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Surgeries involving the use of some insufflation equipment were halted immediately after the Hospital Authority found 142 Japan-made devices may malfunction and cause cardiac arrest during operations.
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At least 30 operations for this week have had to be rescheduled. And the Hospital Authority is tracking down patients who had abdominal and colorectal surgery recently.
The authority's action follows the recall in August of the US Food and Drug Administration's Olympus-made devices as they could pump too much air into the body without warning, with air embolism and cardiac arrhythmias among potential consequences.
The authority said yesterday it is "very concerned" about the potential malfunction of the Olympus "High Flow Insufflation Unit, Model UHI-4."
After receiving a notification from the Department of Health, the authority said it "worked with different hospital operation theaters to assess the situation immediately.
"The authority 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 said it has asked other suppliers to provide alternative devices urgently. The first batch of alternative devices is expected to be distributed to public hospitals this week.
"In order to mobilize resources to maintain emergency surgeries, it is estimated that around 30 elective surgeries - mainly laparoscopic minimally invasive surgeries - scheduled at Tuen Mun Hospital, Pok Oi Hospital and Caritas Medical Centre are required to reschedule in the coming week," the authority said.
"The authority has contacted the supplier to express concern regarding the safety corrective action of the devices and requested it to resolve the problems together with taking remedial measures to minimize the impact on patient services as soon as practicable."
The US FDA device recall is classified as Class 1 - indicating continued use of the device may cause serious injury or death.
According to an FDA notice, there have been 21 malfunctions in the United States, resulting in 10 serious injuries and one death.
The agency highlighted this recall is a correction - for repair, modification, adjustment or inspection of the device without its physical removal to another location - and not dropping the product from use.
Olympus initiated the recall in August with 3,136 devices distributed between May 2012 and August.
Alex Lam Chi-yau, chairman of the Hong Kong Patients' Voices, told The Standard yesterday that the issue could affect more than 400 patients.
"Usually a doctor can conduct surgeries for four patients a day with the device," Lam said, adding that laparoscopic and endoscopic surgeries to detect abdominal and colorectal illness are common procedures in hospitals.
"Over 100 devices were halted," he added. "That's a large number."
Lam also urged the Hospital Authority to find alternatives from other brands and reschedule affected procedures at private hospitals to minimize the impact on patients in the short run.
The authority should also conduct a thorough examination of other devices in the market, he said.
In response to media enquiries, CUHK Medical Centre in Ma Liu Shui said it has already suspended the use of five devices of the same model after receiving the notification from the Department of Health.
But it noted that services at its surgery rooms remain normal.
Saint Teresa's Hospital in Kowloon City said it possesses four of these devices.
"However, we started to replace these devices with devices manufactured by other brands two years ago," it said. "None of those devices are currently in use at the hospital."
The Hong Kong Adventist Hospital in Tsuen Wan stopped using devices of the same model immediately after the alert was raised and used alternative devices so no surgeries or patients were affected.
ayra.wang@singtaonewscorp.com
