At Cambridge Polymer Group, we are constantly pushing the boundaries of polymer science to develop innovative solutions for our clients. Our recent advancement in hydrogel technology aims to enhance surgical training by offering realistic tissue phantoms that more closely mimic the behavior of human tissue during electrosurgical procedures.
The Challenge: Realistic Tissue Simulation
As the medical device industry moves away from animal and cadaveric testing, there is a growing need for synthetic tissue models that can replicate the nuanced responses of human organs. While many commercially available phantoms may look realistic, they often fall short in simulating crucial aspects of tissue behavior during surgical interventions.
One of our clients approached us with a specific challenge: developing a synthetic tissue phantom that could char and smoke realistically during electrosurgical procedures, just like natural tissue. This behavior is critical for effective surgical training, especially when using high-energy intervention devices like electrocautery or radiofrequency ablation tools.
Our Solution: The “e-tissue” Hydrogel
Drawing inspiration from the Maillard reaction, the chemical process responsible for food browning, Research Scientist Joseph White and his CPG team developed a novel “e-tissue” hydrogel formulation. This innovative material not only provides a realistic tactile feel but also responds to electrical energy in a manner consistent with natural tissue.
Key features of our e-tissue hydrogel:
Chars and produces smoke under bipolar and monopolar electrosurgical intervention
Cuts realistically during electrosurgical procedures
Offers appropriate electrical conductivity and thermal decomposition properties
Provides a tactile feel similar to natural tissue
Putting e-tissue to the Test
To demonstrate the effectiveness of our e-tissue hydrogel, we conducted comparative tests using chicken heart tissue (a common surrogate for human tissue in surgical training) and our synthetic models. The results were notable:
Both translucent and red-colored e-tissue options produced char and smoke during bipolar electrocautery, closely mimicking the behavior of the chicken heart tissue.
When cast into specific anatomical shapes (such as a papilla), the e-tissue model charred and smoked realistically under monopolar electrocautery during simulated sphincterotomy training.
Implications for Surgical Training and Medical Device Development
Our e-tissue hydrogel opens new possibilities for surgical training and medical device testing:
Enhanced realism: Trainees can experience tissue responses that closely match real-life scenarios, improving the quality of their training.
Ethical considerations: Reduced reliance on animal and cadaveric tissue for training and testing.
Consistency and repeatability: Unlike natural tissue with its short shelf life, our synthetic models offer stable and consistent properties for repeated use.
Customization potential: The hydrogel can be tailored to mimic specific tissue types or anatomical structures.
The Future of Synthetic Tissue Models
At Cambridge Polymer Group, we are committed to advancing the field of synthetic tissue modeling. Our expertise in hydrogel chemistry, materials science, and custom test design positions us uniquely to develop application-specific tissue phantoms for a wide range of medical applications.
Whether you are looking to create surgical training tools, test beds for new medical devices, or marketing demonstrators, our team is ready to help you bring your vision to life. Contact us today to learn more about how our custom tissue model services can benefit your organization.
California, known for its progressive stance on environmental and health issues, is once again at the forefront of regulatory change. On September 25, 2024, California Governor Gavin Newsom signed the Toxic-Free Medical Devices Act (AB 2300) into law. The legislation prohibits the use of certain ortho-phthalates, specifically di-(2-ethylhexyl) phthalate (DEHP), in intravenous (IV) solution containers and tubing products.
What Are Phthalates?
Phthalates are a group of chemicals used to make plastics, primarily polyvinyl chloride (PVC),more flexible and durable. These additives are commonly found in various medical products, including medical devices such as IV bags, tubing, and catheters. They have also been used more broadly in industries ranging from toys to tools, although legislation is generally already in place outside of medical devices. In some cases, these compounds can be present at greater than 30% of the mass of the material.
Toxic Free Medical Devices Act – California AB 2300
California’s ban on phthalates in medical devices stems from growing concerns about their potential health risks. Phthalates are known endocrine disruptors and have been linked to various health issues, including reproductive problems and developmental disorders.
The ban on intentionally added DEHP will take effect on January 1, 2030, for IV containers, and January 1, 2035, for IV tubing. This legislation aligns with similar restrictions in the European Union. It is important to note that unintentionally added DEHP may still be present in quantities at or below 0.1% weight per weight (w/w).
The legislation exempts certain medical devices, including:
Human blood collection and storage bags
Apheresis and cell therapy blood kits and bags, including integral tubing
DEHP’s unique properties are considered necessary for improved red blood cell quality and stability. In the case of blood storage, changing materials is not so straightforward because DEHP acts to stabilize the blood and improve the quality of the stored blood, a phenomenon that is still not well understood.
Implications for the Medical Device Industry
Regulatory Compliance
The California medical device phthalate ban will require some manufacturers to reformulate their products, potentially leading to significant changes in production processes and materials used, including:
Reviewing and updating product portfolios to identify all items containing DEHP
Developing and implementing plans to phase out DEHP-containing products
Ensuring compliance with new regulations across the supply chain
Updating documentation and labeling to reflect changes in material composition
Supply Chain Adjustments
The new legislation will necessitate changes throughout the supply chain, including:
Sourcing new raw materials and components
Qualifying new suppliers who can provide phthalate-free alternatives
Potentially relocating or modifying manufacturing facilities
Updating inventory management systems to track and phase out DEHP-containing products
Innovation and R&D
Manufacturers will need to innovate and develop alternative materials that can provide the same functionality as phthalates without the associated health risks. This involves:
Investing in research and development of new plasticizers and materials
Collaborating with material scientists and chemical engineers to find suitable alternatives
Conducting extensive testing to ensure new materials meet performance and safety standards
Potentially redesigning products to accommodate new materials
Developing and validating new analytical methods for detecting phthalates
Implementing more stringent quality control measures throughout the manufacturing process
Conducting regular audits and testing of raw materials and finished products
Training staff on new testing procedures and regulatory requirements
Global Impact and Market Dynamics
While specific to California, it is part of a growing trend to phase out phthalates in medical devices. Although currently the FDA does not prohibit the use of these compounds in medical devices, the California legislation increases pressures on US manufacturers to phase out these materials, and increasingly aligns with EU proposals. This may result in:
Pressure on manufacturers to adopt phthalate-free alternatives globally
Changes in competitive landscape as companies adapt at different rates
Potential for early adopters to gain market share in regions with stricter regulations
Increased scrutiny of phthalates in medical devices by regulatory bodies worldwide
Challenges and Opportunities
The ban presents both challenges and opportunities for the medical device industry. Initially, there may be increased costs associated with research, development, and retooling of production lines. However, this could lead to more sustainable and safer products in the long run.
By eliminating potentially harmful chemicals from medical devices, manufacturers can boost consumer confidence and potentially gain a competitive edge in the market. Medical device manufacturers should start exploring alternative materials and testing methodologies to ensure compliance with new regulations.
The California ban on phthalates in medical devices represents a significant step towards safer healthcare products. As the regulatory landscape continues to evolve, adaptability and a commitment to safety will be key for success in the medical device industry.
How Cambridge Polymer Group Can Help
As experts in polymer science and material selection, Cambridge Polymer Group is well-positioned to assist companies in navigating these changes.
Material Selection
In addition to regulatory considerations, the choice of starting material must be driven by the anticipated end-use. Our team provides holistic thinking on material selection, considering factors such as downstream sterilization techniques that often dictate upstream material choices. We begin by obtaining a detailed description of your target application, including the expected environment, intended lifespan, and any specific material properties required.
We can help you evaluate potential alternatives that satisfy both California and EU requirements. Our approach considers not only the engineering and performance aspects but also biological safety and material regulatory trends. We assemble a list of candidate materials, filter them based on your specific needs, and can perform custom tests relevant to your application.
Chemical Characterization
Our state-of-the-art instrumentation and experienced scientists can perform extractables and leachables studies, identify and quantify chemical constituents, and evaluate potential degradation products. We use techniques such as Q-TOF, GC-MS, LC-MS, FTIR, and NMR to provide detailed chemical profiles of materials. Our testing protocols are designed to meet regulatory requirements and industry standards, ensuring thorough characterization of your device materials.
Toxicological Risk Assessment
To provide comprehensive support to our clients, Cambridge Polymer Group has partnered with Gradient, a leading environmental and risk sciences consulting firm. This collaboration allows us to offer expert toxicological risk assessment services for medical devices. Gradient’s board-certified toxicologists (DABTs) bring decades of in-house experience at medical device companies. They have a strong track record in helping clients achieve regulatory approval and address inquiries from US FDA and European Union (EU) notified bodies.
Biological Evaluation Plan
Our team at Cambridge Polymer Group can conduct biological risk assessments for medical devices in accordance with ISO 10993 standards. We evaluate the biocompatibility of materials, assess potential biological hazards, and determine the overall biological safety of devices. Our approach includes analyzing chemical characterization data, reviewing toxicological information, and assessing the risk of adverse biological responses. We can help you develop a biological evaluation plan, interpret test results, and prepare comprehensive biological risk assessment reports to support regulatory submissions.
As the medical device industry adapts to these new regulations, Cambridge Polymer Group and Gradient are committed to providing the expertise and support needed to ensure compliance and maintain product quality. For more information or to discuss how we can assist your company, please contact us.
Increasingly, manufacturers and product designers across all industries are using new materials in novel applications and pushing existing materials into new uses that stretch their performance to the limit. These materials do not always behave as expected, and conventional material specification sheets and standard testing methods are no longer enough.
Today’s successful products can only be obtained through a multi-disciplinary approach, with an emphasis on safety. Developers need deep expertise in materials across industries, along with a thorough understanding of polymer science. This includes the impact of additives, manufacturability (encompassing cleaning and sterilization), biocompatibility, and the intended use of the device or product.
Enhanced Client Collaboration through SME Leadership
To address this growing need for materials expertise, Cambridge Polymer Group is implementing a new five-position management structure. This structure empowers senior Subject Matter Experts to remain at the forefront of client collaboration – a cornerstone of CPG’s successful partnerships. This strategic shift ensures dedicated resources for complex projects, delivering the hands-on materials support clients increasingly require.
Leadership Team Focused on Client Success
Vice President of Research, Dr. Gavin Braithwaite, will step into the newly created position of Chief Executive Officer.
“By staffing our newly designed senior management structure with seasoned scientists, we can ensure the continued delivery of high-quality science to our clients, while placing a stronger emphasis on product development and challenging testing projects,” said Braithwaite. “I am excited to grow the development aspect of our work and build a deeper relationship with our clients, helping them decrease risk, expand into new markets, and increase profitability.”
After 27 years as Cambridge Polymer Group’s President, Dr. Stephen Spiegelberg is moving into the new role of Chief Scientific Officer (CSO).
This transition will enable Dr. Spiegelberg to spend more time collaborating with clients and working on large-scale projects in his subject matter expertise, such as biocompatibility, root cause analysis, product development, and medical device cleaning.
“I am personally looking forward to having more scientific interactions with our clients, spending more time on ASTM and AAMI standards development, and studying industry trends to help assist in product development,” said Spiegelberg.
Jaimee Robertson will oversee research operations in the newly created role of Director of Consulting Services.
Robertson will work with CEO Gavin Braithwaite and CSO Stephen Spiegelberg to develop and implement CPG’s research strategy and assist clients in their development projects and root cause analysis work.
Norma Turner will manage lab operations and testing services as Director of Analytical Services.
Turner will ensure CPG’s full-service laboratory provides essential support for R&D and consulting projects, as well as value-add to routine analytical testing clients. Norma will be leveraging her extensive experience in ASTM and ISO standards testing to help with both routine and non-routine testing, including residue analysis and extractables and leachables testing.
Dr. Rebecca Bader, Associate Director of Chromatography, will oversee the direction of this critical department and lead CPG’s biocompatibility and risk assessment group.
Bader’s material science and analytical chemistry expertise combined with her biocompatibility experience will help clients navigate the challenging regulatory landscape.
Benefits for Our Clients
Deeper Collaboration with Material Experts: Our clients will continue to benefit from close collaboration with CPG’s SMEs.
Enhanced Support for Complex Projects: The new structure ensures dedicated resources for even the most demanding R&D initiatives.
Future-Proofed Innovation: CPG is positioned to deliver the advanced materials expertise needed to bring groundbreaking products to market.
We are confident that this new operating model will allow us to further strengthen our partnerships and empower our clients to achieve their innovation goals.
Together, let’s turn groundbreaking ideas into reality.
Contact Us
If you have any questions or are interested in learning more about how CPG’s materials science expertise can benefit your business, please email or call us at 617-629-4400 today.
Thirsty the Hydrogel
Was a sodium polyacrylate soul
With a Bakelite pipe and a resin nose
And two eyes made by injection mold
Oh, Thirsty the Hydrogel
Is a feat of science, so they say
He was made of fake snow
And the lab techs know
How he wicked moisture away
There must have been some water in
That plastic hat they found
For when they placed it on his head
He began to swell around
Oh, Thirsty the Hydrogel
Was absorbent as he could be
He could hydrate
to 300 times his weight
Not the same as you and me
Oh, Thirsty the Hydrogel
Knew the temp was warm that day
But he said, “Let’s play and perform TGA
Because I won’t melt away”
Down to the laboratory
With a pipette in his hand
Running here and there
Volumizing scientists’ hair
Saying, “Deform me if you can”
They chased him through the lab benches
Right past a Research Scientist II
And Thirsty only stopped a moment
When she yelled, “You’re not wearing shoes!!!!”
Hmm, Thirsty the Hydrogel
Had to apply his linking agent spray
No need to wave goodbye, he said, “Don’t you cry
Because crosslinks save the day!”
Slurpity, slurp, slurp, slurpity, slurp slurp
Look at Thirsty grow!
Slurpity, slurp slurp, slurpity, slurp slurp
Over streams of aqueous flow!
CPG Holiday Hours
In observance of the holidays, Cambridge Polymer Group will be closed on Friday, December 22nd, and Monday, December 25th. We will be open Tuesday, December 26th, to Thursday, December 28th, closing again on Friday, December 29th, and Monday, January 1st. We will return to regular business hours on Tuesday, January 2nd.
Figure 1: Compilation of bullet hole damage found on planes that returned from battle.
In analysis of data, bias can lead to an incorrect interpretation of the data if the analyst has a firmly-held preconceived notion of the study outcome, or if a complete dataset is not considered. The analyst may not be aware that they are biasing their data interpretation. A careful analyst will always question their study interpretations to make sure that bias has not crept in.
Mathematician’s Insight Led to Critical Breakthrough in World War II
An example of bias can be found in World War II. The Navy wanted to reduce airplane loss during battles. They thought more armor reinforcement would help protect the planes, but they needed to be strategic in where to place the armor; heavier planes used more fuel and were less maneuverable. They collected data on the accumulated bullet holes on planes returning from battle in Europe, and compiled it into an image like that shown in Figure 1. They noted that the bullet damage was largely segregated to the wings and fuselage, and there was little damage to the engines. Based on this analysis, they initially concluded that more armor was needed on the wings and fuselage.
A statistician in their group, Abraham Wald, looked at the data and had a different interpretation after considering the larger picture. He realized that a dataset was missing from the analysis, namely the planes that did not return from battle. All the planes that led to the data set in Figure 1 were able to return to base and, hence, did not have critical damage.
Wald initially speculated that bullets holes should be randomly distributed over the plane and that the dataset in Figure 1 was biased by considering only the planes without critical damage. He further speculated that planes that took hits to the engines were unable to return to base, suffering critical damage and, hence, were not part of the dataset. In consideration of the entire dataset, the conclusion would be to armor the engines, and that the wings and fuselage could withstand damage without crashing. Wald therefore looked for where there were no bullets to arrive at his conclusion.
Overcoming Bias in Medical Device Materials Analysis
Cambridge Polymer Group considers this approach when conducting analysis projects for clients. For instance, in extraction studies for ISO 10993-18, if we do not see potentially toxic compounds in an extract using one detector, we use another detector on the same extract to see if compounds are identified with a different detection mode. This approach is particularly necessary when we are looking at the bill of materials for a medical device to identify what detector will reliably pick up potential extractable materials. Just because one detector does not pick up a compound does not mean the compound is not there.
Cambridge Polymer Group is helping to organize a workshop on Best Practices for Precision and Bias for Medical Device Standardization, to be held in May of 2024 in Philadelphia. This workshop will discuss how to conduct interlaboratory studies on test methods to generate statistical information relevant for a precision and bias (P&B) statement in an ASTM test method, how to use P&B information, and when a P&B study is not appropriate.
A call for abstract submission will be going out later this year. Please contact Cambridge Polymer Group if you would like to present or attend the workshop.
Although this title manages to capture three yawn-inducing groups of words[1] (“non-volatile residue,” “standardization”, and “ASTM”), when these groups are combined, they represent an important subject for manufacturers of medical devices. Non-volatile residues (NVR) are those residues that can be removed from a medical device that are not intended to be part of the device, and are of sufficiently low volatility that they do not evaporate upon removal of extraction solvent. NVRs are often used to assess how clean a device is, or how effective a manufacturing process is.
The American Society for Testing and Materials (ASTM), the United States Pharmacopeia (USP), and the International Standards Organization (ISO) employs the concept NVR in several of their standards. For example, in extraction and leaching studies of medical devices used for chemical risk assessment per ISO 10993-18 and USP, NVR measurements of components that can be extracted from finished medical devices are used to established both the total mass of extractable residue as well as an indication of whether exhaustive extraction conditions have been achieved.
NVR Standards for Medical Devices
Scientists at Cambridge Polymer Group are involved in drafting several new standards involving NVR assessment. In ASTM committee F42.07.03 for additive manufacturing of medical devices, a new standard is being developed to quantitatively measure residual powder bed feedstock on additive-manufactured medical devices, with one required test using NVR measurements. This draft standard is currently titled Standard Test Method for Additive Manufacturing for Medical – Powder Bed Fusion – Assessment of Residual Powder (WK82776).
Another standard that involves NVR measurements is ASTM F2459 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis, which is primarily used as a measurement of how clean medical devices are. This standard, which originated at Cambridge Polymer Group, is currently being modified to include plastic and ceramic medical devices.
At Cambridge Polymer Group, we are regularly involved with measuring NVR in medical devices to help ensure safety and compliance to standards. Contact us to have us help you with your NVR measurements.
[1] To some. To Cambridge Polymer Group, they each are a riveting subject.
Dr. Rebecca Bader is Cambridge Polymer Group’s Associate Director of Chromatography and our biocompatibility specialist. She has a PhD in Materials Science from Oregon State, a master’s in chemistry from Princeton, and has taught biomedical engineering at Syracuse University. Becky worked for CPG for four years until 2019 when she moved to the West Coast. We are thrilled that she has returned, both to the East Coast and to CPG.
How did your time away from Cambridge Polymer Group help you in your current role?
“I worked with a pharma company, doing contract research for formulations and drug delivery. I picked up some GMP skills. I decided though that I wanted to work in medical device because I really missed contract research in material science. I very much missed materials, so I took a series of NAMSA classes on 10993-18 and biocompatibility to get into the industry. I leveraged that certificate along with my previous CPG experience to apply for biocompatibility expert roles, which focused on my material science expertise combined with my knowledge of the ISO standard.
I was hired by a medical device company as a biocompatibility engineer in their Regulatory Affairs department. I was able to pick up on FDA and EU regulatory expectations, beyond just biocompatibility.
Over the past two years, I also completed some women’s leadership courses from Cornell University.”
Now that you’re back on our team, how do CPG clients benefit from your experience?
“I can now provide more regulatory input as well as biological risk assessments that are tailored to the appropriate market.”
Do you have any advice for women trying to advance in science?
“It’s OK to stand your ground and to ask for what you think you deserve. Those are both things that women struggle with inherently, a little bit. Women tend to be less confrontational. I also think it’s OK to be emotional sometimes.”
What is your favorite part of your job?
“I get to work with brilliant people who care about science and are ethical and above board. Also, I love bringing in new business related to medical device and biocomp.”
What are your favorite activities outside of the office?
“Triathlon. My gift to being an athlete is endurance. I can hold the same effort level indefinitely. I used to be a competitive marathon runner but I’ve switched to only racing Ironman where the marathons are a little slower.
I’ve been to the world championships four times now, and I’m not satisfied with how I’ve done, so I keep going back to race. This past year I had heat stroke and Covid, it was the slowest race I’ve ever done.
Running is my favorite thing in the whole world; it’s my stress release. I love training with my dogs and my person, Adam. I have springer spaniels because they’re the most hyper dogs, and they suit my personality. They run with me, they swim, they’re very Becky-like. Adam shares my love for exercise and my passion for material science.”
Becky is racing Ironman in Lake Placid this week, but she’ll be back next week, ready to apply her winning combination of expertise and endurance to your material science challenges. Feel free to reach out about your ISO 10993 needs.
Many medical devices, including surgical tools, cutting templates, trial devices, and long term implants, are produced using additive manufacturing technology via the powder bed fusion (PBF) process. PBF offers a significant benefit in medical device production by enabling the creation of highly customized and patient-specific solutions.
PBF in Medical Device Manufacture
However, this unique manufacturing process has features that require specific characterization to ensure safety and biocompatibility. PBF often results in residual powder, which is hard to remove even with the use of post processing. Powdered material on the finished device could have clinical significance depending on the quantity of powder and anatomical location of the device.
The surface texture of PBF parts can vary greatly, ranging from rough and porous to smooth and dense. The surface finish can have a significant impact on the biocompatibility and the performance of the device. Additionally, the surface finish can affect the wear characteristics and potential for corrosion or delamination. Surface characterization of the PBF process is essential to ensure the safety and efficacy of the device.
ASTM Standards for Medical Devices Made by Additive Manufacturing
ASTM is working on standards to assess residual powder on medical devices. ASTM F3335 (Standard guide for assessing the removal of residues from medical devices made by powder bed fusion) has been available for a few years. ASTM is working on a supplementary test method standard for assessing residual powder (working item WK82776).
Another standard released by ASTM is F3456, which outlines how AM manufactures will reuse unused powder so they can report this process to regulators. ASTM is also working on a guide for material process validation in AM manufactured parts (WK72659).
These standards will help ensure the safety and efficacy of AM manufactured medical devices and provide guidance for manufacturers. This guidance is critical for the development and commercialization of AM-manufactured medical devices.
Committee F04 on Medical Devices sponsored a workshop on discussion setting limits for residues on medical devices during cleaning validation on May 9, 2023 in Denver, CO. The conference was organized by Stephen Spiegelberg (Cambridge Polymer Group) and Ralph Basile (Healthmark), and included presenters from testing laboratories, device manufacturers, material manufacturers, regulators, toxicologists, and cleaning consultants.
Randy Thoma (Veeasquared) presented a historical perspective on the Sulzer Interop recall in the early 2000s, which prompted the formation of the cleaning task group in ASTM. Jeff Rufner and Ben Grosjean (Zimmer) discussed how to leverage residues in clinically-successful devices in establishing acceptance limits. Allan Kimble (J&J) focused his talk on test methods and their suitability towards patient safety.
Becky Bader (Cambridge Polymer Group) presented a summary of standards related to particulate levels and measurement techniques and gaps in this standardization. A presentation by Daniel Curtin (Edwards Lifesciences) focused on designing a cleaning validation approach for multi-component cleaning processes. Boopathy Dhanapal presented the current information on ISO standards related to cleaning and levels. Clement Cremmel (Ultraschall) described ultrasonic cleaning and examples of establishing limits in cleaning metallic devices. Reto Luginbuehl (Blaser) described chemical deformation of lubricants and the use of toxicology data to determine limits. Barbara and Ed Kanegsberg (BFK) talked about cleaning standards.
In the afternoon, Isaac Mohar (Gradient) discussed how toxicology is used to establish limits, which was continued in the next talk by Robert Mueller (Nelson Labs), who presented on the use of ISO 10993-18/17 for establishing limits. Terra Kremer (J&J) led a discussion on the using of the Spaulding classification system to establish limits for re-usable devices. The discussion of re-usables continued with a talk about cleaning dental products by Spiro Megremis (ADA Science and Research Institute), and a study of test soils for cleaning validation by Stephen Morris (Stryker).
The day finished with a talk by Terry Woods (FDA) on the FDA’s use and reliance on standards, followed by a group discussion of gaps in standards and the need for additional standards related to setting limits. This work will be conducted within task group F04.15.17.
The Environmental Protection Agency (EPA) is proposing new standards on chemicals used to sterilize medical devices, including ethylene oxide (EO/EtO), one of the more commonly used sterilants. However, ethylene oxide has recently been scrutinized due to safety concerns about workers’ EtO exposure at sterilization facilities.
The EPA is proposing a decrease in the highest allowable airborne concentration of ethylene oxide. The proposed level of EtO is 0.2 parts per million (ppm), which is lower than the current standard of 1 ppm.
This proposed standard is based on recent research that suggests that long-term exposure to an amount of EtO greater than 0.2 ppm can be hazardous to human health. The EPA also proposes that sterilization facilities must implement rigorous monitoring and reporting protocols to ensure the safety of workers and surrounding communities.
Although ethylene oxide is a toxic gas, it is an effective sterilant for many medical devices that cannot be sterilized by ionizing radiation (gamma, e-beam, or X-ray) or through steam autoclaves, due to the polymer composition of these devices.
Some trade associations are concerned about the EPA’s proposal. They believe the safety requirements will take longer than 18 months to put into place. A slowdown of EtO sterilization could affect the supply chain of billions of medical devices per year, negatively impacting patients’ access to health care.
Consider Alternative Sterilization Modalities
This slowdown may push device manufacturers to consider other sterilization modalities. CPG has expertise in radiation chemistry of polymers, as well as how temperature can affect these materials, and can assist clients in developing and validating appropriate sterilization processes for medical devices.
Medical device manufacturers who make changes in their sterilization method, process or facility outlined in their original Premarket Approval must submit a PMA supplement so that the FDA can review the changes. 510(k) holders would need to consult FDA guidance on whether a change in sterilization modality on their device would require a new 510(k) submission.
CPG’s team of materials experts can explain the complexities of the sterilization process and provide guidance on the best options to meet regulatory requirements. We can help clients evaluate sterilization modalities, and if a change in the sterilization method is required, we can provide support in filing the appropriate PMA supplement or 510(k).
Our polymer scientists can provide answers to any questions you may have and offer a comprehensive plan to ensure your medical device is compliant with FDA requirements. Contact one of our scientists today for a consultation.
