Heart scan criticisms spark tighter controls

Regulations on the use of medical devices will be tightened to ensure quality service for patients, the government said yesterday.

The review by the Health, Welfare and Food Bureau is in response to criticisms over the effectiveness of a hi-tech heart scan used at Matilda Hospital, reported by the South China Morning Post this week.

The machine is the only one of its kind in Hong Kong and has been used on an estimated 4,000 patients since December 2000.

The scans cost $3,000 for a one-off or $11,000 if part of an executive check-up. The Hong Kong College of Cardiology said this week it was considering issuing guidelines on the electron beam tomography (EBT) heart scan, after some cardiologists questioned its accuracy.

Doctors estimate that dozens of patients might have been sent into a panic after receiving EBT reports of high calcium scores and heart disease. At least three patients are known to have undergone invasive angiograms in response to EBT scan results only to find out they were disease-free.

A Health, Welfare and Food Bureau spokesman said: 'The government is looking into the regulations covering medical devices. The principles of regulation will address the quality, safety and efficacy of the equipment using a risk-based approach.'

Only medium and high-risk products will be required to be registered. Adverse incidents in their use will be reported to authorities.

The bureau reminded doctors that 'screening tests or investigations should be prescribed based on their professional judgment'.

The heart scan detects the presence of calcified plaque in the arteries of the heart, a 'marker' for the hardening of the blood vessels.

Graphic: SCAN30GET