Disposable, Medical Masks: Regulation & Testing
Updated: Jul 27, 2021
Procurement professionals have worked tirelessly over the past few months to provide vital PPE to their organisations in some of the most challenging situations of their careers.
This guide is written to help those departments navigate the complexities of regulatory and testing issues relating to disposable, medical masks.
DEFINITIONS OF MEDICAL MASKS
Disposable, medical masks are referred to by various different names across the world.
In Europe, they are known as Type IIR masks.
In Australia & New Zealand, they are known as Level 2 masks.
In the US & Canada, they are known as ASTM 2 masks.
The Paragon medical mask meets the requirements set out in the 3 regions specified above. In order to meet these standards, there is a rigorous set of testing to which the product must be subjected.
Bioburden testing takes a product which is packaged for delivery, and tests the level of cleanliness of the product, by testing it for the presence of pathogens, dust, dirt and bacteria.
The product is placed in a sterile bag with a solvent which removes any bioburden. This solvent is then placed on a petri dish to enable cultures to be grown and counted.
In order to pass this test, the product must be made in an environment with a high level of cleanliness.
BACTERIA FILTRATION EFFICIENCY (BFE)
BFE Testing determines the effectiveness of the finished product to filter bacteria from the air.
The product is placed inside a vacuum column to act as a filter material. A set quantity of staphylococcus bacteria is then passed through this filter, and the bacteria which passes through the mask are collected in a vacuum at the other side.
This bacteria is then counted and calculated as a percentage of the total of the original contaminants.
In order to pass this test, the product must filter out greater than 98% of the bacteria.
DIFFERENTIAL PRESSURE TEST
In order to determine the physical attributes of the product, in a scenario where the user is strenuously exhaling or coughing, the product is subjected to a pressurised air test on opposing sides of the mask.
This test measures, to a high degree of accuracy, the properties of the mask to withstand high pressures.
In this type of mask, the outer layer is a hydrophobic material, meaning it is repellent to splashes of fluid.
This test determines the level of splash resistance.
FRAUD, MISREPRESENTATION & TRACEABILITY
There have been many reports of fraud, significant and dangerous quality issues and misrepresentation as regards to medical masks over the previous several months.
One major source of these problems relates to the meltblown inner layer which provides the filtration properties to the product. Non-medical grade filtration material is about 1/3 the price of a medical-grade material and, as this material is in short supply and in near infinite demand, corners have been cut in regard to the inclusion of this material in the mask.
It is very difficult to determine the difference between medical and non-medical grade filtration material to the naked eye. To be absolutely sure, one must perform the BFE test as outlined above, but it is impractical to conduct this testing on all masks delivered to a healthcare facility.
There have been reports of these lower level masks being re-branded and re-boxed into packaging which claims these are medical masks. This puts healthcare workers and patients in a very high risk situation.
The New York Times reported on the F.D.A decision to ban faulty masks. “Millions of these masks, produced in China, have been bought by or donated to American hospitals and distributed to others on the front line of the Covid-19 outbreak. Starting in mid-April, tests conducted by the Centers for Disease Control and Prevention revealed that some of the products did not meet medical standards for protection against the coronavirus.”1
Global supply lines involving a complex network of pop-up manufacturers who export via warehousing companies to regional importers in the target market who then resell onto local distributors leaves much opportunity for traceability, labelling and quality issues.
Certificates are supplied by accredited certification bodies to give an assurance of the quality of the masks that are subjected to said test. However, the only way to ensure that subsequent products are made to that same standard is to have robust, documented, audited and high-quality systems in place.
If you do not have the opportunity to personally inspect the supply chain, to audit and documented process, or do you have a short supply chain from manufacture to delivery, there is a large opportunity for fraud in the supply chain. A supplier could provide a certificate for authentication and approval, but could fulfil the order with any mask that may have little or no bearing to the original certificate.
To eliminate the risk of such fraud and counterfeiting, we manufacture 100% of our product and have a direct to end user relationship as far as possible. We contract directly with health systems, hospitals, and large healthcare organisations to ensure that the product leaves our accredited medical device factory and is delivered direct to the health care worker on the front line.
For medical devices there are strict labelling requirements. These are set out in their relevant standards in various regions around the world. These standards are referred to as:
EUROPE: Medical Device Regulation (MDR)
AUSTRALIA: Therapeutic Goods Administration (TGA)
NORTH AMERICA: Food & Drug Administration (FDA)
The quality of the labelling is an indicator of the depth of understanding that the manufacturer has about the requirements of medical devices manufacturing. Four example, in Europe all medical devices must have the following symbols:
Date of manufacture
The market is awash with examples of supposed medical masks which do not have these basic requirements fulfilled. If the supplier cannot get the labelling correct, how can they assure the quality of the product inside the box?
For information on Paragon Health visit www.paragonhealth.eu or contact us for a direct conversation regarding your needs for medical personal protective equipment.
Nicas, J., & Kaplan, S. (2020, May 07). F.D.A. Bans Faulty Masks, 3 Weeks After Failed Tests. Retrieved August 10, 2020, from https://www.nytimes.com/2020/05/07/health/masks-banned-n95-coronavirus.html