Who needs to take action?
Following a second Field Safety Notice (FSN) from Olympus Ireland (Ref: QIL FY24-EMEA-38-OMSC-06 UHI-4 CR Board – Issued 21 Mar 2024), in relation to the Olympus Insufflation Units-UHI-4 the HSE is recommending the removal of the device from use.
This alert is for action by all HSE and HSE Funded Services that are using Olympus High Flow Insufflation Unit UHI – 4 (see Appendix A). UHI – 4 is used to facilitate laparoscopic and endoscopic observation, diagnosis, and treatment. It is used to insufflate the abdominal cavity and colon and provides automatic suction and smoke evacuation.
What is the issue?
This updated alert pertains to a second FSN in relation to the UHI-4 medical device. The FSN highlights an increased trend in complaints about the device control panel and sets out the findings from a root cause investigation regarding the previously reported over-insufflation risk. In light of this recent FSN a HSE Serious Incident Management Team (SIMT) meeting was held with stakeholders and a decision has been made by the HSE to remove all affected devices from use at the earliest opportunity. The HSE Medical Devices Office has been in direct contact with each site individually and provided advice and information on ordering replacement devices. The HSE Medical Devices Office will be in contact with sites seeking updates in relation to progress in replacement of devices and any supports that may be required as part of the change process.
How to take action?
- Circulate this HSE NPSA to relevant staff including but not limited to Clinical Directors, Surgeons, Anaesthetists, operators of the device, staff working in theatres/endoscopy units, managers of those areas and medical device engineers.
- Replace all affected UHI-4 devices at the earliest opportunity.
- While waiting for a replacement unit to be provided alternative devices should be used where available.
- During the transition period, in the absence of an alternative device, where cancelling surgeries or procedures may lead to greater risk or harm, the HSE recommends that extreme caution is exercised in the continued use of the UHI-4 device, noting the new information in the FSN (Nov 23). Heightened vigilance is required through careful physiological monitoring for signs of complications.
- If using a UHI-4 device the lead surgeons should conduct a call out – ‘insufflation commencing – please be extra vigilant...’ to the attending anaesthetist during insufflation of the peritoneal cavity to allow hyper-vigilance to observe for bradycardias etc.
- The risks associated with insufflation, with reference to the FSN should be included in the consent process.
- Report any incidents or near misses related to medical devices onto the National Incident Management System (NIMS), to the device manufacturer and the HPRA
When does action need to be completed?
Please circulate this HSE NPSA to relevant staff by latest 27th March 2024.
Whilst the replacement of the device is dependent on some external factors, the HSE Medical Devices Office will be in contact with sites seeking updates in relation to progress in replacement of devices.
Download the alert as a PDF
Download the HSE NPSA Local Action Plan