Medical gown
From Wikipedia, the free encyclopedia
This article is about gowns worn by healthcare personnel as personal protective equipment. For gowns worn by patients, see Patient gown.
Medical gowns are hospital gowns worn by medical professionals as personal protective equipment (PPE) in order to provide a barrier between patient and professional. Whereas patient gowns are flimsy often with exposed backs and arms, PPE gowns as seen below in the cardiac surgeon photograph cover most of the exposed skin surfaces of the professional medics.
In several countries, PPE gowns for use in the COVID-19 pandemic became in appearance more like cleanroom suits as knowledge of the best practices filtered up through the national bureaucracies. For example, the European norm-setting bodies CEN and CENELEC on 30 March 2020 in collaboration with the European Commissioner for the Internal Market made freely-available the relevant standards documents in order “to tackle the severe shortage of protective masks, gloves and other products currently faced by many European countries. Providing free access to the standards will facilitate the work of the many companies wishing to reconvert their production lines in order to manufacture the equipment that is so urgently needed.”[2]
Local variants
United States
In the United States, medical gowns are medical devices regulated by the Food and Drug Administration. FDA divides medical gowns into three categories. A surgical gown is intended to be worn by health care personnel during surgical procedures. Surgical isolation gowns are used when there is a medium to high risk of contamination and a need for larger critical zones of protection. Non-surgical gowns are worn in low or minimal risk situations.[4]
Surgical and surgical isolation gowns are regulated by the FDA as a Class II medical device that require a 510(k) premarket notification, but non-surgical gowns are Class I devices exempt from premarket review. Surgical gowns only require protection of the front of the body due to the controlled nature of surgical procedures, while surgical isolation gowns and non-surgical gowns require protection over nearly the entire gown.[4]
In 2004, the FDA recognized ANSI/AAMI PB70:2003 standard on protective apparel and drapes for use in health care facilities. Surgical gowns must also conform to the ASTM F2407 standard for tear resistance, seam strength, lint generation, evaporative resistance, and water vapor transmission. Because surgical gowns are considered to be a surface-contacting device with intact skin, FDA recommends that cytotoxicity, sensitization, and irritation or intracutaneous reactivity is evaluated.[4]
China
On 22 January 2020, a doctor wearing special PPE suit for the Wuhan coronavirus outbreak treats a patient in Hubei Hospital
The First Affiliated Hospital of the Zhejiang University School of Medicine in Hangzhou, Zhejiang Province, People’s Republic of China developed their own protocol and equipment during the early months of the COVID-19 pandemic. A screenshot of the cover of the Handbook of COVID-19 Prevention and Treatment shows a picture of two rows of medical personnel, each wearing PPE gowns and PPE masks and PPE hoods and PPE goggles.
During the COVID-19 pandemic in Wuhan, doctors were provided with full PPE gown suits as early as January 2020.
European Union
During the COVID-19 pandemic, the European Commissioner for the Internal Market on 30 March 2020 listed the applicable norms for to help manufacturers re-convert their production lines:[2]
- Protective masks
EN 149 2009-08: Respiratory protective devices – Filtering half masks to protect against particles – Requirements, testing, marking EN 14683 2019-10: Medical face masks – Requirements and test methods
- Eye protection
EN 166 2002-04: Personal eye-protection – Specifications
- Protective clothing
EN 14126 2004-01: Protective clothing – Performance requirements and tests methods for protective clothing against infective agents EN 14605 2009-08: Protective clothing against liquid chemicals – performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]) EN ISO 13688 2013-12 Protective clothing – General requirements (ISO 13688:2013) EN 13795-1 2019-06: Surgical clothing and drapes – Requirements and test methods – Part 1: Surgical drapes and gowns EN 13795-2 2019-06: Surgical clothing and drapes – Requirements and test methods – Part 2: Clean air suits
- Gloves
EN 455-1 2001-01 Medical gloves for single use – Part 1: Requirements and testing for freedom from holes EN 455-2 2015-07: Medical gloves for single use – Part 2: Requirements and testing for physical properties EN 455-3 2015-07: Medical gloves for single use – Part 3: Requirements and testing for biological evaluation EN 455-4 2009-10: Medical gloves for single use – Part 4: Requirements and testing for shelf life determination EN 420 2010-03: Protective gloves – General requirements and test methods EN ISO 374-1 2018-10 Protective gloves against dangerous chemicals and micro-organisms – Part 1: Terminology and performance requirements for chemical risks EN ISO 374-5 2017-03: Protective gloves against dangerous chemicals and micro-organisms – Part 5: Terminology and performance requirements for micro-organisms risks (ISO 374-5:2016)
https://en.wikipedia.org/wiki/Medical_gown