About the gown surgery isolation under protective clothing

by:Huiya     2020-12-06
Kits for personal protective equipment used in the healthcare environment. If the wearer contact with potential infectious liquid and solid materials, which is used to protect the wearer from infection or the spread of disease. They can also be used to help prevent gown wearer pollution vulnerable patients, such as patients with immune system is weak. Gown is part of the infection control strategies. In type used in the healthcare environment, there are many terms including gown, gowns, protective clothing, non-surgical, operation and the operating room. In 2004, the FDA approved by consensus standard American national standards institute/association for the advancement of medical devices ( ANSI / AAMI) PB70:2003, 'liquid barrier performance and used for medical care facilities protective clothing and the classification of the curtain'. The standard of the new term to describe the gown is intended for the medical institutions and other protective clothing barrier protection level, and the verification and validation of a new definition of level of protection required test methods and results: performance level 1: when using the minimum risk, for example, in the basic nursing, standard isolation, tourists' overall level or standard used in the medical treatment unit 2: low risk, is used to draw blood, for example, stitching, intensive care unit ( ICU) Or pathology laboratory level 3: moderate risk, and is used for arterial blood, for example, insert vein ( IV) Line, the emergency room or trauma cases 4: high risk, to use, for example, in the long run, fluid strong surgery, surgery, need resistance of pathogens or suspect infectious diseases. Gown surgery served by the FDA as a class II medical device regulatory, need 510 ( k) The pre-ipo notice. Gown is a personal protective clothing, aimed at by the medical staff to wear in the process of surgery, in order to protect the patients and medical staff from microorganisms, body fluids and particulate matter. Due to the controlled properties of surgery, national standards have described the key protected areas. As shown in figure 1: key areas including from the chest and shoulder blades to knee from sleeves to the elbow at the top of the sleeve. Surgical clothing can be used for any risk level ( 1 - Level 4) 。 All operation must be labeled gown. Protective clothing when there is a risk of moderate to high pollution and should be taken more than traditional surgery critical region, the use of protective clothing. Protective clothing, operation by the FDA as a class II medical device regulatory, need 510 ( k) The pre-ipo notice. As shown in figure 2, in addition to bind belt, cuff and hem, isolation cover all areas of operation are considered important protection areas, and must meet the highest liquid barrier protection grade. All seams must be the same as the other dress liquid barrier protection. In addition, the operation isolation cover fabric should be suitable for the intended use of the body. Product name may include, but not limited to, isolation gown, gown or protective clothing. Because the name is not standardized, and therefore described in the case of medium or high risk for isolation precautions or liquid barrier to protect the intended use of product label belongs to this category. The gown the gown is class I device ( From pre-market review) , designed to protect the wearer isolated cases patients with low risk or low risk and the transfer of bodily fluids from microorganisms. In surgery, invasive surgery or not wearing non-surgical moderate to high pollution risk during the suit. Like surgical gowns, non-surgical clothing should also be covering for the body of the task. As shown in figure 2, in addition to bind belt, cuff and hem of the gown to all areas are considered important protection areas, and must meet the highest liquid barrier protection grade. All seams must be the same as the other dress liquid barrier protection. Non-surgical non-surgical under class I device ( From pre-market review) , designed to protect the wearer isolated cases patients with low risk or low risk and the transfer of bodily fluids from microorganisms. In surgery, invasive surgery or not wearing non-surgical moderate to high pollution risk during the suit. Like surgical gowns, non-surgical clothing should also be covering for the body of the task. As shown in figure 2, in addition to bind belt, cuff and hem of the gown to all areas are considered important protection areas, and must meet the highest liquid barrier protection grade. All seams must be the same as the other dress liquid barrier protection. Product name may include, but not limited to, isolation gown, gown or overall. Because the name is not standardized, and therefore in selecting these dresses, please find description for permanent protection under the condition of little or low risk of intended use of the product label. When there is moderate to high risk of contamination and should be taken more critical than traditional surgery area, using surgical gowns.
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