Custom Packaging Typically Required for Orthopedic Devices

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. Jennifer A. Gygi, expert technical consultant, and Wendy Mach, senior expert, technical consulting, at Nelson Laboratories, a Sotera Health company, were among the experts interviewed for the story. Their full input is provided in the following Q&A.
 
Michael Barbella: Please discuss the trends in packaging/sterilization services. 
Wendy Mach: Currently the packaging trends we are seeing from the MDMs is compliance issues from the notified bodies or FDA—specifically associated with the establishment of stability programs and label claims, evaluation of climate conditions for the distribution environment, and as always the justifications associated with sample sizes. One interesting point here is we are actually seeing feedback that even if the company can provide the appropriate justifications associated with testing quantities, some FDA reviewers are stating “Please note that to support a marketing application, a higher degree of reliability (e.g., 95 percent) is typically needed.” The problem with this is it drives MDM’s to increase testing quantities without statistical justification and contradicts the less burdensome approach that the FDA has implemented.
 
Barbella: Why is it important for orthopedic manufacturers to consider sterilization and packaging early in the product design process?
Mach: It helps companies meet their market launch dates by ensuring that any issues associated with the packaging, design, and compliance to the standards have been managed before you actually get the appropriate phase of the test and find failures that could have been prevented by incorporation early in the design.
Jennifer A. Gygi: Sterilization and packaging should always be considered as early in the design process as possible. From a packaging perspective, orthopedic devices tend to be heavier for their size compared to many typical medical devices and usually have features like textured surfaces and sharp or protruding elements that present a challenge to packaging. Most orthopedic devices are not suitable for an “off the shelf” pouch and will likely require custom packaging. Custom packaging requires extra time to design and fabricate and may require additional considerations in regard to the sealing equipment. Thinking ahead in the design process to what the packaging requirements will be for the device can allow a device manufacturer to perform some of the custom packaging design steps in parallel with the product design, potentially saving weeks or months on the overall timeline. 
 
Barbella: How has the COVID-19 pandemic changed the packaging/sterilization industry (if at all)? Will these changes be permanent? 
Gygi: Most packaging materials have been in use for decades and nothing about COVID-19 has changed how well those materials maintain a sterile barrier. The packaging supply chain seems to be robust (at least as good as every other supply chain these days) and there was less demand for some medical devices as elective procedures were cancelled due to lockdowns, which meant less devices were manufactured and packaged.
 
Barbella: Where do you see the packaging/sterilization industry headed in five years?
Gygi: There is a trend in the industry to reduce packaging waste, which may prompt some device manufactures to reconsider their packaging systems. The packaging system includes both the sterile barrier system that protects the device and the extra layers of packaging, which protect the sterile barrier from damage. Careful consideration of packaging design may allow some reduction in the amount of overall packaging (either by a thinner gauge material for the sterile barrier, or eliminating a layer of protective packaging). However, any packaging changes will likely require revalidation to ensure the reduction doesn’t increase the risk of a non-sterile product.