![DonningCDC2020](https://upload.wikimedia.org/wikipedia/commons/b/b5/DonningCDC2020.jpg)
Medical gowns are
hospital gowns worn by medical professionals as
personal protective equipment
Personal protective equipment (PPE) is protective clothing, helmets, goggles, or other garments or equipment designed to protect the wearer's body from injury or infection. The hazards addressed by protective equipment include physical, e ...
(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
The COVID-19 pandemic, also known as the coronavirus pandemic, is an ongoing global pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The novel virus was first identi ...
became in appearance more like
cleanroom suit
A cleanroom suit, clean room suit, or bunny suit, is an overall garment worn in a cleanroom, an environment with a controlled level of contamination. One common type is an all-in-one coverall worn by semiconductor and nanotechnology line product ...
s as knowledge of the
best practices
A best practice is a method or technique that has been generally accepted as superior to other known alternatives because it often produces results that are superior to those achieved by other means or because it has become a standard way of doing ...
filtered up through the national bureaucracies. For example, the European norm-setting bodies
CEN and
CENELEC
CENELEC (french: Comité Européen de Normalisation Électrotechnique; en, European Committee for Electrotechnical Standardization) is responsible for European standardization in the area of electrical engineering. Together with ETSI (telecommun ...
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."
History
The concept of PPE in regards to medical professionals was seen as early as the 17th century
Plague doctor's outfit.
During the
Ebola crisis
The 2013–2016 epidemic of Ebola virus disease, centered in West Africa, Western Africa, was the most widespread List of Ebola outbreaks, outbreak of the disease in history. It caused major loss of life and Socioeconomics, socioeconomic disr ...
of 2014, the
WHO
Who or WHO may refer to:
* Who (pronoun), an interrogative or relative pronoun
* Who?, one of the Five Ws in journalism
* World Health Organization
Arts and entertainment Fictional characters
* Who, a creature in the Dr. Seuss book '' Horton He ...
published a rapid advice guideline on PPE coveralls.
Types
The different levels of various gown types are categorized as follows:
Local variants
United States
In the United States, medical gowns are
medical devices
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...
regulated by the
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
. 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.
Surgical and surgical isolation gowns are regulated by the FDA as a
Class II medical device
Due to the many regulations in the industry, the design of medical devices presents significant challenges from both engineering and legal perspectives.
Medical device design in the United States
The United States medical device industry is one ...
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.
In 2004, the FDA recognized
ANSI
The American National Standards Institute (ANSI ) is a private non-profit organization that oversees the development of voluntary consensus standards for products, services, processes, systems, and personnel in the United States. The organi ...
/
AAMI
Australian Associated Motor Insurers Limited (commonly referred to as AAMI) is an Australian general insurance provider offering car, home, CTP and business insurance. AAMI has vehicle assessment centres in Victoria, New South Wales, Queensland ...
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.
China
![A doctor wearing special protective suit for the Wuhan coronavirus outbreak treat patient in Hubei TCM Hospital, Wuhan](https://upload.wikimedia.org/wikipedia/commons/2/21/A_doctor_wearing_special_protective_suit_for_the_Wuhan_coronavirus_outbreak_treat_patient_in_Hubei_TCM_Hospital%2C_Wuhan.jpg)
The First Affiliated Hospital of the
Zhejiang University School of Medicine in
Hangzhou
Hangzhou ( or , ; , , Standard Mandarin pronunciation: ), also romanized as Hangchow, is the capital and most populous city of Zhejiang, China. It is located in the northwestern part of the province, sitting at the head of Hangzhou Bay, whic ...
,
Zhejiang Province,
People's Republic of China
China, officially the People's Republic of China (PRC), is a country in East Asia. It is the world's most populous country, with a population exceeding 1.4 billion, slightly ahead of India. China spans the equivalent of five time zones and ...
developed their own protocol and equipment during the early months of the
COVID-19 pandemic
The COVID-19 pandemic, also known as the coronavirus pandemic, is an ongoing global pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The novel virus was first identi ...
. 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
The COVID-19 pandemic, also known as the coronavirus pandemic, is an ongoing global pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The novel virus was first identi ...
in
Wuhan
Wuhan (, ; ; ) is the capital of Hubei Province in the People's Republic of China. It is the largest city in Hubei and the most populous city in Central China, with a population of over eleven million, the ninth-most populous Chinese city an ...
, doctors were provided with full PPE gown suits as early as January 2020.
European Union
During the
COVID-19 pandemic
The COVID-19 pandemic, also known as the coronavirus pandemic, is an ongoing global pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The novel virus was first identi ...
, the European Commissioner for the Internal Market on 30 March 2020 listed the applicable norms for to help manufacturers re-convert their production lines:
*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
and PB
;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)
Israel
![Ibngvirol001](https://upload.wikimedia.org/wikipedia/commons/4/47/Ibngvirol001.jpg)
As seen in the accompanying gallery figure, at least one
Israel
Israel (; he, יִשְׂרָאֵל, ; ar, إِسْرَائِيل, ), officially the State of Israel ( he, מְדִינַת יִשְׂרָאֵל, label=none, translit=Medīnat Yīsrāʾēl; ), is a country in Western Asia. It is situated ...
i hospital had access to full
Tyvek
Tyvek () is a brand of synthetic flashspun high-density polyethylene fibers. The name "Tyvek" is a registered trademark of the American multinational chemical company DuPont, which discovered and commercialized Tyvek in the late 1950s and early ...
PPE gowns as early as 17 March 2020 during the
COVID-19 pandemic
The COVID-19 pandemic, also known as the coronavirus pandemic, is an ongoing global pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The novel virus was first identi ...
.
Italy
In an early April article, 20 doctors from the whole of Italy describe their experience with coronavirus patient care. Their conclusion reads:
Their findings are set out in a table entitled "Necessary personal protection equipment":
*
FFP2 facial mask or (in case of maneuvers at high risk of generating aerosolized particles:) FFP3 facial mask
*Disposable long sleeve waterproof coats, gowns, or
Tyvek
Tyvek () is a brand of synthetic flashspun high-density polyethylene fibers. The name "Tyvek" is a registered trademark of the American multinational chemical company DuPont, which discovered and commercialized Tyvek in the late 1950s and early ...
suits
*Disposable double pair of
nitrile gloves
*Protective goggles or visors
*Disposable head caps
*Disposable long shoe covers
*Alcoholic hand hygiene solution
Criticisms
In a May 2017 research article, several French scientists complained that there was little harmonization across Europe for the names of
pathogens
In biology, a pathogen ( el, πάθος, "suffering", "passion" and , "producer of") in the oldest and broadest sense, is any organism or agent that can produce disease. A pathogen may also be referred to as an infectious agent, or simply a ger ...
, and went on to describe the PPE norms and regulations in France for
infectious diseases under
BSL-3.
See also
*, historical equivalent
*
Hazmat suit
A hazmat suit (hazardous materials suit) is a piece of personal protective equipment that consists of an impermeable whole-body garment worn as protection against hazardous materials. Such suits are often combined with self-contained breathing ...
*
Workplace hazard controls for COVID-19
Hazard controls for COVID-19 in workplaces are the application of occupational safety and health methodologies for hazard controls to the prevention of COVID-19. Vaccination is the most effective way to protect against severe illness or death f ...
References
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Gowns
Medical equipment
Headgear
Occupational safety and health
Risk management in business
Industrial hygiene
Environmental social science
Working conditions
Personal protective equipment