PETALING JAYA: Medical devices such as blood pressure monitors are designed for clinical use and typically require regular calibration as recommended by the manufacturers, says the Malaysian Pharmacists Society (MPS).
This was in reference to complaints of inaccurate readings by some devices including unauthorised ones being sold online.
“There have been documented cases where inaccurate readings led to inappropriate health decisions, especially in the management of chronic conditions like heart disease or diabetes, where readings directly impact treatment,” said MPS president Prof Amrahi Buang.
In some instances, he said, wearable devices have even been reported to interfere with implanted devices such as pacemakers.
“While these incidents are not widespread, they highlight the importance of accuracy, certification and user education when using health monitoring gadgets,” he said when contacted.
As for devices that are sold online, he said these gadgets are relatively safe provided that they are certified by the Malaysian health authorities.
“It can be safe if consumers are careful. All medical devices in Malaysia must be registered with the Medical Device Authority (MDA), so consumers should look for certification.
“Always buy from reputable sources such as community pharmacies, authorised distributors, or official brand websites.”
He said consumers should be wary of counterfeit products or exaggerated claims about the device’s capabilities.
“If a deal seems too good to be true, it probably is,” he cautioned.
Prof Amrahi suggested that consumers be aware of the specific use of a particular device before purchasing it.
“For general fitness tracking, consumer wearables are sufficient.
“But if the device is intended for managing a medical condition such as high blood pressure, opt for certified medical-grade devices.
“Check for the MDA approval and consult your pharmacist or healthcare provider for guidance on the right device, proper usage and interpreting the results,” he said.
This includes the device’s limitations and manufacturer’s service and maintenance recommendations.
Federation of Malaysian Consumer Associations (Fomca) director Saral James Maniam said while the MDA oversees the regulation of medical devices under the Medical Device Act and provides guidelines on device management, there is a notable absence of publicly accessible protocols on the recalibration of home use medical devices.
“This lack of standardised recalibration guidelines can lead to inconsistencies in device performance and potential risks to patient safety,” she said.
She said the risk is higher when the person buys a medical monitoring device online where counterfeit or substandard products were also available.
“Regulatory approval is crucial and consumers should ensure that the device is registered with the MDA and can be verified through the Malaysia Medical Device Register portal.
“It is important to buy only from trusted sellers, preferably reputable online platforms that provide authentic products,” she added.
Although the MDA maintains records of medical device incidents, she said that detailed statistics on issues arising from inaccurate readings are not readily available to the public.
Saral suggested that authorities here adopt best practices measures used in the United Kingdom and Australia with regard to the use of health monitoring devices to better protect consumers.
