The HSE have issued a safety critical national patient safety alert for action by everyone using Olympus High Flow Insufflation Unit UHI-4. 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 alert highlights a field safety notice that the medical device company Olympus has issued after it became aware of patients experiencing complications from over insufflation where UHI-4s were used, including arrythmias, gas embolism and one death.Olympus_Field_Safety_Notice_GnJC0fd

These complications may have been due to over insufflation of the abdominal cavity resulting from use of the UHI-4 during the procedures. This includes events where the device was reported to ‘not alarm’ or otherwise notify the user and events where the device did not relieve the over insufflation to the set pressure.

How to take action?

1. Circulate this to colleagues . HSE_NPSA_Risk_of_patient_harm_from_medical_device_-_Olympus_Insufflation_Unit-UHI-4.       Addendum_Olympus_Insufflation_Unit_UHI-4_JhZtoFb
2. Alternative devices should be used where available.
3. In the absence of an alternative device, the HSE recommends that extreme caution is exercised in the continued use of the Olympus UHI-4 device. Heightened vigilance is required through careful physiological monitoring for signs of complications.
4. If using a UHI-4 device the lead surgeons should conduct a call out – ‘insufflation commencing – please be extra vigilant ….’ to the attending anaesthesiologist during insufflation of the peritoneal cavity to allow hyper-vigilance to observe for bradycardias etc.
5. Please refer to pg.4 of the attached FSN for the action steps to be taken by end user
6. The risks associated with insufflation, with reference to the FSN should be included in the consent process.
7. Report any incident/near miss related to medical devices onto the National Incident Management System (NIMS), to the device manufacturer and the HPRA.

HSE NPSA 0042023 – What does it mean for me as a patient or service user