Warning over Keeler ophthalmic probes
Cryomatic ophthalmic probes manufactured by Keeler are being recalled amid concerns over the risk of infection. The Medicines and Healthcare products Regulatory Agency has issued a Medical Device Alert covering all reusable probes used with a Cryo console. The alert states: "The instructions for use contain inadequately validated re-processing methods. As a result there is a risk of cross infection." The warning follows an earlier Field Safety Notice issued by Keller, which advised that the sterilisation parameters of 134 -137 °C for three minutes have not been validated as an effective method for rendering the device sterile. The alternative gravity method for sterilisation, using the parameters 121-124 °C for 30 minutes, had also not been adequately validated by the manufacturer. The manufacturer said it is currently validating suitable re-processing instructions for the devices and will provide these when available. In the meantime, anyone using the probes is advised to take them out off action and contact the firm.
