Sterilization is an important part of medical device manufacturing. And even single-use products like swabs go through a highly effective sterilization process to ensure they pose negligible health risks to patients.
How Are Puritan’s Products Sterilized?
All of Puritan’s sterile products undergo either ethylene oxide (EtO) gas sterilization or gamma irradiation sterilization before they are sent to customers.
EtO sterilization is used for more delicate instruments and devices that can’t tolerate heat or moisture. These medical devices are treated with EtO gas, which disrupts the DNA of any microorganisms living on them and stops the organisms from reproducing.
Gamma-rays are a form of electromagnetic radiation, like x-rays, but with higher energy. The rays pass through plastics and kill bacteria by breaking the covalent bounds of bacterial DNA. Gamma radiation, which is very penetrating, is commonly used to sterilize disposable medical equipment such as syringes, needles and IV sets.
Read more about medical swab sterilization here.
What Sterilization Method Does Puritan Use?
Puritan utilizes an EtO process for any products packaged in a sterile wrapped peel pouch, including swabs. Both the products and packaging tolerate the EtO process better than other sterilization methods.
Gamma irradiation is used for molded tube products like our dry transport tubes because these products are less permeable and would not be as thoroughly sterilized by EtO.
Should I Be Concerned About Products Sterilized with EtO?
EtO has been used for decades and, according to the FDA, approximately 50% of all sterile medical devices in the U.S. are processed with EtO. Recently, misinformation has circulated on social media about the risk of using swabs sterilized with EtO for COVID-19 testing. These false claims incorrectly associated the risk of long-term EtO exposure to single-use (short-term) devices, such as swabs.
The misinterpretation of information originated from the EPA’s stance concerning EtO processing facilities and from OSHA’s and CDC’s recommendations to not use EtO sterilization for PPE such as respirators. While these circumstances have potential for long-term exposure and their own associated health risks, the same concerns don’t apply to short-term devices like swabs.
What Steps Does Puritan Take to Ensure Safe Sterilization?
Puritan uses a validated EtO method of sterilization that is tightly controlled to help ensure the safety of our medical devices. As part of the sterilization process, EtO gas is removed from the product (via evacuation and air washes) to ensure EtO levels are below those set by national and international standards.
In addition, the sterilization process is revalidated on a routine basis, with sterilized samples tested for residual EtO levels using the international standard ANSI/AAMI/ISO 10993-7:2008.
While our goal is to produce the highest quality swabs as quickly as possible, we are also firmly committed to helping ensure our products pose no significant health risks to patients and customers. To do this, we continue to rely on the best available data, science and manufacturing practices.