Sustainable Packaging Likely in Medtech’s Future

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. Samantha Smith, senior category manager, packaging and labeling, at Medtronic plc, was among the experts interviewed for the story. Her full input is provided in the following Q&A.
 
Michael Barbella: Please discuss the trends in packaging/sterilization services.
Samantha Smith: Packaging—more and more is going to contract manufacturing, which is much more cost effective, especially for orthopedics because of sizing not being known until point of use; shifting the burden of cost/overhead over to a contract manufacturer, frees up cash and cleanroom space within a device manufacturer’s walls.
Sterilization capacity issues are a big topic right now with everyone in a race to figure out how to expand or improve their EO footprint—internal or external capabilities. Also, optimizing sterilization cycles is a consideration—many times, cycles are “cut and paste” and they are not reviewed to see if modifications can be made for different products. From an outside vendor perspective, it will become more important in the coming years. This is a broad, across medical device concept, that is not necessarily geared toward orthopedic products specifically.
Sustainability and the environmental impact of EO and other technologies is being scrutinized, which is leading manufacturers to rethink sterilization and packaging strategies. Traditionally, packaging and sterilization were developed more autonomously and in parallel to each other, whereas now, they are collaborating more during the development process to optimize both sterilization and packaging costs and use.

Barbella: How is packaging and sterilization technology advancing to meet the needs of orthopedic manufacturers?
Smith: Packaging technology is advancing with more unique materials that reduces scuffing, elimination of foam, and unique designs that allow multiple sized product within the same package. It’s becoming more apparent that major packaging suppliers are thinking more about orthopedic products in their material offerings. It’s possible that the materials have been available for a long time, but not applied to orthopedics before—but now they’re recognizing these materials can be more widely used within the orthopedic segment and they are doing focused marketing toward that market for those materials.
There hasn’t been anything apparent for sterilization that is specifically focused on orthopedics.

Barbella: Why is it important for orthopedic manufacturers to consider sterilization and packaging early in the product design process?
Smith: Orthopedic items can be sharp, pointy, and abrasive. If you don’t take the packaging into account early on, you can run into a lot of problems at the end of the project, when it is not a desirable time to have problems come up. Depending on the packaging (and sterilization method), if you’re designing and developing a product for a specific type of sterilization and don’t take that into account, that can also lead to problems. While this concept is generally known, it still can and does happen if the product engineers aren’t working with the packaging and sterilization engineers from the beginning. It is all one system. It could be the greatest product in the world, but if you can’t package and sterilize it? It doesn’t matter.

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?
Smith: Like all companies, adjustments had to be immediately made without any planning. People started working from home, there were PPE shortages, and elective surgeries were down. People were/are afraid of going to the hospital (especially elderly people, the ones needing more orthopedic devices). In general, there has been an uptick in the elective orthopedic surgeries, allowing hospitals to earn money again, after having lost money through the beginning of the pandemic. We’ve also collectively learned a lot more about the virus, allowing us to find ways to prevent it better in the healthcare setting.
With Medtronic’s ventilators, we were able to continue making them the entire time, we also shared the design specifications for one of the ventilators (which would still need FDA/regulatory approval), allowing more ventilators to be come available sooner, to help people who needed them.

Barbella: How can (should) packaging and sterilization providers better manage supply chain risk in the wake of the pandemic?
Smith: Shortages have been most noticed in corrugated boxes. With so much more commerce (consumer) happening via shipping, it has put constraints on the availability of shipping containers for medical device manufacturers. Because the supply is low and demand is high, the prices and lead times for corrugated products have increased.
We have not seen any other shortages/issues in supply for needed packaging materials or sterilization, due to the pandemic
What has been realized is that there isn’t always a contingency plan for many of the packaging materials currently in use—which could have been an issue, had a shortage occurred. New strategies are being developed to allow for more flexibility in future and mitigate potential future issues that might arise.

Barbella: COVID-19 has somewhat doused the controversy surrounding EtO health/environmental risk factors. Has the technology redeemed itself in light of skyrocketing demand for PPE, or is it just on the back burner for now? Will the debate resume once the pandemic is under control?
Smith: It will completely resume once the emergency has passed. Coming out of this, the conversation will focus again on what we are going to do about sterilization. What causes environmental issues has not gone away, it will have to come back because we still have those issues.
The virus has created a conflict with the direction we’d been headed in before it hit—we were starting to use more reusable items (straws, silverware, etc.)—the virus interrupted this movement; it’ll be interesting to see what innovation happens to allow these conflicting concepts of disposable vs. reusable to be more resolved and in harmony.

Barbella: Are there alternative sterilization methods being developed or available that can replace EtO with respect to scalability and material compatibility?
Smith: Not any that are readily apparent or available “right now.” The sterilization methods that are being developed right now are likely five to 10 years out before they become a viable option. Once that happens, the costs involved to change existing products to a different sterilization modality are prohibitive such that the likelihood of existing products being switched is probably not high.

Barbella: How has the COVID-19 pandemic changed the packaging/sterilization industry (if at all)? Will these changes be permanent?
Smith: The base industry has not changed, but what has changed is the concept of dual sourcing and how to manage inventory well enough to be prepared should such a situation arise again. We’ve realized we are much more interlinked in the supply chain that we previously thought—and not confined to just the medical device industry. Other industries and what is going on in them have impacted the medical device industry in ways they haven’t before.

Barbella: Where do you see the packaging/sterilization industry headed in five years?
Smith: Once we come out of this, there is going to be a much higher focus on sustainability. Hospitals and larger purchasing organizations are already asking what we are doing to minimize packaging and make the packaging more sustainable. Medical device packaging companies are recognizing this and starting to develop ways to be more sustainable within themselves (incorporating their own manufacturing waste back into their product stream, even for medical device packaging). Medical device companies will likely push on the supply chain to provide sustainable packaging options—and that they are, themselves, developing sustainable operations—both packaging and sterilization. Are they on the DOW sustainability index? Are they publishing sustainability reports? These things will become more and more important as healthcare facilities are starting expect them.
The shift to electronic vs. printed manuals will definitely impact sterilization allowing the industry to sterilize quicker and more efficiently, as well as impact the packaging and shipping footprint.