Current Regulatory Landscape for EO Residue Levels in Medical Devices: What Manufacturers Need To Know Now and What May Be on the Horizon

The goal for medical device manufacturers that use EO sterilization to minimize patient exposure to EO residues and (and EO derivatives) from their devices and ensure that the levels of residual EO, ethylene chlorohydrin (ECH), and ethylene glycol (EG) pose the least amount of risk possible to the patient during normal product use. Furthermore, testing for ethylene oxide residue on finished devices must be validated and the results documented by manufacturers per current regulations, particularly ISO 10993-7, to earn regulatory approval to market those devices.