Medical gowns arehospital gowns worn by medical professionals aspersonal protective equipment (PPE) in order to provide a barrier between patient and professional. Whereaspatient 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 theCOVID-19 pandemic became in appearance more likecleanroom suits as knowledge of thebest practices filtered up through the national bureaucracies. For example, the European norm-setting bodiesCEN andCENELEC on 30 March 2020 in collaboration with theEuropean 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]
The concept of PPE in regards to medical professionals was seen as early as the 17th centuryPlague doctor's outfit.
During theEbola crisis of 2014, theWHO published a rapid advice guideline on PPE coveralls.[3]
The different levels of various gown types are categorized as follows:[4]
| Level | Risk | Exposure | Product usable as/at | Protection levels | Tests |
|---|---|---|---|---|---|
| One | Minimum | Standard isolation, Basic care | Visitor gown | Allows small amount of fluid penetration. Slight barrier to fluids. | Only one test of water impacting the gown material's surface is conducted to determine barrier protection. |
| Two | Low | Surgical suturing, and during blood draw | Pathology lab,Intensive care unit | Protection from fluids for longer period than level one gowns. | Two tests
|
| Three | Moderate | Intravenous therapy, and to drawarterial blood | InTrauma cases, or atEmergency | Protection from fluids for longer period than level two gowns. | Two tests
|
| Four | High | Surgery, and wherepathogen transmission suspected | Operating theater | Protection against fluids and virus for one hour. | Three tests
|
In the United States, medical gowns aremedical devices regulated by theFood 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.[5]
Surgical and surgical isolation gowns are regulated by the FDA as aClass II medical device that require a510(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.[5]
In 2004, the FDA recognizedANSI/AAMI PB70:2003 standard on protective apparel and drapes for use in health care facilities. Surgical gowns must also conform to theASTM 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.[5]
The First Affiliated Hospital of theZhejiang University School of Medicine inHangzhou,Zhejiang Province,People's Republic of China developed their own protocol and equipment during the early months of theCOVID-19 pandemic. A screenshot of the cover of theHandbook 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 theCOVID-19 pandemic inWuhan, doctors were provided with full PPE gown suits as early as January 2020.
During theCOVID-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]
In an early April 2020 article, 20 doctors from the whole of Italy describe their experience with coronavirus patient care. Their conclusion reads:[6]
Instituting precise well-established plans to perform undeferrable surgical procedures and emergencies on COVID-19-positive patient is mandatory. Hospitals must prepare specific internal protocols and arrange adequate training of the involved personnel.
Their findings are set out in a table entitled "Necessary personal protection equipment":
As seen in the accompanying gallery figure, at least oneIsraeli hospital had access to fullTyvek PPE gowns as early as 17 March 2020 during theCOVID-19 pandemic.
In a May 2017 research article, several French scientists complained that there was little harmonization across Europe for the names ofpathogens, and went on to describe the PPE norms and regulations in France forinfectious diseases underBSL-3.[7]