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Saturday, Apr 13, 2024

Pressure mounts on surgical lights firm

Two records of defective screws in surgical lights manufactured by Swedish medical technology firm Getinge - the same manufacturer of the light that fell at United Christian Hospital Saturday - have rung alarm bells in the United States over the past two years, according to US Food and Drug Administration records.
That comes as the manufacturer faces a safety scare in Hong Kong after a surgical light fell from the ceiling in a public hospital operating theater and injured an anesthetic assistant on the shoulder.

Tim Pang Hung-cheong, a patients' rights advocate with the Society for Community Organization, called on local authorities to review existing risk alert protocols.

He said Saturday's incident revealed safety risks of devices in operating theaters and that the Hospital Authority should conduct a comprehensive inspection and analysis.

"The authority also needs to review whether it needs to shorten the interval between maintenance checks," Pang said.

He also questioned why the defects were not identified during the annual inspection last December and called on both the HA and the manufacturer to address the public once an investigation has been completed.

The lamp in Saturday's incident, manufactured by Swedish medical supply giant Getinge, came loose from a ceiling mount due to defective screws, an initial report has found.

A total of 16 more lights from the same brand were found to have screw defects after the case sparked an investigation and safety checks on surgical lighting across public hospitals.

The authority has asked the manufacturer to submit a report with recommendations for improvement.

Pang also said the FDA last December received an adverse-event report on a surgical light involving the same brand.

The investigation should look into whether local authorities are aware of "foreign risk alerts," Pang added.

According to the FDA's website, a screw was missing from the main tube of the ceiling-mounted Maquet Volista surgical lamp.

"There was no injury reported, however, we decided to report the issue in abundance of caution as missing screw from main tube could lead to fall of the device and as a result of that, could lead to serious injury," the FDA said.

In a January 2021 FDA report also handled as "detachment of device or device component," another light manufactured by Getinge - the Maquet Lucea - was found to be missing a set screw and screw plug.

"There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination," said the FDA.

The Volista and Lucea lamps were manufactured in one of Getinge's production facilities in Ardon, France in 2017 and 2014 respectively.

Pang continued saying that he hoped private hospitals and clinics would also carry out inspections as they may be equipped with similar surgical lights.

Separately, the authority in a statement yesterday said it was not informed by the manufacturer or the maintenance contractor about the missing screw reports received by the FDA.

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