Michael Barbella, Managing Editor04.07.21
It’s not over just yet.
Eclipsed for the past year by COVID-19, medtech’s long-simmering ethylene oxide (EO) controversy could soon flare up (again) as the industry grapples with alternative sterilization methods for its products.
The U.S. Environmental Protection Agency (EPA) is expected to issue a final federal rule this year limiting EO emissions from commercial medtech sterilization plants. Considered a carcinogen, EO has been used for decades to clean medical equipment—from plastic tubing and surgical instruments to hospital gowns and artificial joints. Industry experts estimate the chemical is used to sterilize roughly half of all medical equipment, as it can efficiently kill germs without harming materials.
EO’s link to various cancers and physical ailments have spawned a slew of legal action against companies that operate sterilization facilities. Sterigenics closed its plant two years ago in Willowbrook, Ill., by order of that state’s Environmental Protection Agency, and then shuttered another in Georgia in August 2019 following an investigation by the Georgia Environmental Protection Division.
The shutdowns disrupted the medical device supply chain, prompting the U.S. Food and Drug Administration (FDA) to form a task force on EO sterilization. The agency also launched an “innovation challenge” in July 2019 to develop alternatives to EO sterilization and reduce ethylene oxide emissions to “as close to zero as possible.”
Meanwhile, the EPA earlier this year determined that community-specific warnings about EO risks do not have to be made immediately. The agency—still working on the final federal rule—has committed to notifying communities about EO risks by May 31 and has posted status reports on 25 facilities previously identified as high-risk based on known EO emissions and facility location.
Orthopedic Design & Technology’s January/February feature, “The Total Package,” examines the EO- and pandemic-induced challenges and changes facing packaging and sterilization companies. Jose Arevalo, global business development manager, Tyvek Healthcare; Jennifer Benolken, CPP - MDM and regulatory specialist, packaging engineer, Tyvek Healthcare; Dan Floyd, MDM and regulatory specialist, microbiologist, Tyvek Healthcare; and Nick Packet, MDM specialist, packaging engineer, Tyvek Healthcare; at specialty products giant DuPont, were among the experts interviewed for the story. Their full input is provided in the following Q&A.
Michael Barbella: Please discuss the trends in packaging/sterilization services.
Jose Arevaldo, Jennifer Benolken, Dan Floyd, Nick Packet: There are currently two major trends in packaging: usability and sustainability. Additional topics that are on the horizon center around the use of ethylene oxide and innovation in the sterile barrier system packaging space.
Usability has come more to the forefront due to EU MDR changes, signifying the importance of packaging for successful patient outcomes. Usability often connotates user experience, but it is definitely not limited to only user experience. For the requirement in ISO 11607-1:2019, it is much more expansive. For instance, being able to demonstrate that a package has a clearly identifiable opening mechanism, is important. Another example is the requirement of being able to aseptically present the device once the package is opened—surely, how the user experiences this happening is one thing, but their ability to actually execute aseptic presentation may be something different altogether. While only having what equates to three criteria for meeting the usability requirements for packaging, usability comes across as a “simple” endeavor. However, much like those who’ve deemed medical device packaging so simple that “anyone can do it” and found it completely untrue upon trying to do it themselves, conducting a successful usability study for a medical device is much the same—there is a lot of nuance, experience, and understanding that does not come across in the supporting reference documentation—skills that most packaging engineers do not typically have in their toolbox. Because of this, the medical packaging community has been discussing whether there is need for additional guidance regarding usability—the current sentiment indicates that indeed, there is a need for additional information to help packaging professionals to be able to conduct a solid usability study—especially for those that do not have an internal human factors group within their company. Whether guidance is developed through AAMI, ISO, or ASTM hasn’t been decided, as of yet, although it is likely going to be within ASTM.
Sustainability—this can take on several meanings. On one hand, it means designing a packaging product that reduces or eliminates the risk of failure of medical devices at the point of use, which can have high penalties for high-risk procedures. Hence, packaging that can maintain a sterile barrier from manufacturing, transportation all the way through to point of use can significantly impact sustainability by reducing wastage. On the other hand, sustainability means ensuring the waste is utilized towards creating circularity in the system, reducing environmental footprint. A vast majority of non-hazardous plastic healthcare packaging waste currently ends up in municipal solid waste, because of the complexity in composition which makes recycling challenging and it’s important for the entire value chain to come together to address this issue. DuPont is a member of the Healthcare Plastics Recycling Council (HPRC), an organization that is working with the healthcare value chain (medical device industry raw material suppliers, medical device manufacturers, healthcare facilities, and re-processors) to help address these conundrums, whether it’s through helping connect hospitals to recyclers, or exploring new technologies to enable recycling of healthcare plastics.
A third dimension is addressing post industrial waste, which is where DuPont is committed to implement 4Rs (reduce, reuse, recycle and repurpose)—for instance we use our post-industrial Tyvek to fabricate cores that Tyvek is wound on. Some post-industrial waste is also utilized into healthcare infrastructure applications.
For EO sterilization services, companies are evaluating their sterilization cycles and the role packaging plays. The same is true for gamma sterilization as well—in some cases, people are moving away from gamma, but may possibly need to change packaging or product materials to allow for a different sterilization modality. The FDA has issued a challenge to the industry to develop innovative sterilization methods that reduce the need for EO, however nothing significant has been developed so far. The most promising development is the modification of EO cycles to be more efficient with lower exposure concentrations, taking less time to complete the cycle (using less EO), along with possible shift in how validations are done (move away from overkill method to BI/bioburden method). Reduction of materials used that tend to absorb EO could also be removed. There are two different options being discussed, which include packaging postponement (waiting to complete final packaging until after sterilization) and the removal of IFUs from the shelf carton.
Barbella: How is packaging and sterilization technology advancing to meet the needs of orthopedic manufacturers?
Arevaldo, Benolken, Floyd, Packet: Tyvek has always been a great material for orthopedic devices that require breathable packaging—it is strong, durable, and well suited to handle some of the heavier orthopedic devices out there.
Even with Tyvek though, there are challenges that both sterilization technology and packaging are facing, in general. These challenges make for great opportunities for the packaging and sterility assurance disciplines (as well as some other disciplines) to collaborate and innovate. High level, these opportunities include making changes to optimize sterilization (tailoring cycles for specific products vs. one-size-fits-all model, reducing EO concentration, EO exposure, etc.) and packaging (being more strategic in processing—see packaging postponement below, space used, package form, and contents contained)—both as individual activities as well as in conjunction with each other. In the past, companies have been reticent to modify existing sterilization and packaging on commercialized products, as it is often cost consuming to make the changes and does not always pay off; small tweaks as well as major changes can allow companies to save money and be more sustainable. Contrary to popular belief, it does not always have to mean downgauging the sterile barrier to accomplish these goals; we’ve seen companies maintain the amount of Tyvek they’re using (and in some cases increase it), make changes to their processing and other parts of their device/package system, and save money while also being more sustainable. These strategies are not necessarily specific to orthopedic manufacturers, but can be applied within any realm of medical devices.
Packaging postponement is a packaging strategy that some companies are looking at as a means of reducing the amount of cellulosic material in their packaging (reducing aeration time post-EO cycle)—adding the IFU (and possibly performing destination labeling at point of ship) after sterilization.
Barbella: Why is it important for orthopedic manufacturers to consider sterilization and packaging early in the product design process?
Arevaldo, Benolken, Floyd, Packet: For all sterile products, the sterile package (and sterilization) is equally as important as the device itself in the case of terminally sterile products (device + package + sterilization = sterile product). It’s a simple premise: Without a functional package and appropriate sterilization method that allow a device to be used in a sterile state, you don’t have a product. By starting earlier versus later in the design and development process, concerns regarding the device design and expected manufacturing setting (angular/sharp edges and surfaces, weight distribution, manufacturing, sterilization, equipment needed, volumes) can be brought to light without causing a (potentially major) delay in the product’s development and subsequent commercialization. Nothing is worse than having the package fail testing prior to submission and/or expected launch because there is an issue with the package. There isn’t a lot of time in any product development process to be “off” on your package design. By having the packaging voice in the room during the device design process, modifications can be made to the device to eliminate or reduce harm the device’s shape could potentially cause to the packaging (and possibly prevent additional costs in trying to create a quick fix by adding packaging at the back end of the development process to compensate for a device that is damaging the package’s ability to maintain sterility).
Barbella: How did COVID-19 impact your company? What lessons can providers like yours take from the pandemic and apply to their services going forward?
Arevaldo, Benolken, Floyd, Packet: We are monitoring and responding to the dynamic situation regarding the COVID-19 pandemic. Consistent with our core values, DuPont is also actively managing the impacts to our people and locations and are taking additional steps as the situation unfolds. Our thoughts and concern go out to those directly impacted by the virus and to first responders on the front line. This is an unsettling time for all of us.
We have focused and capable teams working this issue around the world, and we are prepared to navigate through these challenging circumstances with our Core Values at the forefront of everything we do.
There’s been an emphasis on medical and personal protection applications for Tyvek, and we are addressing the demand. New opportunities with existing and downstream customers have sprung up requiring quick action.
Barbella: How can (should) packaging and sterilization providers better manage supply chain risk in the wake of the pandemic?
Arevaldo, Benolken, Floyd, Packet: DuPont Tyvek remains committed to servicing our customer base. We are striving every day to deliver the needed supply to the COVID-19 response with DuPont Personal Protective garments and Tyvek Medical & Pharmaceutical Packaging. This is what we are and what we do. DuPont is proud to support the dedicated healthcare professionals on the frontlines as well as their patients impacted by the virus.
We are able to do this by understanding that maintaining constant contact with customers is critical—demand can shift very quickly and unpredictably based on surgical procedure volume changes or as virus surges continue to pulse through the world. Frequent communication and trust are crucial to understanding how different modes of recovery can be supported, and making potential supply chain disruptions minimal or prevented altogether.
Barbella: COVID-19 has somewhat doused the controversy surrounding EO health/environmental risk factors. Has the technology redeemed itself in light of skyrocketing demand for PPE, or is it just on the back burner for now? Will the debate resume once the pandemic is under control?
Arevaldo, Benolken, Floyd, Packet: It is highly likely the conversation has been delayed as we get through the bigger emergency of dousing the flames of the virus. Even though the discussion has been delayed, we’ve continued to discuss the situation internally. We have been and are identifying partners to study different options (as discussed in question 2) as a means of reducing the impact of any future changes associated with sterilization modalities. We understand the importance of Tyvek in our customers’ products. Discussing impacts of future packaging and sterilization changes means we will be there to address the challenges (opportunities?) as they arise.
Barbella: Are there alternative sterilization methods being developed or available that can replace EO with respect to scalability and material compatibility?
Arevaldo, Benolken, Floyd, Packet: So far, we haven’t seen a solid frontrunner alternative to EO. EO, to date, has been and continues to be the most versatile sterilization modality for medical device products. We participate in a variety of industry forums to be part of the discussion and development of what the future of sterilization will look like and test our materials for compatibility with them.
Barbella: How has the COVID-19 pandemic changed the packaging/sterilization industry (if at all)? Will these changes be permanent?
Arevaldo, Benolken, Floyd, Packet: COVID-19 has impacted every aspect of business and will most definitely have lasting imprints on how we do business into the future – including packaging and sterilization. By continuing to build our relationships with our direct and indirect customers, we are using our past experiences and pivoting as the need arises to be nimble in our response to our customers and the healthcare market.
Barbella: Where do you see the packaging/sterilization industry headed in five years?
Arevaldo, Benolken, Floyd, Packet: To look forward, we have to look backward. Not a lot (yet tons at the same time) has changed in the last five years. Tiny steps go unnoticed, but when you look at the aggregate of change that’s happened, it is clearly dramatic. In the next five years, we’ll likely still be doing many of the same things, but it will also be radically different at the same time. Changes will come in a multitude of ways—not always material focused, but as we evolve, our testing methods will evolve and change, our understanding of the subtle nuance of the science behind what we do will improve, and how we do things (process) will change—we’ll have “aha” moments as well as perplexed “how could we not have thought of this before?!” moments. It’s impossible to predict specifics, but what is guaranteed is that it will not be the same. Change is inevitable and we are ready for it.
Eclipsed for the past year by COVID-19, medtech’s long-simmering ethylene oxide (EO) controversy could soon flare up (again) as the industry grapples with alternative sterilization methods for its products.
The U.S. Environmental Protection Agency (EPA) is expected to issue a final federal rule this year limiting EO emissions from commercial medtech sterilization plants. Considered a carcinogen, EO has been used for decades to clean medical equipment—from plastic tubing and surgical instruments to hospital gowns and artificial joints. Industry experts estimate the chemical is used to sterilize roughly half of all medical equipment, as it can efficiently kill germs without harming materials.
EO’s link to various cancers and physical ailments have spawned a slew of legal action against companies that operate sterilization facilities. Sterigenics closed its plant two years ago in Willowbrook, Ill., by order of that state’s Environmental Protection Agency, and then shuttered another in Georgia in August 2019 following an investigation by the Georgia Environmental Protection Division.
The shutdowns disrupted the medical device supply chain, prompting the U.S. Food and Drug Administration (FDA) to form a task force on EO sterilization. The agency also launched an “innovation challenge” in July 2019 to develop alternatives to EO sterilization and reduce ethylene oxide emissions to “as close to zero as possible.”
Meanwhile, the EPA earlier this year determined that community-specific warnings about EO risks do not have to be made immediately. The agency—still working on the final federal rule—has committed to notifying communities about EO risks by May 31 and has posted status reports on 25 facilities previously identified as high-risk based on known EO emissions and facility location.
Orthopedic Design & Technology’s January/February feature, “The Total Package,” examines the EO- and pandemic-induced challenges and changes facing packaging and sterilization companies. Jose Arevalo, global business development manager, Tyvek Healthcare; Jennifer Benolken, CPP - MDM and regulatory specialist, packaging engineer, Tyvek Healthcare; Dan Floyd, MDM and regulatory specialist, microbiologist, Tyvek Healthcare; and Nick Packet, MDM specialist, packaging engineer, Tyvek Healthcare; at specialty products giant DuPont, were among the experts interviewed for the story. Their full input is provided in the following Q&A.
Michael Barbella: Please discuss the trends in packaging/sterilization services.
Jose Arevaldo, Jennifer Benolken, Dan Floyd, Nick Packet: There are currently two major trends in packaging: usability and sustainability. Additional topics that are on the horizon center around the use of ethylene oxide and innovation in the sterile barrier system packaging space.
Usability has come more to the forefront due to EU MDR changes, signifying the importance of packaging for successful patient outcomes. Usability often connotates user experience, but it is definitely not limited to only user experience. For the requirement in ISO 11607-1:2019, it is much more expansive. For instance, being able to demonstrate that a package has a clearly identifiable opening mechanism, is important. Another example is the requirement of being able to aseptically present the device once the package is opened—surely, how the user experiences this happening is one thing, but their ability to actually execute aseptic presentation may be something different altogether. While only having what equates to three criteria for meeting the usability requirements for packaging, usability comes across as a “simple” endeavor. However, much like those who’ve deemed medical device packaging so simple that “anyone can do it” and found it completely untrue upon trying to do it themselves, conducting a successful usability study for a medical device is much the same—there is a lot of nuance, experience, and understanding that does not come across in the supporting reference documentation—skills that most packaging engineers do not typically have in their toolbox. Because of this, the medical packaging community has been discussing whether there is need for additional guidance regarding usability—the current sentiment indicates that indeed, there is a need for additional information to help packaging professionals to be able to conduct a solid usability study—especially for those that do not have an internal human factors group within their company. Whether guidance is developed through AAMI, ISO, or ASTM hasn’t been decided, as of yet, although it is likely going to be within ASTM.
Sustainability—this can take on several meanings. On one hand, it means designing a packaging product that reduces or eliminates the risk of failure of medical devices at the point of use, which can have high penalties for high-risk procedures. Hence, packaging that can maintain a sterile barrier from manufacturing, transportation all the way through to point of use can significantly impact sustainability by reducing wastage. On the other hand, sustainability means ensuring the waste is utilized towards creating circularity in the system, reducing environmental footprint. A vast majority of non-hazardous plastic healthcare packaging waste currently ends up in municipal solid waste, because of the complexity in composition which makes recycling challenging and it’s important for the entire value chain to come together to address this issue. DuPont is a member of the Healthcare Plastics Recycling Council (HPRC), an organization that is working with the healthcare value chain (medical device industry raw material suppliers, medical device manufacturers, healthcare facilities, and re-processors) to help address these conundrums, whether it’s through helping connect hospitals to recyclers, or exploring new technologies to enable recycling of healthcare plastics.
A third dimension is addressing post industrial waste, which is where DuPont is committed to implement 4Rs (reduce, reuse, recycle and repurpose)—for instance we use our post-industrial Tyvek to fabricate cores that Tyvek is wound on. Some post-industrial waste is also utilized into healthcare infrastructure applications.
For EO sterilization services, companies are evaluating their sterilization cycles and the role packaging plays. The same is true for gamma sterilization as well—in some cases, people are moving away from gamma, but may possibly need to change packaging or product materials to allow for a different sterilization modality. The FDA has issued a challenge to the industry to develop innovative sterilization methods that reduce the need for EO, however nothing significant has been developed so far. The most promising development is the modification of EO cycles to be more efficient with lower exposure concentrations, taking less time to complete the cycle (using less EO), along with possible shift in how validations are done (move away from overkill method to BI/bioburden method). Reduction of materials used that tend to absorb EO could also be removed. There are two different options being discussed, which include packaging postponement (waiting to complete final packaging until after sterilization) and the removal of IFUs from the shelf carton.
Barbella: How is packaging and sterilization technology advancing to meet the needs of orthopedic manufacturers?
Arevaldo, Benolken, Floyd, Packet: Tyvek has always been a great material for orthopedic devices that require breathable packaging—it is strong, durable, and well suited to handle some of the heavier orthopedic devices out there.
Even with Tyvek though, there are challenges that both sterilization technology and packaging are facing, in general. These challenges make for great opportunities for the packaging and sterility assurance disciplines (as well as some other disciplines) to collaborate and innovate. High level, these opportunities include making changes to optimize sterilization (tailoring cycles for specific products vs. one-size-fits-all model, reducing EO concentration, EO exposure, etc.) and packaging (being more strategic in processing—see packaging postponement below, space used, package form, and contents contained)—both as individual activities as well as in conjunction with each other. In the past, companies have been reticent to modify existing sterilization and packaging on commercialized products, as it is often cost consuming to make the changes and does not always pay off; small tweaks as well as major changes can allow companies to save money and be more sustainable. Contrary to popular belief, it does not always have to mean downgauging the sterile barrier to accomplish these goals; we’ve seen companies maintain the amount of Tyvek they’re using (and in some cases increase it), make changes to their processing and other parts of their device/package system, and save money while also being more sustainable. These strategies are not necessarily specific to orthopedic manufacturers, but can be applied within any realm of medical devices.
Packaging postponement is a packaging strategy that some companies are looking at as a means of reducing the amount of cellulosic material in their packaging (reducing aeration time post-EO cycle)—adding the IFU (and possibly performing destination labeling at point of ship) after sterilization.
Barbella: Why is it important for orthopedic manufacturers to consider sterilization and packaging early in the product design process?
Arevaldo, Benolken, Floyd, Packet: For all sterile products, the sterile package (and sterilization) is equally as important as the device itself in the case of terminally sterile products (device + package + sterilization = sterile product). It’s a simple premise: Without a functional package and appropriate sterilization method that allow a device to be used in a sterile state, you don’t have a product. By starting earlier versus later in the design and development process, concerns regarding the device design and expected manufacturing setting (angular/sharp edges and surfaces, weight distribution, manufacturing, sterilization, equipment needed, volumes) can be brought to light without causing a (potentially major) delay in the product’s development and subsequent commercialization. Nothing is worse than having the package fail testing prior to submission and/or expected launch because there is an issue with the package. There isn’t a lot of time in any product development process to be “off” on your package design. By having the packaging voice in the room during the device design process, modifications can be made to the device to eliminate or reduce harm the device’s shape could potentially cause to the packaging (and possibly prevent additional costs in trying to create a quick fix by adding packaging at the back end of the development process to compensate for a device that is damaging the package’s ability to maintain sterility).
Barbella: How did COVID-19 impact your company? What lessons can providers like yours take from the pandemic and apply to their services going forward?
Arevaldo, Benolken, Floyd, Packet: We are monitoring and responding to the dynamic situation regarding the COVID-19 pandemic. Consistent with our core values, DuPont is also actively managing the impacts to our people and locations and are taking additional steps as the situation unfolds. Our thoughts and concern go out to those directly impacted by the virus and to first responders on the front line. This is an unsettling time for all of us.
We have focused and capable teams working this issue around the world, and we are prepared to navigate through these challenging circumstances with our Core Values at the forefront of everything we do.
There’s been an emphasis on medical and personal protection applications for Tyvek, and we are addressing the demand. New opportunities with existing and downstream customers have sprung up requiring quick action.
Barbella: How can (should) packaging and sterilization providers better manage supply chain risk in the wake of the pandemic?
Arevaldo, Benolken, Floyd, Packet: DuPont Tyvek remains committed to servicing our customer base. We are striving every day to deliver the needed supply to the COVID-19 response with DuPont Personal Protective garments and Tyvek Medical & Pharmaceutical Packaging. This is what we are and what we do. DuPont is proud to support the dedicated healthcare professionals on the frontlines as well as their patients impacted by the virus.
We are able to do this by understanding that maintaining constant contact with customers is critical—demand can shift very quickly and unpredictably based on surgical procedure volume changes or as virus surges continue to pulse through the world. Frequent communication and trust are crucial to understanding how different modes of recovery can be supported, and making potential supply chain disruptions minimal or prevented altogether.
Barbella: COVID-19 has somewhat doused the controversy surrounding EO health/environmental risk factors. Has the technology redeemed itself in light of skyrocketing demand for PPE, or is it just on the back burner for now? Will the debate resume once the pandemic is under control?
Arevaldo, Benolken, Floyd, Packet: It is highly likely the conversation has been delayed as we get through the bigger emergency of dousing the flames of the virus. Even though the discussion has been delayed, we’ve continued to discuss the situation internally. We have been and are identifying partners to study different options (as discussed in question 2) as a means of reducing the impact of any future changes associated with sterilization modalities. We understand the importance of Tyvek in our customers’ products. Discussing impacts of future packaging and sterilization changes means we will be there to address the challenges (opportunities?) as they arise.
Barbella: Are there alternative sterilization methods being developed or available that can replace EO with respect to scalability and material compatibility?
Arevaldo, Benolken, Floyd, Packet: So far, we haven’t seen a solid frontrunner alternative to EO. EO, to date, has been and continues to be the most versatile sterilization modality for medical device products. We participate in a variety of industry forums to be part of the discussion and development of what the future of sterilization will look like and test our materials for compatibility with them.
Barbella: How has the COVID-19 pandemic changed the packaging/sterilization industry (if at all)? Will these changes be permanent?
Arevaldo, Benolken, Floyd, Packet: COVID-19 has impacted every aspect of business and will most definitely have lasting imprints on how we do business into the future – including packaging and sterilization. By continuing to build our relationships with our direct and indirect customers, we are using our past experiences and pivoting as the need arises to be nimble in our response to our customers and the healthcare market.
Barbella: Where do you see the packaging/sterilization industry headed in five years?
Arevaldo, Benolken, Floyd, Packet: To look forward, we have to look backward. Not a lot (yet tons at the same time) has changed in the last five years. Tiny steps go unnoticed, but when you look at the aggregate of change that’s happened, it is clearly dramatic. In the next five years, we’ll likely still be doing many of the same things, but it will also be radically different at the same time. Changes will come in a multitude of ways—not always material focused, but as we evolve, our testing methods will evolve and change, our understanding of the subtle nuance of the science behind what we do will improve, and how we do things (process) will change—we’ll have “aha” moments as well as perplexed “how could we not have thought of this before?!” moments. It’s impossible to predict specifics, but what is guaranteed is that it will not be the same. Change is inevitable and we are ready for it.
