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Safety First – How SANOSTEC protects Max-Air Nose Cones and Sinus Cones‘ products for safe use.
Long before the current virus, SARS-CoV-2, SANOSTEC has adhered to the FDA’s guidelines for safe manufacturing and handling of medical devices to insure that our products are safe when used as directed.
List of the steps that we take to insure the product-safety of Nose Cones and Sinus Cones.
Made in the USA in FDA-Certified medical facilities
The first-line of safety that we employ is making all of our products in the USA. It is 10X more costly for us to make our products in the USA versus importing them, however when it comes to safety we think that the price is well worth it.
The medical facilities are inspected routinely by the FDA to insure that they comply with all requirements of safe-product manufacturing and handling, including environmental air cleaning and filtration, and gowned and gloved machine operators.
We take take these precautions when making the Nose Cones and Sinus Cones even though they are not mandated by the FDA for our class of products, which are Class 1 medical devices.
Made from certified USP Class VI medical materials
Our nasal devices because they are worn inside the body must be super safe. That is why we use only USP Class VI medical materials. Certified USP VI is the gold standard of medical materials. The USP VI certification means that the materials are tested to the most stringent standards of bio-compatibility and are safe for implantation in the human body. Read more about USP testing.
This does not imply that our products are implanted, rather that they are made with materials that are much safer than their designated use. Their designated use is for temporary use in the nasal airway.
Packaged in tamper-proof and non-resealable packages
Much like medications, our products are packaged in tamper-proof packages that can not be resealed. Making the packages tamper-proof was of utmost importance to us, so that the product would remain safe and untouched until it is ready to be used.
Tamper-proof packaging is another costly undertaking. In fact over the years one of the complaints that we hear is how difficult it is to remove the product from the package. Although a bit inconvenient, we think that the safe-keeping of the product is worth it.
Safe cleaning and replacement instructions.
Sinus Cones are reusable for up to 90 uses, and the Max-Air Nose Cones are reusable for up to 45 days. Because they are made with premium quality medical materials, they need to be replaced as directed in order to insure safe and effective use.
Before handling or cleaning the Max-Air Nose Cones and Sinus Cones, wash your hands thoroughly with soap and water.
Before using the Cones the first time, soak them in hydrogen peroxide for four minutes and then rinse them in hot tap water while giving them a good rubbing with your clean hands.
If you suffer from a cold or sinus infection while using the Cones, soak the Cones in hydrogen peroxide for 10 minutes before each use. Then rinse in hot tap water while giving the Cones a good rubbing with clean hands.
According to the Centers for Disease Control, the CDC, “Hydrogen peroxide is active against a wide range of microorganisms, including bacteria, yeasts, fungi, viruses, and spores.” And, ” Other studies demonstrated the antiviral activity of hydrogen peroxide against rhinovirus. The time required for inactivating three serotypes of rhinovirus using a 3% hydrogen peroxide solution was 6–8 minutes…” The rhinovirus, which is the virus that causes the common cold, and the SARS-CoV-2 the virus that causes COVID-19, is said to be much easier to inactivate than the rhinovirus.
If you do not have a cold or sinus infection, simply rinse the Cones with hydrogen peroxide and then hot tap water while giving them a good rub with clean hands.
Before inserting the Cones dry them with a lint free cloth, such as a handkerchief or pillow case. We recommend inserting the Cones while they are still warm and dry, which increases their pliability and comfort.
Follow our cleaning and replacement directions for safe and effective use at all times, during a pandemic, flu season or summertime vacation.