by ELKO Filtering
| Tuesday, December 17, 2019 |
Shoddy manufacturing is a detriment to any business or enterprise — but in the healthcare industry, it can be devastating. When it comes to products like medifab mesh, quality control is an absolute necessity.
Manufacturing medifab mesh requires a precise, controlled environment. Unfortunately, there are still manufacturers producing medical mesh in unsafe conditions. When searching for a new manufacturer, it's important to weed out any potential threats.
Fortunately, there are several ways to find out if a manufacturer's products are suited for use in the healthcare industry.
Check for ISO Certifications
Manufacturers who use ISO (International Organization for Standardization) quality control systems make better, more reliable products. You may have heard of the ISO 9001 — a great quality control system for any business.
However, you should also check to make sure that the manufacturer is ISO 13485 certified. This ISO quality control system is tailor made for the healthcare industry. Designed to protect patients from unsafe product, these standards are far more rigorous than the ones found in the ISO 9001 system. An excellent manufacturer will likely be certified in both ISO 9001 and ISO 13485.
Routine Testing for Harmful Substances
Medical mesh is frequently used in situations where lives are at stake. For instance, if you're using medical mesh as a security filter for a transfusion, you don't want there to be any chance of contamination. The same is true for virtually any application of medical mesh, from blood strips to dialysis sets.
A good manufacturer will routinely test their product for potentially harmful substances. Check to make sure that your potential manufacturer is running regular ISO 10993 and cytotoxicity tests on their product.
Safe Environment for Manufacture
In order to safely manufacture medical grade materials, you need a space with clean, filtered air. Make sure that your manufacturer is operating according to ISO "cleanroom" standards.
In manufacturing terms, a "cleanroom" is more than just a clean environment. An ISO cleanroom is a specialized facility in which the air is constantly being filtered to remove particulate. Staff enter and leave the room through an airlock, and protective gear is worn to mitigate the risk of outside contamination.
In the healthcare industry, it's important to exercise the greatest possible care and caution. It's important to use medical mesh that has been produced in a clean, safe environment by people who are operating with caution and respect. At Elko Filtering Co., we supply product from the SEFAR MEDIFAB® product line because we know that their manufacturing standards meet the stringent requirements of the healthcare industry. For more information, contact us today!