Michael Barbella, Managing Editor05.07.21
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. Tom Williams, general manager at Millstone Medical Outsourcing, was among the experts interviewed for the story. His full input is provided in the following Q&A.
Michael Barbella: Please discuss the trends in packaging/sterilization services.
Tom Williams: This year brought with it unprecedented challenges and some changes for OEMs to contend with. Some of these are likely to be more lasting, while others will ultimately be temporary. For example, we’ve seen trends in lead times lengthening and a new pressure in sourcing materials in supply chains.
Other trends are more long-term. FDA and ISO standards always pose an evolving challenge for OEMs, because interpretation and the regulatory landscape can be complex. In 2019 and early 2020, the sterilization industry was very focused on the difficulties with ethylene oxide (EtO) gas. The closure of some sterilization facilities constrained capacity initially, forcing some changeover to alternate methods of sterilization. As the pandemic unfolded, it undoubtedly changed the course of the year, taking focus off of the EtO sterilization method and capacity, but it’s something that may reemerge in the future as a key trend.
Barbella: How is packaging and sterilization technology advancing to meet the needs of orthopedic manufacturers?
Williams: Over the last few years, we’ve seen a rise in the use of pre-validated and universal packaging solutions. These packaging solutions have enabled OEMs to manage risk and uphold quality while controlling costs and accelerating time to market. Innovation in the use of materials and quality processes will continue to push these solutions forward.
This year, we’ve focused on using technology as a way to work smarter. Given that manufactured batch sizes tend to be smaller within orthopedics, packaging isn’t a function we’ll ever be able to fully automate, but we can incorporate automation strategically to drive down cost while managing risk and augmenting our human capital. An example is our implementation of a proprietary vision system to ensure precise, correct alignment of assemblies. Going forward, we anticipate that automation as a complement to the human touch may open up new possibilities for innovation and efficiency.
Barbella: Why is it important for orthopedic manufacturers to consider sterilization and packaging early in the product design process?
Williams: It really comes down to three reasons. First, especially for packaging, it’s beneficial for OEMs to consider product and package design at the same time. Doing so can accelerate time to market while ensuring quality and ultimately patient safety. There can be pitfalls in the package design and validation process that can add significantly to time to market if not considered early and solved with expertise. These include testing for the stresses of distribution and the accelerated aging process.
The second reason to consider sterilization and packaging early on has to do with efficiency. Taking a strategic and proactive approach to the necessary resources and capacity puts an OEM in a much more advantageous position. Management can make better decisions about resource allocation and profitability.
Ultimately, what it comes down to is managing and minimizing risk. When you’ve baked your full spectrum of post-manufacturing needs into your planning process, you are less likely to encounter unwelcome surprises that can compromise quality and safety or delay your time to market. Of course, delayed time to market—or failure to get to market at all—puts your R&D investment and even your bottom line at risk.
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?
Williams: Millstone went into 2020 with orders from Q3 and Q4 2019 already in process. Orthopedic devices have long lead times, so these orders bridged us through the lockdown period. Because of this, we had some business continuity in place, and we turned our attention to our team, policies, and communication during this time.
We focused on our team members to ensure they were healthy physically and mentally during this stressful time. We also ensured we had the most up-to-date health and safety protocols in place to protect our team, and that we kept up with changes as they came (like mask mandates, social distancing and other safeguards). We also strove to be open, flexible, and transparent with our customers and team about challenges we were facing. As a high-growth company, we’re always working to stay ahead of our trajectory from the perspective of both people and process, and our focus remained proactive during this time.
Barbella: How can (should) packaging and sterilization providers better manage supply chain risk in the wake of the pandemic?
Williams: We’ve learned a few key lessons as an industry. Savvy OEMs have been rethinking their sourcing and considering dual sourcing as feasible. This is because we’ve all confronted supply chain vulnerabilities in goods and materials sourced from China during the pandemic. We’ve also seen how critically important communication and transparency are in supply chain coordination: you must be able to rely on your supplier, and industry expertise continues to be indispensable. Finally, we’ve also seen increased focus on forecasting accuracy. We’ve been working with OEMs and helping them understand the details and realities of forecasting, so that forecasts are developed, accurate, robust and relevant to their business.
Barbella: COVID-19 has somewhat doused the controversy surrounding EtO 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?
Williams: We anticipate that the debate will certainly continue. In 2021, a new presidential administration takes office, with a different outlook on environmental issues. This may rekindle the debate.
Barbella: Are there alternative sterilization methods being developed or available that can replace EtO with respect to scalability and material compatibility?
Williams: In early 2020, we were focused as an industry on the fixed capacity of gamma ray sterilization and on the promise of X-ray sterilization. At the time, it had only been prevalent in Europe. New investments in X-ray sterilization facilities in North America this year means that companies are seeing a future here in X-ray sterilization. This technology doesn’t have the fixed constraints of gamma ray sterilization and may prove to be a viable alternative that relieves the industry’s capacity concerns.
Barbella: How has the COVID-19 pandemic changed the packaging/sterilization industry (if at all)? Will these changes be permanent?
Williams: As the pandemic affected supply chains—and supply and demand—we definitely are seeing longer lead times on some consumable items. These tend to relate more to particular suppliers than certain materials. This is because some suppliers are supplying something in high demand during the pandemic—like resealable pouches, tubes, and swabs used in COVID-19 testing kits. As the pandemic ends, demand will ease. Ultimately, it’s important to understand what you’re getting from your suppliers and what else your suppliers are committed to, so you can anticipate and plan around it when lead times shift.
Barbella: Where do you see the packaging/sterilization industry headed in five years?
Williams: Right now, many industries and businesses are finding five years to be a very long horizon in a shifting and highly disrupted present. OEMs have had to make changes during the pandemic, so where the industry goes depends on how lasting these changes may be.
For example, during the pandemic, a lot of orthopedic surgeries are being done at ambulatory surgery centers (ASCs) or in outpatient facilities as hospitals are focused on COVID-19 cases. If an increasing number of orthopedic procedures ultimately remain in these facilities, we may see changes in how instrument sets have traditionally been reprocessed, autoclaved and cleaned. Because these outpatient facilities do not have as much space as hospitals, this change may give rise to more single-use devices. In this case, the number of packaged devices on the market would increase, and we may see higher demand for packaging services in the industry. We’ll know more at the end of 2021 than we do now.
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. Tom Williams, general manager at Millstone Medical Outsourcing, was among the experts interviewed for the story. His full input is provided in the following Q&A.
Michael Barbella: Please discuss the trends in packaging/sterilization services.
Tom Williams: This year brought with it unprecedented challenges and some changes for OEMs to contend with. Some of these are likely to be more lasting, while others will ultimately be temporary. For example, we’ve seen trends in lead times lengthening and a new pressure in sourcing materials in supply chains.
Other trends are more long-term. FDA and ISO standards always pose an evolving challenge for OEMs, because interpretation and the regulatory landscape can be complex. In 2019 and early 2020, the sterilization industry was very focused on the difficulties with ethylene oxide (EtO) gas. The closure of some sterilization facilities constrained capacity initially, forcing some changeover to alternate methods of sterilization. As the pandemic unfolded, it undoubtedly changed the course of the year, taking focus off of the EtO sterilization method and capacity, but it’s something that may reemerge in the future as a key trend.
Barbella: How is packaging and sterilization technology advancing to meet the needs of orthopedic manufacturers?
Williams: Over the last few years, we’ve seen a rise in the use of pre-validated and universal packaging solutions. These packaging solutions have enabled OEMs to manage risk and uphold quality while controlling costs and accelerating time to market. Innovation in the use of materials and quality processes will continue to push these solutions forward.
This year, we’ve focused on using technology as a way to work smarter. Given that manufactured batch sizes tend to be smaller within orthopedics, packaging isn’t a function we’ll ever be able to fully automate, but we can incorporate automation strategically to drive down cost while managing risk and augmenting our human capital. An example is our implementation of a proprietary vision system to ensure precise, correct alignment of assemblies. Going forward, we anticipate that automation as a complement to the human touch may open up new possibilities for innovation and efficiency.
Barbella: Why is it important for orthopedic manufacturers to consider sterilization and packaging early in the product design process?
Williams: It really comes down to three reasons. First, especially for packaging, it’s beneficial for OEMs to consider product and package design at the same time. Doing so can accelerate time to market while ensuring quality and ultimately patient safety. There can be pitfalls in the package design and validation process that can add significantly to time to market if not considered early and solved with expertise. These include testing for the stresses of distribution and the accelerated aging process.
The second reason to consider sterilization and packaging early on has to do with efficiency. Taking a strategic and proactive approach to the necessary resources and capacity puts an OEM in a much more advantageous position. Management can make better decisions about resource allocation and profitability.
Ultimately, what it comes down to is managing and minimizing risk. When you’ve baked your full spectrum of post-manufacturing needs into your planning process, you are less likely to encounter unwelcome surprises that can compromise quality and safety or delay your time to market. Of course, delayed time to market—or failure to get to market at all—puts your R&D investment and even your bottom line at risk.
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?
Williams: Millstone went into 2020 with orders from Q3 and Q4 2019 already in process. Orthopedic devices have long lead times, so these orders bridged us through the lockdown period. Because of this, we had some business continuity in place, and we turned our attention to our team, policies, and communication during this time.
We focused on our team members to ensure they were healthy physically and mentally during this stressful time. We also ensured we had the most up-to-date health and safety protocols in place to protect our team, and that we kept up with changes as they came (like mask mandates, social distancing and other safeguards). We also strove to be open, flexible, and transparent with our customers and team about challenges we were facing. As a high-growth company, we’re always working to stay ahead of our trajectory from the perspective of both people and process, and our focus remained proactive during this time.
Barbella: How can (should) packaging and sterilization providers better manage supply chain risk in the wake of the pandemic?
Williams: We’ve learned a few key lessons as an industry. Savvy OEMs have been rethinking their sourcing and considering dual sourcing as feasible. This is because we’ve all confronted supply chain vulnerabilities in goods and materials sourced from China during the pandemic. We’ve also seen how critically important communication and transparency are in supply chain coordination: you must be able to rely on your supplier, and industry expertise continues to be indispensable. Finally, we’ve also seen increased focus on forecasting accuracy. We’ve been working with OEMs and helping them understand the details and realities of forecasting, so that forecasts are developed, accurate, robust and relevant to their business.
Barbella: COVID-19 has somewhat doused the controversy surrounding EtO 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?
Williams: We anticipate that the debate will certainly continue. In 2021, a new presidential administration takes office, with a different outlook on environmental issues. This may rekindle the debate.
Barbella: Are there alternative sterilization methods being developed or available that can replace EtO with respect to scalability and material compatibility?
Williams: In early 2020, we were focused as an industry on the fixed capacity of gamma ray sterilization and on the promise of X-ray sterilization. At the time, it had only been prevalent in Europe. New investments in X-ray sterilization facilities in North America this year means that companies are seeing a future here in X-ray sterilization. This technology doesn’t have the fixed constraints of gamma ray sterilization and may prove to be a viable alternative that relieves the industry’s capacity concerns.
Barbella: How has the COVID-19 pandemic changed the packaging/sterilization industry (if at all)? Will these changes be permanent?
Williams: As the pandemic affected supply chains—and supply and demand—we definitely are seeing longer lead times on some consumable items. These tend to relate more to particular suppliers than certain materials. This is because some suppliers are supplying something in high demand during the pandemic—like resealable pouches, tubes, and swabs used in COVID-19 testing kits. As the pandemic ends, demand will ease. Ultimately, it’s important to understand what you’re getting from your suppliers and what else your suppliers are committed to, so you can anticipate and plan around it when lead times shift.
Barbella: Where do you see the packaging/sterilization industry headed in five years?
Williams: Right now, many industries and businesses are finding five years to be a very long horizon in a shifting and highly disrupted present. OEMs have had to make changes during the pandemic, so where the industry goes depends on how lasting these changes may be.
For example, during the pandemic, a lot of orthopedic surgeries are being done at ambulatory surgery centers (ASCs) or in outpatient facilities as hospitals are focused on COVID-19 cases. If an increasing number of orthopedic procedures ultimately remain in these facilities, we may see changes in how instrument sets have traditionally been reprocessed, autoclaved and cleaned. Because these outpatient facilities do not have as much space as hospitals, this change may give rise to more single-use devices. In this case, the number of packaged devices on the market would increase, and we may see higher demand for packaging services in the industry. We’ll know more at the end of 2021 than we do now.