Incorporate Packaging, Sterilization Early in Product Design to Avoid Costly Mistakes

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. Tim Eells, marketing manager at WESTPAK Inc., 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.
Tim Eells: The industry must ensure packaging systems and sterile barrier systems perform as intended and continue protecting the patient. Recently, a few partner-clients have requested the use of validated test methods for their testing. Though it doesn’t sound like a big ask, we discovered it was.
 
Barbella: How is packaging and sterilization technology advancing to meet the needs of orthopedic manufacturers?
Eells: The well-proven tests such as Accelerated Aging (ASTM F1980), Shipping/Distribution (ASTM D4169, ASTM D642), and Seal Strength/Peel (ASTM F88) continue regular usage by the orthopedic industry. However, I’m unaware of test protocol working groups in these or any areas focused on future revisions for the orthopedic industry.
 
Barbella: Why is it important for orthopedic manufacturers to consider sterilization and packaging early in the product design process?
Eells: The specialized requirements of orthopedic products make excellent candidates benefitting from early engineering involvement. One of the most significant advantages is reducing the likelihood of expensive mistakes resulting from unknown stakeholders and team members, new or updated product or regulatory requirements, market or customer requirements, unstated material or design assumptions, test protocols, pass/fail differences, etc. As we all know, there generally aren’t extra resources or time available to deal with mistakes occurring late in the process that shouldn’t have happened in the first place.
 
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?
Eells: As the pandemic began in mid-March, we immediately shut down for a few days to understand local and OSHA requirements, create necessary documentation, and form safety implementation leads and teams. It all worked great from the start, and continues to do so. Of course, the priority is ensuring everyone’s safety, whether an employee-owner, a partner-client, or service provider visiting either of the test laboratories. As an essential business, we pivoted with a full operational test team following strict COVID-sanitation protocols within just a few days. All indirect employee-owners who could work from home did beginning that first week, and most have been doing so ever since. A lean, hard-working test team remains working regular shifts on-site to support our partner-clients’ uninterrupted test needs.
 
Barbella: How can (should) packaging and sterilization providers better manage supply chain risk in the wake of the pandemic?
Eells: Perhaps the best risk mitigation is to plan well in advance, allocating sufficient resources in preparation for the worst-case scenario which hopefully never comes. It’s not easy, but the closest you can get to that, the better.
 
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?
Eells: COVID has derailed many things, with health/environmental EtO issues being a good example. Though the problems in the EtO camp won’t disappear, hopefully, they’ll shrink in size and frequency as the industry learns to minimize EtO use while not compromising patient safety. Whenever conflict exists between EtO operations and surrounding communities, communities will likely win, redirecting EtO opps to lesser resistance locales.
 
Barbella: Are there alternative sterilization methods being developed or available that can replace EtO with respect to scalability and material compatibility?
Eells: No, not that I’m aware of. These advantages seem to be the big reason why EtO operations will continue; it’s just a matter of where.