Sam Brusco, Associate Editor09.16.22
Orthopedic devices in the development pathway have more to be evaluated than ever before. Regulatory agencies expect that polymeric materials will be screened for low molecular weight impurities as well as additives like residual monomers and solvents, light stabilizers, and antioxidants.
The U.S. Food and Drug Administration (FDA) is also requiring more detailed material compatibility and device cleaning studies. In addition, packaging is subject to increased scrutiny to include usability testing and environmental impact. Many standards are being rewritten as well, with regulatory agencies more willing to accept novel analytical techniques.
Regulatory bodies are also building a stronger understanding of the complexities of chemistry testing to perform toxicological risk assessment and biocompatibility. Testing laboratories must therefore be at the forefront of analytical knowledge to partner with orthopedic device makers.
To better identify and assess the market trends, forces, and challenges in orthopedic device testing and analysis, ODT spoke with the following industry experts over the past few weeks:
Sam Brusco: How are trends in medical/orthopedic devices affecting testing and analysis services?
Peter Bailey & Landon Goldfarb: Across all industries, the variety of testing applications and overall testing volume is on the rise. In the medical device industry specifically, the advent of “smart” devices such as wearable sensors and closed-loop drug delivery systems (i.e., continuous glucose monitors and insulin pumps) has ushered in new testing requirements around electrical components such as PCB boards and connectors. These complex components often require specialized fixturing and additional integrated measurement devices, such as voltage or resistance meters. Testing volume has also been increasing due to widespread supply chain issues; many companies are now employing dual sourcing strategies to better prepare for potential shortages and many are researching alternative production methods like additive manufacturing (AM) to circumvent delays related to traditional manufacturing. All of these situations require new material and component validation and testing on a massive scale.
Orthopedic medicine in particular is being heavily impacted by advances in AM, which makes it possible to easily produce customized products—something that traditional manufacturing does not do well. One example is bone plates used for maxillofacial surgery, where parts need to be carefully tailored to the patient and are typically developed from detailed scans. However, AM parts also require more testing compared to traditionally manufactured parts. Furthermore, while the performance of AM parts is thoroughly understood in regards to static testing, there are still questions to be answered regarding the long-term effects of microscopic defects as determined by fatigue loading and fracture toughness testing.
John Nino: Short staffing and supply chain issues at vendors can lead to long turnaround times. Manufacturers need to qualify alternative vendors or bring services in-house. Between ethylene oxide (EO) sterilizer shutdowns, the pandemic, and remediation for EU MDR, there has been an increase in demand for sterilization validation and re-qualification. For medical package testing, many sample sizes are increasing from 30 to 60—particularly for high-risk implant products.
Thor Rollins: One of the biggest recent trends that have impacted medical/orthopedic devices is around supply chain issues. In my 20 years of testing medical devices, I have never seen so many change evaluations. Being their supplier changes the material themselves or they cannot provide the material anymore, so sourcing an alternative material becomes needed. We are seeing issues with raw materials, packaging, and even processing chemicals. We are evaluating the impacts of these changes more now than ever.
Christopher Scott: The incorporation of electronic and computerized elements into the orthopedic industry have introduced a new world of testing requirements for companies. The days of running through a checklist of standardized testing to complete the DIVVL requirements for a design history file are gone. Much more thoughtful risk analyses are now needed to develop a robust testing program and ensure the safety and efficacy of the new device and system design.
Don Tumminelli: The push and enforcement of the FDA to have medical device manufacturers (MDMs) validate their reprocessing instructions has led to many companies being caught off guard during regulatory audits and/or CE marking with notified bodies. Some companies find themselves in these situations while acquiring other companies and/or product lines. If you are acquiring another company or product, you also acquire their regulatory practices and procedures. Before making that purchase a subject matter expert should look into the Instructions For Use (IFU) and make sure the reprocessing is validated. Otherwise, you may find yourself spending a lot of time and money playing catch up. At the end of the day, if you have a reusable device, the specific instructions for how to reprocess the device between patients must be outlined in the IFU, then backed up by a validation or justification to assure patient safety.
Brusco: What technological innovations and/or new equipment offerings have impacted your testing services/equipment business?
Bailey & Goldfarb: Across the industry, the additional volume of testing has prompted an increase in demand for automated or semi-automated testing systems. More and more frequently, companies are designing testing programs to account for additional volume in the future. Identifying the pains around manual testing has led to a full suite of automation options, from XY stages to collaborative robots being used in conjunction with a standard test system. In addition, many manufacturers are interested in implementing Industry 4.0 tools in their manufacturing operations, requiring full integration of the automated test systems into their production line. Understanding the variety of Manufacturing Execution Systems [MES] used within the industry has been essential to provide the communication necessary to enable closed loop feedback, utilizing test results to optimize upstream process parameters.
Nino: Environmentally sustainable, low-EO cycles are to be the new norm in sterilization. LSO partners with contract sterilizers to develop new cycles that reduce EO usage by about half. We also offer small-batch in-house EO sterilization at just 170g EO per run. The 3M model GS8X EO sterilizer offers more customization for sterilization cycles than the previous model, which greatly helps in troubleshooting (e.g., blown package seals, wet packages, discolored labels, high EO residuals).
Rollins: We are still seeing a slow but constant shift to in-vitro alternative testing. Most regulatory agencies have initiatives to replace animal testing. With that, there are many advances in the realms of in-vitro alternatives. The challenge is to standardize and get global acceptance of these new test methods.
Tumminelli: At this time, there hasn’t been a huge change in the equipment used to reprocess medical devices. In the world of device cleaning, many companies keep developing washer disinfectors that are more efficient and offer more capability to clean more types of devices so hospitals have faster turnaround between uses. If dealing with CE marking or the EU, be ready to validate thermal disinfection using the Ao method. ISO 10993 outlines specific levels of Ao and this disinfection step has been coined "interim disinfection” to help protect the user more than the patient when it comes to disinfection. Regarding sterilization, there is a large interest in low-temperature sterilization, with hydrogen peroxide being the new leader. There are many choices on the market now to choose from to reprocess the most heat-sensitive and delicate devices.
Brusco: How have recent FDA guidelines impacted device testing requirements and/or methodologies?
Bailey & Goldfarb: Guidelines on cardiovascular stents have shifted toward increasingly far-reaching modeling and underpinning data. While this does not take away the relevance of traditional “test to success” methodologies, it has significantly expanded the expected burden of proof in developing the design, which includes collecting more data about material and element performance. These expectations are now extending to other types of devices, which could mean a more widespread need to evaluate characteristics such as fatigue-life relationships and effects of biaxial stresses.
Dr. David Locke: On April 11, 2022, FDA issued guidance on Orthopedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway Guidance for Industry. This guidance provides performance criteria for orthopedic fracture fixation plates in support of the Safety and Performance Based Pathway. The Safety and Performance Based Pathway applies to certain, well understood device types, where a submitter would demonstrate a new device meets FDA-identified performance criteria to demonstrate the device is as safe and effective as a legally marketed device. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for orthopedic fracture fixation plates will have the option to use the performance criteria proposed in their issued guidance (such as the one above) to support substantial equivalence, rather than a direct comparison of the performance of the subject device to a predicate device.
This guidance document is relevant due to FDA recognizing in some cases, it may be more burdensome for a submitter to conduct testing against an appropriate predicate device to demonstrate equivalence for the necessary set of performance and technological characteristics, than to demonstrate their device meets appropriate performance criteria established by FDA. Accordingly, FDA concluded the optional device-specific Safety and Performance Based Pathway utilizing the performance criteria identified in this guidance provides a less burdensome policy consistent with the public health.
Nino: For sterilization, ISO 10993-7:2008/Amd.1:2019, Applicability of allowable limits for neonates and infants, was recognized by the FDA in 2020. Previously, EO residual limits were set with the assumption that devices will only be used on 70kg adult males. Device manufacturers are now expected to set limits based on patient population demographics and device use.
For medical package testing, ASTM F1980-21, Standard guide for accelerated aging of sterile barrier systems and medical devices, recognized in May 2022, has a transition period until July 9, 2023. Now, manufacturers must incorporate how relative humidity affects devices, whether negatively or positively; it has to do with the device.
Rollins: The biggest impact we have seen is around extractable and leachable testing. It’s a relatively new science for medical devices—although not new for pharma or food—and there is a new standard out (ISO 10993-18) to try to help give guidance, but it also carries increased scrutiny with the FDA. Because test methods are variable from lab to lab and the standardization doesn’t exist yet, we are seeing much more attention from the FDA on the methods themselves.
Scott: The FDA has been placing a greater focus on data integrity for laboratories, particularly around electronic data. The impact for laboratories is the additional level of internal IT expertise now required to ensure the computerized management of laboratory generated test data is fully compliant with Part 11 regulations and ALCOA+ data recording principles.
Tumminelli: At this time, the FDA guidance document for reprocessing devices is the gold standard to ensure and enforce that reprocessing instructions are validated. In this document there is guidance on cleaning, disinfection, and sterilization requirements that an MDM would need to comply with. This document was first published in 2015 but continues to be the document used most and referenced in deficiencies when reprocessing is lacking or not validated. Once again, many MDMs have been caught off guard during a submission with either inadequate validation or no validation at all. Dry time validations seem to be one study missed most often. If you have a steam sterilization cycle in your IFU, be prepared to validate the drying time associated with reprocessing your orthopedic set.
Brusco: What changes do you expect for device testing and analysis in the coming years?
Bailey & Goldfarb: One of the most prominent trends is the production of smaller and smaller devices. Micro-electrical mechanical systems (MEMS) are increasingly finding their way into medical devices and implants. For example, this technology can add more functionality into orthopedic implants, providing real-time force data to offer the patient suggestions about body posture and estimate implant fatigue. Evaluating the functionality of these devices will require analyzing micro forces and displacements as well as micron-level repeatability to test various locations on these components. Visual analysis will also increasingly be required to properly evaluate the failure mechanism of these devices, adding an additional layer of analysis beyond simple numerical results.
Dr. Locke: Thanks to the increasing complexity of medical devices, coupled with evolving manufacturing technologies, new materials, and more stringent regulations, medical device testing and analysis is booming. With this in mind, it’s safe to say areas such as contact sports, where the speed and violence of person-to-person contact is increasing significantly, will continue to drive the demand for new and innovative orthopedic and sports injury devices. This, in turn, will no doubt lead to “increased” premarket and post-market testing of these new devices. One can expect future orthopedic device testing will include the normal standardized testing (e.g., biocompatibility, sterilization, stability) but we can also expect new testing requirements to appear that are yet to be standardized, such as testing for products that contain new and unique forms of software and/or artificial intelligence (AI). Although the goal of both organizations and regulators is to reduce the burdensome nature of pre and post-market testing, orthopedic device manufacturers should not expect a reduction in testing anytime soon but instead should plan for the traditional device testing required for premarket approval—while also keeping an eye out for new forms of testing that just might become the new normal in the not-too-distant future.
Nino: For sterilization, in the last three years, regulators have been looking more closely at Ethylene Oxide (EO) residuals. With lower limits in ISO 10993-7:2008/Amd.1:2019, we need to be smarter about how we test devices and get the testing done right the first time. I expect to see more product-specific protocols for testing EO residuals. There are too many devices being tested under incorrect assumptions. Manufacturers should only be testing the portions that contact the patient, using extraction conditions that represent realistic worst-case exposure.
For medical package testing, we expect changes in new materials due to pandemic-related shortages, which will lead to more validations being performed.
Rollins: I see more standardization in extractable and leachable testing and more global acceptance of in-vitro alternatives.
Scott: As testing requirements continue to proliferate, manufacturers will find great value in partnering with laboratories that are able to provide a broad range of testing services and can reduce the need to coordinate with different service providers. Additionally, large global device companies will seek to partner with laboratories that operate on an equivalent scale, are able to provide testing in the multiple regions they conduct business, and have regulatory expertise in the necessary areas.
Tumminelli: AAMI has just published an actual cleaning standard called AAMI ST98. I expect the FDA to immediately recognize and enforce this standard as it has been in the works for a long time. AAMI standards have a six-month grace period to ease into but I wouldn’t be surprised if the FDA will enforce sooner than that. There are some new requirements revealed and manufacturers will need to work with testing labs for interpretation when developing validation protocols. If working with a pre-submission, that would be a good time to tackle and run the test protocol by the FDA.
Brusco: Is there anything else you’d like to say regarding the subject?
Nino: TÜV has free checklists on its website for manufacturers to check their compliance.
Tumminelli: AAMI has been working on a new TIR 109 that will outline requirements for offsite transportation of reprocessed devices. For instance, if a sterile processing department would like to outsource or use a partner facility to help reprocess their devices, there needs to be a safe way to get the contaminated and/or sterile devices back and forth from the facilities. This document will address how to contain and control many aspects associated with temperature and humidity control, as well as package integrity during the transportation. This could apply to loaner sets, etc. as they move from facility to facility.
The U.S. Food and Drug Administration (FDA) is also requiring more detailed material compatibility and device cleaning studies. In addition, packaging is subject to increased scrutiny to include usability testing and environmental impact. Many standards are being rewritten as well, with regulatory agencies more willing to accept novel analytical techniques.
Regulatory bodies are also building a stronger understanding of the complexities of chemistry testing to perform toxicological risk assessment and biocompatibility. Testing laboratories must therefore be at the forefront of analytical knowledge to partner with orthopedic device makers.
To better identify and assess the market trends, forces, and challenges in orthopedic device testing and analysis, ODT spoke with the following industry experts over the past few weeks:
- Peter Bailey, principal scientist—dynamic applications and Landon Goldfarb, biomedical market manager at Instron, a Norwood, Mass.-based manufacturer of tensile, compression, fatigue, impact, rheology, and structural testing machines as well as services for calibration, verification, training, technical support, and assistance with laboratory management.
- Dr. David Locke, chief clinical research officer at Canyon Labs, a Bluffdale, Utah-based firm that offers a wide range of microbiology and chemistry lab testing services that meet or exceed regulatory and industry standards.
- John Nino, CEO of Life Science Outsourcing, a Brea, Calif.-based FDA-registered and ISO 13485-certified organization with services and capabilities spanning the complete product lifecycle.
- Thor S. Rollins B.S. RM (NRCM), director of toxicology and E&L consulting at Nelson Laboratories, a Salt Lake City, Utah-based global provider of laboratory testing and expert advisory services for medtech and pharmaceutical companies.
- Christopher Scott, VP of Eurofins Medical Device Testing, a Lancaster, Pa.-based network of laboratories that provides the optimal testing strategy for all types of class I, II, and III medical devices.
- Don Tumminelli, senior technical manager, client services at HIGHPOWER Validation Testing & Lab Services, a Rochester, N.Y.-based validation and testing laboratory serving the medical, dental, pharmaceutical, and industrial industries.
Sam Brusco: How are trends in medical/orthopedic devices affecting testing and analysis services?
Peter Bailey & Landon Goldfarb: Across all industries, the variety of testing applications and overall testing volume is on the rise. In the medical device industry specifically, the advent of “smart” devices such as wearable sensors and closed-loop drug delivery systems (i.e., continuous glucose monitors and insulin pumps) has ushered in new testing requirements around electrical components such as PCB boards and connectors. These complex components often require specialized fixturing and additional integrated measurement devices, such as voltage or resistance meters. Testing volume has also been increasing due to widespread supply chain issues; many companies are now employing dual sourcing strategies to better prepare for potential shortages and many are researching alternative production methods like additive manufacturing (AM) to circumvent delays related to traditional manufacturing. All of these situations require new material and component validation and testing on a massive scale.
Orthopedic medicine in particular is being heavily impacted by advances in AM, which makes it possible to easily produce customized products—something that traditional manufacturing does not do well. One example is bone plates used for maxillofacial surgery, where parts need to be carefully tailored to the patient and are typically developed from detailed scans. However, AM parts also require more testing compared to traditionally manufactured parts. Furthermore, while the performance of AM parts is thoroughly understood in regards to static testing, there are still questions to be answered regarding the long-term effects of microscopic defects as determined by fatigue loading and fracture toughness testing.
John Nino: Short staffing and supply chain issues at vendors can lead to long turnaround times. Manufacturers need to qualify alternative vendors or bring services in-house. Between ethylene oxide (EO) sterilizer shutdowns, the pandemic, and remediation for EU MDR, there has been an increase in demand for sterilization validation and re-qualification. For medical package testing, many sample sizes are increasing from 30 to 60—particularly for high-risk implant products.
Thor Rollins: One of the biggest recent trends that have impacted medical/orthopedic devices is around supply chain issues. In my 20 years of testing medical devices, I have never seen so many change evaluations. Being their supplier changes the material themselves or they cannot provide the material anymore, so sourcing an alternative material becomes needed. We are seeing issues with raw materials, packaging, and even processing chemicals. We are evaluating the impacts of these changes more now than ever.
Christopher Scott: The incorporation of electronic and computerized elements into the orthopedic industry have introduced a new world of testing requirements for companies. The days of running through a checklist of standardized testing to complete the DIVVL requirements for a design history file are gone. Much more thoughtful risk analyses are now needed to develop a robust testing program and ensure the safety and efficacy of the new device and system design.
Don Tumminelli: The push and enforcement of the FDA to have medical device manufacturers (MDMs) validate their reprocessing instructions has led to many companies being caught off guard during regulatory audits and/or CE marking with notified bodies. Some companies find themselves in these situations while acquiring other companies and/or product lines. If you are acquiring another company or product, you also acquire their regulatory practices and procedures. Before making that purchase a subject matter expert should look into the Instructions For Use (IFU) and make sure the reprocessing is validated. Otherwise, you may find yourself spending a lot of time and money playing catch up. At the end of the day, if you have a reusable device, the specific instructions for how to reprocess the device between patients must be outlined in the IFU, then backed up by a validation or justification to assure patient safety.
Brusco: What technological innovations and/or new equipment offerings have impacted your testing services/equipment business?
Bailey & Goldfarb: Across the industry, the additional volume of testing has prompted an increase in demand for automated or semi-automated testing systems. More and more frequently, companies are designing testing programs to account for additional volume in the future. Identifying the pains around manual testing has led to a full suite of automation options, from XY stages to collaborative robots being used in conjunction with a standard test system. In addition, many manufacturers are interested in implementing Industry 4.0 tools in their manufacturing operations, requiring full integration of the automated test systems into their production line. Understanding the variety of Manufacturing Execution Systems [MES] used within the industry has been essential to provide the communication necessary to enable closed loop feedback, utilizing test results to optimize upstream process parameters.
Nino: Environmentally sustainable, low-EO cycles are to be the new norm in sterilization. LSO partners with contract sterilizers to develop new cycles that reduce EO usage by about half. We also offer small-batch in-house EO sterilization at just 170g EO per run. The 3M model GS8X EO sterilizer offers more customization for sterilization cycles than the previous model, which greatly helps in troubleshooting (e.g., blown package seals, wet packages, discolored labels, high EO residuals).
Rollins: We are still seeing a slow but constant shift to in-vitro alternative testing. Most regulatory agencies have initiatives to replace animal testing. With that, there are many advances in the realms of in-vitro alternatives. The challenge is to standardize and get global acceptance of these new test methods.
Tumminelli: At this time, there hasn’t been a huge change in the equipment used to reprocess medical devices. In the world of device cleaning, many companies keep developing washer disinfectors that are more efficient and offer more capability to clean more types of devices so hospitals have faster turnaround between uses. If dealing with CE marking or the EU, be ready to validate thermal disinfection using the Ao method. ISO 10993 outlines specific levels of Ao and this disinfection step has been coined "interim disinfection” to help protect the user more than the patient when it comes to disinfection. Regarding sterilization, there is a large interest in low-temperature sterilization, with hydrogen peroxide being the new leader. There are many choices on the market now to choose from to reprocess the most heat-sensitive and delicate devices.
Brusco: How have recent FDA guidelines impacted device testing requirements and/or methodologies?
Bailey & Goldfarb: Guidelines on cardiovascular stents have shifted toward increasingly far-reaching modeling and underpinning data. While this does not take away the relevance of traditional “test to success” methodologies, it has significantly expanded the expected burden of proof in developing the design, which includes collecting more data about material and element performance. These expectations are now extending to other types of devices, which could mean a more widespread need to evaluate characteristics such as fatigue-life relationships and effects of biaxial stresses.
Dr. David Locke: On April 11, 2022, FDA issued guidance on Orthopedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway Guidance for Industry. This guidance provides performance criteria for orthopedic fracture fixation plates in support of the Safety and Performance Based Pathway. The Safety and Performance Based Pathway applies to certain, well understood device types, where a submitter would demonstrate a new device meets FDA-identified performance criteria to demonstrate the device is as safe and effective as a legally marketed device. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for orthopedic fracture fixation plates will have the option to use the performance criteria proposed in their issued guidance (such as the one above) to support substantial equivalence, rather than a direct comparison of the performance of the subject device to a predicate device.
This guidance document is relevant due to FDA recognizing in some cases, it may be more burdensome for a submitter to conduct testing against an appropriate predicate device to demonstrate equivalence for the necessary set of performance and technological characteristics, than to demonstrate their device meets appropriate performance criteria established by FDA. Accordingly, FDA concluded the optional device-specific Safety and Performance Based Pathway utilizing the performance criteria identified in this guidance provides a less burdensome policy consistent with the public health.
Nino: For sterilization, ISO 10993-7:2008/Amd.1:2019, Applicability of allowable limits for neonates and infants, was recognized by the FDA in 2020. Previously, EO residual limits were set with the assumption that devices will only be used on 70kg adult males. Device manufacturers are now expected to set limits based on patient population demographics and device use.
For medical package testing, ASTM F1980-21, Standard guide for accelerated aging of sterile barrier systems and medical devices, recognized in May 2022, has a transition period until July 9, 2023. Now, manufacturers must incorporate how relative humidity affects devices, whether negatively or positively; it has to do with the device.
Rollins: The biggest impact we have seen is around extractable and leachable testing. It’s a relatively new science for medical devices—although not new for pharma or food—and there is a new standard out (ISO 10993-18) to try to help give guidance, but it also carries increased scrutiny with the FDA. Because test methods are variable from lab to lab and the standardization doesn’t exist yet, we are seeing much more attention from the FDA on the methods themselves.
Scott: The FDA has been placing a greater focus on data integrity for laboratories, particularly around electronic data. The impact for laboratories is the additional level of internal IT expertise now required to ensure the computerized management of laboratory generated test data is fully compliant with Part 11 regulations and ALCOA+ data recording principles.
Tumminelli: At this time, the FDA guidance document for reprocessing devices is the gold standard to ensure and enforce that reprocessing instructions are validated. In this document there is guidance on cleaning, disinfection, and sterilization requirements that an MDM would need to comply with. This document was first published in 2015 but continues to be the document used most and referenced in deficiencies when reprocessing is lacking or not validated. Once again, many MDMs have been caught off guard during a submission with either inadequate validation or no validation at all. Dry time validations seem to be one study missed most often. If you have a steam sterilization cycle in your IFU, be prepared to validate the drying time associated with reprocessing your orthopedic set.
Brusco: What changes do you expect for device testing and analysis in the coming years?
Bailey & Goldfarb: One of the most prominent trends is the production of smaller and smaller devices. Micro-electrical mechanical systems (MEMS) are increasingly finding their way into medical devices and implants. For example, this technology can add more functionality into orthopedic implants, providing real-time force data to offer the patient suggestions about body posture and estimate implant fatigue. Evaluating the functionality of these devices will require analyzing micro forces and displacements as well as micron-level repeatability to test various locations on these components. Visual analysis will also increasingly be required to properly evaluate the failure mechanism of these devices, adding an additional layer of analysis beyond simple numerical results.
Dr. Locke: Thanks to the increasing complexity of medical devices, coupled with evolving manufacturing technologies, new materials, and more stringent regulations, medical device testing and analysis is booming. With this in mind, it’s safe to say areas such as contact sports, where the speed and violence of person-to-person contact is increasing significantly, will continue to drive the demand for new and innovative orthopedic and sports injury devices. This, in turn, will no doubt lead to “increased” premarket and post-market testing of these new devices. One can expect future orthopedic device testing will include the normal standardized testing (e.g., biocompatibility, sterilization, stability) but we can also expect new testing requirements to appear that are yet to be standardized, such as testing for products that contain new and unique forms of software and/or artificial intelligence (AI). Although the goal of both organizations and regulators is to reduce the burdensome nature of pre and post-market testing, orthopedic device manufacturers should not expect a reduction in testing anytime soon but instead should plan for the traditional device testing required for premarket approval—while also keeping an eye out for new forms of testing that just might become the new normal in the not-too-distant future.
Nino: For sterilization, in the last three years, regulators have been looking more closely at Ethylene Oxide (EO) residuals. With lower limits in ISO 10993-7:2008/Amd.1:2019, we need to be smarter about how we test devices and get the testing done right the first time. I expect to see more product-specific protocols for testing EO residuals. There are too many devices being tested under incorrect assumptions. Manufacturers should only be testing the portions that contact the patient, using extraction conditions that represent realistic worst-case exposure.
For medical package testing, we expect changes in new materials due to pandemic-related shortages, which will lead to more validations being performed.
Rollins: I see more standardization in extractable and leachable testing and more global acceptance of in-vitro alternatives.
Scott: As testing requirements continue to proliferate, manufacturers will find great value in partnering with laboratories that are able to provide a broad range of testing services and can reduce the need to coordinate with different service providers. Additionally, large global device companies will seek to partner with laboratories that operate on an equivalent scale, are able to provide testing in the multiple regions they conduct business, and have regulatory expertise in the necessary areas.
Tumminelli: AAMI has just published an actual cleaning standard called AAMI ST98. I expect the FDA to immediately recognize and enforce this standard as it has been in the works for a long time. AAMI standards have a six-month grace period to ease into but I wouldn’t be surprised if the FDA will enforce sooner than that. There are some new requirements revealed and manufacturers will need to work with testing labs for interpretation when developing validation protocols. If working with a pre-submission, that would be a good time to tackle and run the test protocol by the FDA.
Brusco: Is there anything else you’d like to say regarding the subject?
Nino: TÜV has free checklists on its website for manufacturers to check their compliance.
Tumminelli: AAMI has been working on a new TIR 109 that will outline requirements for offsite transportation of reprocessed devices. For instance, if a sterile processing department would like to outsource or use a partner facility to help reprocess their devices, there needs to be a safe way to get the contaminated and/or sterile devices back and forth from the facilities. This document will address how to contain and control many aspects associated with temperature and humidity control, as well as package integrity during the transportation. This could apply to loaner sets, etc. as they move from facility to facility.
