Michael Barbella, Managing Editor12.09.22
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. Don Tumminelli, senior technical manager of Client Services at HIGHPOWER Validation Testing & Lab Services, 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?
Don Tumminelli: In the reusable device world there has been a shortage in sterilization wrap, which has created a logistical supply chain issue in the central service department. The quickest fix so that devices can be processed and keep devices in circulation is sourcing a rigid sterilization container. These devices are FDA-cleared for the specific sterilization mobility, similar to wraps, so if the IFU and label claims match the sterilization wrap, these can also be used in place of the warp. This is good news for the rigid container companies and not so good news for sterilization wrap companies.
Barbella: What critical sterilization parameters impact packaging material selection and packaging design?
Tumminelli: All sterilization packaging systems must undergo multiple testing to demonstrate the material to withstand the sterilization parameters, maintain sterility post processing, and also allow for the sterilant to penetrate and achieve the required sterility assurance level (SAL). When it comes to critical parameters, each modality has its limitations, so each modality should be validated separately. To put this in perspective, the more aggressive or stringent the parameters, the more vulnerable the packaging material is to break down and not be able to pass these tests. For instance, hydrogen peroxide is becoming more popular in hospitals today. These systems vary in parameters and concentration or peroxide, so the higher the concentration the more aggressive the cycle can be. While a higher concentration may increase the probability of SAL it can also decrease the ability of the material from maintaining sterility post-processing of the material degrade.
Barbella: What challenges, if any, do 3D printed orthopedic devices introduce into the sterilization and packaging process? Please elaborate.
Tumminelli: From my perspective I do not see why a 3D printed device would be treated any differently than other methods of manufacturing when it comes to sterilization and packaging. I would think all the current validation methods would also apply. Maybe the bigger challenge is integrating the 3 D printing into a manufacturing lin,e especially if manufacturing is occurring in an asepticley classified facility.
Barbella: How can supply chain-related packaging material shortages best be managed? What options are available to packaging/sterilization providers?
Tumminelli: Great question and this is happening as we speak with sterilization wrap, as discussed previously. The best way to manage is not to have a single source of packing but rather validate and/or qualify a secondary source so you are not caught off-guard if/when this happens. As mentioned there are many options to packaging including, pouches, wrap, containers, and tyvek lidded trays.
Barbella: How can packaging material changes affect the packaging and/or sterilization process? What is required from a validation standpoint?
Tumminelli: Any time there is a change in packaging, an assessment must be made to look at various aspects such as regulatory and validation. The assessment should look at the changes and determine if the change affects any specifications, claims, etc. If the charges are justified and do not significantly affect the regulatory claims and/or performance of the device, then it may be possible to move forward with a letter to file. Anything else would require revalidation activities and possibly refiling.
Barbella: How have packaging and sterilization providers learned to better manage supply chain risk in the wake of COVID-19?
Tumminelli: As much as they can in regards to resources. Of course, the biggest concern at this time is the raw material, as supply chain interruptions are still very well alive.
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?
Tumminelli: As we know the EtO concerns are still active, however, the topic has slowed a bit in light of the medical device shortages due to COVID-19. It seems that many of the devices still require EtO and the risk to processing is not greater than the risk of COVID-19. There are companies working on alternative methods as we speak, such as chlorine dioxide, hydrogen peroxide, and paramedic acid, along with newer gamma technology. I would suspect that within the next decade we will have alternatives in place for EtO for single-use devices. I believe EtO will continue to be used in healthcare for reusable devices for quite some time to come.
Barbella: Where is the packaging/sterilization industry (for orthopedics) headed in the next five years?
Tumminelli: I really do not see many changes in near future other than looking at alternative sterilization modalities for the single-use devices. I am not aware of many new packaging materials available.
Barbella: Are there any additional comments you’d like to share regarding orthopedic medical device packaging/sterilization that ODT readers should know?
Tumminelli: AAMI is working on standardizing how packaging systems used in healthcare are used for offsite transportation. For instance, there are many facilities that will outsource their cleaning and/or sterilizations of reusable devices for various reasons. This means soiled/contaminated devices will leave their facility, be processed by another facility, and returned back sterile ready to be used. This entire process of transportation between facilities is being discussed for policy and best practices. Stay tuned as AAMI committee members work through the details.
“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. Don Tumminelli, senior technical manager of Client Services at HIGHPOWER Validation Testing & Lab Services, 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?
Don Tumminelli: In the reusable device world there has been a shortage in sterilization wrap, which has created a logistical supply chain issue in the central service department. The quickest fix so that devices can be processed and keep devices in circulation is sourcing a rigid sterilization container. These devices are FDA-cleared for the specific sterilization mobility, similar to wraps, so if the IFU and label claims match the sterilization wrap, these can also be used in place of the warp. This is good news for the rigid container companies and not so good news for sterilization wrap companies.
Barbella: What critical sterilization parameters impact packaging material selection and packaging design?
Tumminelli: All sterilization packaging systems must undergo multiple testing to demonstrate the material to withstand the sterilization parameters, maintain sterility post processing, and also allow for the sterilant to penetrate and achieve the required sterility assurance level (SAL). When it comes to critical parameters, each modality has its limitations, so each modality should be validated separately. To put this in perspective, the more aggressive or stringent the parameters, the more vulnerable the packaging material is to break down and not be able to pass these tests. For instance, hydrogen peroxide is becoming more popular in hospitals today. These systems vary in parameters and concentration or peroxide, so the higher the concentration the more aggressive the cycle can be. While a higher concentration may increase the probability of SAL it can also decrease the ability of the material from maintaining sterility post-processing of the material degrade.
Barbella: What challenges, if any, do 3D printed orthopedic devices introduce into the sterilization and packaging process? Please elaborate.
Tumminelli: From my perspective I do not see why a 3D printed device would be treated any differently than other methods of manufacturing when it comes to sterilization and packaging. I would think all the current validation methods would also apply. Maybe the bigger challenge is integrating the 3 D printing into a manufacturing lin,e especially if manufacturing is occurring in an asepticley classified facility.
Barbella: How can supply chain-related packaging material shortages best be managed? What options are available to packaging/sterilization providers?
Tumminelli: Great question and this is happening as we speak with sterilization wrap, as discussed previously. The best way to manage is not to have a single source of packing but rather validate and/or qualify a secondary source so you are not caught off-guard if/when this happens. As mentioned there are many options to packaging including, pouches, wrap, containers, and tyvek lidded trays.
Barbella: How can packaging material changes affect the packaging and/or sterilization process? What is required from a validation standpoint?
Tumminelli: Any time there is a change in packaging, an assessment must be made to look at various aspects such as regulatory and validation. The assessment should look at the changes and determine if the change affects any specifications, claims, etc. If the charges are justified and do not significantly affect the regulatory claims and/or performance of the device, then it may be possible to move forward with a letter to file. Anything else would require revalidation activities and possibly refiling.
Barbella: How have packaging and sterilization providers learned to better manage supply chain risk in the wake of COVID-19?
Tumminelli: As much as they can in regards to resources. Of course, the biggest concern at this time is the raw material, as supply chain interruptions are still very well alive.
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?
Tumminelli: As we know the EtO concerns are still active, however, the topic has slowed a bit in light of the medical device shortages due to COVID-19. It seems that many of the devices still require EtO and the risk to processing is not greater than the risk of COVID-19. There are companies working on alternative methods as we speak, such as chlorine dioxide, hydrogen peroxide, and paramedic acid, along with newer gamma technology. I would suspect that within the next decade we will have alternatives in place for EtO for single-use devices. I believe EtO will continue to be used in healthcare for reusable devices for quite some time to come.
Barbella: Where is the packaging/sterilization industry (for orthopedics) headed in the next five years?
Tumminelli: I really do not see many changes in near future other than looking at alternative sterilization modalities for the single-use devices. I am not aware of many new packaging materials available.
Barbella: Are there any additional comments you’d like to share regarding orthopedic medical device packaging/sterilization that ODT readers should know?
Tumminelli: AAMI is working on standardizing how packaging systems used in healthcare are used for offsite transportation. For instance, there are many facilities that will outsource their cleaning and/or sterilizations of reusable devices for various reasons. This means soiled/contaminated devices will leave their facility, be processed by another facility, and returned back sterile ready to be used. This entire process of transportation between facilities is being discussed for policy and best practices. Stay tuned as AAMI committee members work through the details.
