PPE Kits (Approval and Export)

Introduction

Personal protective equipment, hand hygiene, and waste management materials are some of the measures that are adopted during infection prevention. Personal protective equipment is the set of garments that acts as a shield by protecting the health care workers or any other person from getting infected. PPE kit consists of gloves, masks, and gowns, and in case of high airborne infection, it includes goggles, faces shield, head-cover and rubber boots as well. The purpose of obtaining PPE kit certification is to manufacture PPE equipment. These PPE Kits act as a barrier between the healthcare worker and infectious agents or body fluids. Therefore, it reduces the risk of COVID-19 spread.

PPE industries deal with complexity, competitiveness and challenges, which ultimately lead to an improvement in the quality of personal protective equipment. Also dealing with problems helps the industry in improving margins, quality and reduce the cost of production.

PPE Kit Certification during COVID-19

Lately, the Union Ministry of Textile, India has come out with a certain set of guidelines that are essential for Personal Protective Equipment test centres and manufacturing units to adhere to. Instances have been recorded where manufacturers were caught selling PPEs to the private hospitals that nearly failed the quality tests at the test centres.

Current pandemic COVID-19 has forced the Ministry of Health & Family Welfare, Government of India, to formulate strict guidelines regarding the manufacturing and testing process of PPE related to which the ministry has already published comprehensive guidelines. Though, the Ministry of Textile has happened to issue a notice about the guidelines that are to be followed with immediate effect that will guarantee the refinement in the quality of Personal Protective Equipment Body Coveralls.

The notification states that officially there are only two recognized laboratories responsible for carrying out the test on Body Coveralls (PPE) in India, South India Textile Research Association (SITRA), Coimbatore and Defence Research & Development Establishment (DRDE), Gwalior.

Guidelines cover strict rules to be adhered to by the testing centres and manufacturing units, such as, generating a Unique Certification Code (UCC-COVID-19) for each proto-type test conducted at SITRA/DRDE, manufacturing of PPE garment in accordance with material and quality according to the tested and certified prototype, putting up tamper-proof stickers which include Name of Manufacturer, SITRA/DRDE Unique Identification Code, Test Standard, Date of Manufacturing and Batch.

Testing and Certification of Samples of PPE Body Coverall for Covid-19, by INMAS

Government of India has assigned Institute of Nuclear Medicine & Allied Sciences (INMAS) the responsibility to test the Personal Protective Equipment (PPE) Body Coverall Samples for COVID-19, submitted by the potential manufacturers in India ss per the guidelines vide letter F.No. 8/4/2020-R&D dated 22nd April, 2020 issued by the Ministry of Textiles, Government of India. A Synthetic Blood Penetration Resistance Test is conducted, and the INMAS presents test reports.

Benefits of Personal Protective Equipment

Cleaning and hygiene play an important role in protecting you from life-threatening viruses and reliable disinfectant cleaners. Investing in PPE kit can deliver numerous benefits to you and your staff, and one should not take PPE Kit Certification for granted. The major motive is to keep the employees or other working staff safe by reducing their risk of getting infected. Below are some benefits of the PPE Kits.

  • Prevention From Exposure

In layman’s terms, prevention from exposure means protecting your employees from harmful bacteria so that they will not get sick. It is the responsibility of the employer to make sure that his employees are secured and protected after performing their duties.

  • Minimize The Level Of Risk

In case of disclosure to any harmful bacteria or germs, the PPE kits will help in minimizing the level of risk and potentially saving the employee’s life.

  • Protects The Spread Of Germs

PPE kit acts as a lifesaver by averting the growth of germs and bacteria from one individual to another. For example, often, the dentist wears headgear during the process of treatment to protect themselves from getting infected from bacteria.

Points to Remember While Using PPE
  • PPEs do not serve as an alternative to preventive public health measures. Etiquettes such as hand hygiene, proper cleaning should be followed adequately.
  • Try to follow social distancing by maintaining a distance of at least 1 metre from people around you and suspects as well.
  • Try to adhere to the protocol laid down for getting rid of PPEs as detailed in the infection prevention and control guideline available on the website of MOHFW.
Personal Protection Equipment (PPE) – Specification

Gloves

  • Nitrile
  • Non-sterile
  • Powder-free
  • Outer gloves preferably reach mid-forearm (minimum 280 mm total length)
  • Different sizes

Coverall (Medium and Large)

  • Impermeable to blood and body fluids
  • Single use
  • Avoid colors such as black
  • Go for light colors as they help better in detecting possible contamination
  • Thumb/finger loops to anchor sleeves in place
  • Quality complaint related to the following standards
  • Meets or exceeds ISO 16603 class 3 exposure pressure or equivalent

Goggles

  • Well fit transparent glasses with zero power plus covered from all sides with adjustable holders
  • Flexible frame that fits easily to all face contour without much of a pressure
  • Cover eyes and the surrounding areas
  • Fog resistant
  • Scratch-resistant
  • An adjustable band which do not loose while performing the clinical activity
  • Indirect venting which helps in reducing fogging
  • Re-usable or disposable
  • Quality complaint with the below standards or equivalent:
  • EU standard directive 86/686/EEC, EN 166/2002
  • ANSI/SEA Z87.1-2010

N-95 Masks

  • Shape that will not subside simply
  • High filtration efficiency
  • Breathability is efficient with expiratory valve
  • Quality complaint with standards for medical N95 respirator:
  • NIOSH N95, EN 149FFP2, or equivalent
  • Fluid resistance: minimum 80mmHg pressure based on ASTM F1862, ISO 22609, or equivalent
  • Quality complaint related to standards to particulate respirator that can be worn with full-face shield.

Shoe Covers

  • Made up of the same fabric as of coverall
  • Should cover the entire shoe and reach above ankles

Face Shield

  • Made out of clear plastic and provides good visibility to both the wearer and patient
  • Advertisement
  • Adjustable band to attach firmly around the head and fit snugly against the forehead
  • Fog resistant
  • Completely covers the sides and length of the face
  • Re-usable or disposable
  • Quality complaint with the below standards or equivalent:
  • EU standard directive 86/686/EEC, EN 166/2002
  • ANSI/SEA Z87.1-2010
Approvals and Licenses of PPE kits

Requirements of CE Marking

Normally, the manufacture is under an obligation to assure conformity with all the prescribed requirements. The term “requirements” means that the PPE Kits must meet EU Directives. However, a manufacturer does not need to comply with EU Directives if it has obtained CE Marking. In India, the requirements for obtaining CE Marking are as follows:

  • The manufacturer must have a complete understanding concerning EU requirement for the PPE product;
  • The manufacturer must verify that the products are being produced as per the norms of relevant EU requirements;
  • All the products must be tested and checked by a Notified Body;
  • Examine all the PPE products;
  • The manufacturer must check that all the products have successfully fulfilled the technical requirement;
  • The manufacturer must affix the CE marking on the PPE Product;
  • The manufacturer must sign an EU (European Union) declaration of conformity.
Validity Period of CE Certification

A CE Certification remains valid for a period of three years. This certificate is issued by the Notified Bodies. However, the validity period is one year for the devices having high risk. The status of CE Marking depends on the quality system certification.

GMP Certification

GMP (Goods Manufacturing Practises) certification deals with the manufacturing of natural and pharmaceutical products manufacturing. These guidelines are made to make sure that the products are safe to use and comply with quality standards. Further, GMP Certification includes production aspects, initial material, equipment, premises, etc. Moreover, these guidelines also deal with safety, health, and hygiene maintenance. The first step of obtaining this certification is to complete an application process. An authorized person is responsible to file an application for GMP certification inside the company seeking the certification. GMP certificate will issued in the name of the registered company and will remain valid till three years. This certificate will reflect the scope of certification along with the name and the address of the manufacturing place of the company.

Principles of GMP Certification

The principles of GMP Certification can be summarised as:

  • The Manufacturing processes must be clearly defined and controlled;
  • Any changes concerning the manufacturing processes must go under examination and evaluation;
  • The procedures and instructions of manufacturing must be free from uncertainty and ambiguity;
  • The operators must have received the training in a prescribed way, i.e., a way in which they are able to carry out document procedures.

FDA Certification

The Food and Drug Administration plays an important role in curbing the infectious deadly diseases. The Food and Drug Administration is setting its sights to provide time to time direction to give wings to the response efforts to this Pandemic. With the issue of this guidance, the FDA is providing a policy to make the general use face masks available to the general public and respirators for health care professionals.

This policy will remain in action only during the time of public health emergency related to COVID-19 as proclaimed by the Health and Human Services Department (HHS Department).

FDA Approval for Medical Devices

FDA is known for regulating a wide array of products like a drug, food, cosmetics as well as medical devices. There are many set standards of FDA on which it measures the quality of products. The requirements vary from one product category to another. Very often, class 1 and class 2 medical devices do not need approval by the Food and Drug Administration. Class 3 medical devices must have FDA approval for the marketing of products. Class 2 medical devices demand a marketing clearance from the FDA side. FDA registration and device listing are mandatory for all medical device establishments.

IMA Approval

Indian Medical Association remains in touch with the National Medical Associations of different countries to share relevant information and spread awareness about the best practices to be adopted at the Indian and International level. Approval of the Indian Medical Association plays an important role, especially in the time of grave medical emergency. Their stamp of approval works for the benefit of the products, and it’s a sign that the products are healthy since they are approved by IMA.

Export of PPE Kits

All other items that are part of PPE kits continue to remain prohibited partially relaxing export norms, the Central Government on 29th June 2020 permitted shipments of Personal Protection Equipment (PPE) medical coveralls for COVID-19 with a monthly export quota of 50 lakh units. The product was banned for export earlier, but it has now been moved to the restricted category.

In a notification, the Directorate General of Foreign Trade (DGFT) said: “A monthly quota of 50 lakh PPE medical coverall for COVID-19 units has been fixed for issuance of an export licence to the eligible applicants to export PPE medical coveralls for COVID-19 as per the criteria to be separately issued in a trade notice“.

According to an update on 10th July 2020, India was declared as the 2nd largest manufacturer of PPE kits in the global markets.

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Also Read: The Tale of Rise in Cases of Domestic Violence in India amid Covid-19

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