Important Safety Alerts

The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom issued a medical device alert concerning detergent and disinfectant wipes used on reusable medical devices with plastic surfaces.

The MHRA and Health Facilities Scotland have received incident reports relating to detergent and disinfectant wipes that have degraded plastic surfaces of medical devices and affected their performance and integrity. The reports describe damage to devices such as tympanic thermometers, patient monitors, infusion pumps, dialysis fluid filters, peritoneal dialysis transfer sets and infant warmers. According to the MHRA, detergent and disinfectant wipes can damage plastic surfaces of medical devices if they are not compatible with the surface material. Therefore, damaged surfaces may compromise the ability to decontaminate medical devices adequately and / or may interfere with device function.

Therefore, the MHRA provided the following advice: reminded all staff involved in the decontamination of medical devices to:-

• Identify all device decontamination processes that include using a detergent and/or disinfectant wipe on a plastic surface and ensure that you have a compatible process in accordance with the device manufacturer's instructions. If in doubt contact the device manufacturer for clarification.
• Look for signs of damage to the medical device and follow local reporting procedures as appropriate;
• If the manufacturer's decontamination instructions are inadequate, report this fact to the manufacturer.
• Ensure that all staff involved in decontamination processes are fully trained and that this training is regularly updated.

For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON254849

Posted on 28 March 2013