Michael Barbella, Managing Editor12.13.22
Earlier this fall, the Advanced Medical Technology Association (AdvaMed) released a fact sheet on ethylene oxide (EtO) sterilization to refute fallacies about medtech manufacturers’ preferred disinfecting method.
“A false emerging narrative suggests ethylene oxide (EtO) sterilization is ‘cheaper, easier, and faster than alternatives and thus preferred,” states the fact sheet, released Nov. 1. “Modern Healthcare called it a ‘relatively cheap process that easily penetrates products, making it an attractive choice for device makers.’”
For many device makers, EtO is the only sanitizing option due to product size, shape, design complexity, or material composition. Some materials, in fact, actually degrade under radiation or steam decontamination processes.
Consequently, EtO sterilization has gained favor with the medtech industry over the last several decades despite its high costs. AdvaMed’s fact sheet notes that ethylene oxide is “often the most expensive, time consuming, and inefficient” sterilizing method. It’s also a more harmful method for human health, given its designation as a carcinogen by the U.S. Environmental Protection Agency.
Emissions from EtO sterilization facilities have prompted concerns and lawsuits from both (neighboring) residents and state and local governments. Eliminating ethylene oxide as a cleaning tool would have disastrous public health consequences, as more than half of all medical devices undergo this method of decontamination. “Elimination of this sterilization technology would introduce the real risks of increased morbidity and mortality,” AdvaMed has stated.
ODT’s packaging and sterilization feature delves into the controversy surrounding EtO disinfection as well as the trends and market forces driving the final stages of product development. Tom Williams, general manager at Millstone Medical Outsourcing, was among the experts interviewed for this feature; his full input is provided in the following Q&A:
Michael Barbella: What are the latest trends in packaging/sterilization services?
Tom Williams: It’s been a wildly disrupted two years, and “normal” in 2022 will continue to require navigating uncertainty and strain. Supply chain pressure continues to be a major factor across industries, including orthopedics, affecting sourcing, manufacturing, coordination, and packaging. In packaging, we’re seeing some trends toward a smaller packaging footprint for certain products. For example, a wider range of orthopedics products are now being packaged in vacuum-sealed pouches, even those that would have been traditionally packaged in a thermoform tray. In addition, increasing regulatory oversight and evolving standards have created new (and sometimes significant) complexity in compliance for orthopedics. After a pandemic delay, the EU MDR went into effect in May 2021, requiring OEMs to convert packaging from non-sterile to sterile for sales in the EU. We saw some late scrambling to meet the enforcement date. In addition, ISO 13485:2016 has brought more focus to in-process testing to prove the capability of processes with continual monitoring. These changes, among others, make independent industry expertise in compliance critically important, especially in a rapidly evolving industry. In sterilization, the industry will continue adoption of X-ray sterilization for medical devices. The first U.S. facility to offer this sterilization method opened in 2021; its availability lifted some of the persistent capacity constraints related to gamma and EtO.
Barbella: What critical sterilization parameters impact packaging material selection and packaging design?
Williams: Selection of sterilization method starts with the product’s materials and properties. For instance, gamma cannot be used on products with electronic components, so these must be sterilized with hydrogen peroxide or EtO. Moreover, it’s not just how materials are affected at the time of sterilization, but also how they behave post-sterilization: plastics or polymers can become brittle and degrade over time if sterilized with gamma, or cross-linking can occur. For package design, a key consideration is whether the sterile barrier is porous or non-porous, and/or if there is an oxygen content requirement.
Barbella: What challenges, if any, do 3D printed orthopedic devices introduce into the sterilization and packaging process? Please elaborate.
Williams: Again, material is a critical factor. Many 3D-printed devices have surfaces intended to promote tissue growth. This adds complexity to how we sterilize and safely package the device. To illustrate this from a geometry standpoint, these tissue-promotion surfaces have a rougher surface, so we must address the question of whether gamma can penetrate, or a gas is needed. If we’re sending it through gamma or e-beam, we also need to consider the potential for polymer cross-linking, which can happen during these sterilization methods.
Barbella: How can supply chain-related packaging material shortages best be managed? What options are available to packaging/sterilization providers?
Williams: Material shortages have been a persistent supply chain challenge for 2020 and 2021. We all remember the early-pandemic toilet paper shortages, and how they made people behave. Shortages can compel people—and firms and suppliers—to hoard in an effect to stay ahead. This hoarding can compound the difficulties of sourcing. Because of this, a continued focus on supplier management is essential. At present, this entails having a risk-based supplier management program to establish redundant suppliers and managing the supply chain in a more strategic and less tactical way. This is about getting more granular in forecasting, lead times, and coordination, and integrating much more communication up and down the supply chain. This granularity must extend to more foresight and redundancy, too, for things that are scarcer—think about pouches, for example, which have been in short supply.
Barbella: How can packaging material changes affect the packaging and/or sterilization process? What is required from a validation standpoint?
Williams: Even minor changes like a different adhesive can have major impacts in sterile integrity and seal strength. The material we use is a key point for validation to align with ISO requirements, and changes can require revalidation. Because of ongoing supply chain problems, OEMs have considered substitutions that could be available with much shorter lead times. What they don’t always realize is that shortening a lead time might seem to be a solution, but it introduces three months or more of validation work.
Barbella: How have packaging and sterilization providers learned to better manage supply chain risk in the wake of COVID-19?
Williams: Supply chain has really been the number-one story of the last two years. And the pressure has come not only from supply chains built for efficiency and not resilience, but also from material shortages resulting from new needs like PPE and shipping delays around the world. These challenges demand that OEMs move away from tactical management and embrace a strategic approach to supply chain management that focuses on integration, emphasizes resilience over efficiency, and injects more communication touchpoints into the supply chain. These can help you understand the challenges your Tier 2 and 3 vendors are facing much earlier, enabling you to be proactive in addressing them before they derail lead times and coordination. The urgency to make this shift is real. Over the last two years, we’ve worked with an increasing number of OEMs in our Tier 1 services. In this approach to expert sourcing, we coordinate with the OEM’s chosen contract manufacturer to receive products, perform quality critical inspection, and provide best-in-class cleaning, packaging, and sterilization. This kind of expert and comprehensive approach can help OEMs weather the next storms in supply chain management.
Barbella: What kinds of alternative sterilization methods are companies embracing to reduce their dependency on EtO, given the technology’s much-publicized health/environmental risk factors?
Williams: The introduction of X-ray sterilization to the U.S. market is a game-changer for orthopedics for several reasons. It’s a more stable method. And as noted above, it doesn’t have the capacity constraints of gamma sterilization. It’s also not encumbered by the health and environmental risk factors of EtO. There’s another advantage, too. X-ray sterilization can be used on larger components and even pallets, which means devices and products can be sterilized more efficiently.
Barbella: Where is the packaging/sterilization industry (for orthopedics) headed in the next five years?
Williams: When we look two to five years out, there are a lot of exciting developments on the horizon. Robotic assisted surgery platforms are ascendent, so we’ll be seeing more of these devices come to market, and increased use in both hospital and ASC settings. Techniques like 3D printing and additive manufacturing, as well as the rise of smart or “sensorized” devices, will potentially create shifts or adaptations in the packaging and sterilization processes. More immediately, the shift of more elective surgeries to the ASC setting and the increasing use of robotic assisted surgery platforms will result in more single-use devices. This in turn will increase the demand on sterilizers and packagers. As OEMs and partners look beyond 2022, it will be essential to adopt methods with greater capacity and plan for this increased demand. This is where shifting to X-ray sterilization is likely to be critical in the near-term.
Barbella: Are there any additional comments you’d like to share regarding orthopedic medical device packaging/sterilization that ODT readers should know?
Williams: As we look back over the tumultuous last two years, we have an important opportunity to learn from what we’ve been through. Those who succeed in the orthopedic industry will be those who take the lessons of 2020 and 2021 to heart, shifting from a tactical to strategic approach to manage the supply base in a different way. Otherwise, when the next supply chain shock hits, we’ll be facing some of the same pressures and problems.
“A false emerging narrative suggests ethylene oxide (EtO) sterilization is ‘cheaper, easier, and faster than alternatives and thus preferred,” states the fact sheet, released Nov. 1. “Modern Healthcare called it a ‘relatively cheap process that easily penetrates products, making it an attractive choice for device makers.’”
For many device makers, EtO is the only sanitizing option due to product size, shape, design complexity, or material composition. Some materials, in fact, actually degrade under radiation or steam decontamination processes.
Consequently, EtO sterilization has gained favor with the medtech industry over the last several decades despite its high costs. AdvaMed’s fact sheet notes that ethylene oxide is “often the most expensive, time consuming, and inefficient” sterilizing method. It’s also a more harmful method for human health, given its designation as a carcinogen by the U.S. Environmental Protection Agency.
Emissions from EtO sterilization facilities have prompted concerns and lawsuits from both (neighboring) residents and state and local governments. Eliminating ethylene oxide as a cleaning tool would have disastrous public health consequences, as more than half of all medical devices undergo this method of decontamination. “Elimination of this sterilization technology would introduce the real risks of increased morbidity and mortality,” AdvaMed has stated.
ODT’s packaging and sterilization feature delves into the controversy surrounding EtO disinfection as well as the trends and market forces driving the final stages of product development. Tom Williams, general manager at Millstone Medical Outsourcing, was among the experts interviewed for this feature; his full input is provided in the following Q&A:
Michael Barbella: What are the latest trends in packaging/sterilization services?
Tom Williams: It’s been a wildly disrupted two years, and “normal” in 2022 will continue to require navigating uncertainty and strain. Supply chain pressure continues to be a major factor across industries, including orthopedics, affecting sourcing, manufacturing, coordination, and packaging. In packaging, we’re seeing some trends toward a smaller packaging footprint for certain products. For example, a wider range of orthopedics products are now being packaged in vacuum-sealed pouches, even those that would have been traditionally packaged in a thermoform tray. In addition, increasing regulatory oversight and evolving standards have created new (and sometimes significant) complexity in compliance for orthopedics. After a pandemic delay, the EU MDR went into effect in May 2021, requiring OEMs to convert packaging from non-sterile to sterile for sales in the EU. We saw some late scrambling to meet the enforcement date. In addition, ISO 13485:2016 has brought more focus to in-process testing to prove the capability of processes with continual monitoring. These changes, among others, make independent industry expertise in compliance critically important, especially in a rapidly evolving industry. In sterilization, the industry will continue adoption of X-ray sterilization for medical devices. The first U.S. facility to offer this sterilization method opened in 2021; its availability lifted some of the persistent capacity constraints related to gamma and EtO.
Barbella: What critical sterilization parameters impact packaging material selection and packaging design?
Williams: Selection of sterilization method starts with the product’s materials and properties. For instance, gamma cannot be used on products with electronic components, so these must be sterilized with hydrogen peroxide or EtO. Moreover, it’s not just how materials are affected at the time of sterilization, but also how they behave post-sterilization: plastics or polymers can become brittle and degrade over time if sterilized with gamma, or cross-linking can occur. For package design, a key consideration is whether the sterile barrier is porous or non-porous, and/or if there is an oxygen content requirement.
Barbella: What challenges, if any, do 3D printed orthopedic devices introduce into the sterilization and packaging process? Please elaborate.
Williams: Again, material is a critical factor. Many 3D-printed devices have surfaces intended to promote tissue growth. This adds complexity to how we sterilize and safely package the device. To illustrate this from a geometry standpoint, these tissue-promotion surfaces have a rougher surface, so we must address the question of whether gamma can penetrate, or a gas is needed. If we’re sending it through gamma or e-beam, we also need to consider the potential for polymer cross-linking, which can happen during these sterilization methods.
Barbella: How can supply chain-related packaging material shortages best be managed? What options are available to packaging/sterilization providers?
Williams: Material shortages have been a persistent supply chain challenge for 2020 and 2021. We all remember the early-pandemic toilet paper shortages, and how they made people behave. Shortages can compel people—and firms and suppliers—to hoard in an effect to stay ahead. This hoarding can compound the difficulties of sourcing. Because of this, a continued focus on supplier management is essential. At present, this entails having a risk-based supplier management program to establish redundant suppliers and managing the supply chain in a more strategic and less tactical way. This is about getting more granular in forecasting, lead times, and coordination, and integrating much more communication up and down the supply chain. This granularity must extend to more foresight and redundancy, too, for things that are scarcer—think about pouches, for example, which have been in short supply.
Barbella: How can packaging material changes affect the packaging and/or sterilization process? What is required from a validation standpoint?
Williams: Even minor changes like a different adhesive can have major impacts in sterile integrity and seal strength. The material we use is a key point for validation to align with ISO requirements, and changes can require revalidation. Because of ongoing supply chain problems, OEMs have considered substitutions that could be available with much shorter lead times. What they don’t always realize is that shortening a lead time might seem to be a solution, but it introduces three months or more of validation work.
Barbella: How have packaging and sterilization providers learned to better manage supply chain risk in the wake of COVID-19?
Williams: Supply chain has really been the number-one story of the last two years. And the pressure has come not only from supply chains built for efficiency and not resilience, but also from material shortages resulting from new needs like PPE and shipping delays around the world. These challenges demand that OEMs move away from tactical management and embrace a strategic approach to supply chain management that focuses on integration, emphasizes resilience over efficiency, and injects more communication touchpoints into the supply chain. These can help you understand the challenges your Tier 2 and 3 vendors are facing much earlier, enabling you to be proactive in addressing them before they derail lead times and coordination. The urgency to make this shift is real. Over the last two years, we’ve worked with an increasing number of OEMs in our Tier 1 services. In this approach to expert sourcing, we coordinate with the OEM’s chosen contract manufacturer to receive products, perform quality critical inspection, and provide best-in-class cleaning, packaging, and sterilization. This kind of expert and comprehensive approach can help OEMs weather the next storms in supply chain management.
Barbella: What kinds of alternative sterilization methods are companies embracing to reduce their dependency on EtO, given the technology’s much-publicized health/environmental risk factors?
Williams: The introduction of X-ray sterilization to the U.S. market is a game-changer for orthopedics for several reasons. It’s a more stable method. And as noted above, it doesn’t have the capacity constraints of gamma sterilization. It’s also not encumbered by the health and environmental risk factors of EtO. There’s another advantage, too. X-ray sterilization can be used on larger components and even pallets, which means devices and products can be sterilized more efficiently.
Barbella: Where is the packaging/sterilization industry (for orthopedics) headed in the next five years?
Williams: When we look two to five years out, there are a lot of exciting developments on the horizon. Robotic assisted surgery platforms are ascendent, so we’ll be seeing more of these devices come to market, and increased use in both hospital and ASC settings. Techniques like 3D printing and additive manufacturing, as well as the rise of smart or “sensorized” devices, will potentially create shifts or adaptations in the packaging and sterilization processes. More immediately, the shift of more elective surgeries to the ASC setting and the increasing use of robotic assisted surgery platforms will result in more single-use devices. This in turn will increase the demand on sterilizers and packagers. As OEMs and partners look beyond 2022, it will be essential to adopt methods with greater capacity and plan for this increased demand. This is where shifting to X-ray sterilization is likely to be critical in the near-term.
Barbella: Are there any additional comments you’d like to share regarding orthopedic medical device packaging/sterilization that ODT readers should know?
Williams: As we look back over the tumultuous last two years, we have an important opportunity to learn from what we’ve been through. Those who succeed in the orthopedic industry will be those who take the lessons of 2020 and 2021 to heart, shifting from a tactical to strategic approach to manage the supply base in a different way. Otherwise, when the next supply chain shock hits, we’ll be facing some of the same pressures and problems.
