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Selection of Surgical Clothing And Drapery For Medical Institutions And Related Standards

Mar. 23, 2019

Quality Standard and Selection of Surgical Gowns and Drapes in Healthcare Facilities.


In the process of surgery, medical personnel are easily exposed to the blood and body fluids of patients and exposed to various blood-borne pathogenic factors.Surgical clothing and drapes are used to maintain a sterile environment and to protect patients and health care workers from contamination. The quality and performance of the product should meet the requirements of the product in the expected exposure environment.Therefore, in this paper, the quality standard of protective equipment is associated with clinical selection, and the quality standard for each performance meeting clinical requirements is compared and analyzed, which can be used as a reference for the quality index of clinical selection ofsurgical gowns and sheets, as well as a basis for production enterprises to select production indicators.


1.       Material ans Methods


Standards for the selection and quality standards of surgical clothing and bedding, including: AORN's guidelines for the selection of surgical clothing and bedding, AAMI's standards for the barrier effect of surgical clothing, EN 13795 standards for the quality of surgical clothing and bedding, and China's YY0506 standards for the quality of surgical clothing and bedding, etc.


2.       Results


To summarize the relevant standards and guidelines, the quality and performance requirements of surgical clothing and shop sheet mainly include the following aspects.


2.1.1 barrier capability requirements


According to AORN guidelines, 'the material used for surgical clothing and drapes should prevent the penetration of blood and other fluids.'According to the barrier capability, AAMI classifies the materials of the surgical suit into 4 grades, and its use can be determined according to the classification index of AAMI.Grade 1 ~ 4 materials are all used for the key parts of surgical clothing and draping.Surgical suits with different barrier abilities can be used for different operations, such as routine operations, operations with high blood loss, and infectious operations.


The European Union EN 13795 standard requires the barrier ability of surgical clothing, including resistance to dry and wet microorganisms and resistance to liquid penetration.According to different purposes, the surgical clothing is divided into ordinary surgical clothing and enhanced surgical clothing.General surgery is used for routine surgery with less blood loss, while intensive surgery is used for surgery with longer operation time and more blood loss, such as orthopedic surgery and gastrointestinal surgery.


2.1.2 requirements for wear resistance and tensile resistance


AORN's guiding principle is that surgical gowns and drapes are maintained for their integrity and tolerability, including tear, puncture and wear resistance.


The standards of the United States and the European Union have relevant provisions on tensile strength and bursting strength, but the test methods of the two standards are different.EN 13795 adopted ISO 13938 -- 1, ISO 9073 -- 3:19 8 methods for bursting strength and tensile strength, while ASTM D 4966 Martindale test was used for the wear resistance index proposed by AAMI


2.1.3 catting requirements


Under AORN guidelines, 'surgical gowns and drapery should be low foul-foul-foul-foul-foul-foul-foul-foul-foul-foul-foul-foul-foul-fenced'.The standards of the United States and the European Union have the relevant provisions of the catch-all, but the test methods and standards are different.


2.1.4 flame retardant requirements


Under AORN guidelines, 'surgical gowns and drapes should be flame-resistant.'The standards of the United States all involve the relevant indicators of flame retardancy, while the standards of the European Union do not.


2.1.5 comfort requirements


Under AORN guidelines, "operating gowns and sheets should be comfortable


Comfortable and maintains the wearer's body temperature.Neither the AAMI standard nor EN 13795 covers such items.


2.2 discuss


2.2.1 barrier force requirements


Surgical clothing materials should be chosen based on the level of exposure to blood and body fluids that the user may be exposed to.In the surgery with almost no exposure to blood and body fluids for a short time, it is enough to wear the surgical clothing with minimal protective performance. If the operation is long and complex and the exposure opportunity of blood-borne pathogenic factors increases, the surgical clothing with stronger barrier ability should be selected.


The standard of AAMI is different from EN 13795 to some extent. The barrier capacity standard of AAMI is mainly aimed at resisting liquid penetration.EN 13795, on the other hand, contains resistance to microorganisms and liquid penetration by hydrostatic pressure measurements and bacterial penetration tests.EN 13795 is relatively strict with the requirement of 100 cmH 2O for the hydrostatic pressure in the key area of the strengthened surgical suit.AAMI level 3 specifies 50 cmH 2O.


2.2.2 wear resistance and tensile resistance requirements


Incomplete or easily torn clothing can cause microorganisms, particles, and fluids to pass between sterile and germy areas, exposing patients to exogenous organisms, and healthcare workers to blood-borne pathogenic agents.It is necessary to ensure the wear resistance and stretch resistance of the surgical clothing no matter it is reused or disposable.Both the AAMI standard and EN 13795 require wear resistance and tensile resistance.


2.2.3 catting requirements


Particles of the wool are scattered around the environment and bacteria stick to them.The bacteria-carrying trichoderma may colonize surgical wounds, causing the body to react to foreign bodies and triggering infection.Studies have shown that 2 mg of dust from a wound is 9 times more likely to cause staphylococcus aureus infection than no dust.


2.2.4 flame retardant requirements


Surgical clothing and drape materials may be flammable. Special care should be taken when exposed to light and heat sources, electronic surgical equipment, lasers and other energy devices.The choice of surgical clothing and drapes should be consistent with acceptable flammability standards to provide the safest environment for patients and healthcare personnel.The standards of the United States all involve the relevant indicators of flame retardancy, while the standards of the European Union do not.

2.2.5 comfort requirements


Surgical clothing and drapes should be free of toxic substances and allergens.The suit should also be flexible enough for the medical staff.AAMI and EN 13795 had no relevant indexes.International standards for comfort include:


(1) cup crush energy test;


(2) convenient to wear;


(3) maintain the wearer's body temperature (thermal resistance) ASTM D 1518;


(4) good air permeability (air permeability test ISO 9237).


According to the above quality standards and guiding principles, surgical staff and hospital procurement staff can choose appropriate surgical clothes and sheets to protect medical staff from the contamination of various risk factors during surgery and protect patients from the contamination from medical staff.




3 conclusion


AORN "operation suits and draping selection guide" from the perspective of clinical application of proposed suits and draping quality performance problems that should be paid attention to when the choice, and the AAMI surgery barrier uniform standard, EN 13795 surgery and draping quality standard and our country YY0506 operation suits and draping quality standards, respectively from the perspective of the quality standards of materials and surgical clothing quality standard index is put forward.In this paper, the quality standards for each performance meeting clinical requirements are analyzed, which can be used as a reference for the quality index of clinical selection of surgical clothing and drapery, as well as a basis for enterprises to select production indexes.


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