The Health Sciences Authority (HSA) has found that some digital and infra-red thermometers classified as medium risk Class B devices, that are being supplied and sold in Singapore have not been registered. HSA would like to reassure consumers that while these thermometers are unregistered, based on post marketing surveillance in Singapore, no safety or quality issues or any adverse events have been detected or reported to date.
2 To address the administrative oversight of some dealers in not registering their devices, HSA is currently working with the suppliers and retailers to remove all unregistered thermometers from the shelves and has sent out a circular to all its registrants, importers and wholesalers to remind them of the need to register the thermometers and to apply for the appropriate dealer licences. They have also been asked to stop any import, supply and sales of the unregistered thermometers immediately until the thermometers have been registered with HSA.
Consumer Advisory
3 Consumers are reminded to purchase from reliable retailers and not to purchase from internet websites, as the origin and quality of the thermometers cannot be verified. Consumers may wish to refer to the list of registered Class B thermometers in Annex A.
4 Regarding the appropriate use of thermometers, patients and caregivers are advised to seek medical attention promptly if they have any health concerns, irrespective of their temperature readings from the thermometer, as temperature is only one of the parameters used in the management of any patients with fever. Patients and caregivers should consider other factors such as age, concurrent medical conditions, presence of other symptoms (such as chills or shivering), and general well-being of the patient.
HEALTH SCIENCES AUTHORITY
SINGAPORE
24 OCTOBER 2014