Home Education Technical Standards and Regulatory Requirements for Surgical Gown

Technical Standards and Regulatory Requirements for Surgical Gown

by Skopje Macedonsko

The United States is the first country in the world to implement surgical gown and surgical drapes. The US Occupational Safety and Health Administration (OSHA) issued a regulation in 1991 to reduce the risk of health care workers being exposed to blood-borne diseases. The regulations require medical personnel to use appropriate personal protective equipment (PPE) to avoid contact with infectious agents.

According to medpurest.com, the regulations indicate that the surgical gown needs to be based on the volume or total amount of blood and body fluid produced during the operation of the surgical operation, as well as the duration of the operation. The following three aspects are mainly included:

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1. Areas exposed to the blood, including the face, limbs, etc., and the manner of exposure, including pressure and flowing liquids, water droplets, etc.

2. Exposure of blood and body fluids

3. The continuous operation of the operation, from the intravenous injection between the short iliac crest to the cardiothoracic surgery between the long sputum. According to OSHA’s specified protective regulations, the American Medical Device Promotion Association (AAMI) classifies the protective properties of surgical gown materials into four levels

Level 1 is the lowest risk for liquid exposure, spray and sputtering, and the surgical gown is under minimal stress, such as eye surgery, lumpectomy, and skin biopsy.

Level 2 is used for small amounts of liquid exposure, with the lowest risk of low spray and sputtering, and low pressure on the surgical gown, such as hernia repair, tonsillectomy, and angiography. This level of surgical gowns must pass the anti-penetration waterproof test and hydrostatic test.

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Level 3 surgical gown is used for medium fluid exposure, medium jet and sputtering risks, and have higher pressure on surgical gowns, such as shoulder surgery, prostate resection, and other similar procedures and procedures. This level of the surgical gown has higher index requirements for water seepage and hydrostatic pressure tests.

Level 4  is used for a large number of liquid exposures, high injection and sputtering risks, and high pressure on the surgical gown, such as hip replacement, cesarean section, cardiovascular surgery and all surgeons’ hands. Into the patient’s surgery and operation. This level requires that the surgical gown must pass two tests for blood and virus leakage.

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In addition, the surgical gown is divided into key areas that are relatively easy to contact with body fluids, including the chest and forearm; and non-critical parts that are not easily accessible to body fluids, including the back and legs, and the overall degree of protection of the surgical gown is based on the lowest level in the critical area.

The EU countries have also adopted and implemented the Medical Device Guidelines (93/42 EEC), which has been half-effective since June 1998 and has become a mandatory decree of the EU. The corresponding surgical clothes product standard EN13795, the surgical gown is divided into standard type and reinforced plastic, and the protection area of the surgical gown is defined in the same way as the American standard and is divided into a main protective area and a secondary protective area.

The test indicators were tested for hydrostatic pressure and thousands of wet bacterial penetration tests as a standard test for barrier performance to replace the blood and microbial penetration test in the US standard.

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