The sudden closure of a medical device sterilization plant in February and a second plant closure planned for later this year have raised questions about the effects on medtech manufacturers. Medical Design & Outsourcing asked Dan Fowler of WuXi AppTec about the implications and options for the industry.
MDO: What can medtech manufacturers do to mitigate the impact of the sterilization plant closures?
Fowler: First, they can determine if any of their products have been validated at alternative EO facilities or under another sterilization method, such as radiation. This may provide alternative solutions. Second, they can evaluate whether they manufacture similar products, such as reusable devices, that can meet the same clinical needs and alleviate pressure on their inventory. Finally, they can establish open communications with regulators to develop plans for completing revalidations and discuss how to fast-track the revalidation data submission to a regulatory agency and expedite the regulatory review process.
If going down the path of revalidation, establishing open communication with regulators can help ease the resubmission process. The FDA is evaluating ways to assist device manufacturers with submissions directly related to the Sterigenics Willowbrook, Ill. plant shutdown in an attempt to mitigate shortages to patients.
MDO: What’s the difference between EO and radiation sterilization?
Fowler: Both are well-established industry methods for sterilizing medical devices, and each has pros and cons. In order to select the best sterilization method for a device, it’s critical to consider the materials used in its construction. Those materials and the chosen sterilization method both have effects on device safety, functionality, and reliability that are considered and validated during the design and development phases.
MDO: Are there cost savings or ease-of-use considerations with radiation versus EO?
Fowler: Cost depends on several factors, including volume expectations, vendor capacity and logistics. If switching from EO to radiation, manufacturers must weigh the time and cost it will take to execute a new sterilization validation, as well as any other safety and performance validations. The time and cost of a design history file review as part of resubmission to a regulatory agency for approval can also affect investment return for a project such as this.
These cost savings issues are inherently complex. For example, a switch from EO to radiation requires a product design evaluation. A manufacturer must first consider the following questions:
- Are the product’s materials compatible with radiation?
- Is the product’s safety data affected by the change in sterilization modality?
- Will a switch affect packaging?
- How much revalidation work is necessary?
- What are the changes to the product specification (material selection, packaging, shelf life, extractables/leachables, biocompatibility)?
There are also costs to resubmit and additional time required, which could also result in market delays.
MDO: How might these closures affect a product’s European Union’s Medical Device Regulation (MDR) timeline?
Fowler: The MDR planning process could certainly be affected. Before the Sterigenics plant closure, a product family may have had enough data for sterilization validations from the initial gap analysis. Perhaps a previous vendor was qualified and the process validated in accordance with the latest ISO sterilization standards, such as ISO 11135. However, if a manufacturer must change vendors, this requires added validation and documentation of the change in the medical device manufacturer’s design files according to their quality management system.
Going forward, regulatory bodies may consider sterilization changes to be significant enough to cause a cascade of implications for a product’s launch from today through the MDR transition process.
There are a few guiding questions to consider. First, under the current E.U. Medical Device Directive (MDD) certificate, is there enough time to complete the change, supply a notified body with the documentation, and receive a CE mark under MDD? If not, this may affect the device manufacturer’s decision on product/project prioritization in bringing a product family into compliance.
Without a validated CE Mark under MDD by May 26, 2020, they would need to decide on prioritization because it is just as much of a business decision as it is a compliance requirement. Medical device manufacturers must evaluate the gaps to implement the sterilization vendor or modality change in order to determine where the product, in its current form, ranks in it is go-to-market strategy under MDR. Essentially, the question to answer is: Is the product’s market value sufficient to offset the cost to bring the product into compliance with MDR?
The work required to be fully MDR-compliant may involve more time and resources than what was needed to support a sterilization vendor change.
MDO: Does this present any positive opportunities for a medical device manufacturer?
Fowler: The closures may lead manufacturers to conduct a supply chain risk analysis. This could help determine if they need to address other serious risks, such as secondary or tertiary vendor validations or validations of alternate sterilization methods.
MDO: Who should be involved internally and externally to ease the transition?
Fowler: A vendor or sterilization method change is, at a minimum, a three-party process. The key players include the medical device manufacturer, the sterilization company and the laboratory testing facility. A medtech manufacturer’s product management and other business partners, regulatory affairs, quality engineering and product development teams play a role in the transition. A manufacturer may also need procurement and other business partners to find and qualify a new vendor
