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The number of COVID-19 diagnoses has been rising, and there is constant domestic news about the shortage of medical protective masks, medical protective clothing, and other materials. The shortage of medical protective clothing has become the heart disease of patients receiving new coronavirus infections in hospitals. This article will introduce the classification, grade, scope of application, standard and putting on and taking off of medical protective clothing.
Classification and scope of medical protective clothing
Medical protective clothing includes all kinds of clothing especially worn in the medical environment, so there are many classification methods.
- According to usage
According to the use and occasion, it can be divided into daily work clothes, surgical clothes, isolation clothes, and protective clothes.
Daily work clothes refer to white coats worn by medical staff in their daily work, also known as white coats.
Surgical gown refers to specially designed clothing worn in the operating room.
Isolation gown refers to the clothing worn by medical staff when they are in contact with patients or when family members visit patients.
Protective clothing refers to the clothing worn by people in special areas such as medical emergency, entering infectious disease areas, electromagnetic radiation areas, etc.
- According to the service life
According to the service life, medical protective clothing can be divided into disposable protective clothing and reusable protective clothing.
The standards for domestic medical disposable surgical gowns are the industry standards YY / T 0506-2016 “Surgical drapes, surgical gowns and cleans for patients, medical personnel and instruments implemented by the State Food and Drug Administration from January 1, 2017 clothes”. The standard that medical disposable protective clothing complies with is the technical requirements for medical disposable protective clothing that will be implemented from March 1, 2010, specified by the China National Standardization Administration: GB19082-2009.
Disposable protective clothing is discarded after use without disinfection or washing. It is easy to use and can avoid cross-infection. However, the degradation of disposable materials is easy to cause environmental pollution. Generally, surgical protective clothing and isolation clothing with high protective requirements are used in this way. Types of. After repeated use, it needs to be washed and sterilized at high temperatures. The comfort of the material is usually better, but the protection performance is usually poor. The washing and disinfection process will also increase the cost of a lot of manpower and water resources. Most of the daily work clothes (white coats) use this type.
- According to the material
According to different processing techniques of materials, medical protective clothing is divided into woven and non-woven protective clothing.
Woven materials are mainly used for processing reusable medical protective clothing, including traditional woven fabrics, high-density fabrics, coated fabrics, and laminated fabrics. Traditional woven fabrics are mainly made of blended yarns of synthetic fibers such as cotton fiber or polyester and cotton. They have good comfort and are mainly used in daily work clothes (white coats). High-density fabrics are woven from high-count cotton yarn or other ultra-fine synthetic fiber filaments. The yarn gap is very small. Due to the capillary action of the fiber, it has moisture permeability and then is treated with a fluorocarbon, silicone, or another waterproofing agent. Liquid permeability, mainly used for surgical gown materials that need a better waterproof effect. Coated and laminated fabrics are used to enhance the material’s impermeability and are used in protective clothing materials that use harsh environments. The coated fabric is processed by coating, the surface is closed by the coating agent, and it has anti-permeability. The hydrophilic groups in the coating or a special method to form a microporous structure to ensure the moisture permeability of the fabric. Laminated fabric is a composite of fabric and a special film (such as microporous film, polyurethane vinegar permeable film, etc.) through a lamination process, such as Teflon super waterproof and breathable composite fabric. Because the micropore diameter of the main body membrane of the fabric is much smaller than the water droplet diameter, it can prevent the penetration of blood, body fluids, etc. The high porosity of the micropores is larger than the diameter of the water vapor molecules, and the water vapor molecules can pass freely, so the moisture permeability is good.
Non-woven fabric protective clothing materials are basically disposable, using more spun-bonded non-woven fabrics, spun lace non-woven fabrics, SMS (spunbond-meltblown-spunbond) composite nonwoven fabrics, flash method Non-woven fabrics and spun-bonded fabric laminated products, etc. Generally, non-woven protective clothing has better protection than mechanical materials.
In addition to these, there are special medical protective clothing, which can be divided into three categories, and its scope of application is as follows:
- Chemical protective clothing
Chemical protective clothing is protective clothing worn to protect itself from chemical hazards or corrosive substances when handling hazardous medical chemicals. In addition to chemical resistance, chemical protective clothing requires stricter requirements on the tightness and seam structure of the clothing.
- Electromagnetic radiation protective clothing
Electromagnetic radiation protective clothing is an item of protective clothing that implants very fine conductive fibers in the fabric material so that the protective clothing does not generate static electricity and can shield electromagnetic waves in the range of 100kHz to 300GHz. It is mainly used by the operating crowd of electronic medical equipment systems in hospitals.
- Nuclear and radiation protective clothing
Used in a nuclear radiation environment (small dose, large range of ionizing radiation, mainly with α and β rays) to prevent the aerosol and dust from invading the human body. It has the functions of protecting radioactive aerosols, protecting more than 150 kinds of toxic and corrosive gases, liquids and solids, protecting potential radioactive particles and liquids from invading the body, and 100% blocking dry particles above 0.2μm.
Medical protective clothing grade
China’s protective clothing classification standard is the People’s Republic of China pharmaceutical industry-standard YY / T 1499-2016 “liquid barrier performance and classification of medical protective clothing”, which divides medical protective clothing into 4 levels in total, the higher the level, the better the protective performance.
| Barrier level | Liquid exposure risk | Reference surgery | Performance requirements | |
| AAMI Level 1 | Very little liquid splash or less pressure on the patient | Ophthalmology, simple ENT surgery | Must pass spray impact penetration test, seepage volume <4.5g | |
| AAMI Level 2 | More fluid injection and pressure | Simpler orthopedics include surgery to bind tourniquet, tonsillectomy, appendectomy, etc | 1, must pass the spray impact penetration test, the amount of water seepage <1g
2. A hydrostatic pressure test, hydrostatic pressure> 20cm.H2O
| |
| AAMI Level 3 | More body fluid splashes, more pressure | Mastectomy, some general surgical procedures |
| |
| AAMI Level 4 | Need the most advanced protective surgical drapes and high protective surgical gowns | Major chest surgery, orthopedics without tourniquet surgery, implant surgery, cardiac surgery, cesarean | 1，Surgical gown: In addition to reaching the level 3 test requirements, you must pass the Bacillus virus penetration test
2. Surgical draping: In addition to reaching the level 3 test, it must pass the artificial synthetic blood penetration test
|
According to the different requirements of the protection level, the non-woven fabric and film used are also different. Polyethylene breathable membrane / non-woven fabric composite material has an excellent effect on blocking bacterial particle penetration and liquid penetration, and the feel can be adjusted by changing the softness of the composite fabric, which has strong tensile strength, good breathability, and comfortable performance Greatly improved, can withstand disinfection treatment, does not contain toxic ingredients, weighs 60 ~ 100g / m2, has a good price-performance ratio, medical disposable protective clothing made with it can protect medical personnel from pollution by pollution sources, overcome cross-infection To effective protection.
The “Notice on Issues Related to the Production and Use of Protective Clothing during Epidemic Situations” states that when medical protective clothing is insufficient, emergency medical supplies protective clothing may be used.
Emergency medical supplies protective clothing shall comply with the European Union medical protective clothing EN14126 standard (where the liquid barrier level is above 2) and obtain the EU CE certification, or liquid compact protective clothing (type 3, comply with EN14605 standard), spray dense protective clothing (type 4, Comply with EN14605 standard), anti-solid particulate protective clothing (type5, comply with ISO13982-1 & 2 standards). Protective clothing for emergency medical supplies is only used to isolate wards (rooms) and quarantine wards (rooms). It cannot be used to isolate intensive care units (rooms) and other places with strict microbiological index control. All localities are invited to organize health departments to guide hospitals, disease control centers, and other units to regulate the rational use of emergency medical material protective clothing.
Medical protective clothing-related standards
In our country, the corresponding standard for medical protective clothing is the National Standard GB 19082-2009 “Technical Requirements for Medical Disposable Protective Clothing”, which not only specifies the appearance of protective clothing, but also the liquid barrier function, Filtration performance, microbiological index, residual amount of ethylene oxide, taking performance and comfort performance have been made strict regulations.
China’s protective clothing classification standard is the People’s Republic of China pharmaceutical industry-standard YY / T 1499-2016 “liquid barrier performance and classification of medical protective clothing”, which divides medical protective clothing into 4 levels in total, the higher the level, the better the protective performance.
Internationally, the European standard EN14126-2003 “Protective clothing-Performance requirements and test methods for protective clothing against infectious sources” divides protective clothing into 6 categories. The biomarker protective clothing marked with the letter “B” can be used for medical care Personal protection; American standard NFPA1999: 2018 “Protective clothing and equipment for emergency medical operations”, which specifies detailed protective clothing and equipment, and does not classify medical protective clothing.
Whether the medical protective clothing meets the standard needs to be checked by the testing agency. The medical protective clothing testing institutions with full project testing qualifications are Beijing Medical Device Inspection Institute, Anhui Food, and Drug Inspection Institute, Hubei Medical Device Quality Supervision and Inspection Institute, China Food and Drug Inspection Institute (China National Drug Inspection Institute) Institute) and the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center.
At present, most of the national standard medical protective clothing production uses ethylene oxide sterilization, which takes 7-14 days. However, after verification, the sterilization time can be controlled within 1 day, but considering that radiation sterilization may have a certain impact on the structural strength of the protective clothing, the “Emergency Code” limits the use period of radiation sterilized medical disposable protective clothing Within 1 month.
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