HA stops using 142 Olympus insufflators in hospitals amid safety concerns

The Hospital Authority (HA) announced on Sunday to suspend the use of 142 insufflation devices in public hospitals immediately after some patients in the United States experienced complications due to the devices over-inflating air into the body without warning.

The HA and the Department of Health (DH) received notification from Olympus Hong Kong and China Limited regarding the product “Olympus High Flow Insufflation Unit (Model number: UHI-4)” that a Field Safety Corrective Action notice was issued.

The device uses carbon dioxide to inflate the abdomen or colon during laparoscopic or endoscopic surgeries. Over-insufflation may lead to complications, including air embolism, arrhythmias, pneumothorax, and potentially death.

According to a notice issued by the United States Food and Drug Administration (FDA), as of October 31, there have been 21 malfunctions, ten serious injuries, and one death related to issues of the unit over-inflating air into patient bodies without warning.

To date, the DH has not received any reports of adverse events in Hong Kong related to the issue.

About 200 units of the concerned device have been distributed to public hospitals, private hospitals, and a day procedure center locally.

It is estimated that around 30 elective surgeries scheduled at Tuen Mun Hospital, Pok Oi Hospital, and Caritas Medical Centre are required to be rescheduled in the coming week. Emergency surgeries in public hospitals are not affected.

The HA said it has implemented a series of contingency measures, including using alternative devices of other brands or models, and deploying alternative devices among hospitals to maintain emergency surgeries. 

The authority also requested other suppliers to support the services by providing alternative devices in stock urgently, with the first batch of insufflators expected to be distributed to public hospitals within the coming week.