Living and working in Illinois, Orlov has become well-versed in the ongoing controversy over ethylene oxide (EtO), a widely-used gas sterilant for medical equipment and supplies. First prepared in 1859 and employed mainly to manufacture polyester fibers, EtO has become the preferable medtech sterilization method, accounting for more than half of all device disinfections, according to industry estimates. EtO boasts several advantages over other cleaning processes (radiation, moist heat, dry heat, vaporized hydrogen peroxide, gas plasma), most notably its prowess in harmlessly penetrating packaging and plastic, as well as its ability to sanitize complex product configurations (e.g., connectors, interior tubing, two or more contact surfaces, etc.).
EtO, however, is not without its drawbacks: It is volatile, costly, time-consuming (typically 16-18 hours/cycle), and a potential health threat. The compound is one of 187 hazardous air pollutants regulated by the U.S. Environmental Protection Agency (EPA); it was officially deemed a carcinogen in 1985 and linked to diseases such as breast cancer, leukemia, and lymphomas in 2016. Shortly thereafter, the agency identified several U.S. census tracts vulnerable to elevated cancer risks from EtO emissions.
One of those tracts was Willowbrook, Ill., where air monitoring had detected possibly hazardous EtO levels outside a medical device sterilization plant operated by Sterigenics LLC, a global provider of industrial sterilization solutions for the medical device, pharmaceutical, commercial, and food industries. The Illinois Environmental Protection Agency closed the facility last February—citing excessive emissions—but Sterigenics disputed the reported amounts of EtO gas released by the plant (less than 0.1 percent, the company claimed) and noted the facility operated well within federal ethylene oxide emission standards. “...less than one-tenth of 1 percent of the EO used in the sterilization process is released into the atmosphere—exceeding regulatory requirements and representing one of the highest control levels in the country for this industry,” Sterigenics said in a statement.
In its attempt to allay concerns in the Willowbrook community, though, Sterigenics inadvertently ignited an explosive national debate over EtO’s potential health hazards, both real and perceived. The ensuing brouhaha—a host of communal protests, regulatory reassessments, and (mostly) unflattering media blitzes—ensnared several other sterilization service providers, impacting operations in Colorado, Georgia, Illinois, and Michigan; and threatening the medical device (sterilization) supply chain.
Eventually, the uproar became too overwhelming an obstacle for Sterigenics. In late September 2019, the company abandoned plans to reopen its Willowbrook plant and instead shifted its attention to Cobb County, Ga., where deja vu circumstances were playing out. Although it initially faced the same outcome, the company’s shuttered Cobb County facility has (temporarily) been enlisted in the fight against COVID-19.
Understandibly, the global coronavirus pandemic has shoved the EtO controversy to the back burner for the time being. But the issue is not about to fade into oblivion: The EPA is rewriting EtO emissions rules, proposing a 93 percent cut in discharges, and also is updating its characterization of EtO concentrations.
Public outcry, meanwhile, is still intensifying, with citizens, local lawmakers, and state environmental officials in Georgia and Michigan clamoring for tighter regulations. In February, 11 state attorneys general demanded the EPA strengthen national emission standards to better safeguard Americans’ health.
Amidst such efforts to severely limit, if not outright ban, EtO emissions are conflicting discharge data, media reports, and tabloid-style social media warnings of ethylene oxide’s potential health dangers—all of which have clouded the truth about industrial use of the carcinogen.
Thus, when the EPA released new EtO emissions data for the Waukegan, Ill., region earlier this year, Orlov—president of both Right Healthcare Ventures LLC and the Waukegan Chamber of Commerce—looked to “informed sources” for analysis of the data. He was seeking the truth, though the truth has been easily evasive amongst all the noise from 24-hour news channels and social media posts from “people that don’t really know what they are talking about for a problem that may not exist.”
Medical Product Outsourcing has been on its own quest for the truth about EtO sterilization and its potential health impacts since the controversy erupted last winter. Over the past several weeks, the magazine spoke to more than a half-dozen companies for perspective on ethylene oxide, sterilization, alternative disinfection methods, COVID-19, packaging, and the industry’s future. Sterigenics submitted a formal statement discussing its efforts to control emissions and potentially reduce the amount of EtO used in each sterilization cycle (see sidebar, page 58). Other participants included:
Jose Arevalo, global business development manager, Tyvek Healthcare; Jennifer Benolken, CPP - MDM and regulatory specialist, packaging engineer, Tyvek Healthcare; Dan Floyd, MDM and regulatory specialist, microbiologist, Tyvek Healthcare; and Nick Packet, MDM specialist, packaging engineer, Tyvek Healthcare; at specialty products giant DuPont.
Jennifer R. Asleson, president of Quality, Microbiology & Sterilization Services, a firm in Colorado offering microbiology and sterilization consulting services to medical device and pharmaceutical manufacturers.
Gerry DiBattista, vice president of marketing, PTFE, at Porex Corporation, a global developer of advanced porous solutions and a member company of the Filtration Group.
Seán Egan, director of global marketing and Vice of Customer development at Nelipak Healthcare Packaging, a Cranston, R.I.-headquartered designer, developer, and manufacturer of custom designed thermoformed packaging for medical device and pharmaceutical firms.
Brandon Hoser, sales manager at Packworld USA, a Nazareth, Pa.-based manufacturer of validatable medical heat sealing equipment and impulse heat sealing pharmaceutical packaging machines.
Roy E. Morgan, vice president of engineering, at Eagle Medical Inc., a Paso Robles, Calif.-headquartered provider of FDA-compliant assembly, packaging and in-house hydrogen peroxide gas plasma specific and contract irradiation (gamma, e-beam) sterilization services for the medical device industry.
Christopher A. Murphy, marketing manager at package testing, medical device and combination products testing laboratory DDL Inc.
Tom Williams, general manager at Millstone Medical Outsourcing, a Fall River, Mass.-based provider of customized outsourcing solutions to the medical device industry.
Michael Barbella: What are the current trends in packaging and sterilization services?
Jose Arevalo, Jennifer Benolken, Dan Floyd, Nick Packet: There are currently two major trends in packaging: usability and sustainability. A third topic around the use of ethylene oxide is also quickly evolving, but the next steps and impact to packaging are unknown at this time.
Usability has come more to the forefront due to EU MDR changes, signifying the importance of packaging for successful patient outcomes. Usability often connotates user experience. For the requirement in ISO 11607-1:2019, however, it is much more expansive. Being able to demonstrate a package’s ability to have its opening mechanism easily identifiable.
Sustainability is widely discussed but few have actual solutions on how to address the challenge as there is a lack of re-processors that take medical waste. In addition, waste from medical packaging can be confusing to the end user as to which waste stream it can go into. Recycling can be an option for a healthcare facility, but only if they can find a re-processor. Once a re-processor is found, the sorting of the waste within the healthcare facility becomes more critical, as it is not going directly to the trash anymore. They are then faced with the challenge of who sorts the waste. They will also need to develop a means of being able to identify that which can be recycled and that which has to be thrown out—medical packaging does not always come with indicators on it, as consumer products do, to indicate which stream it can go into. The Healthcare Plastics Recycling Council is an organization that is working with the healthcare value chain (medical device industry raw material suppliers, medical device manufacturers, healthcare facilities, and re-processors) to help address these conundrums.
For sterilization services, restrictions are being placed in the ethylene oxide (EtO) supply chain—companies are evaluating their sterilization cycles and the role packaging plays. The same is true for gamma sterilization as well—in some cases, people are moving away from gamma, but may possibly need to change packaging or product materials to allow for a different sterilization modality. In fact, the EPA has shut down some facilities due to emissions, with concerns over causing cancer around the facilities. These shutdowns continue even in current times and reopening is not foreseen unless safety procedures/compliance to local laws is completed. The FDA has issued a challenge to the industry to develop innovative sterilization methods that reduce the need for EtO, however nothing significant has been developed so far. The most promising development is the modification of EtO cycles to be more efficient with lower exposure concentrations, taking less time to complete the cycle (using less EtO), along with a possible shift in how validations are done (move away from overkill method to BI/bioburden method). Materials used that tend to absorb EtO could also be reduced. There are two different options being discussed, which include packaging postponement (waiting to complete final packaging until after sterilization) and the removal of IFUs from the shelf carton.
Gerry DiBattista: Many of the current trends in packaging and sterilization services revolve around the reduction of waste and the development of more sustainable, reusable options. Some examples of these trends include the transition away of “Blue-Wrap” used to protect surgical equipment against potential contamination when it is being sterilized but is non-reusable and has to be disposed of after use. An alternate solution for sterilization that is more sustainable and increasing in usage are sterilization containers, or autoclave containers, which are used to sterilize instruments and surgical tools in hospitals, clinics, and dental offices. These containers are reusable, but the standard filters used in the containers are disposable. As a result, another trend that is occurring is the development of reusable filters for the sterilization containers so there is virtually no waste at all.
Brandon Hoser: An increased focus for machines complying to 21 CFR Part 11 is noticeable. Organizations are striving for better traceability. Knowing which operator is signed into a machine and logging the rest of the data points during machine operation is increasingly important.
Roy E. Morgan: There are three key trends that we are seeing in the marketplace for packaging and sterilization services within the last year; 1) Big concerns about the long-term viability of EtO sterilization suppliers and the risks associated with potential plant closures due to health and safety concerns and the concomitant supply chain constraints that creates, 2) Continued interest in standardized packaging configurations that can save time in development for new startups looking to reduce time-to-market, 3) Desire for improved packaging materials to combat sterility barrier failures due to distribution system challenges (moisture, vibration, impact, drop, aging). On the sterilization side, Eagle has recently noticed an uptick in interest with our vertically integrated capacity for hydrogen peroxide gas plasma sterilization, which we attribute to item 1 above.
Christopher A. Murphy: The increased complexity and broader diversity of medical devices, especially in the combination product realm as pharmaceutical and medical device companies dabble more in the same space, is raising awareness of the need for packaging validation and accreditation with a greater focus on usability rather than just functionality. In addition, OEMs also have to meet updated regulatory requirements, such as the EU’s new Medical Device Regulations (MDRs), which is driving demand for testing, particular packaging validations.
Tom Williams: In the immediate present, the greatest change related to the COVID-19 pandemic is the radical increase in demand for low-cost packaging of auxiliary products for testing—specifically test swabs. Before the COVID-19 emergency, the big trend in the U.S. market was the migration from non-sterile product lines to sterile packaging in preparation for the EU MDR’s original May 2020 date of application. Now that this date has been pushed out by a year, the impact on long-range planning is less clear. At Millstone, it’s our opinion that most companies will proceed with their changeovers as planned; many of them were already well underway.
Barbella: What factors are currently driving these trends in packaging/sterilization services?
Arevalo, Benolken, Floyd, Packet: Regulatory influences are ultimately the driving force behind these trends in packaging and sterilization. There are many reasons for the continued development of regulatory standards, but societal pressure and awareness of issues, like EtO, are a significant reason behind regulatory change.
Jennifer Asleson: In sterilization, everything is focused on reducing the amount of EtO used for terminal sterilization. This is driving companies to look for creative ways to achieve the required sterility assurance levels while reducing the amount of EtO and the time of exposure. Sterilization in primary packaging to reduce the amount of corrugated present in the load is an option that is getting serious consideration by many companies. This creates challenges to legacy shipping studies but can allow for a much shorter exposure time and potentially allow for a lower EtO concentration which can help with EO residual levels as well.
DiBattista: As with many trends, a key factor is decreasing cost. A reusable container as well as a reusable filter within that container is less expensive than buying many single-use items. For example, one reusable sterilization container filter can be used for thousands of cycles—sometimes the entire life of the container. Other key factors include:
- The rising trend in hospitals to use more sustainable items to decrease overall facility waste
- Reduction in healthcare worker infection risk by using a container instead of Blue-Wrap, which can be easily compromised since it requires human intervention
- Increase in labor efficiency where reusable items don’t need to be prepared or re-assembled for each use
- Increase in bacterial filtration efficiency with the use of different materials in the reusable containers and filters than can be used in single-use options, which allow the instruments to be remain sterilized longer.
Hoser: Mitigating failures is always a driver. Being able to control what an operator has access to so they do not change a validated process avoids failures. If a failure does occur, recording the operating history of the machine helps an organization to isolate the root cause of the failure. One medical device manufacturer was using a machine susceptible to parameter changes by the operator. An operator decided to make a parameter change which caused pouches to open after sterilization. Because there was no data logging, the medical device manufacturer had to not only repackage what went through sterilization, but also all sealed pouches because they could not isolate when the change occurred.
Morgan: Impacts created by sterilization plant closures for a variety of reasons have created shortages of capacity industry-wide that are pushing OEMs to find alternatives that help meet the need to safely and effectively sterilize devices for market. On the packaging side, there seems to be a renewed focus on costs (burn-rates) of getting to market. When combined with a good understanding of how activities concatenate to logically test for sterility and packaging robustness, shorter design cycles and more sharply targeted test-cycles are possible. At Eagle, we are able to provide high levels of design capability, along with crucial initial test loops to ensure that packaging performance meets both criteria within the timeframes set by customers goals.
Murphy: Complying with the new EU MDR and other regulations continues to drive most of the trends with packaging services. Packaging is still considered an accessory to a medical device under MDR, as it was under the previous directives. Package validations are performed according to ISO 11607. Most all legacy devices will need to redo their packaging validations, particularly transportation distribution testing, in order to prepare the documentation now required under the MDR that was not required before. Due to COVID-19 and other factors, it was recently announced that the date to comply with EU MDR has been pushed back a year to May, 26, 2021.
Williams: The factors in play are, as mentioned above, the date of application for EU MDR, the current COVID-19 emergency, and the overall push, especially in orthopedics, to find all possible cost efficiencies in sterilization, packaging, and other post-manufacturing services.
Barbella: How has the COVID-19 pandemic affected the industry, and specifically, your company?
Arevalo, Benolken, Floyd, Packet: For both DuPont and industry as a whole, it’s still rapidly changing. Most people are still in a transition process that will continue to evolve as the virus progresses around the world into herd immunity (and/or a vaccine is discovered and administered).
a. Elective surgeries have come to a near standstill (starting back up again, slowly)—this is also impacting the sterilization market.
b. Personal protection gear needs have exponentially increased.
c. High volume, disposable (“single use”) items continue to have sustained needs, although, there has been a shift as to where they are needed.
d. Higher awareness and demand for top-level microbial barrier and the cleanliness of packaging materials—there are many unknowns, so to reduce the question of whether a material will prevent ingress or not, higher level microbial barrier materials are more trusted right now.
e. Speed to market and responsiveness—what is important has shifted; the universal drive to improve things now and immediately has made the direction we are taking change.
f. Shortages have driven protocol changes, such as the re-use of single use PPE items—N95 masks specifically; regulatory bodies are allowing re-use through disinfection/sterilization. Desperate times call for desperate measures. What’s happening right now is completely unprecedented.
Asleson: The COVID-19 pandemic has caused a few of my clients to delay projects and one has had to cancel their contract as they were greatly impacted by the cessation of elective surgeries.
Overall my clients have been continuing to use my services as we provide the support for their routine monitoring of bioburden and other activities that feed into the sterility assurance program. The biggest impact has been the delay of onsite work including audits of vendors and testing laboratories.
DiBattista: The market for sterilization containers is generally soft now, as hospitals have been postponing elective surgeries, and these containers are more often used in ORs. However, an area we are seeing that is increasing is the use of surface disinfection systems over sterilization as hospitals look at the importance of an overall clean environment versus just sterilizing surgical instruments. As surface disinfection using UV-C energy is being shown to deactivate the COVID-19 pathogen, manufacturers are increasing their production of UV disinfection units that contain reflective media like PTFE within its reaction chamber.
Egan: During this unprecedented time, Nelipak has been fortunate enough to remain open for business at all 10 of our facilities worldwide with no significant supply disruptions. Because Nelipak is in the business of providing sterile barrier packaging for a variety of critical and life-sustaining healthcare applications, our business operations are considered essential and we continue operating in support of our customers and supply chain partners. In this time of immediate need we are directing product development resources and production capacity to help customers meet the emerging challenges of COVID-19. As a result of the rapid mobilization by our product development and operations teams, we have been able to respond to changing demands in the market for medical and pharmaceutical products. Several of our sites in the U.S. and Ireland have worked with customers to rapid prototype and ramp up manufacturing of much needed face shields to meet increasing market demand. In addition to the PPE opportunities, we have redirected some of our added value service capabilities to filling and packaging our customer’s proprietary products which are used in COVID-19 related applications.
Hoser: COVID-19 has everyone’s attention and many are working on contributing where possible. Test kits, future vaccines, and PPE need sterile packaging. Gowns, masks, and other PPE require heat seals to form sterile barriers. All of this contributes to higher demand for heat sealing equipment.
Morgan: Here at Eagle we are working hard to support our industry that is in dire need of several key items we can produce. Part of that has been a unique repurposing of our sterilization process to provide a crucial ingredient to other local businesses that have also repurposed their business models. Eagle is providing donated hydrogen peroxide sterilant diluted down to a nominal three percent to local distilleries that have repurposed their businesses to produce FDA-compliant hand sanitizer. The local shortages have been severe, as supplies are purchased at exceedingly high rates during the COVID-19 crisis, and Eagle is stepping up to help our local businesses meet this crucial need.
Murphy: The main challenge for package testing has been getting samples shipped to our lab due to interruptions in the supply chain. Many MDMs have also put some projects on hold due to hospitals not doing elective surgeries and to save costs.
Williams: In general, the medical manufacturing industry has been impacted significantly by the CMS guidance on delaying all elective surgeries and non-essential medical, surgical, and dental procedures. As these delays took effect in many U.S. states, manufacturers have closed or reduced operations. There has been a subsequent ripple effect on manufacturing lines and inventory. As reopenings proceed, states will open up elective surgeries. How quickly the industry rebounds may depend on unemployment. There are now 22 million people suddenly unemployed and without health insurance; how many of them had elective surgeries scheduled? And how can or will those procedures go ahead if patients now find themselves without insurance?
For the industry, overcoming distribution challenges will also be key. Inventory is stacking up at distribution centers. A surge in elective surgeries is widely anticipated as surgeons schedule cases six or even seven days a week after reopening; compare this to pre-pandemic levels of three or four days. Manufacturers need to have a plan for how to react to dramatically increased demand on capital assets.
Turning to Millstone specifically, our customer base includes many orthopedic OEMs, and orthopedics has a long lead time of 12 to 20 weeks. Because of these long lead times, we have not yet felt the effect in lower volumes. Going forward, the ultimate impact of this stage of the pandemic for us will be closely tied to how (and how quickly) the industry as a whole rebounds.
Barbella: How has EtO criticism impacted medical device sterilization services, and the industry as a whole? How has it impacted your company, specifically?
Asleson: The whole EtO situation is unfortunate as the science and headlines tell very different stories. EtO is used in the manufacturing of a very wide range of products including cosmetics, soaps, fabrics, and household cleaners. The sterilization portion of the industry is very small in terms of usage of EtO and has been done safely for many years. This has really hurt a lot of companies who have had to identify a new vendor and get the process validated, which is a lengthy and expensive project not budgeted for. It has helped my company as we provide validation protocols, reports, and technical support for these validations but it has been stressful for the clients. Many companies are out of inventory, cannot sterilize at their old facility, and a new process takes many months to complete. There have been some really close calls this last year.
DiBattista: While quite a few EtO facilities have been shut down in the past due to their inability to find a safer way to manage the toxic gases generated during the process, many have been reopened due to COVID-19 and the need dry sterilization. The shutdown of EtO facilities has not impacted us significantly—we continue to receive inquiries around the compatibility of PTFE and other materials with EtO sterilization.
Morgan: The shortage in capacity has been severely felt industry-wide. The impacts that directly affect Eagle have been increased inquiry about EtO alternatives or smaller-scale, nimble EtO facilities to help cover overflow and NPI demands. What’s not clear yet is how the restart of the economy will impact the already constrained marketplace and where device OEMs will go in search of increased capacity once market conditions ascend in the direction of normalcy. If the demand remains strong for EtO but plant closures cannot be remedied with new construction or retrofit, there will be a strong push toward alternatives that can keep device makers in the market and profitably sterilizing with good controls. We are beginning to see some of this line of inquiry at Eagle, and as the bolder device makers take advantage of the FDA’s more cooperative stance on working with them to adopt these alternative sterilization methods, we expect to see more business moving toward our hydrogen peroxide sterilization.
Murphy: We have noticed many companies looking for alternative sterilization methods through some of the testing projects we have seen.
Williams: In the wake of EtO’s challenges with the EPA, the industry has had to confront capacity limits. Some OEMs have made the move to gamma radiation sterilization, but there is finite capacity because the radioactive isotope is a finite resource. It’s clear innovation in new approaches will be needed. During the COVID-19 crisis, however, some of the facilities shuttered for EtO emissions have been given special dispensation to open to sterilize devices.
At Millstone, concerns and closures over EtO have had two clear effects. First, we are providing more engineering guidance to companies considering alternative methods of sterilization for their products. Second, we are more frequently introducing pre-validated and universal packaging options to manufacturers; these approaches allow them to shift to different methods of sterilization faster, helping them in some cases speed time to market while upholding safety.
Barbella: Are there alternative sterilization methods being developed or available that can replace EtO with respect to scalability and material compatibility?
DiBattista: A few alternative sterilization methods we have seen being developed to replace EtO are gamma radiation and vaporized hydrogen peroxide. The latter is the closest to EtO and doesn’t off-gas, as the process produces inert molecules such as water or oxygen; however the sterilization doesn’t penetrate as deeply into the devices being sterilized as much as EtO does. Both of these processes are compatible with many of the materials that we work with.
Morgan: Yes, the challenges are in the scale-up of most of these technologies compared to EtO. Additionally, like all sterilization methods, there are some limitations to the application to tubular structures and powders and liquids that nearly all chemical forms of sterilization suffer from. The current pandemic crisis has shined a light on the need for robust and easily scalable forms of sterilization that can be deployed in flexible ways to not only meet the emergency situation we encounter today, but also to address the more routine forms of daily sterilization of devices for market distribution. If anything, it brings attention to the fact that sterilization is a crucial part of the supply chain, and in times of pandemic become mission-critical functions that form part of the national security backbone of the country.
Williams: As noted above, gamma radiation sterilization has become the fallback for many OEMs that previously relied on EtO sterilization. It presents its own challenges in fixed capacity and in material compatibility. In our opinion, X-ray sterilization would be more efficient and less complex, as it doesn’t require a radioactive isotope; electricity is the source, and it isn’t finite. It may become the method of choice in the future.
Barbella: Is packaging becoming more “environmental-friendly” due to concerns about increasing levels of medical waste? Is there a way to reduce medtech packaging to cut down on medical waste?
Arevalo, Benolken, Floyd, Packet: This is something on everyone’s minds these days. Sustainability needs to be viewed as an overall concept, which includes the waste stream, but also efficient design for reduced wastage and environmental footprint. Companies are working on different alternatives from a material through design perspective, as well as downstream waste management. It is becoming a means of differentiation by medical device manufacturers for capturing GPO contracts. A combinatorial approach—company-specific CSR initiatives along lifecycle management across the value chain through collaboration—being shepherded by HPRC (Healthcare Plastics Recycling Council) as an example.
Cost is often the larger driver where sustainability is a natural by-product (downgauging, downsizing, etc.). Each change needs to be considered from a risk standpoint, because from an overall cost model perspective, driving the cost down in one component through downgauging/downsizing, can have detrimental effects elsewhere in the packaging (possibly sterilization) system, including facilitation at point of use where changes could render the packaging unusable.
DiBattista: In general, we have seen trends toward manufacturers looking for packaging options that don’t include single-use plastics as well as more biodegradable options.
Egan: There is an estimated one million tons of clean, non-infectious healthcare plastic generated in healthcare facilities each year, according to The Healthcare Plastics Recycling Council. Finding a way to minimize the waste stream that ends up in landfills—and the resulting impact it can have on the environment—is challenging but important. One area where there is an opportunity to reduce waste through increased design innovation and process and material optimization is in healthcare packaging.
More and more OEMs are expecting their partners to participate in environmentally responsible practices, and rightfully so. Healthcare organizations are increasingly pushing back on OEMs to look at both device and packaging sustainability during development. One example is Group Purchasing Organizations for healthcare programs in the U.S., who increasingly strive to drive purchasing behavior through responsible sourcing decisions. Medical OEMs bidding for contracts need to show they can meet attributes such as device and packaging recyclability, removal of polystyrene from packaging and potential use of recycled content in primary packaging.
Medical device packaging manufacturers are rising to the challenge by increasing the emphasis they place on the sustainability of their products and operations. Packaging manufacturers are looking to reduce packaging size, eliminate unnecessary components, streamline shipments whenever possible, and some are even working with the end-user hospitals to increase education around proper recycling and reuse.
Morgan: Terminally Sterilized Single Use Devices (TSSUDs) are often criticized for the wasteful nature of packaging that can be entailed in their delivery to patients. Recent COVID-19 pandemic alarm over insufficient disposable PPE and its reuse have shined a bright light on the necessary role of disposable packaging/PPE/disposables and elements of protection provided to humans worldwide.
Balancing environmental impact vs. safety, however, is an important key question designers should always keep at the front of their minds when considering package design. Without question, wanton use of excessive packaging, or packaging that cannot be recycled or is made of exceptionally high carbon-footprint materials should be minimized, if it cannot be eliminated. This is principally why early design considerations are important, as it provides time to survey supply chains for materials and methods that meet more environmentally friendly life cycles without compromising the necessary toughness and durability needed to keep both patients and healthcare practitioners safe.
Murphy: While there is always a push to make packaging more “environmentally-friendly” the challenge is developing packaging that maintains its sterility. As a result, most MDMs fall back and use packaging that has been proven to work and most importantly held up to regulatory standards.
Williams: Pre-validated packaging can help OEMs be more efficient with their resources. First, a universal packaging design can fit up to 80 percent of orthopedic and spine products in either a tray or pouch design. This means such packaging can be used for multiple product families independent of geometry and weight—this is consolidated package design. By reducing the overall number and kind of materials needed, OEMs can simplify the supply chain and decrease resource waste.
Barbella: Where do you see the industry headed in five years?
Arevalo, Benolken, Floyd, Packet: That is a great question and what we spend a considerable amount of time on. However, it will likely be much of the same as to what we’ve been seeing as of late: a) medical device manufacturers placing more weight on the role of packaging in their products’ success in the marketplace; b) end users having a larger voice earlier in the process, to make sure the success of the product is there from the get-go versus waiting for a product iteration; c) coordination between developing and developed economies towards harmonization of standards; and d) improved post-consumer recycling infrastructure for healthcare packaging.
DiBattista: We see a few major industry trends over the next five years: Hospitals trying to reduce waste and costs as much as possible—since many of the sterilization container manufacturers also supply single-use filters as consumables, we’ll start seeing new companies that are only focused on multi-use containers that require no human interaction at all and will compete with the traditional companies in the space today.
Depending on which direction legislation moves after COVID-19, some regions may move to UV-C disinfection over sterilization for certain areas in the hospital. This may be more cost-effective and provide for increased breadth of what can be disinfected versus using sterilization only. Some areas of the hospital are regulated—such as operating rooms—and therefore would have to remain with traditional sterilization methods, but the ability to disinfect more areas will show an increase in UV-C usage.
Reducing waste from reuse of PPE by using UV-C disinfection chambers will also occur.
Egan: We cannot have a disconnect between the medical device product, its packaging, and the sterilization process. This must be perceived as “the complete process” to ensure efficiency and efficacy, and I think over the next five years we will be even closer to achieving this by working the product, packaging and sterilization processes in parallel (through partnership) to improve efficiency and accelerate time to market.
Morgan: Industry will continue to make stronger pushes for standardized packaging that will both lower costs and shorten development cycles for new product introduction (NPI). Eagle will be there with solutions that can meet both the timelines and the versatility called for during initial device development. As part of our 2020/21 offering Eagle is completing a new development program; Packaging Accelerated Timeline Help (PATH system), that will provide NPI developers with flexible, standardized alternatives that can be used to deliver TSSUDs to market with significantly reduced timelines. The value of this approach we believe will not only help startups and established device companies get product to market faster, but do so with robust and reliable packaging that maintains the necessary safety controls required by FDA and EU regulatory agencies.
Murphy: New advances in equipment and technologies are always being developed to help make packaging and the testing of it more accurate and efficient. Organizations such as ISO and ASTM continue to work to update and refine the standards to improve testing methodologies. For instance, as changes with the way products are shipped or delivered, testing standards must also be adjusted to meet these changes. And, as innovation in product development continues, new test methods must be developed to match these updates.
Williams: First—and we’re seeing this right now—there is a shift to outsourcing packaging design and validation. This makes sense: outsourcing these capabilities to an expert partner lets OEMs focus more of their resources on building and design products while ensuring quality processes and, ultimately, patient safety. This industry is very competitive, so smart resource allocation and coordination is (and will continue to be) key to maintaining an edge.
Second, the challenges presented by sterilization capacity will need to be addressed. OEMs need to pay specific attention to shifting to more efficient means of sterilization in the near future and to managing risk when it comes to current and alternative sterilization methods for legacy as well as new products.
Although it currently is overshadowed by the global coronavirus pandemic, ethylene oxide (EtO) sterilization remains a controversial issue for the medical device industry. The Environmental Protection Agency is proposing limits on EtO emissions as lawmakers and community activists throughout the United States continue to press for outright bans of the chemical in their respective neighborhoods. Sterigenics LLC, a global sterilization solutions provider, has been in the crosshairs of these objectors for quite some time now. In the following statement (provided exclusively to MPO), the company discusses the steps it is taking to improve the safety of ethylene oxide sterilization.
“Sterigenics is a leading global provider of mission-critical sterilization services to the healthcare industry across multiple methods, including Gamma, ethylene oxide (EO), e-beam and X-ray sterilization, and is exploring potential new sterilization methods, including initiatives like its commercial agreement with Noxilizer. We are method-agnostic, working with medical product and device manufacturers to deploy the sterilization method that best meets the needs of its products to protect patients, healthcare workers and others.
“According to the FDA, more than 20 billion devices sold in the U.S. every year are sterilized with EtO, accounting for approximately 50 percent of devices that require sterilization. While other methods of sterilization are possible for some devices, EtO is the only method that satisfies FDA-approved sterilization validations for many devices as well as the only method that effectively sterilizes and does not damage many medical devices during the sterilization process.
“Sterigenics understands and takes seriously our responsibility to sterilize these vital healthcare products while protecting employees and the communities in which we operate.
We are proud to be one of several companies that safely sterilizes critical and lifesaving medical products. While the ongoing battle against the COVID-19 pandemic has brought the critical need for sterilized medical products to the forefront, the historical demand for sterilized medical supplies and products will continue to exist well beyond the current crisis.
“Sterigenics will continue to work with communities and regulators to ensure a strong emission control environment across our network of EtO sterilization facilities. These include facility enhancements like those recently completed in Georgia, which established our facility as one of the most advanced sterilization facilities in terms of emission control in both Georgia and the U.S.
“In addition, in connection with our selection by the FDA to participate in the agency’s efforts to reduce EtO usage, we have embarked on our Reduce, Reuse, Reclaim initiative. Under this initiative, we will work with customers to reduce the amount of EtO they use in each sterilization cycle, explore engineering solutions to reuse EtO within the same cycle, and evaluate technology to reclaim EtO from a sterilization cycle to be used again.”