Medical Device

Kenyataan Akhbar KPK 3 Ogos 2020 - Isu Keselamatan Penggunaan Termometer Inframerah Tanpa Sentuh

Kementerian Kesihatan Malaysia (KKM) memandang serius isu yang tular di laman sosial berkaitan keselamatan penggunaan termometer inframerah tanpa sentuh yang dikatakan boleh menyebabkan kecederaan kepada otak dan lebih spesifik kepada kelenjar pineal. Semasa pandemik COVID-19, termometer inframerah tanpa sentuh dan pengimbas haba telah digunakan secara meluas dan penting sebagai satu kaedah saringan dalam pengawalan wabak COVID-19.1

Termometer inframerah tanpa sentuh bukanlah alat penembak dan tidak memancarkan radiasi. Ia direkabentuk untuk mengesan dan menyerap isyarat sinaran inframerah dari permukaan kulit yang diubah menjadi isyarat elektrik. Litar elektronik di dalam termometer ini memproses isyarat elektrik tersebut untuk menentukan suhu tubuh manusia yang diukur dan memaparkannya di skrin paparan. Oleh kerana termometer inframerah tidak memancarkan radiasi berbahaya, ianya selamat untuk digunakan.2,3,4

Terdapat juga termometer inframerah yang menggunakan laser untuk membantu penentuan titik (spot) arah di mana suhu hendak diukur. Laser yang digunakan adalah pada kadar 630 – 670 nm yang mengeluarkan tenaga kurang dari 1 mW cm2, iaitu lebih rendah dari komponen inframerah dari sinaran cahaya matahari.5

Pengukuran suhu badan dengan termometer inframerah biasanya dilakukan samada di permukaan kulit dahi atau di membran timpanik. Walaupun bacaan suhu di membran timpanik lebih tepat tetapi kaedah pengukuran di permukaan kulit dahi lebih mudah untuk saringan populasi. Terdapat juga kajian yang telah dilakukan untuk pengukuran suhu di pergelangan tangan. Walaubagaimanapun, bukti saintifik yang ada pada masa ini, tidak dapat memastikan ketepatan bacaannya.6

Kajian yang dilaksanakan oleh Cawangan Penilaian Teknologi Kesihatan, KKM mendapati tiada bukti saintifik mengenai kesan sampingan penggunaan termometer inframerah untuk mengukur suhu di dahi.6

ASPEK PERUNDANGAN

Termometer, termasuk termometer inframerah tanpa sentuh, digunakan untuk menentukan suhu tubuh manusia adalah termasuk dalam definisi “peranti perubatan” dan tertakluk kepada keperluan pendaftaran di bawah Akta Peranti Perubatan 2012 (Akta 737). Namun, dalam keadaan darurat, seperti semasa pandemik COVID-19, pengimportan dan pembekalan termometer inframerah boleh dibenarkan melalui laluan akses khas tertakluk pada syarat-syarat tertentu dan untuk jangka masa yang terhad.

Bagi pendaftaran dan pemasaran termometer di Malaysia, ia perlu mematuhi pelbagai standard untuk menunjukkan keselamatan dan prestasinya. Antara standard yang perlu dipatuhi untuk termometer inframerah adalah seperti berikut:

  • ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes
  • ISO 14971: Medical devices - Application of risk management to medical devices
  • IEC 60601-1-11: Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
  • ISO 14155: Clinical investigation of medical devices for human subjects - Good clinical practice
  • IEC 62366-1: Medical devices - Part 1: Application of usability engineering to medical devices
  • IEC 62304: Medical device software - Software life cycle processes
  • EN 1041: Information supplied by the manufacturer of medical devices
  • ISO 80601: Medical electrical equipment. Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement

Setakat ini, sebanyak 64 jenama termometer inframerah telah didaftarkan dan menerima kebenaran untuk diimport dan dibekalkan ke Malaysia. Melalui laluan akses khas, tujuh jenama termometer inframerah lain telah diberikan kebenaran untuk tujuan sama bagi memenuhi keperluan semasa wabak COVID-19.

KKM sedar tentang terdapatnya termometer inframerah yang tidak berdaftar atau mendapat kebenaran akses dalam pasaran. Adalah diingatkan bahawa KKM melalui Pihak Berkuasa Peranti Perubatan (PBPP) akan terus memantau situasi ini dan akan mengambil tindakan terhadap mana-mana perlanggaran undang-undang sebagaimana yang diperuntukkan di bawah Akta 737.

Sekian, terima kasih.

 

DATUK DR. NOOR HISHAM ABDULLAH

KETUA PENGARAH KESIHATAN MALAYSIA

3 Ogos 2020 @ 3.00 petang

 

 

PRESS STATEMENT

MINISTRY OF HEALTH MALAYSIA

3 AUGUST 2020 

 

SAFETY ISSUES OF NON-CONTACT INFRARED THERMOMETERS

 

Ministry of Health (MOH) Malaysia is concerned about the safety issue of non-contact infrared thermometers which is viral in social media. They have been claimed to be associated with brain injury especially to pineal gland. The thermometers and thermal scanner cameras have been used widely as part of screening and preventive measures during the COVID-19 pandemic.

Non-contact infrared thermometer is not a shooting device emitting radiation. It is designed to detect and absorb heat in the form of infrared rays emitted from human body and converts it into electricity. The electronic circuit within the thermometer processes the electrical signal to determine the temperature and display the reading on a screen. Since infrared thermometers do not emit harmful radiations, it is safe to be used (2,3,4). Some infrared thermometers used laser to aim the spot where the temperature is to be measured. The laser used is usually within the range of 630 – 670 nm that emits energy less than 1 mW cm2 which is lower than infrared from sunlight.

There are two common sites for infrared thermometers measurement, namely forehead or tympanic membrane in the ear. Even though, the accuracy of temperature measurement on tympanic membrane is better, forehead site is more easily access for population screening. There are studies that evaluated wrist as a site for temperature measurement. However, the available evidence unable to determine its accuracy.

A rapid review conducted by Health Technology Assessment Section (MaHTAS), MOH found no scientific evidence on the adverse events of infrared thermometers used on the forehead.

LEGAL ASPECT

Thermometer, including non-contact infrared thermometer, that is intended to be used in measuring temperature of human body is a medical device and subject to registration requirement under Medical Device Act 2012 (Act 737). However, in emergency situation, such as during the COVID-19 pandemic, importation and supply of infrared thermometer may be allowed via special access route subject to certain conditions and for a limited time frame.

For the thermometer to be registered and subsequently placed in Malaysian market, it must comply with various standards demonstrating its safety and performance. Amongst the standards applicable to infrared thermometers are as follows:

  • ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes
  • ISO 14971: Medical devices - Application of risk management to medical devices
  • IEC 60601-1-11: Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
  • ISO 14155: Clinical investigation of medical devices for human subjects - Good clinical practice
  • IEC 62366-1: Medical devices - Part 1: Application of usability engineering to medical devices
  • IEC 62304: Medical device software - Software life cycle processes
  • EN 1041: Information supplied by the manufacturer of medical devices
  • ISO 80601: Medical electrical equipment. Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement

To-date, a total of 64 brands of infrared thermometer have been registered and permitted to be imported and supplied in Malaysia. Under special access route, another seven brands of the thermometer have been given permission to cater the needs during COVID-19 outbreak. MOH is aware of the availability of infrared thermometers that are not registered or have no special access permission in the market. Through the Medical Devices Authority, the ministry is monitoring this situation and will take action against any breach of the law as provided under Act 737.

Thank you.

 

DATUK DR NOOR HISHAM ABDULLAH

DIRECTOR GENERAL OF HEALTH MALAYSIA

 

3rd August 2020

References:

  1. Tattersall GJ. Infrared thermography: A non-invasive window into thermal physiology. Comp Biochem Physiol A Mol Integr Physiol. 2016;202:78-98. doi:10.1016/j.cbpa.2016.02.022

  2. Luo Yaping, Design of data acquisition system based on LabVIEW for infrared thermometer, Intelligence Detection.5(2014)52-56.

  3. Li Nana, Design of infrared temperature measurement system based on MLX90615 and MSP430, Journal of Sensors and Systems. 9(2011) 115-117.

  4. Guangli Long, Design of A Non-Contact Infrared Thermometer, International Journal on Smart Sensing And Intelligent Systems Vol. 9, No. 2 June 2016

  5. User’s Guide OMEGASCOPE Handheld Infrared Thermometer with Laser Sighting. Available at https://stevenengineering.com/tech_support/PDFs/33HHOS530.pdf

  6. Non-contact infrared thermometer. MaHTAS COVID-19 Rapid Evidence Update. Ministry of Health Malaysia, 2020.

Categories: Medical Device, Press