CDRH to Survey Manufacturers in Prep for Device Shortages

Regulatory NewsRegulatory News | 22 November 2019 |  By 

As the medical device industry grapples with the closure of sterilization facilities, the US Food and Drug Administration (FDA) is going to try to stay ahead of any device shortages by calling certain device manufacturers that produce an “essential medical device.”

The Center for Devices and Radiological Health (CDRH) said it identified the need to “acquire and maintain” data on the domestic device inventory, manufacturing capabilities, distribution plans, and raw material constraints “for devices that would be in high demand and/or would be vulnerable to shortages in specific disaster/emergency situations or following specific regulatory actions.”

The announcement of the survey comes as FDA has tracked the recent closure of a large ethylene oxide (EO) sterilization facility in Illinois (Sterigenics), the temporary closure of another large Sterigenics facility in Georgia, and the potential closure of a large Becton Dickinson sterilization facility in Georgia. The agency said on a page updated Friday that it is “concerned about the future availability of medical devices and impending medical device shortages.”

According to comments ahead of an FDA meeting on EO earlier this month, device manufacturer Medtronic noted that 60% of its medical devices and instruments are sterilized using EO as it’s the only sterilization method that has been validated and shown to meet requirements set by FDA.

For its upcoming survey, FDA said it estimates that about 260 manufacturers will be contacted four times per year either to obtain primary data or to verify/validate data. FDA also estimates that manufacturers will be able to complete each data request in 30 minutes or less.

“Such data could support prospective risk assessment, help inform risk mitigation strategies, support real-time decision making by the Department of Health and Human Services during actual emergencies or emergency preparedness exercises, and mitigate or prevent harm to the public health,” FDA said.

The plans to try to mitigate device shortages were hatched more than a decade ago, although the first notice seeking public comment (no comments submitted) on the shortage data collection was published in 2018.

In this latest Federal Register notice on submitting the proposal for data collection to the Office of Management and Budget (OMB), FDA also criticized some device production methods while explaining that the total burden is higher than initially thought.

The notice says: “There is an increase (an adjustment) of 332 hours in the total estimated burden compared with that identified in the information collection request previously approved by OMB. This increase reflects changes in market demands, in which manufacturers are increasingly adopting just-in-time production methods.”

Federal Register notice


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