There are many types of masks used for medical purposes, but they all have some common features. In this article, we will look for answers to the questions of how to understand the quality of medical masks, what should we pay attention to when buying medical masks.

Source: medline

This article, which we prepared with reference to the medical mask, includes surgical mask, N95, KN95 and 3M mask models and types. It is possible for you to evaluate in a similar way. We discussed 4 items how to understand the quality of medical masks and what you should pay attention to.

1. Things to pay attention to in mask boxes

Before we get to the things you need to pay attention to in mask boxes, let’s explain the term “Non-sterile Product” that most sellers hesitate to write on the mask boxes. Let’s start by answering how to get a sterile mask. In this long process from the manufacturing of the mask fabric material to the production of the masks and the packaging stage, the ground is prepared for the formation of a microbial environment on the masks. Many factors such as the bad ventilation conditions of the environment where masks are produced, the operators do not use gloves and masks, employing personnel who are not aware of GMP (good manufacturing practices), and packaging without using gloves and masks if packaging by hand, affect the sterility of the production. In fact, the production of sterile and non-sterile masks is the same, but before entering the packaging, the masks are disinfected by various methods. The most preferred methods are sterilization gas (such as ethylene oxide) and microorganisms under UV light to be purified at the maximum level and packaging in a sealed manner.

Since the term non-sterile often creates a negative perception in the user, vendors prefer not to write this statement. Most of the products sold in the market are non-sterile masks. Generally packaged in 50 pieces, stacked in boxes and open masks can be given as an example. Since the sterile products are used in operating theaters, they come in single packs, specially sealed. So are non-sterile masks unsafe? It is impossible to answer this directly, but choosing companies that are audited by independent firms and certified by accredited institutions will give more confidence. In order to have an idea about this, we will talk about the concept of accreditation in the following sections. At least, it is obvious that we need to keep companies that have grasped the seriousness of the business and made the necessary investments in this direction.

Now let’s get to the factors that we need to pay attention to in the mask boxes. In our previous article, we mentioned that there may be types of masks with or without meltblown in the market. Most of the mask boxes sold do not contain information about the mask fabric. How much weight (gram / m2) fabrics were used and we cannot see the information about the filter ratios that we will explain in item 3. Of course, this situation greatly affects the price of the mask sold. In addition to the cost difference between the Meltblown mask and the masks with all layers of spunbond, the production prices can be drastically reduced by choosing a very light fabric weight. In this case, we have to doubt whether products with less fabric weight than they should have been used and without a filter layer actually meet the statements on the box. Be sure to request detailed information about the product from the manufacturers, want to see the test reports and examine the products yourself, taking into account the steps we will mention below.

In order for companies that manufacture medical masks to create a Product Tracking System (UTS) record and continue their legal production, There are some required certificates. Basically, the documents they need to get are ISO 9001, ISO 13485 and the EC Declaration of Conformity. Companies can also obtain certificates such as GMP, ISO 31000, ISO 14001 externally if they wish. Of course, as with any product, it is required to have a CE certificate. But is it enough for us to have these documents? What does it really mean to have these documents? Before answering these questions, we will examine the concepts of declaration and accreditation in the certificates.In fact, with the EC declaration of conformity, the manufacturer declares that he produces by meeting the required standards. However, we need an independent system to confirm that it has actually fulfilled and implemented this statement. In this case, manufacturers are required to have CE tests (EN 14683, etc.) performed by accredited laboratories to certify that their products meet the required standards. Similarly, ISO certificates are issued by certification bodies with declaration or accreditation. Of course, this certification agencies also still is accredited by a national or international independent organizations.

TURKAK the accreditation body (Turkey), IAS (America), UKAS (United Kingdom) or DAkkS (Germany) can give you an example. There is a price difference between accredited certificates and non-accredited certificates. In addition, there is a price difference according to the accreditation bodies. According to my researches, the institution I found safest was TÜRKAK. I can say that TÜRKAK inspections are applied seriously. We see that most mask manufacturers with accredited certificates have IAS accreditation. I can say that it is easier and even cheaper to obtain the certificates of foreign accreditation institutions.

The important thing to be aware of here is whether the company really has a CE certificate. They may write this on the mask box but may not actually have this document and tests. Another important issue is whether the certificates and tests are accredited. Having these documents, of course, does not mean that everything is “very good”, but we should also keep the companies that invest and show this care apart.

2. How to check certificate and test reports

We mentioned that medical masks should be tested by accredited organizations. In this section, we will talk about how to check whether the tests performed really give the results we want and whether they are made according to the required standards. The test for medical face masks is evaluated according to the EN 14683 standard. You can think of this standard as a check-up package. Just as your doctor asks you to have a series of tests to make a diagnosis, similar procedures are required to determine whether the masks meet the required standards. However, what if you ask your doctor to take the tests you find expensive by talking to your doctor? In this case, it will be difficult to make a definitive diagnosis, right? Similarly, companies whose masks do not pass the test can only have the tests they provide to show that they have passed. In fact, this situation has ceased to be a test in accordance with the standards, it has obtained an optional test appearance. It is important that you examine the documents precisely in this matter.

EN 14683 Microbiological Test Report Sample

The example above has been prepared according to the EN 14683 standard and we see this clearly in the report and also shows us in summary which tests performed are successful. As we will explain in Article 3, 3 of the 4 tests to be done were applied and it was documented that it was a Type II mask by passing through 2 of them. Now let’s check the values ​​of the tests applied in this report.

Differential Pressure Test Example

In the above test process, the average result was obtained as 44.4 Pa / cm2, but the desired value should be below 40 Pa / cm2, so the mask remained from this test.

Bacteria Filtering Efficiency Test Example

In the above test process, bacteria meet the type I, type II and type IIR standards as the filtration efficiency is over 98%. We have seen that many of the tests performed meet some and not others. So what is the final result of the test? We will talk about the tests that must pass in item 3. You can evaluate the masks you bought according to this scale. We have seen that the most important factor determining the mask quality and protection for the end user is the results of these reports.

Cytotoxicity Test

Also, let’s note that the method applied in the report is within the scope of accreditation.Knowing such details are factors that help us better understand the quality of the mask. It is useful to know what kind of mask you want as an end user.

Finally, let’s talk about the fabric weights that a mask should have. It is preferred that the outer and inner layers of the mask are between 15 and 25 g / m2 (usually spunbond fabric) and in the middle layer (filter) between 25 and 35 g / m2 (usually meltblown fabric) [1].

3. Classification of masks according to the degree of protection

We mentioned that mask manufacturers must pass their products through certain tests and obtain a certificate of conformity. There are classifications showing the degree of protection of the masks. companies engaged in the production mask according to European norms in Turkey, type I, type II and to categorize their products in 3 categories, including type II travelers. While the mask we can use in daily life is type I, the surgical masks used by doctors during surgery are type IIR.

Surgical Mask Standards According to European Norms [1] Many countries develop different standards to meet their own needs. USA also has its own standards, close to European norms. Similarly, it has created a standard to meet the needs of its own country in China. In addition to infectious diseases, air pollution in China is a big problem, so it can include different tests or do not consider it necessary.

Surgical Mask Standards According to American Norms [1] It is important to know that it does not meet. It should be decided according to which standards will be exported.

Comparison of European and American Norms

As a result, when you supply masks, ask what standard you buy. Most of the medical mask boxes do not indicate which class the product belongs to, so you should ask the manufacturer to show the test results.

4. How to query the mask supplier from the UTS System

In order for the masks to be legally sold, they must be registered with the Product Tracking System (ÜTS) and have a barcode for each model. It is possible to inquire from the system whether it is an imported product or a mask manufacturer. You can inquire about the list of registered companies at utsuygulama.saglik.gov.tr ​​from the list medical devices step. For disposable masks, you can list all registered companies by entering the GMDN code 35177. If you cannot see any barcodes on the mask box, you should be suspicious. You will probably not find the company record when you search from the site.

Example Use to Find Companies from the ÜTS System

As you can see in the system, there may be a lot of different models belonging to the same company. Different barcodes for each product have been introduced into the system. When you click on the barcode, you will see detailed information about the product. Product tag, image, origin etc. You can access information. You can see if the barcode here and the barcode on the box match. By comparing the product image with the image you have bought, you can see if it is the right product.

Source

[1] Cemal KIRMAN, “General Information of the Covid 19 Crisis Period”, April 2020, TMMOB Chamber of Textile Engineers Presentation

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