News
Is Vaporized Hydrogen Peroxide the Right Sterilization Modality for your Device?
According to the FDA, Vaporized Hydrogen Peroxide (VH2O2 or VHP) is an Ethylene Oxide alternative that merits broader adoption due to its long history of safety and effectiveness. As such, VHP was re-categorized and is now listed among the examples of “Established Category A” sterilization methods in the 2024 updated guidance document. Per the FDA’s Suzanne Schwartz, “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.”
Devices that are particularly suited to VHP sterilization are:
- Pre-filled syringes and ampules
- Devices that contain Li-ion batteries
- UHMW Polymer devices
- Devices with circuit boards and non-volatile memory
- Most implantable orthopedic devices
- and many more
VHP compares favorably to EO in critical time-to-market attributes as well: cycle development and validation times are much shorter and VHP production load processing takes a fraction of the time. EO off-gassing typically takes 24 hours to complete while VHP total processing time is as little as 2 hours.
From left: Brant Gard, CEO of Blue Line, Jeff Sauter, Dir Business Development of SteriTek, Michael Spalding, CEO of Pacific Biolabs, Nora Crivello, CEO of Westpak, Roy Morgan, CEO of Eagle Medical
Medical Device Suppliers Unite to Form the WCDA
The West Coast Device Alliance fournder are: Eagle Medical, West Pak, Pacific BioLabs, Blue Line Sterilization, and Steri-Trek.
Omar Ford February 20, 2024
Throughout the past few years, a significant number of mergers and acquisitions in the medical device supplier’s space have occurred. The consolidation has created headwinds for some of the smaller companies in the market making it more difficult to compete.
Earlier this month, during MD&M West, five suppliers in the medical device industry, as a response to the mass consolidation efforts in the industry, formed the West Coast Device Alliance (WCDA).
Roy Morgan, president and CEO of Eagle Medical, spoke to MD+DI about the impetus behind the WCDA. “The impact these consolidations have in our industry has to do with the power of brand recognition that these large multi-national conglomerates can create,” Morgan told MD+DI. “They have the marketing budgets and the advertising budgets that are of such scale that they can eclipse other players in the marketplace. It creates this … bright light in the industry that makes it challenging for independent players to achieve this sort of brand awareness.”
The founding members of the WCDA are:
- Eagle Medical, specializing in FDA-compliant assembly, packaging, and in-house Hydrogen Peroxide Gas Plasma (HPGP) specific sterilization
- West Pak, a 3rd-party, independent-laboratory specializing in package validation and product testing
- Pacific BioLabs, a contract research organization specializing in microbiology, services for living organisms in vivo as well as analytical chemistry and cell-based bioassay culture samples in vitro for the medical device and pharmaceutical industries
- Blue Line Sterilization Services, ethylene oxide sterilization services
- Steri-Tek, a high-volume E-beam and X-ray contract sterilizer as well as R&D innovation center.
“The simple virtue of combining many different types of businesses with the clarity of end-to-end provision for product realization in the medspace … you’re able to give the uninitiated in our industry a sense of clarity of pathway,” Morgan said. “When you’re one component in that landscape like an Eagle, Pacific BioLabs or WestPak, as the independents are that are part of this WCDA, it is more difficult to give them that same degree of clarity. A big part of why we wanted this was to educate each other and give each other that same level of specificity of pathway.”
There’s potential for more companies to join but that’s definitely in the future Morgan, noted. “A membership aspect of the WCDA is definitely in the cards,” he said.
MDDI Article
From right: Roy Morgan, Jody Birks, and Chris Hunting
True-Validated Packaging Wins Innovation Award at BIOMEDevice Silicon Valley!
Novel Pre-Validated Packaging Solution Takes Home Hardware
November 16, 2023
People’s Choice for Innovation Excellence
Product: PATH™ (Packaging Accelerated Timeline Help)
Company: Eagle Medical Packaging, Sterilization, Inc.
Product Description:
“Pre-validated” packaging has been developed in recent years as a way to shorten packaging development timelines; unfortunately, the pre-validated solutions currently available to the medical industry are insufficient. Pre-validations were performed with empty packaging material, which offers no guarantee that the sterile barrier will survive the distribution and delivery process with anything other than air inside. Perhaps the empty package meets all specifications, but it certainly behaves differently with an actual device inside, which could result in a puncture or tear that renders the contents useless due to sterility compromise. Furthermore, when creating and testing a new package, it could fail validation at any point in the process. A project could be 20 weeks into a 26 week process when testing reveals that the packaging fails after aging, which sadly resets the development clock, representing an existential threat to many start-ups.
Eagle Medical is proud to announce the Packaging Accelerated Timeline Help (PATH) system. PATH True-Validated® packaging is completely validated in accordance with ISO 11607-1:2015 and medical industry standards. True-Validated packaging compresses timelines by eliminating the need to design and build packaging, source materials, validate processes, and test the packaging. The True-Validated system includes both inner and outer sterile barrier (suitable for implants) along with a single pack product box and labeling. Additionally, PATH participants receive a complete representative data set backed by reports, charts, and protocols based on actual distribution testing after sterilization, that allows easy adoption of the packaging and process into any QMS. The sole remaining task is to write up the adoption rationale and submit to the FDA. The resulting contraction in launch schedule equates to $250,000 to $1 million in average burn-rate savings, and can provide the competitive edge required to win the race to market.
Article originally appeared on biomedevicesiliconvalley.com
BIOMEDevice Article
From left: Brant Gard, CEO of Blue Line, Jeff Sauter, Dir Business Development of SteriTek, Michael Spalding, CEO of Pacific Biolabs, Roy Morgan, CEO of Eagle Medical, Nora Crivello, CEO of Westpak
Eagle Medical Leads Formation of the West Coast Device Alliance
Founders Hold Historic Charter Signing Ceremony at MD&M West
Eagle Medical, Inc. is honored to lead the formation of the West Coast Device Alliance (WCDA), a strategic partnership comprised of five leading California-headquartered medtech solution providers. The WCDA will deliver end-to-end accelerated commercialization solutions to manufacturers in the medical device, pharmaceutical, and biotech spaces.
At MD&M West in Anaheim, senior leaders from each organization took part in a commemorative Charter signing ceremony to certify their commitment to each other, and the industry. “As market consolidation amongst medtech contractors continues to accelerate, device manufacturers are eager to find solution providers that are able to improve overall time to market without sacrificing the necessary quality and regulatory compliance standards” Eagle Medical President and CEO Roy Morgan stated.
“The West Coast Device Alliance will deliver customers with a collection of trusted partners with more than 80 years of experience across the entire medical product development lifecycle, while providing an holistic view of the supply chain, greater market intelligence, and the ability to execute collectively while retaining full autonomy.” Nora Crivello, WESTPAK’s President and CEO, explains, “By coming together in this strategic alliance, we mark the beginning of a new chapter, one where together we can accelerate progress, drive change, and most importantly, support our customers’ speed to market. Our companies share a similar mindset, values, and customer base, so this alliance was a no-brainer. I’m really excited for our shared future.”
Each of the five WCDA founders were strategically selected for their contribution of unique expertise and resources to the medtech industry:
- Eagle Medical, Inc.: Specializes in device assembly, packaging, and VH2O2 sterilization; Eagle is the largest industrial hydrogen peroxide gas plasma sterilizer in North America
- Pacific BioLabs: Specializes in microbiology, services for living organisms in vivo, and analytical chemistry and cell-based bioassay culture samples in vitro for medical device and pharmaceutical industries
- Steri-Tek: Specializes in high-volume E-beam and X-ray contract sterilizing and serves as an R&D innovation center
- Blue Line Sterilization Services: Specializes in ethylene oxide (EO) sterilization services
- WESTPAK, Inc.: Specializes in product and package testing for the medical device, pharmaceutical, computer/electronics, consumer goods, food & beverages, and other industries
Informa Article
FDA Facilitates Broader Adoption of Vaporized Hydrogen Peroxide for Medical Device Sterilization
Agency Continues to Encourage Ethylene Oxide Sterilization Alternatives
For Immediate Release: January 08, 2024
Today, the U.S. Food and Drug Administration is announcing that it considers vaporized hydrogen peroxide (VHP) to be an established method of sterilization for medical devices, recognizing VHP’s long history of safety and effectiveness. The FDA has revised the final guidance, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, to list VHP as an example of an Established Category A method of sterilization. This update will facilitate broader adoption of VHP as a sterilization method for the medical device industry, is part of the agency’s multi-pronged approach to reducing the use of ethylene oxide (EtO) where possible and further supports the agency’s efforts to advance medical device supply chain resiliency.
Effective sterilization processes are necessary for certain devices to be safe because sterilization inactivates or kills potentially harmful microorganisms. In addition to effectively inactivating or killing potentially harmful microorganisms, sterilization processes must not damage devices. For many devices marketed as sterile, a premarket submission must contain information sufficient to show the sterilization process is effective and consistent with internationally accepted consensus standard(s) that the FDA has recognized.
EtO is the most commonly used sterilization method for medical devices in the U.S., with more than 20 billion devices sold in the U.S. every year sterilized with EtO, accounting for approximately 50% of devices that require sterilization. Since 2019, the FDA has promoted the development of alternatives to EtO and has implemented a number of programs and initiatives to support innovation in medical device sterilization. This includes developing Sterilization Master File Pilot programs to support certain changes to sterilization processes, launching innovation challenges to encourage new strategies to reduce EtO emissions and the development of new sterilization methods or technologies and proactively engaging with industry to help advance innovative alternatives to EtO.
“The FDA’s commitment is to protect public health, a critical mission in today’s complex medical device ecosystem,” said Suzanne Schwartz, M.D., M.B.A., director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health. “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. As innovations in sterilization advance, the FDA will continue to seek additional modalities that deliver safe and effective sterilization methods that best protect public health.”
Methods with a long history of safe and effective use on medical devices are considered Established Category A sterilization methods and include moist heat, dry heat, EtO and radiation. With the recent FDA recognition of the ISO standard 22441:2022, the FDA is adding VHP to Established Category A, which the agency expects will strengthen industry’s capacity to adopt alternative sterilization processes that pose less potential risk to the environment and communities in which they operate.
The FDA remains committed to reducing adverse impacts to the environment and public health and to developing solutions that avert potential shortages of devices that the American public relies upon.
FDA Press Release
Eagle Medical Launches Novel Pre-Validated Packaging Solution
The company’s Packaging Accelerated Timeline Help (PATH) solution is capable of garnering a device submission in as little as three weeks
Charles Sternberg, Associate Editor, 02.15.23
Eagle Medical Packaging, Sterilization Inc., headquartered in Paso Robles, California, has introduced a fully pre-validated packaging solution to the medical device industry in the U.S.
Pre-validated packaging has been available for a number of years, helping OEM’s shave a few weeks off of a typical 9 to 12 month development schedule. In contrast, Eagle Medical says its Packaging Accelerated Timeline Help (PATH) solution is capable of garnering a device submission in as little as three weeks. According to CEO Roy Morgan, “our True-Validated packaging system has the potential to transform the industry. Pre-validated packaging has proven to be valuable to OEMs with tight launch schedules and our solution takes that concept to its logical conclusion. We’ve pre-validated every step of the packaging and sterilization process and we include a complete, submission-ready document set.” The only task left to the OEM is to write the adoption rationale and submit to the FDA.
According to the company, the key to PATH is the ‘worst-case’ proxy device that was designed and manufactured by Eagle Medical, and contains many of the materials and characteristics of common orthopedic devices. This allows the OEM to utilize the substantial equivalence adoption rationale in their submission. According to Morgan, “the predicate device that we designed, truly is the worst-case device that we’ve ever seen. We deliberately pushed packaging systems beyond their limits, then established maximums to achieve validation. But the end result is that a wide variety of medical devices will be compatible with our True-Validated packaging system”.
Startup and early-stage orthopedic device manufacturers requiring expedited development timelines are prime candidates for PATH, Morgan said. “Startup device companies frequently fail to consider packaging until it’s too late and they burn through capital as their device goes through months of testing. And one failed test along the way can reset the development clock. PATH mitigates that risk and ensures commercialization in the shortest timeframe possible.”
Eagle Medical has submitted an application for a Master File which is currently being evaluated by the FDA.
MPO Magazine Press Release