During the operation, medical staff is most likely to be exposed to the patient's blood and various liquids, which will be exposed to a variety of pathogenic factors. Surgical gowns and surgical drapes are mainly used to maintain aseptic environment and to protect patients and hospital workers from contamination. Therefore, its quality and performance should meet the requirements of the product in the expected exposure environment to play a corresponding role. Therefore, in this paper, the quality standard of the surgical gown and the surgical drape is associated with the clinical selection, and the quality standard for each performance of the clinical requirement is compared and analyzed. It can be used not only as a reference for clinical selection of surgical drapes and gowns, but also as an index basis for medical suppliers to select surgical drapes and gowns manufacturers.

Standard selection: AAMI surgical clothes barrier action standard, EN13795 surgical drapes and gowns quality standard

1.Barrier capability requirement

According to the barrier ability, AAMI classified the surgical materials into 4 grades. Its use can be determined according to the grading index of AAMI. Grades 1-4 are used for key points in surgical gowns and drapes. Surgical gowns with different barrier abilities can be used for different operations, such as conventional surgery, surgery with a large amount of bleeding, infectious surgery, etc.

AAMI PB70 Liquid Protection Test Project, Indicators and Uses

The requirements of the European Union's EN13795 standard for the barrier capacity of surgical gowns mainly include resistance to dry and wet microbes and resistance to liquid penetration. Surgical gowns are divided into standard surgical gowns and reinforced surgical gowns according to different purposes. Ordinary surgical gowns are used for routine surgery with less bleeding, and reinforced surgical clothes are used for surgery with longer operation time and more bleeding, such as orthopedic surgery and gastrointestinal surgery.

EN 13795 Surgical clothes Quality Standards

Remarks: a-Test status of the indicator: select the bacterial liquid with a concentration of 108 CFU/g, and shake the bacteria for 30 min;

b-The lowest significant difference (LSD) of BI reached 0.98 in the 95% confidence interval, which is the lowest value between the two materials, and the difference is not within 0.98BI;

c-For the purpose of this standard, log10CFU ≤ 2 means a maximum of 300 CFU;

d-BI=6.0，Indicates no penetration in this standard;

e-Strictly maintain the sterile area during operation, including the front part of the waist, the upper part, the arms;

f-Areas with less sterility during operation, including the back, front and lower waist

The material of the surgical gown should be selected based on the exposure of the blood and body fluids that the user may face. In the short-term surgery with little exposure to blood and body fluids, you can wear minimal protective performance surgery clothes. If the operation time is long and complicated, and the exposure of blood-borne virulence factors increases, surgical gowns with stronger barrier capabilities should be selected.

The standard of AAMI is different from EN13795. The barrier capacity standard of AAMI is mainly for resisting liquid penetration. The test methods include impact penetration test and hydrostatic pressure test. EN13795 contains resistance to microorganisms and resistance to liquid penetration. Test methods include hydrostatic pressure measurement and bacterial permeation experiments. EN 13795 requires a hydrostatic pressure of ≥100cmH2O for the key areas of the reinforced surgical gown, which is relatively strict; Level 3 of the AAMI standard specifies ≥50cmH2O.

2.Abrasion Resistance, Tensile Resistance

Both the US and EU standards have provisions for tensile strength and burst strength, but the two standard test methods are different. EN13795 uses ISO 13938-1, ISO 9073-3:198 for burst strength and tensile strength, while AAMI's wear resistance index uses the ASTM D 4966 Martindale test.

Standard Comparison of Tensile Strength and Bursting Strength of Surgical Gowns

Incomplete or tearable surgical gowns can cause microbes, particles and liquids to pass between sterile and bacteriological areas, expose patients to exogenous organisms, and expose medical care to blood-borne diseases. Regardless of repeated use or disposable surgical gowns, it is necessary to ensure the abrasion resistance and stretch resistance of the surgical gown. AAMI's standards and EN13795 have requirements for wear resistance and tensile resistance.

3.Blanking requirements

Surgical gowns and surgical drapes should be low-grade blanking. There are regulations in the US and EU standards, but the test methods and standards are different.

The Comparison of the Standard of Surgical Gown Blanking

The particles of a wool floc are scattered in the environment, and the bacteria will adhere to it. The bacteria-carrying batt may colonize the surgical wound, causing the body to respond to foreign bodies and easily cause infection. Related studies have shown that there is 2mg dust in the wound, and the incidence of Staphylococcus aureus infection is 9 times higher than that without dust.

4. Flame retardant requirements

Surgical gowns and surgical drapes should be resistant to burning. Relevant indicators of flame retardancy are covered in the US standards, but not in the EU standards.

US Standard on the Flame Retardancy of Surgical Drapes and Gowns

Surgical gowns and drape materials may be flammable, and special care should be taken when exposed to light sources and heat sources, electrosurgical equipment, lasers, and other energy devices. The choice of surgical gowns and drapes should be consistent with acceptable flammability standards to provide the safest environment for patients and healthcare professionals. Relevant indicators of flame retardancy are covered in the US standards, but not in the EU standards.

5.Comfort Requirement

According to AORN guidelines, surgical gowns and surgical drapes should be comfortable and maintain the wearer's temperature. Nami's standards and EN13795 standards do not cover such projects. Surgical gowns and drapes should be free of toxic substances and allergens. Surgical gowns should also be flexible enough for medical personnel.There are no relevant indicator standards for AAMI and EN13795. The international standards related to comfort include:（1）the fabric is not easy to deform (cup crush energy test);(2)easy to wear;(3)keeping the body temperature of the wearer (thermal resistance) ASTM D 1518;(4)good air permeability

According to the above quality standards and guidelines, surgical personnel and hospital procurement personnel can choose appropriate surgical gowns and surgical drapes to protect medical personnel from various risk factors during surgery and protect patients from medical personnel.

At Lantian Medical Supplies, we’re committed to ensuring your safety every step of the way. By crafting surgical drapes and gowns with integrity and care, we’re proud to give you everything you need, so you can be certain that you have the right surgical drapes and surgical clothes for every procedure. When you choose Lantian Medical, you’re getting more than a physical product. We’re dedicated to making sure you have what is needed to give you peace of mind. Insights that give your staff every advantage. The integrity that’s woven into every product we craft. A portfolio of products that accommodate every need.

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