Device Firms Discuss Ethylene Oxide Sterilization Ahead of FDA Committee Meeting

Regulatory NewsRegulatory News | 28 October 2019 |  By 

On 6 and 7 November, a US Food and Drug Administration (FDA) medical devices advisory committee will meet to discuss the use of ethylene oxide (EO) to sterilize medical devices and the risks of infection with reprocessed duodenoscopes.

The meeting comes as the agency is actively exploring new methods of sterilization, as sterilization facilities have closed down in recent months because of environmental concerns with emissions and as postmarket surveillance studies of duodenoscopes indicated “higher-than-anticipated contamination rates after reprocessing.”

The panel plans to discuss how to reduce EO emissions without compromising the sterility or effective processing of devices and recommendations to reduce the risk of infection from reprocessed duodenoscopes.

Ahead of the FDA meeting, device manufacturers are explaining why they continue to rely on EO sterilization, why any major shift away from EO will be difficult and other reprocessing considerations.

Medtronic, for instance, notes that 60% of its medical devices and instruments (which tens of millions of patients rely on) are sterilized using EO as it’s the only sterilization method that has been validated and shown to meet requirements set by FDA and other regulators.

“Medtronic is very concerned by recent calls to ban or significantly restrict the use of EO in the US,” the company said, noting that such a move would have adverse effects on public health.

The company also explains how its sterilization facilities’ EO emissions “are carefully monitored at all times” to ensure government standards are met. Medtronic says it’s researching new sterilization techniques, although this work “is still at an early stage, and further study is needed to determine whether these efforts will translate into practical, safe and effective sterilization processes that are relevant for a broad range of medical devices.”

A validation phase of another study on whether Medtronic can reduce EO use by as much as 50% is expected to be completed next summer, the company adds, explaining how any changes to established sterilization practices “will take time.”

Industry group AdvaMed further clarifies that any changes to minimize EO use, “would likely require extensive product and/or process modifications; validation and verification testing; potential facility upgrades; and required notifications, clearances and approvals from FDA.”

Similarly, BD, which may have one of its Georgia-based EO facilities shuttered because of emissions concerns, explains how EO is “proven to be the safest and most effective way to sterilize” about 50% of all devices. The company also notes that “effective cycle development and robust preventive maintenance” keep uncontrolled EO emissions “to a very low level.”

On the topic of duodenoscope contamination, Boston Scientific explains the background story of how in 2013, the CDC alerted FDA to a duodenoscope-associated E. coli outbreak. The company calls on FDA to “continue its diligence in investigating the limitations of duodenoscope reprocessing and communicating clearly with the healthcare community. This includes precise reporting of data on the contamination/infection risks and the etiology of the problem (biofilm) while avoiding recommendation of solutions that are unproven and risk being found to be ineffective in their ability to reduce EAIs [endoscope associated infections].”

Boston Scientific also discusses single-use endoscopes, the potential for added costs and that a “significant number of endoscopists do not seem to appreciate the significance of the problem and the need for change.
The reasons for this are multifactorial. Endoscope associated infections (EAI) are hard to detect, the symptoms they cause in patients variable, and the timeline to development of symptoms potentially long (i.e. weeks to months after the procedure) making linkage to the procedure unclear to an examining clinician.”

In addition, Fujifilm discusses how it’s developing alternatives to the reprocessing of fixed end cap duodenoscopes and has recently released a duodenoscope with removable single-use distal end cap.



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