It’s not over just yet.
 
Eclipsed for the past year by COVID-19, medtech’s long-simmering ethylene oxide (EO) controversy could soon flare up (again) as the industry grapples with alternative sterilization methods for its products.
 
The U.S. Environmental Protection Agency (EPA) is expected to issue a final federal rule this year limiting EO emissions from commercial medtech sterilization plants. Considered a carcinogen, EO has been used for decades to clean medical equipment—from plastic tubing and surgical instruments to hospital gowns and artificial joints. Industry experts estimate the chemical is used to sterilize roughly half of all medical equipment, as it can efficiently kill germs without harming materials.
 
EO’s link to various cancers and physical ailments have spawned a slew of legal action against companies that operate sterilization facilities. Sterigenics closed its plant two years ago in Willowbrook, Ill., by order of that state’s Environmental Protection Agency, and then shuttered another in Georgia in August 2019 following an investigation by the Georgia Environmental Protection Division.
 
The shutdowns disrupted the medical device supply chain, prompting the U.S. Food and Drug Administration (FDA) to form a task force on EO sterilization. The agency also launched an “innovation challenge” in July 2019 to develop alternatives to EO sterilization and reduce ethylene oxide emissions to “as close to zero as possible.”
 
Meanwhile, the EPA earlier this year determined that community-specific warnings about EO risks do not have to be made immediately. The agency—still working on the final federal rule—has committed to notifying communities about EO risks by May 31 and has posted status reports on 25 facilities previously identified as high-risk based on known EO emissions and facility location.
 
Orthopedic Design & Technology’s January/February feature, “The Total Package,” examines the EO- and pandemic-induced challenges and changes facing packaging and sterilization companies. Seán Egan, director of Global Marketing & VoC Development for Nelipak Healthcare Packaging, was among the experts interviewed for the story. His full input is provided in the following Q&A.
 
Michael Barbella: Please discuss the trends in packaging/sterilization services.
Seán Egan: Sustainability is a growing focus for convertors, OEMs and end users alike when it comes to driving overall healthcare packaging innovation. Waste reduction through efficient design reduces material usage and results in less energy required to manufacture product, while reduced footprint can decrease sterilization and transportation costs through higher loading factors. Additionally, better packaging is helping to protect devices that may be affected by some sterilization methods such as EtO. For example, a catheter set that has relaxed during the sterilization process may lose its shape. A redesigned tray can eliminate that risk by keeping the components in their correct form during sterilization with knurling features that ensure efficient flow of the gas during the cycle to fully sterilize the device. Increased functionality is also leading to packaging that is easier to use in the OR and ER, where packaging is helping to reduce risk by presenting components in the order that they need to be used -- and in some cases, to actually help prep the device before being presented to the patient.  
 
Barbella: How is packaging and sterilization technology advancing to meet the needs of orthopedic manufacturers?
Egan: Packaging engineers are being challenged to cut costs by reducing the amount of packaging required to ship orthopedic (and other) devices -- without compromising product integrity or the sterile barrier. With new product introductions, lead times for packaging development needs to be considered, as do new packaging formats or materials that require extensive validation testing, and if the trials are unsuccessful, costly delays are be avoided. Consequentially, OEMs are still reluctant to embrace new packaging formats unless there is a strong business need to work outside of tried and tested solutions. Furthermore, instances of particulates inside of packages can cause a recall due to manufacturing issues, so it’s important to work with a packaging contract manufacturer that is ISO 13485 certified and can demonstrate strong Good Manufacturing Practice (GMP), producing product in ISO-classified cleanrooms.
 
Barbella: Why is it important for orthopedic manufacturers to consider sterilization and packaging early in the product design process?
Egan: By considering packaging as early as possible in the development process, orthopedic OEMs and packaging providers can better ensure that devices and packaging will be well-suited for each other. Some OEMs don’t realize how critical innovation is early on in the design phase of their packaging. Medical packaging manufacturers can be more than just product suppliers – they should become true partners to the OEM that work collaboratively with them to design optimized products fit-for-purpose, reduce waste, and even improve the experience for the end-user.
 
Barbella: How did COVID-19 impact your company? What lessons can providers like yours take from the pandemic and apply to their services going forward?
Egan: While COVID-19 certainly upended daily life and created economic uncertainty around the world, lives depend on the healthcare industry and it is even more critical now than ever. Doctors, dentists, clinics and hospitals globally resumed routine appointments and elective procedures under new norms as soon as it was deemed safe enough to do so, and the need for effective healthcare packaging remains – and even continues to grow.
Nelipak management has taken significant steps throughout our global manufacturing network to keep production lines running as an essential business in support of our customers, supply chain partners and ultimately the patients we collectively serve. Despite the challenges of Covid-19, Nelipak has continued to make great progress on a range of new initiatives, including investments in our plants, improving quality, raising customer service levels, driving innovation and building our organization and capabilities to supply customers with both rigid and flexible packaging. As an essential business, we consistently remained open for business at all 10 of our facilities worldwide to keep our customers up and running with no significant supply disruptions. From the onset of the pandemic we implemented a formal COVID-19 monitoring process led by Nelipak global executive leadership and involving a cross-functional team. We continue to take action to promote employee and community safety in line with WHO, CDC, ECDC and local government guidelines.
 
Barbella: How can (should) packaging and sterilization providers better manage supply chain risk in the wake of the pandemic?
Egan: Our ability to seamlessly scale production to meet demand recovery depends upon how well we can work together with our customers to proactively coordinate the ramp-up of their production needs. Without effective collaborative forecasting and pre-planning, Nelipak would not be able to service all customers within standard lead-times given the supply chain disruptions caused by the pandemic.
Throughout the pandemic, we have encouraged clear and proactive communication with our customers. Our sales and customer service teams reach out frequently, but we also ask that customers communicate to us on a regular basis about what they are seeing in their business and the market segments they serve. By working together, we can help anticipate customer needs and give our respective teams and the customers we collectively serve the best chance to succeed as business ramps back up.
  
Barbella: Where do you see the packaging/sterilization industry headed in five years?
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.