FDA-Approved Contract Sterilization of Medical Devices

ClorDiSys Solutions, Inc is recently approved by the United States Food and Drug Administration (FDA) for contract sterilization of medical devices using our chlorine dioxide gas process (registration # 3013115071).  The ability for chlorine dioxide gas sterilization to be used in such a way is a tremendous advancement for the industry.  Ethylene oxide (EtO) has typically been the industry standard for medical device sterilization, especially in terms of contract sterilization.  However, for years, there has been a concern over EtO’s harmful environmental and health impact, as well as its overall volatility that prevents certain items like embedded batteries to be decontaminated.  In fact, in 2019, EtO contract sterilizer firms in Illinois were shut down over health concerns due to harmful emissions, an issue that rose in magnitude after five women claimed that working at the plant led to their cancer diagnosis.  Although these plants are dangerous, officials warned that shutting them down could lead to medical device shortages.  This dilemma stresses the need for alternative medical device sterilization options to become more prevalent in the industry.  Chlorine dioxide gas is a direct replacement for EtO, without the negative aspects that ethylene oxide is known to have.  Chlorine dioxide is a non-carcinogenic residue free gas that is a registered sterilant by the United States Environmental Protection Agency (EPA).  Its non-explosive behavior allows for items with sensitive components, such as embedded batteries, to be safely and effectively sterilized.  With no need for capital expense or additional in-house labor, contract sterilization services from ClorDiSys provide an affordable option for medical device manufacturers.  The devices can be initially sent to ClorDiSys so a cycle can be validated, and any necessary regulatory actions can be pursued.  Then, on an as needed or pre-scheduled basis, the device manufacturer can ship items for sterilization following their customized protocol.  Overall, contract sterilization provides a low-risk and low-cost option that ensures effective results with greater ease and peace of mind.

Learn more about ClorDiSys Contract Sterilization services here. 

Contact us for more information on any of the listed applications or to explore additional applications not listed. Specific testing with your device is always recommended.

What is Contract Sterilization?

ClorDiSys Solutions has decades of microbial remediation expertise and offers Contract Sterilization Services to a wide variety of industries. There are two basic types. One is where we sterilize FDA regulated 510K Medical Devices in our FDA registered facility. If you’re interested in learning more about that, please come back for next week’s blog where we discuss that topic. The other is when we decontaminate your devices, equipment, supplies, and products at our facility, then ship them back to you or onward to a third party like a customer. ClorDiSys utilizes chlorine dioxide gas for sterilization instead of other commonly used gamma irradiation, ethylene oxide gas, steam, or electron beam methods. Our chlorine dioxide gas is a US EPA registered sterilant capable of killing all viruses, bacteria, fungi, and spores. It is also effective against beta lactams such as Penicillins, Cephalosporins, and Carbapenums as well as amplicons and pinworm eggs. 

When outsourcing sterilization of components, supplies, medical devices, and equipment, consider your current needs as well as plans for future growth. The outsourcing of sterilization provides convenience, efficiency, and initial cost savings (dependent on size and frequency). ClorDiSys decontaminates a wide assortment of products within the multiple decontamination chambers at our New Jersey facility to fit whatever size items required. Customers can choose to single or double wrap items in Tyvek and may include biological indicators as well. Biological Indicators (BIs) are used to challenge the efficacy of a decontamination/sterilization cycle. Turnaround time is traditionally 24 hours, with items typically being shipped back the day after they arrive. In some cases, turnaround time can be hours, with the items arriving, being treated, and shipped on the same day. Upon completion, you will be issued a Contract Decontamination Certification Sheet describing the process and showing the sterilization cycle data.

Learn more about ClorDiSys Solutions’ Contract Sterilization Services here, and contact us for a free consultation.