier performance. You can see the details associated with performance levels 1 to 4 here.
Sterility Information for Gowns
Not all medical protective gowns are sold sterile. When selecting a gown, some of the information you can look out for on the label includes;
The Sterilization method to be used, how to validate sterilization, standard level of measurement on the same, the ability of the packaging material to maintain sterility level, appropriate residue level if Ethylene Oxide is used, or radiation dosage if applicable.
Biocompatibility Information for Gowns
Surgical gowns come into contact with the skin for prolonged periods, and therefore the FDA has specifications regarding cytotoxicity, sensitization, irritation, and intracutaneous reactivity.
Biological evaluation should have been done on the material, and a biocompatibility endpoint assessment report available.
For a more detailed step-by-step guide on how to select the appropriate PPE for you, take a look at the CDC recommendations here.
Sources
Suzhou Vegas International Trade Co., Ltd: Antibacterial CPE Gowns