FDA to Focus on Lowering Ethylene Oxide Emissions

Recently the FDA conducted a public advisory committee meeting to comment on the feasibility of various strategies to reduce (or completely eliminate) ethylene oxide (EtO) emissions from large-scale, medical device sterilization facilities. The meeting of the Medical Devices Advisory Committee followed on the heels of three high-profile, domestic EtO sterilization plant shutdowns. The loss of capacity from these three plant closures led to concerns about product shortages and highlighted the challenges of managing EtO emissions.1

According to the FDA, of the three most used medical device sterilization options (steam, EtO or gamma radiation) EtO is by far and away the most popular, especially for devices with numerous layers of packaging or with hard-to-reach crevices, lumens or dead spaces. EtO is used to sterilize over half of the 40 plus billion medical devices sold in the U.S. each year.2

During the past year, many of the commercial medical device EtO sterilization facilities have come under fire over concerns that nearby residents exposed to heightened EtO emissions may have a higher risk of developing cancer.(3) The competing public health issues that the FDA is trying to address is the potential harm to nearby residents from those EtO emissions against the possible widespread shortages of lifesaving medical devices if the commercial use of EtO sterilization is restricted or, even worse, eliminated.

Given that this is one of the largest, most pressing public healthcare issues in the country, Novo Surgical is publishing the FDA’s summary of the recent public advisory committee meeting for your use and review. We would encourage you to share this important committee meeting summary with members of your staff and with administration at your facility.

“The meeting in Gaithersburg, MD, brought together government officials as well as experts in industry, healthcare, materials science, and public health advocacy. Topics included the potential medical device shortages that could result from sterilization plant closures, the impacts of regulatory changes or limited availability of EtO on industry and healthcare delivery organizations, alternative methods for medical device sterilization, and the public health impact of long-term exposure to high levels of EtO in the environment.

On the first day (November 6, 2019) of panel deliberation, the panel discussed that, if EtO sterilization is reduced, eliminated or replaced to a different sterilization modality, there are options that can mitigate the impact of medical devices shortages.  The panel’s consensus was that FDA should prioritize stakeholder communication and work to facilitate validation of sterilization processes.

The panel discussed how FDA can help mitigate device shortages due to reduced device sterilization capabilities.  The panel’s consensus reemphasized the need for stakeholder communication and collaboration to help manage shortages, including working collaboratively with other government entities, on the federal and state level. The panel also recommended that it may be appropriate to enhance FDA’s ability to respond to device shortages by incorporating processes currently used with drug shortages that would necessitate additional authorities for FDA.

The panel deliberated on the possibility of changing EtO sterilization cycles or sterilization loads to reduce EtO use while maintaining effective sterilization. The panel’s consensus was that there were potential methods that appeared viable, but no single method would address all issues and that manufacturers and contract sterilizers should pursue all applicable methods for reducing EtO use.

The panel considered various methods to validate EtO sterilization cycles in hopes of reducing EtO-use while still maintaining an effective sterilization process.  The panel recommended that FDA encourage the use of alternatives to the overkill validation method which are included in the consensus standards for EtO sterilization processes.

The panel discussed the sterilization of some medical devices to a less rigorous sterility assurance level (SAL) (e.g. 10-5, 10-4, etc. instead of 10-6) be considered as part of the approach to reduce sterilant use.  The panel’s consensus was that consistent with current standards, FDA should consider moving to a risk-based assessment of the SAL for some sterilized medical devices. 

The panel discussed existing large-scale industrial sterilization modalities as a possibility that can take over a portion of the EtO sterilization. The panel deliberations identified that none of the currently available large-scale industrial modalities have the capacity or material compatibility necessary to take over a significant fraction of the medical devices currently sterilized via EtO. At the same time, the panel saw merit in actively pursuing exploration of the alternative modalities that could potentially provide some relief to the ecosystem, recognizing that the capacity for EtO sterilization is significantly constrained at present.

The panel recommended that manufacturers review which sterilization modalities may be compatible with their devices and where possible validate alternate methods. The panel also recommended that FDA continue to collaborate with industrial stakeholders to facilitate industrial efforts to develop alternatives to EtO sterilization as well as utilization of optimized EtO processes that use less EtO and emit less EtO into the environment in the near term.

On the second day (November 7, 2019) of panel deliberation on the topic of EtO sterilization of medical devices, the panel discussed the potential for sterilization modalities currently with limited or unknown industrial capacity to serve as an alternative to EtO. The panel discussed a possible timeline for implementing these modalities and the impact they may have on current medical device manufacturing practices, as well as FDA’s role as a facilitator for utilization of these modalities.”4

After two days of discussion, it became clear that there is no one type of sterilization method or procedure that can or will take the place of EtO sterilization in the next 5 - 10 years. Accordingly, it was decided that the FDA’s focus should be on finding better, safer ways to use EtO. In the end, the panel recommended the FDA not move to replace EtO in the short term, but to work with state governments to reduce the possibility of sterile medical device shortages due to legislative efforts and find new ways to use less EtO, and to use it more responsibly.

 

1 https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-6-7-2019-general-hospital-and-personal-use-devices-panel-medical-devices-advisory-committee

2 https://www.fda.gov/

3 “BD to suspend sterilization plant after FDA warning on device shortages” by Maria Rachal, MEDTECHDIVE, Oct. 28, 2019.

4 “24-Hour Summary General Hospital and Personal Use Devices Panel Advisory Committee Meeting November 6-7, 2019.” Food and Drug Administration Freedom of Information Staff (FOI) 5600 Fishers Lane, HFI-35 Rockville, MD 20851