Aktualisiert: 31. März 2020
As an apparel desiger it is important to deliver goods that meet needs. Currently medical workers are in need of PPE. Some things to be aware of in regards to PPE is the following
3. Safety concerns
So lets review the first need. Purpose. What makes a N95 mask any different than a surgical mask or a homemade cotton mask?
N95 RESPIRATOR MASK
These masks are ANTIVIRAL. A antiviral particle can be the size of 40-160 Nanometers. The size is just slightly bigger than human DNA. Meaning it is way smaller than even a tuberculosis germ. Virus particles are much more pesky and dangerous than the common cold. N95 masks need to clear various tests such as...
Filtration performanceASTM F2299, ASTM F2101—This test method measures the initial filtration efficiency of materials used in medical face masks by sampling representative volumes of the upstream and downstream latex aerosol concentrations in a controlled airflow chamber.
Fluid resistance (splash and spray)—Currently, FDA requires ASTM F1862—Standard Test Method for Resistance of Surgical Mask to Penetration by Synthetic Blood for validation of fluid resistance on surgical N95 respirators.
Flammability— 16 CFR 1632 Flammability testing and its applicability regarding all health care settings and in surgical settings as well as explore the current test method and alternative test methods that could be considered.
Biocompatibility and usability— Test methods that evaluate biocompatibility and usability, including is-sues of cytotoxicity, sensitization, and irritation. For example polypropylene is used vs. latex due to latex related allergies. ISO 10993-10:2010, ISO 10993-7:2008(R)2012. Abrassion resistance, pilling and etc are also required.
legal: Health Act (Public Law 91-173) and the Occupational Safety and Health Act of 1970 (Public Law 91-596). NIOSH’s charge is now detailed in Title 42, Part 84 of the CFR. CAL PROP 65, AND ETC.
These protect the wearer from aerosol contamination during various procedures used in the ICU. A person working with viruses for 12 hours a day 4-5 days a week is currently using the same mask. Many think that applying a cotton mask over the N95 will help, however cotton DOES NOT PROTECT AGAINST VIRUS PARTICLES.
All items must also have MSDS sheets and testing to ensure the safety requirement is met. If not met the patient and medical staff can be exposed to viruses unknowingly. The MAYO clinic uses 8 different respirator mask types from 3 different manufactruring companies to achieve proper mask fit. Also a part of the biocompatibility tests.
Respirators are particularly useful when concerned about airborne transmission of varicella, tuberculosis, influenza, or severe acute respiratory syndrome (SARS),COVID19, and are particularly useful when intubating a patient or performing a bronchoscopy, so the filtration performance of an N95 respirator is important in those settings. It can also stop Byssinosis that cotton masks can produce as they break down in laundering process. Byssinosisis a disease caused by contaminated fibers that stick to lung tissue and bronchial areas due to breathing in.
Elastomeric Respirators with P100 cartridgesN95
These are masks that can be reused over and over again. Often times we see these at the dentist or on CPAP machines. They are a bit more comfortable, but do require good cleaning before and after each use.
Elastomeric masks must also pass testing and meet the materials requirement set forth by the FDA, Osha, and etc.
Some will also come with airflow attachments when working in conditions that require regulated air.
Surgical masks are used in NON-VIRAL conditions. So if you think you are treating someone with the flu, SARS, Covid19, you would not want this as the mask of choice. It is a great mask for splashes, the common cold, and protecting others from our own sick germs. This is also great for allergy sufferers.
These masks offer about a 44% protection rate with virus transfer. The N95 offers a 97% protection rate. As you can see the differences for a person working with infectious disease would be learning the N95 over a surgical mask. The following tests are also required for safety and use in medical settings.
ASTM F1862 test method standard, which assess-es whether the synthetic blood penetrates into the layers of the mask.
ASTM F2100 as the consensus standard for performance specifications of the materials used in respirators and medical face masks.
Cotton masks have been made to counterbalance the shortage of mask supplies, or used as covers for N95 masks. It is important to note that surgery and medical procedure have been around for a relatively short time. Cotton was the chosen fabric used during the spanish flu of 1918. However doctors of the period requested 6 layers or more of fabric. Often doubling up. Wearing 12 layers. This was because the masks didn't do well in regards to virus germs. This was due to a few inherent qualities of cotton. They are as follows.
1. Absorbent material (hydrolipic) - Meaning splashes are absorbed and virus passes through. all other masks remain hydrophobic
2. Cotton is not a antimicrobial material. It can't protect the user from virus.
3. Fiber breakdown in use.: When textiles are spun and used we have small staple fibers that breakdown. The fibers create lint and even fiber dust. When a user must wear this everyday, they are being exposed to loose staple fibers that are contaminated with germs. These loose fibers can easily make their way up the nose or into bronchial. Byssinosisis a disease caused by contaminated fibers that stick to lung tissue and bronchial areas due to breathing in. Creating infection or spread of germs. This was one of the reasons for the development/ inventing of a disposable mask.
Any site selling these cotton masks should be able to produce tests to ensure it meets medical standards. Otherwise a disclaimer must be posted outlining the fact that the item is a fashion mask and doesn't help users avoid a viral transmission of germs.
Some medical professionals have forgotten education around the requirements. This why we see some lack of knowledge in medical circles. Thats okay, they are not designers of these goods. They are the people that take care of everyone else and can't be replaced. Lets ensure they get the safest goods possible.
List of needs: Physical donations differ from hospital to hospital, but raising $$$ is needed. Many states are having issues with funding or approval of items. So money is essential.
N95 medical masks- not latex Approved by FDA
Surgical masks- no latex- approved by FDA
Medical gloves- no latex
Face Shields; Approved by FDA
Surgical garment protectors
Some organizations to go through are...
Funding / Involvement/Professional: www. tnyscm.com
Individual Maker : Nabld.com
FDA Clearance: Contact local FDA branch
For questions , please feel free to email me.