Surgical gowns and isolation gowns have always been commonly used personal protective equipment in hospitals, but everyone is still ambiguous about the difference between the two. This article will explore the differences between isolation gowns and surgical gowns from the dimensions of their functions, usage environment, usage methods, and technical standards. Essential difference.
The difference between the function and use environment of surgical gown and isolation gown
1.Main purpose and function
As a necessary protective clothing during surgery, it is used to reduce the risk of medical staff contacting pathogenic microorganisms, and at the same time, it can also reduce the risk of pathogenic microorganisms spreading between medical staff and patients. It is a safety barrier for sterile areas during surgical operations. Surgical gowns play a two-way protective role during surgery .
The surgical gown establishes a barrier between the patient and the medical staff, and reduces the probability of the medical staff coming into contact with the patient's blood or other body fluids and other potential sources of infection during the operation;
The surgical gown can block the spread of various bacteria colonized/adhered to the skin or clothing surface of medical staff to surgical patients, and effectively avoid multi-drug resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE) and other cross-infection.
After strict aseptic disinfection, it is used for invasive treatment of patients in a special operating room.
1.Main purpose and function
The American standard ASTM F3352-19 defines medical isolation gowns as protective clothing used to protect medical personnel, visitors and patients from the transfer of microorganisms and body fluids in patient isolation situations. To prevent patients from being infected, it is a two-way isolation.
Medical isolation gowns are specified in ASTM F3352-19 to protect healthcare workers, patients, and visitors from blood, body fluids, and other potentially infectious materials during patient care or patient treatment. The main emphasis here is on blood and body fluids, and there is no mention of viruses transmitted through the air, such as the new coronavirus.
"Full coverage" is specified in ASTM F3352-19, which means that at least the front, sides, and back of the arms and body are fully covered from the knees to the neck (excluding the neck) during exercise. We can see that the protection range of the medical isolation gown is from the knee to the neck below (excluding the neck), not the whole body coverage from head to toe, and the head, neck, hands and feet are not covered.
2.1.When in contact with patients with infectious diseases transmitted by contact, such as patients with multidrug-resistant bacteria infection, etc.
2.2.When implementing protective isolation for patients, such as the diagnosis, treatment and nursing of patients with large-area burns and patients with bone grafts.
2.3. It may be splashed by the patient's blood, body fluids, secretions, and feces.
2.4.Enter key departments such as ICU, NICU, protective ward, etc.
How to use isolation gowns and surgical gowns:
Youtube link for your reference：https://www.youtube.com/watch?v=rl0NWa1xr9o (Infringing deletion)
Youtube link for your reference：https://www.youtube.com/watch?v=31rEOB9AwG4 (Infringing deletion)
Technical standards and regulatory requirements for surgical gowns and isolation gowns
OSHA issued rules in 1991 requiring health care workers to use appropriate personal protective equipment to avoid contact with infectious agents. The regulations point out that different protection levels of surgical gowns should be formulated according to the blood generated during the surgical operation, the volume or total amount of blood, and the duration of the operation. According to the protection regulations specified by OSHA, AAMI divides the protective performance of surgical gown materials into four class:
1. Level 1 is used for liquid exposure, with the lowest risk of jetting and sputtering, and the surgical gown receives the least pressure, such as surgery or operations such as eye surgery, breast tumor resection, and skin biopsy.
2. Level 2 is used for small liquid exposure, low risk of jetting and sputtering, and lower pressure on surgery. Similar procedures or procedures such as hernia repair, tonsil surgery, and angiography. This level of surgical gown must pass the anti-penetration heatstroke test and hydrostatic pressure test.
3. Level 3 surgical gown is used for moderate liquid exposure, with medium spray and sputter risk, and the pressure on the surgical gown is high. Higher, this level of surgical gown has higher index requirements for water seepage and hydrostatic pressure test.
2. Level 4 is used for large liquid exposure, high risk of jetting and sputtering, and high pressure on surgical gowns, such as hip replacement, cesarean section, cardiovascular surgery and all surgeons' hand meetings. Procedures and operations that enter the patient's body. This level requires surgical gowns to pass both blood and virus leakage tests.
This diagram shows the critical zones on a surgical gown.
Critical Zones are defined as the areas where direct contact with blood, bodily fluids, and other potentially infectious material is most likely to happen (Areas A and B). For surgical gowns, this includes the fabric and the construction (sleeve seams, front tie attachment) in areas A and B.
The entire gown (Areas A, B, and C), including seams but excluding cuff, hems, and bindings, is required to have a barrier performance of at least Level 1.
The back of the surgical gown (Area D) may be non-protective.
AAMI liquid barrier standards also apply to surgical drapes.
This is the testing standard for surgical gowns in YY/T0506: http://www.gkgzj.com/u/cms/www/201910/14144657e911.pdf
In addition to YY/T0506 formulated by China, the main international surgical gown standards are:
American Association for the Advancement of Medical Devices (AAMI): AAMI PB-70
EN13795 developed by the European Standards Committee
ISO16542 specified by the International Organization for Standardization
American Society for Testing and Materials: ASTM F2407-06
1.Level 1 Gowns offering level 1 protection provide minimal protection and tend to be used in general hospital circumstances or when medical and healthcare workers are offering just basic care and don’t require sterile gowns. These gowns provide a slight barrier against fluids, but aren’t suitable for blood draws, ICUs, pathology labs.
2.Level 2 Isolation gowns are ideal for low risk circumstances like blood draws from veins or work in pathology labs and ICUs and don’t require sterile gowns. Level 2 gowns are tested by pressurizing the material used to make the gowns and by impacting the gowns with water. These gowns can block more fluid than level 1 gowns and are effective against fluid penetration that might occur through splatter or soaking.
3.Level 3 Gowns with level 3 protection are ideal for moderate risk scenarios such as blood draws from arteries, inserting IVs, and ER or trauma work which require sterile gowns and equipment. These gowns are also effective against splatters and soaking. The same tests used for level 2 gowns are used to test the efficacy of level 3 gowns.
4.Level 4 gowns offer the highest level of protection available and are used for all high risk circumstances (e.g. during surgery in an operating room that requires sterile equipment). These heavy-duty gowns can prevent fluid and virus penetration for up to an hour. These gowns are tested by subjecting them to simulated blood containing a virus. If at the end of the test the virus didn’t penetrate the gown, then the gown can be designated as level 4. These gowns offer pathogen resistance, protection against non-airborne diseases, and work as a barrier to large amounts of fluids for extended periods of time.
The following table shows the performance indicators of the isolation suit in AAMI PB70
Relevant standards for isolation gowns in GB/T 38462-2020
Microbiological index requirements of isolation gowns in GB/T 38462-2020
At present, the main international isolation clothing standards are:
In line with YY/T 0506.2-2016 "Surgical drapes, surgical gowns and clean clothes for patients, medical staff and instruments - Part 2: Performance requirements and test methods", there are specific specifications for the dry and wet state to block the penetration of microorganisms and the water resistance index. It can also play the protective effect of medical isolation clothing, and can be used as a substitute when medical isolation clothing cannot be obtained.
Writen by KYD,a profession isolation and Medical gowns machine manufacturer
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