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| THE MINISTRY OF HEALTH | SOCIALIST REPUBLIC OF VIETNAM |
| No. 1616/QD-BYT | Hanoi, April 08, 2020 |
THE MINISTER OF HEALTH
Pursuant to the Government’s Decree No.75/2017/ND-CP dated July 20, 2017 on functions, duties, powers and organizational structure of Ministry of Health;
Pursuant to the Prime Minister’s Decision No. 447/QD-TTg dated April 01, 2020 on COVID-19 epidemic declaration;
At the request of the Head of the Department of Medical Equipment and Health Works - Ministry of Health,
HEREBY DECIDES:
Article 1. Promulgated together with this Decision are the interim guidelines on technical requirements for COVID-19 personal protective equipment and classification and selection thereof.
Article 2. National Institute of Medical Device and Construction and other designated bodies shall formulate procedures for assessment and testing of COVID-19 personal protective equipment and organize such assessment and testing in accordance with the specifications stated in these guidelines.
Article 3. This Decision takes effect from the date on which it is signed.
Article 4. Head of Office of the Ministry of Health; Head of Department of Medical Equipment and Health Works, Chief Inspector of the Ministry of Health; heads of affiliates of the Ministry of Health; Head of National Institute of Medical Device and Construction, heads of relevant units and relevant individuals shall implement this Decision./.
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| P.P. THE MINISTER |
ON TECHNICAL REQUIREMENTS FOR COVID-19 PERSONAL PROTECTIVE EQUIPMENT AND CLASSIFICATION AND SELECTION THEREOF
(Enclosed with Decision No. …../QD-BYT dated …/.../2020 by Minister of Health)
COVID-19 personal protective equipment (hereinafter referred to as “COVID-19 PPE”) is a type of personal protective equipment (PPE) that protects health care workers against the risk of infection when they come into contact with blood, bodily fluids and droplets containing infectious agents from patients. PPE can also protect patients against residential and transient microorganisms from health care workers and the hospital environment or limit the spread of pathogens to the environment. Use of PPE when caring for confirmed or suspected COVID-19 cases is one important precaution against transmission for health care workers.
Many safety organizations around the world have published guidelines for use of PPE in healthcare settings. These documents are formulated based on the ANSI/AAMI PB 70:2012 standard for liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities from the American National Standards Institute (ANSI) and Association for the Advancement of Medical Instrumentation (AAMI). For products of other standards, acceptable equivalents to levels of barrier performance from other common international standards are provided for in Table 3.
PPE is elaborated in Decision No. 468/QD-BYT dated February 19, 2020 by the Minister of Health on guidelines for infection prevention and control for COVID-19 acute respiratory disease in healthcare establishments. COVID-19 PPE is a type of PPE that protects all skin surfaces of the user against COVID-19.
These guidelines aim to provide guidelines on (1) technical standards for COVID-19 PPE; (2) classification of COVID-19 PPE; and (3) selection of COVID-19 for professional operations. These guidelines may be amended as more data becomes available.
COVID-19 PPE manufacturers and providers shall follow these guidelines when assessing and classifying levels of protection and labeling. Such assessment and classification of levels of protection and labeling must be carried out by sufficiently competent units designated by the Ministry of Health or possessing documentary proof of their capabilities to meet the technical criteria stated herein that are valid according to regulations.
COVID-19 PPE using units shall choose the type of PPE suitable for their professional operations based on these guidelines.
These guidelines are formulated based on the following common standards:
- ANSI AAMI PB 70:2012. Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
- ISO 22609. Clothing for protection against infectious agents - Medical face masks - Test method for resistance against penetration by synthetic blood.
- ASTM F1670 / F1671 M-13. Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System.
- EN 14126. Protective clothing - Performance requirements and tests methods for protective clothing against infective agents.
- AAMI TIR 11:2005. Selection and use of protective apparel and surgical drapes in health care facilities.
- BS EN 13795-3:2019. Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment – Performance requirements and performance levels.
- TCVN 6343-1:2007 and 6343-2:2007. Single-use medical examination gloves.
- EN 166/2002. Personal eye protection - Specifications.
- WHO list of Personal Protective Equipment for Infection and Prevention Control.
- TCVN 8389-1:2010. Normal medical face mask.
- TCVN 8389-2:2010: Medical face mask preventing bacteria.
- EN 149 : 2001 + A1: 2009 FFP2 NR D; NIOSH-42C FR84.
- EN 14683 : 2019. Medical face masks - Requirements and test methods.
- EN ISO 11737-1.
- Decision No. 468/QD-BYT dated February 19, 2020 on guidelines for infection prevention and control for COVID-19 acute respiratory disease in healthcare establishments.
These guidelines are applicable to COVID-19 PPE.
These guidelines are not applicable to surgical apparel, drapes or other types of PPE.
COVID-19 PPE is a type of PPE used in COVID-19 prevention and control. Its main components consist of one-piece or separate head cover and protective clothing, and protective gear (shoe covers, safety goggles and/or face shields, masks and medical gloves) capable of protecting all skin surfaces of the user against the risk of infection upon contact with blood, bodily fluids and droplets containing pathogens from patients or potential carriers.
5.1. General provisions
- One-piece or separate head cover and protective clothing, and shoe covers must be made of non-woven and non-absorbent fabrics capable of protecting against microorganisms in bodily fluids and classified according to Section 5.2, be easy to use and airy, and not cause great discomfort or any allergic reaction for the user. The head cover must fit the user’s face and leave the eyes uncovered to prevent obstructing the user’s view. The surface must be clean, have tight seams and have no loose thread or visible defect.
- Protective gear[1] must comply with the standards provided for from Section 5.2.3 to Section 5.2.6 of this document.
5.2. COVID-19 personal protective equipment
5.2.1. Components: one-piece or separate head cover and protective clothing, and protective gear (shoe covers, safety goggles or/and face shields and medical masks and gloves).
5.2.2. Technical requirements for one-piece or separate head cover and protective clothing
5.2.2.1. Design and size: based on body height/weight.
5.2.2.2. Bioburden (according to EN ISO 11737-1):
One-piece or separate head cover and protective clothing + shoe covers and protective gear used in sterile areas (according to professional requirements) must be sterilized and have a bioburden of ≤ 30 cfu/g.
5.2.2.3. Barrier performance requirements
Table 1 summarizes the 4 levels of barrier performance for one-piece or separate head cover and protective clothing + shoe covers.
Table 1. Levels of barrier performance[2]
| Level of barrier performance | Test | Result | AQL[3] (Alpha=0.5) | RQL[4] (Beta=0.10) |
| Level 1 | AATCC 42 | ≤ 4.5 g | 4% | 20% |
| Level 2 | AATCC 42 AATCC 127 | ≤ 1.0 g ≥ 20 cm | 4% 4% | 20% 20% |
| Level 3 | AATCC 42 AATCC 127 | ≤ 1.0 g ≥ 50 cm | 4% 4% | 20% 20% |
| Level 4 | ASTM F1671 | Pass | 4% | 20% |
5.2.3. Technical requirements for face shields
- Material: disposable or reusable clear and flexible plastic that can be cleaned or disinfected.
- Visual field: capable of preventing fogging and providing sufficient visibility for users.
- Size: cover both ears and extend below the chin.
5.2.4. Technical requirements for medical gloves: meet TCVN 6343-1:2007 and 6343-2:2007 standards for single-use medical examination gloves.
5.2.5. Technical requirements for safety goggles: meeting EN 166/2002 or ANSI Z87 or TCVN 5039:1990 standard.
- Material: the frame shall be made of flexible PVC that does not cause any allergic reaction to the face; the glasses must be transparent and not cause visual distortion. The reusable or disposable goggles must be cleanable and disinfectable.
- Visual field: capable of preventing fogging and providing sufficient visibility for both health care workers and patients.
- Size: fit the face.
5.2.6. Technical requirements for masks
- Respirator masks must meet the EN 149:2001 + A1: 2009 FFP2 NR D and EN 14683:2019 type I, II or IIR, NIOSH-42C FR84 standards (e.g. masks meeting the N95 or FFP2 standard or equivalent).
- Medical masks must meet the TCVN 8389-1:2010 or TCVN 8389-2:2010 standard.
- Anti-droplet and antibacterial cloth masks must meet the requirements stated in Decision No. 870/QD-BYT dated March 12, 2020 by the Ministry of Health.
6. Classification of COVID-19 personal protective equipment
Table 2 provides for the 4 levels of protection of COVID-19 PPE, which are determined based on the level of barrier performance of the one-piece or separate protective clothing and head cover and sorted from lowest to highest.
Table 2. Levels of protection of COVID-19 personal protective equipment
| Level of protection of COVID-19 personal protective equipment | Area A (front side) Level of barrier performance according to Table 1 | Area B (sleeves) Level of barrier performance according to Table 1 | Area C (back side) Level of barrier performance according to Table 1 |
| Level 1 | Level 1, 2, 3 or 4 | Level 1, 2, 3 or 4 | Level 1 |
| Level 1, 2, 3 or 4 | Level 1 | Level 1, 2, 3 or 4 | |
| Level 1 | Level 1, 2, 3 or 4 | Level 1, 2, 3 or 4 | |
| Level 2 | Level 1, 2, 3 or 4 | Level 2, 3 or 4 | Level 2 |
| Level 1, 2, 3 or 4 | Level 2 | Level 2, 3 or 4 | |
| Level 2 | Level 2, 3 or 4 | Level 2, 3 or 4 | |
| Level 3 | Level 3 or 4 | Level 3 or 4 | Level 3 |
| Level 3 or 4 | Level 3 | Level 3 or 4 | |
| Level 3 | Level 3 or 4 | Level 3 or 4 | |
| Level 4 | Level 4 | Level 4 | Level 4 |
Table 3 describes the acceptable equivalents to the levels of barrier performance stated in these guidelines from other common international standards.
Table 3. Acceptable equivalents to levels of barrier performance from other common international standards
| Barrier performance | EN 14126 standard (Section 4.1.4.1) |
| Level 1 | Level 1 |
| Level 2 | Level 2; Level 3 |
| Level 3 | Level 4; Level 5 |
| Level 4[5] | Level 6 |
7. Required components of COVID-19 personal protective equipment
COVID-19 PPE must be used in a manner that protects all skin surfaces of the user against the risk of infection upon contact with blood, bodily fluids and droplets containing pathogens from patients or potential carriers. Table 4 describes the components that are required for each level of COVID-19 PPE.
Table 4. Required components of COVID-19 personal protective equipment
|
| Level 1 COVID-19 personal protective equipment | Level 2 COVID-19 personal protective equipment | Level 3 COVID-19 personal protective equipment | Level 4 COVID-19 personal protective equipment |
| Head cover and clothing | + | + | + | + |
| Safety goggles | + | +/- | None | None |
| Face shield | None | +/-* | + | + |
| Medical gloves | + | + | + | + |
| Shoe covers | +/- | + | + | + |
| Masks | Masks meeting the requirements stated in Decision No. 870/QD-BYT or higher standards | Medical masks of TCVN 8389-1:2010 or 8389-2:2010 standard | Masks of N95, FFP2 or EN 14683 standard Type I,II,IIR or equivalent | Masks of N95, FFP2 or EN 14683 standard Type I,II,IIR or equivalent |
Note:
+ : Required.
- : Not required.
+/- : Might or might not require.
.* : If used, safety goggles are not required.
Note:
a) One-piece head cover and clothing are required for levels 3 and 4 COVID-19 PPE. Shoe covers are not required for level 1 COVID-19 PPE.
b) PPE-using units may decide to use alternatives to medical masks in case of shortage of masks of N95/FFP2 standard or equivalent.
8. Guidelines on selection and use of COVID-19 personal protective equipment
Table 5 provides recommendations on selection of COVID-19 PPE.
Table 5. Selection and use of COVID-19 personal protective equipment by location, user and professional operation
| Location | User | Professional operation | Level of COVID-19 personal protective equipment |
| 8.1. In healthcare establishments | |||
| Screening rooms | Health care workers | Consultation with and physical examination of patients with no respiratory symptoms | Level 3 or higher |
| Health care workers | Consultation with and physical examination of patients with respiratory symptoms | Level 4 | |
| Cleaning staff | After and during consultations and physical examination of patients with respiratory symptoms | Level 3 or higher | |
| Health care workers | Preliminary screening with no direct contact | Level 2 | |
| Emergency departments receiving patients with undetermined COVID-19 transmission risks | Health care workers | Procedures potentially capable of generating aerosols or surgeries | Level 4 |
| Health care workers | All activities | Level 3 | |
| Isolation areas | Health care workers | Direct patient care without aerosol generation | Level 3 or higher |
| Procedures potentially capable of generating aerosols or surgeries | Level 4 | ||
| Cleaning staff | Entering patient rooms | Level 3 or higher | |
| Laboratories testing samples of confirmed or suspected COVID-19 cases | Health care workers | All activities | Level 4 |
| Transport of COVID-19 cases | All staff, including health care workers | All activities | Level 3 or higher |
| Other areas with patient presence in the isolation area | All staff, including health care workers | Any activity without contact with patients | Level 3 |
| Departments of infection control | Handlers of waste in hospitals | Collection and handling of waste in hospitals | Level 3 or higher |
| Morgues | All staff, including health care workers | All activities | Level 4 |
| 8.2. In communities | |||
| Houses of patients with respiratory diseases | Health care workers | Direct assistance or care for patients with respiratory diseases at home | Level 2 |
| 8.3. Ports of entry | |||
| Administrative areas | All staff | All activities | Level 1-2 (upon close contact) |
| Screening areas | Staff | First round of screening (taking temperature) with no direct contact | Level 1-2 |
| Staff | Second round of screening (interviewing passengers with respiratory symptoms or coming from infected areas). | Level 2 | |
| Cleaning staff | Cleaning of areas where patients with fever are being screened | Level 2 | |
| Temporary isolation areas (in ports of entry) | Staff | Entering the isolation area but not providing direct assistance | Level 2 |
| Staff and health care workers | Assisting passengers being transported to healthcare establishments | Level 2 | |
| Cleaning staff | Cleaning of isolation areas | Level 2 | |
| Ambulances or shuttle buses | Health care workers | Transport of suspected cases to healthcare establishments | Level 3 |
| Drivers | Only driving suspected cases and the driver compartment is separated from the patient compartment | Level 2 | |
| Assisting suspected cases with entering or exiting the vehicle | Level 3 | ||
|
| Cleaning staff | Cleaning after and during transport of suspected cases to healthcare establishments | Level 2 |
| 8.4. In quarantine zones | |||
| Guard booths | Police, military forces, militia and self-defense forces and health care workers | Outdoor security | Level 1-2 (upon close contact) |
| Vehicle disinfection points | Health care workers and armed forces | Vehicle disinfection | Level 1-2 |
| Areas for reception of quarantined persons | Health care workers | Initial health check and classification of quarantined persons upon reception | Level 2 |
| Temporary quarantine rooms | Health care workers | Monitoring health of persons with symptoms suspicious of COVID-19 | Level 2 |
| 8.5. Quick response teams | |||
| Anywhere | Quick response team members | All activities with close or direct contact with suspected or confirmed cases | Level 3 or higher |
| 8.6. Sample collecting areas and sample preservation and transport outside of healthcare establishments | |||
| Mobile sampling units | Technicians and health care workers | Respiratory specimen collection | Level 4 |
| Technicians and health care workers | Sample preservation and transport | Level 2 | |
| Sample collecting and processing rooms in other healthcare facilities (CDCs, research institutes, etc.) | Technicians, health care workers | Collection of respiratory specimens and testing of samples of confirmed or suspected cases | Level 4 |
9.1. Packaging
Based on the manufacturer’s packaging specification, PPE used in operating rooms or other locations requiring PPE use (according to professional indications) must be packaged in a sterile manner[6].
9.2. Labeling
- Products shall be labeled according to the Government's Decree No. 43/2017 dated April 14, 2017 on goods labels.
- Manufacturers must specify the following information on the main (or sub) labels of their products:
a. Applicable standard(s).
b. Level of protection (according to Table 2)
c. Size based on body height or manufacturer's size (e.g. S,M,L,XL, etc.)
d. The “biohazard prevention” symbol
[1] Safety goggles, face shields, masks, medical gloves and shoe covers.
[2] Reference classification of barrier performance in the ANSI AAMI PB 70:2012 standard.
[3] AQL: acceptable quality level
[4] RQL: rejectable quality level.
[5] Classified as level 4 if passes the ASTM - F1671 penetration of Phi-X174 bacteriophage test.
[6] If any component required by Table 4 is missing from the packages provided by the manufacturer, the PPE-using unit shall supplement such component to ensure protection of the users.
- 1Decision No. 447/QD-TTg dated April 01, 2020 on Declaration of COVID-19 epidemic
- 2Decision No. 870/QD-BYT dated March 12, 2020 on Temporary technical guidelines for fabric anti-droplet and bacteria prevention facemasks
- 3Decision No. 468/QD-BYT dated February 19, 2020 on guidelines for infection prevention and control for COVID-19 acute respiratory disease in healthcare establishments
- 4Decree No. 75/2017/ND-CP dated June 20, 2017, defining functions, tasks, powers and organizational structure of Ministry of Health
- 5Decree No. 43/2017/ND-CP dated April 14th, 2017, on good labels
Decision No. 1616/QD-BYT dated April 08, 2020 on interim guidelines on technical requirements for COVID-19 personal protective equipment and classification and selection thereof
- Số hiệu: 1616/QD-BYT
- Loại văn bản: Quyết định
- Ngày ban hành: 08/04/2020
- Nơi ban hành: Bộ Y tế
- Người ký: Trương Quốc Cường
- Ngày công báo: Đang cập nhật
- Số công báo: Dữ liệu đang cập nhật
- Ngày hiệu lực: 08/04/2020
- Tình trạng hiệu lực: Kiểm tra