Medical gown

Last updated
Surgeons in gowns ready to perform heart surgery. Cardiac surgery operating room.jpg
Surgeons in gowns ready to perform heart surgery.
The CDC recommends four steps to putting on personal protective equipment (PPE) DonningCDC2020.jpg
The CDC recommends four steps to putting on personal protective equipment (PPE)

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.

Contents

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]

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 of 2014, the WHO published a rapid advice guideline on PPE coveralls. [3]

Types

The different levels of various gown types are categorized as follows: [4]

LevelRiskExposureProduct usable as/atProtection levelsTests
OneMinimumStandard isolation, Basic careVisitor gownAllows 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.
TwoLow Surgical suturing, and during blood draw Pathology lab, Intensive care unit Protection from fluids for longer period than level one gowns.Two tests
  1. Water impact on gown's surface for barrier protection.
  2. Pressure test of the material.
ThreeModerate Intravenous therapy, and to draw arterial blood In Trauma cases, or at Emergency Protection from fluids for longer period than level two gowns.Two tests
  1. Water impact on gown's surface for barrier protection.
  2. Pressure test of the material.
FourHigh Surgery, and where pathogen transmission suspected Operating theater Protection against fluids and virus for one hour.Three tests
  1. Water impact on gown's surface for barrier protection.
  2. Pressure test of the material.
  3. Barrier protection level against simulated blood containing virus

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. [5]

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. [5]

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. [5]

China

On 22 January 2020, a doctor wearing special PPE suit for the Wuhan coronavirus outbreak treats a patient in Hubei Hospital A doctor wearing special protective suit for the Wuhan coronavirus outbreak treat patient in Hubei TCM Hospital, Wuhan.jpg
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]

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
EN 166
2002-04: Personal eye-protection – Specifications
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
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

On 17 March 2020, a Magen David Adom hospital worker dressed in protective gear walks beside a mobile intensive care unit Ibngvirol001.jpg
On 17 March 2020, a Magen David Adom hospital worker dressed in protective gear walks beside a mobile intensive care unit

As seen in the accompanying gallery figure, at least one Israeli hospital had access to full Tyvek PPE gowns as early as 17 March 2020 during the COVID-19 pandemic.

Italy

In an early April 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":

Criticisms

In a May 2017 research article, several French scientists complained that there was little harmonization across Europe for the names of pathogens, and went on to describe the PPE norms and regulations in France for infectious diseases under BSL-3. [7]

See also

Related Research Articles

Personal protective equipment Equipment designed to help protect an individual from hazards

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, electrical, heat, chemicals, biohazards, and airborne particulate matter. Protective equipment may be worn for job-related occupational safety and health purposes, as well as for sports and other recreational activities. Protective clothing is applied to traditional categories of clothing, and protective gear applies to items such as pads, guards, shields, or masks, and others. PPE suits can be similar in appearance to a cleanroom suit.

Surgical mask Mouth and nose cover against bacterial aerosols

A surgical mask, also known by other names such as a medical face mask or procedure mask, is a personal protective equipment used by healthcare professionals that serves as a mechanical barrier that interferes with direct airflow in and out of respiratory orifices. This helps reduce airborne transmission of pathogens and other aerosolized contaminants between the wearer and nearby people via respiratory droplets ejected when sneezing, coughing, forceful expiration or unintentionally spitting when talking, etc. Surgical masks may be labeled as surgical, isolation, dental or medical procedure masks.

Medical glove Single-use glove worn during medical examinations and procedures

Medical gloves are disposable gloves used during medical examinations and procedures to help prevent cross-contamination between caregivers and patients. Medical gloves are made of different polymers including latex, nitrile rubber, polyvinyl chloride and neoprene; they come unpowdered, or powdered with corn starch to lubricate the gloves, making them easier to put on the hands.

Respirator Device worn to protect the user from inhaling contaminants

A respirator is a device designed to protect the wearer from inhaling hazardous atmospheres, including fumes, vapours, gases and particulate matter such as dusts and airborne pathogens such as viruses. There are two main categories: the air-purifying respirator, in which respirable air is obtained by filtering a contaminated atmosphere, and the air-supplied respirator, in which an alternate supply of breathable air is delivered. Within each category, different techniques are employed to reduce or eliminate noxious airborne contaminants.

Medical device Device to be used for medical purposes

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 assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.

Infection prevention and control is the discipline concerned with preventing healthcare-associated infections; a practical rather than academic sub-discipline of epidemiology. In Northern Europe, infection prevention and control is expanded from healthcare into a component in public health, known as "infection protection". It is an essential part of the infrastructure of health care. Infection control and hospital epidemiology are akin to public health practice, practiced within the confines of a particular health-care delivery system rather than directed at society as a whole.

A technical textile is a textile product manufactured for non-aesthetic purposes, where function is the primary criterion. Technical textiles include textiles for automotive applications, medical textiles, geotextiles, agrotextiles, and protective clothing.

Isolation (health care) Measure taken to prevent contagious diseases from being spread

In health care facilities, isolation represents one of several measures that can be taken to implement in infection control: the prevention of communicable diseases from being transmitted from a patient to other patients, health care workers, and visitors, or from outsiders to a particular patient. Various forms of isolation exist, in some of which contact procedures are modified, and others in which the patient is kept away from all other people. In a system devised, and periodically revised, by the U.S. Centers for Disease Control and Prevention (CDC), various levels of patient isolation comprise application of one or more formally described "precaution".

Scrubs (clothing) Lightweight, washable clothing worn by hospital staff or other medical personnel

Scrubs are the sanitary clothing worn by physicians, nurses, and other workers involved in patient care in hospitals. Originally designed for use by surgeons and other operating room personnel, who would put them on when sterilizing themselves, or "scrubbing in", before surgery, they are now worn by many hospital personnel.

Usage of personal protective equipment

The use of personal protective equipment (PPE) is inherent in the theory of universal precaution, which requires specialized clothing or equipment for the protection of individuals from hazard. The term is defined by the Occupational Safety and Health Administration (OSHA), which is responsible for PPE regulation, as the "equipment that protects employees from serious injury or illness resulting from contact with chemical, radiological, physical, electrical, mechanical, or other hazards." While there are common forms of PPEs such as gloves, eye shields, and respirators, the standard set in the OSHA definition indicates a wide coverage. This means that PPE involves a sizable range of equipment. There are several ways to classify them such as how gears could be physiological or environmental. The following list, however, sorts personal protective equipment according to function and body area.

Halyard Health

Halyard, formerly Kimberly-Clark Health Care, now part of Owens & Minor, sells sterilization wrap, facial protection, gloves, protective apparel, surgical drapes and gowns in more than 100 countries.

Prevention of viral hemorrhagic fever

Prevention of viral hemorrhagic fever is similar for the different viruses. There are a number of different viral hemorrhagic fevers including Ebola virus disease, Lassa fever, Rift valley fever, Marburg virus disease, Crimean-Congo haemorrhagic fever (CCHF) and yellow fever. Lassa, Ebola, Marburg and CCHF can be spread by direct contact with the body fluids of those infected. Thus the content here covers the prevention of Ebola.

N95 respirator Particulate respirator meeting the N95 standard

An N95 filtering facepiece respirator, commonly abbreviated N95 respirator, is a particulate-filtering facepiece respirator that meets the U.S. National Institute for Occupational Safety and Health (NIOSH) N95 classification of air filtration, meaning that it filters at least 95% of airborne particles. This standard does not require that the respirator be resistant to oil; another standard, P95, adds that requirement. The N95 type is the most common particulate-filtering facepiece respirator. It is an example of a mechanical filter respirator, which provides protection against particulates but not against gases or vapors. An authentic N95 respirator is marked with the text "NIOSH" or the NIOSH logo, the filter class ("N95"), a "TC" approval number of the form XXX-XXXX, the approval number must be listed on the NIOSH Certified Equipment List (CEL) or the NIOSH Trusted-Source page, and it must have headbands instead of ear loops.

The COVID-19 pandemic in Armenia is part of the worldwide pandemic of coronavirus disease 2019 caused by severe acute respiratory syndrome coronavirus 2. The virus was confirmed to have reached Armenia on 1 March 2020 when its first case was reported. It has spread to all of the regions (marz) of Armenia and has caused 4,400 deaths.

Workplace hazard controls for COVID-19 Prevention measures 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 from COVID-19. Multiple layers of controls are recommended, including measures such as remote work and flextime, increased ventilation, personal protective equipment (PPE) and face coverings, social distancing, and enhanced cleaning programs.

Shortages related to the COVID-19 pandemic Medical material and other goods shortages caused by the COVID-19 pandemic

Shortages of medical materials, manufacturing and consumer goods caused by the COVID-19 pandemic quickly became a major issue worldwide, as did interruptions to the global supply chain, which has challenged supply chain resilience across the globe. Shortages of personal protective equipment, such as medical masks and gloves, face shields, and sanitizing products, along with hospital beds, ICU beds, oxygen therapy equipment, ventilators, and ECMO devices were reported in most countries.

PPE Portrait project Way to humanize medical staff wearing PPE

The PPE Portrait project started during the 2014–2015 Ebola outbreak in Liberia by artist Mary Beth Heffernan as a way to humanize physicians, nurses and other medical professionals wearing full personal protective equipment (PPE). Patients experiencing one of the most terrifying times of their lives are unable to see the faces of their medical staff, but having a photo sticker on the staff member's PPE gown allows the patient to better relate to their caregiver. This project was revived in 2020 by Stanford social scientist Cati Brown-Johnson and featured on The Rachel Maddow Show, NPR, Smithsonian magazine and KQED.

EN 149 is a European standard of testing and marking requirements for filtering half masks. Such masks cover the nose, mouth and chin and may have inhalation and/or exhalation valves. EN 149 defines three classes of such particle half masks, called FFP1, FFP2 and FFP3, according to their filtering efficiency. It also classifies masks into "single shift use only" or "re-usable ", and an additional marking letter D indicates that a mask has passed an optional clogging test using dolomite dust. Such mechanical filter respirators protect against the inhalation of particulates such as dust particles, droplets, and aerosols.

United States responses to the COVID-19 pandemic Actions by the United States regarding the COVID-19 pandemic

The United States' response to the COVID-19 pandemic with consists of various measures by the medical community; the federal, state, and local governments; the military; and the private sector. The public response has been highly polarized, with partisan divides being observed and a number of concurrent protests and unrest complicating the response.

Medical textiles Textiles for medical and healthcare use

Medical textiles are various fiber-based materials intended for medical purposes. Medical textile is a sector of technical textiles that focuses on fiber-based products used in health care applications such as prevention, care, and hygiene. The spectrum of applications of medical textiles ranges from simple cotton bandages to advanced tissue engineering. Common examples of products made from medical textiles include dressings, implants, surgical sutures, certain medical devices, healthcare textiles, diapers, menstrual pads, wipes, and barrier fabrics.

References

  1. "Sequence for Putting On Personal Protective Equipment (PPE)" (PDF). CDC. Archived (PDF) from the original on 5 March 2020. Retrieved 8 March 2020.
  2. 1 2 "COVID-19: DIN makes standards for medical equipment available". DIN Deutsches Institut für Normung e. V. 2020-03-30.
  3. "Personal protective equipment for Ebola outbreak" (PDF). WHO. 31 October 2014.
  4. Health, Center for Devices and Radiological (2021-01-13). "Medical Gowns". FDA.
  5. 1 2 3 "Medical Gowns". U.S. Food and Drug Administration. 2020-03-11. Retrieved 2020-05-06.{{cite web}}: CS1 maint: url-status (link)
  6. Coccolini, F.; Perrone, G.; Chiarugi, M.; Di Marzo, F.; Ansaloni, L.; Scandroglio, I.; Marini, P.; Zago, M.; De Paolis, P.; Forfori, F.; Agresta, F.; Puzziello, A.; d'Ugo, D.; Bignami, E.; Bellini, V.; Vitali, P.; Petrini, F.; Pifferi, B.; Corradi, F.; Tarasconi, A.; Pattonieri, V.; Bonati, E.; Tritapepe, L.; Agnoletti, V.; Corbella, D.; Sartelli, M.; Catena, F. (2020). "Surgery in COVID-19 patients: Operational directives". World Journal of Emergency Surgery. 15 (1): 25. doi:10.1186/s13017-020-00307-2. PMC   7137852 . PMID   32264898.
  7. Pastorino, Boris; De Lamballerie, Xavier; Charrel, Rémi (2017). "Biosafety and Biosecurity in European Containment Level 3 Laboratories: Focus on French Recent Progress and Essential Requirements". Frontiers in Public Health. 5: 121. doi: 10.3389/fpubh.2017.00121 . PMC   5449436 . PMID   28620600.