Panel Urges Risk-based Sterility Assurance for Devices

Worried about device shortages that could occur from recent closures due to environmental concerns at facilities that use ethylene oxide (EtO) to sterilize medical devices, FDA convened an advisory committee last week to discuss options and alternative sterilization methods. Members of FDA’s General Hospital and Personal Use Devices Panel of the Medical Device Advisory Committee discussed whether some devices could be held to a less rigorous sterility assurance level (SAL) as part of the approach to reduce EtO 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,” a just-posted FDA summary says. “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.”

Some panel members recommended that device companies explore alternative sterilization modalities to see whether they may be compatible with their devices and where possible validate alternative 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.”

Many stakeholders are concerned about shortages occurring from the recent closure of a Sterigenics ethylene oxide sterilization facility in Illinois, the temporary closure of another Sterigenics facility in Georgia, and the potential closure of a large Becton Dickinson sterilization facility in Georgia could affect the availability of some sterile medical devices used by health care delivery organizations and patients, a recent FDA notice says.

There are several methods used to sterilize medical devices, but ethylene oxide is the most common, well-established and scientifically-proven, FDA notes. “Medical devices made from certain polymers (such as plastic or resin), metals, or glass — or devices that have multiple layers of packaging or hard-to-reach crevices — are likely to be sterilized with ethylene oxide to avoid product damage during the process,” it explains. “These include surgical kits used in emergency procedures such as emergency Caesarean sections (‘C-sections’) and in routine procedures such as cardiac surgery and hip or knee replacement surgeries. Without adequate availability of ethylene oxide sterilization, we anticipate a national shortage of these devices and other critical devices including feeding tube devices used in neonatal intensive care units, drug-eluting cardiac stents, catheters, shunts and other implantable devices.”

In light of these concerns, FDA is urging device makers that use ethylene oxide facilities to assess their inventory for any future impacts of sterilization facility closures on their product distribution. The agency also says device firms should report product supply issues.