Quyết định 1616/QĐ-BYT năm 2020 hướng dẫn tạm thời về kỹ thuật, phân loại và lựa chọn bộ trang phục phòng, chống dịch Covid-19 do Bộ Y tế ban hành

DECISION

ON INTERIM GUIDELINES ON TECHNICAL REQUIREMENTS FOR COVID-19 PERSONAL PROTECTIVE EQUIPMENT AND CLASSIFICATION AND SELECTION THEREOF

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./.

INTERIM GUIDELINES

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)

1. General introduction

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.

2. References

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.

3. Scope

These guidelines are applicable to COVID-19 PPE.

These guidelines are not applicable to surgical apparel, drapes or other types of PPE.

4. Definition

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. Technical requirements

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.

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.

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

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

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

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

9. Packaging and labeling

9.1. Packaging

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

Safety goggles, face shields, masks, medical gloves and shoe covers.

Reference classification of barrier performance in the ANSI AAMI PB 70:2012 standard.

AQL: acceptable quality level

RQL: rejectable quality level.

Classified as level 4 if passes the ASTM - F1671 penetration of Phi-X174 bacteriophage test.

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.

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