The Health Sciences Authority (HSA) is a statutory board of the Singapore Ministry of Health, and one of its leading areas of work is the Health Products Regulation Group. Its stringent regulatory checks on health products in the country are to ensure that standards of safety, quality and efficacy are met.

Since January 2012, all digital and infrared thermometers (oral, under-arm, rectal, behind ear, forehead, temporal, etc.) come under the regulation of the Health Products Act. This is due in part to the influx of unverified thermometers during the SARS and H1N1 pandemics which occurred in 2003 and 2009 respectively, where the public faced potential risk when purchasing and using thermometers which could not reliably detect fevers.

Since then, thermometers have to be registered with the Singapore Medical Device Register, and importers and wholesalers have to be TS-01 Certified (GDPMDS – Good Distribution Practice for Medical Device in Singapore) before applying to HSA to become licensed importers and/or wholesalers.

In addition to the arduous licensing process, the thermometer will need to be registered with the Singapore Medical Device Register (SMDR) before approval is provided for import, marketing and sale. The thermometer must be approved by at least one of five Reference Agencies from the European Union, USA, Australia, Canada and Japan. HSA uses Reference Agencies from these countries as a benchmark.

The registration and licensing process seeks to safeguard the consumers by verifying and ensuring that thermometers have the documentation to support basic quality before being imported and sold, and that the dealers have best practice in importing, stocking and distributing them. Buying an unregistered thermometer puts you at risk of getting one that may be counterfeit, incapable of detecting a proper temperature, or may even cause harm.

For more information on the regulations, please contact – Medical Device Branch, Health Products Regulation Group, Health Sciences Authority at 6866 3560 or email hsa_md_info@hsa.gov.sg

The new generation of thermometers are contactless. These thermometers are taking over the more commonly used traditional ear and underarm thermometers for very practical reasons – they are easy to use, fast, comfortable, hygienic and suitable for all ages. They are beneficial to both user and subject. Compared to traditional thermometers, new generation thermometers are created with advanced technologies and therefore, they are designed to outperform older technologies.

Not all thermometers are created equal. Most thermometers that are available in the retail sector are made for home use, and those used in clinical environments such as hospitals are of a much higher grade and better quality.

Home-use thermometers are used occasionally and mostly by the same family members to obtain a basic temperature reference. Therefore, home-use thermometers need only use components such as temperature sensors and microprocessors that are sufficiently good, and are put through basic tests and certifications. They are almost never subjected to stringent clinical studies in hospital or medical settings, which is why they are often used for light duty and are more affordable.

Conversely, clinical-use thermometers need to focus on proven accuracy, consistency and durability. Therefore, they are made with heavy-duty components such as superior temperature sensors to provide superior sensitivity, accuracy, consistency and durability; and superior microprocessors with proven algorithms which are suitable for reading and reflecting thousands of reliable temperatures on a daily basis. Additionally, clinical-use thermometers are subjected to continual technological advancements, tests and certifications, including clinical studies in hospital or medical settings to prove their claims and improve their quality. These make clinical-use thermometers generally more expensive than home-use ones.

When selecting a thermometer, check who the manufacturer is. Look up the brand and find out if the thermometer is designed and manufactured by a medical device company or an industrial device company. It would be more sensible to purchase a thermometer from a manufacturer who is focused purely on designing and manufacturing medical devices.

There are 4 classes of lasers – Class 1 to Class 4, with varying levels of power or energy beam and wavelengths of the emitted radiation. This classification depicts the potential for causing harm, with Class 1 being considered to be incapable of producing damaging radiation, and Class 4 which is hazardous to the eye when exposed to a direct beam or even reflections of the beam, and this class of lasers may even start fires and cause damage to skin.

Some thermometers use Class 2 lasers, which is also used in laser pointers. Presently, Class 2 lasers are not required to be licensed and a warning label will suffice. However, Class 2 lasers can cause permanent damage to the eyes even from a one-second exposure to the beam. This is especially dangerous to children and even adults when using a forehead/temporal thermometer that has a Class 2 laser.

A thermometer is a scientific device and should never be calibrated by the user. Calibration should only be performed by trained personnel using scientific procedures under controlled environments and using certified equipment. Untrained users can often cause the thermometer to be calibrated incorrectly, which will then lead to inaccuracies and may prevent the detection of fevers. Thermometers that require users to calibrate before use or occasionally should be avoided.

Different types of thermometers have different temperature ranges. For instance, an underarm thermometer and a rectal thermometer may reflect different temperature readings. User manuals of thermometers should advise on the temperature range and fever points. Thermometers that provide core body temperature range with corresponding fever points according to age will give you a better temperature reference. Core body temperature, which is the temperature deep within the organs, is most likely the best and most preferred reading by medical professionals.

It is a misconception to think that everyone’s temperature range and fever point are similar. There is no ‘one-temperature-fits-all’ fever point. In fact, age and metabolic rates have an effect on one’s temperature range. The younger a person, the higher the metabolic rate, and hence the higher the body temperature range, which means that with the occurrence of a fever, it will result in an even higher temperature. Conversely, in the elderly, metabolic rates decrease which means that in the event of a fever, the reading is recorded at a reduced temperature point.

Therefore, a good thermometer will have the appropriate literature advising on the type of temperature readings, the temperature range for different age groups and their corresponding fever points.

All thermometers have a lifespan, which is largely based on the durability of the temperature sensor. This determines how many times temperature can be read before a thermometer expires. Also, when temperature sensors are worn, they become insensitive and produce low readings of 35+°C, or even lower, which are inaccurate. Electronics may also degrade over time and cause inaccurate readings. For greater assurance, buy a thermometer that has a temperature sensor proven to provide a high number of readings, as a safeguard has a warranty of at least 2 years, and that offers a 1-for-1 exchange in case of a manufacturing defect.

When thermometers start giving inaccurate temperature readings, replacing the batteries will not help make it more accurate. Batteries are simply an energy source, and if it is still providing inaccurate readings, then it is defective or damaged, and will need to be replaced.

For practical reasons and in case of emergency, buy a thermometer that uses ordinary batteries which are easily available (eg. AA or AAA batteries). Also important is to use a thermometer where the battery compartment can be easily opened without the use of tools.

In Singapore, there is a lack of information on thermometers. Most of these thermometers are offered for sale by general traders who do not have sufficient knowledge in their products, and are often over-priced as well. An online search will reveal that prices of thermometers can double or triple prices of similar reputable devices elsewhere in the world. Therefore using price as a guide to determine the quality of a thermometer is imprecise. Instead, learn about the quality of a thermometer through careful study. Sales representatives of quality devices will typically offer more information than requested, confidently provide longer warranties and offer other types of guarantees.

Despite strict regulations and checks, unregistered thermometers continue to be illegally imported and distributed by unlicensed importers and wholesalers – contravening the Health Products Act. This will inevitably endanger users and their loved ones.

Some of the illegal devise may have recognizable brand names with proper packaging. However, if these products are not registered with the SMDR, their claims and certifications may very well be fraudulent. Even if the devices were registered with the SMDR, they may not be imported and distributed by a HSA-licensed importer, in which case, the thermometers could be counterfeit as well.

It is our duty to ensure that the public is well-informed and safeguarded from illegal thermometers that can potentially endanger lives, especially when they are unreliable in detecting fevers, be it an illness or a pandemic situation.

Should you have doubts about the legitimacy of any thermometer available in Singapore, please do not hesitate to contact us and we will assist in ascertaining the validity of the thermometer against the HSA’s register.