FDA Alternate Sterilization Decision Enables Broader Med Device Adoption
Sterilization is a critical step in the production and use of medical devices, as it helps prevent infections and ensures the devices perform as intended. However, the methods and standards for sterilization are not static; they evolve with scientific discoveries, technological innovations, and emerging safety concerns.
A recent development is the FDA’s addition of vaporized hydrogen peroxide (VHP) as an established category A sterilization method. VHP is a safer, more environmentally friendly sterilization method that can accelerate advancements in the medical device industry. The implications for medical device OEMs and other manufacturers include the ability to leverage new materials and manufacturing processes and meet growing consumer demand.
VHP: A Viable Alternate Sterilization Method
Historically, the most common method of sterilization for medical devices has been ethylene oxide (EtO). EtO is used to sterilize more than 20 billion medical devices, or about half of all devices, sold in the U.S. each year.[i]
While EtO is highly effective at sterilizing equipment, it also poses significant environmental and public health challenges. The FDA’s addition of VHP as an approved method, comes, in part, in response to Environmental Protection Agency proposals to reduce EtO emissions at commercial sterilization facilities by as much as 80 percent. The risks associated with EtO can also lead to supply chain shortages, as seen when the Illinois EPA issued a SEAL order that shut down several sterilization facilities.[ii]
For the medical device industry, the approval of VHP provides an alternative for some medical devices and enables broader adoption. The FDA’s Suzanne Schwartz said, “Vaporized hydrogen peroxide’s addition as an established sterilization method helps us build a more resilient supply chain for sterilized devices that can help prevent medical device shortages.”[iii]
Accelerating Medical Device Innovation
The approval of VHP as a sterilization method opens exciting new opportunities and markets for the medical device and equipment industry. For applications that require a heating source—including blood and fluid warming, insufflation and ablation devices, sterilization, patient comfort, and cell incubation for laboratories—Backer Hotwatt collaborates with OEMs to develop custom heating solutions.
VHP sterilization has potential applications across a wide variety of systems and devices, including portable and fixed systems, medical devices and equipment, research laboratory equipment, and a variety of healthcare environments.
Among these applications are:
Medical Device Sterilization: VHP can be used to sterilize surgical instruments, endoscopes, catheters, and implants. Its ability to penetrate complex shapes and delicate materials without leaving residues makes it suitable for a broad range of medical equipment.
Pharmaceutical Manufacturing: VHP sterilization can be used in pharmaceutical manufacturing facilities to decontaminate equipment, facilities, and cleanrooms. It ensures the sterility of manufacturing environments and prevents cross-contamination in pharmaceutical production.
Biological Safety Cabinets (BSCs) and Isolators: VHP can be employed for sterilizing biological safety cabinets, laminar flow hoods, and isolators used in microbiological laboratories, pharmaceutical research, and biocontainment facilities. It helps maintain aseptic conditions and prevents the spread of pathogens.
Laboratory Equipment Sterilization: VHP can be used for sterilizing laboratory equipment such as incubators, biosafety cabinets, centrifuges, and pipettes. It helps maintain sterile conditions in research laboratories, diagnostic facilities, and biotechnology laboratories.
Precise Heating for Optimal Sterilization
Backer Hotwatt has extensive experience in developing precise heating elements for sterilization devices that perform at the desired outputs and provide unfailing performance. These systems use patented, proven efficacy in sterilization methods and technology.
If you would like to learn more about how we can help you engineer a custom heating solution, leveraging VHP sterilization methodology, contact our team. By collaborating early in the design process, we can help you develop an effective heating system, advance your technology, and speed time-to-market.
[i] https://www.medtechdive.com/news/ethylene-oxide-medical-device-regulations-epa-fda/700742/#:~:text=EtO%20is%20used%20to%20sterilize%20more%20than%2020%20billion%20medical,year%2C%20according%20to%20the%20FDA.
[ii] https://www.illinois.gov/news/press-release.19717.html
[iii] https://www.fda.gov/news-events/press-announcements/fda-facilitates-broader-adoption-vaporized-hydrogen-peroxide-medical-device-sterilization