Earlier this fall, the Advanced Medical Technology Association (AdvaMed) released a fact sheet on ethylene oxide (EtO) sterilization to refute fallacies about medtech manufacturers’ preferred disinfecting method.
 
“A false emerging narrative suggests ethylene oxide (EtO) sterilization is ‘cheaper, easier, and faster than alternatives and thus preferred,” states the fact sheet, released Nov. 1. “Modern Healthcare called it a ‘relatively cheap process that easily penetrates products, making it an attractive choice for device makers.’”
 
For many device makers, EtO is the only sanitizing option due to product size, shape, design complexity, or material composition. Some materials, in fact, actually degrade under radiation or steam decontamination processes.
 
Consequently, EtO sterilization has gained favor with the medtech industry over the last several decades despite its high costs. AdvaMed’s fact sheet notes that ethylene oxide is “often the most expensive, time consuming, and inefficient” sterilizing method. It’s also a more harmful method for human health, given its designation as a carcinogen by the U.S. Environmental Protection Agency.
 
Emissions from EtO sterilization facilities have prompted concerns and lawsuits from both (neighboring) residents and state and local governments. Eliminating ethylene oxide as a cleaning tool would have disastrous public health consequences, as more than half of all medical devices undergo this method of decontamination. “Elimination of this sterilization technology would introduce the real risks of increased morbidity and mortality,” AdvaMed has stated.
 
ODT’s packaging and sterilization feature delves into the controversy surrounding EtO disinfection as well as the trends and market forces driving the final stages of product development. Robert Hegedus, senior Quality Assurance manager at Cranberry Township, Pa.-based Cadence Inc., was among the experts interviewed for this feature; his full input is provided in the following Q&A:
 
Michael Barbella: What are the latest trends in packaging/sterilization services?
Robert Hegedus: The industry is continually exploring options to ensure that packaging materials and sterilization methods are adequate in ensuring safe delivery of medical devices. Some of the latest trends involve improved testing methods that ensure packaging reliability and integrity to prevent contamination of products. Manufacturers are continually evaluating alternative materials and configurations to prevent moisture exposure, light, and bacteria. In addition, reviewing methods to reduce costs and lead times are also at the industry forefront in response to current supply chain challenges.
 
Barbella: What critical sterilization parameters impact packaging material selection and packaging design?
Hegedus: It is critical when evaluating packaging materials that the risks from the sterilization methods are assessed. Different types of sterilization methods impact materials and products in different ways.
For example, gamma sterilization is a method of sterilization that utilizes high energy gamma rays to emit radiation to kill microorganisms. It is crucial that manufacturers of devices understand the impacts of the gamma rays on their material selection. This method is compatible with most plastics and other packaging materials, but under some circumstances can impact the stability of materials, making them brittle and more susceptible to exposure. EO (ethylene oxide) is another highly used sterilization method in the medical device industry that exposes products to EO gases. As a result, packaging materials must be breathable to allow for exposure to these gases.
 
Barbella: What challenges, if any, do 3D printed orthopedic devices introduce into the sterilization and packaging process? Please elaborate.
Hegedus: Cadence Inc. does not currently sterilize any 3D printed devices, but some of the perceived challenges when selecting an adequate sterilization method are understanding the impacts to not only the packaging but to the device itself. For instance, the radiation from gamma sterilization may impact plastics, making them brittle. Under this circumstance, a manufacturer may be more inclined to utilize alternative methods such as EO.
 
Barbella: How can supply chain-related packaging material shortages best be managed? What options are available to packaging/sterilization providers?
Hegedus: COVID-19-related supply chain challenges are having an impact on packaging materials used in medical products. Cadence is not immune to these issues and has been working with original equipment manufacturers (OEMs) to assess equivalent materials that can be used to reduce dependency and materials with extended lead times. These changes are not easy and require extensive testing and qualification to ensure adequacy of the materials.
 
Barbella: How can packaging material changes affect the packaging and/or sterilization process? What is required from a validation standpoint?
Hegedus: Packaging changes can be very impactful if all risks are not fully assessed to ensure that the new material is adequate in preventing contamination or even damage. Packaging materials must be assessed and validated to the following, but not limited to:

• Transit testing 
• Stability testing 
• Peal strength
• Burst testing
• Sealing equipment validation 

Barbella: How have packaging and sterilization providers learned to better manage supply chain risk in the wake of COVID-19?
Hegedus: Manufacturers have been evaluating alternative methods. In addition to packaging materials, sterilization methods are also a risk. As a result, alternative sterilization methods are being evaluated to ensure minimal impacts. Some alternative methods that have been implemented in recent years are nitrogen oxide and X-ray sterilization. Cadence has also looked to diversify by identifying and qualifying additional sterilization providers and testing labs in order to reduce dependency upon one 3^rd party sterilizer.
 
Barbella: What kinds of alternative sterilization methods are companies embracing to reduce their dependency on EtO, given the technology’s much-publicized health/environmental risk factors?
Hegedus: As outlined above, since 2019 the FDA and regulators have been evaluating alternative sterilization services to reduce dependence on EO sterilization, which has been the primary method used in the medical device industry. Based on some quick research, below are a few alternative methods:

• NovaSterillis – Supercritical carbon dioxide sterilization
• Vaporized hydrogen peroxide (Steris)
• X-ray 

Barbella: Where is the packaging/sterilization industry (for orthopedics) headed in the next five years?
Hegedus: I am not up to speed on all of the latest industry trends, but I see the industry continuing to implement solutions, methods, and materials to: reduce processing times, reduce environmental impacts, reduce costs, and improve packaging integrity and stability.