The COVID-19 global outbreak highlights higher importance to the medical devices sterilization
COVID-19 has upset the whole world at every level: health, finance, social… Nobody is indifferent faced to this situation, that has called the attention of many people to value the healthcare and medical device industries.
The sterilization has always been essential in the medical device companies to ensure the patient safety and to help to eliminate infections, but with the current situation the sterilization is on the agenda, especially the ethylene oxide sterilization which is one of the most important sterilization processes, used to sterilize more than 50% of the worldwide medical devices production.
Ethylene oxide sterilization, THE sterilization process for medical devices
This process is worldwide used for many decades, and it has won its spurs during all these years thanks to its efficiency and easy way to sterilize at low temperature. It should be noted that the EtO sterilization is ideal for the medical devices that cannot be sterilized with traditional sterilization processes like steam. Indeed, the EtO sterilization is a cold sterilization process especially suitable for the medical devices that cannot withstand the high temperatures.
As examples, syringes, gowns, gloves, catheters, products with plastic tubing, respiratory devices, masks, are the typical medical devices that can be sterilized by Eto sterilization,....
Nowadays, the EtO sterilization doesn’t have any feasible substitute for industrial production of these medical products. Indeed, other sterilization processes such as the radiation, moist-heat sterilization, dry-heat sterilization or plasma gas can damage or deteriorate the products, increasing patient infection risks. The EtO sterilization method is an effective process for the destruction of the viruses, bacterium and other microorganisms. Some tests have been performed as well to demonstrate that the EO has also a power to reduce the level of endotoxins.
The EtO sterilization plays an important role in the battle against COVID-19
In the sterilization world, the EtO process is one of the most essential for decontamination and disinfection of many medical device products.
This process has been always very required, and the sterilization market has constantly increased its volume for many years. Recently, this demand has received a peak due to the necessity of fighting the COVID-19.
If we look at the USA, the EtO sterilization is a topic of several publications. To understand what’s going on, we have to come back at the beginning of last year. In 2019, some sterilization facilities that use ETO gas to sterilize medical equipment in some states had to shut down, or at least to temporary stop their production. The reason of these shutdowns were due to lawsuits over high ethylene oxide emissions. These closures have contributed to medical devices supply shortages, make it more difficult for the COVID-19 battle.
However, federal regulators as the U.S Food and Drug Administration (FDA) have recently asked the governor of Georgia to reopen the medical device EtO sterilization plants that sterilize essential PPE products like gowns, respiratory devices, masks and gloves, indispensable for the hospitals to respond to the COVID-19 pandemic.
According to the Commissioner of Food and Drugs Stephen M. Hahn “Much of the PPE also requires certain sterilization”, “Due to the recent challenges with the closure of some commercial sterilizers, such as the Sterigenics facility located in Cobb Country, the supply of critical PPE during the COVID-19 outbreak has been further limited”.
All the above described shows that today, the Ethylene Oxide Sterilization is essential to ensure the safety of medical products, and then the safety of people.
EtO sterilizers for medical device and pharmaceutical industries, manufactured by RSD
RSD is clear about its targets and commitments “to manufacture high-quality sterilizers based on EtO sterilization turnkey solutions that are totally adapted to our customer’s needs, yielding a high level of safety, reliability and productivity”.
We are expert in EtO sterilization and we manufacture industrial sterilizers according to the most stringent international standards and regulations.
We offer one of the best worldwide technology regarding the EtO sterilization, proposing a modular design with several options such as:
- Preconditioning & degassing cells
- Automatic conveyor system
- Catalytic system
- EtO monitoring system
- Parametric release
- Vacuum degassing chamber
We propose complete solutions for which we manage all the project phases:
Our specific know-how and experience endorse us.
Don’t hesitate to contact us for further information.