I would like to highlight the rampant trend of unlicensed practitioners called sonographers or ultrasonographers in the private health care sector in Malaysia.
Over the past decade, there has been a rapidly increasing number of these sonographers/ ultrasonographers performing complex diagnostic procedures on members of the public for a fee without any qualifications recognised by the Ministry of Health, Malaysia (MOH) or even a license to do so.
Diagnostic ultrasound is a medical procedure that requires specific recognised training and complex diagnostic ultrasound procedures requires specialist medical training or even sub-specialised training.
In Malaysia, current clinical guidelines stipulate that a registered medical practitioner can perform only basic diagnostic ultrasound scans. For complex diagnostic ultrasounds, such as for example, detailed foetal anomaly scans at a minimum, specialist training is required.
The latest MOH guidelines on Ultrasound usage in Medical Practice (November 2022) states that the individual performing a complex diagnostic ultrasound, such as detailed foetal anomaly scans, is required first to undergo specific training under the direct supervision of a Maternal Foetal Medicine Obstetrics and Gynaecological sub specialist prior to performing such procedures on members of the public.
This entire process takes three years post-specialisation, not mere months to ensure that the registered specialist is adequately trained prior to performing complex diagnostic procedures on members of the public.
This means that a registered medical practitioner has to undergo not only recognised specialist training, but sub-specialised training prior to performing complex diagnostic ultrasound scans, such as detailed foetal anomaly scans.
It is also a requirement that a registered medical practitioner has to undergo, as a minimum, recognised specialist training prior to performing complex diagnostic ultrasounds of the abdomen, heart and musculo-skeletal system.
These requirements are in place to ensure patient or public safety as only with adequate knowledge of anatomy, clinical expertise and hands on training can an accurate diagnosis be achieved after performing an ultrasound scan.
The clinical and ethical requirements that have been placed on the registered medical practitioner performing diagnostic ultrasound is rather considerable and rightfully so. Every registered medical practitioner in the private sector is mandated to take professional indemnity insurance to ensure that should they make an error in diagnosis, members of the public that have suffered harm due to such an error will be adequately compensated.
Sonographers or ultrasonographers are licensed and well-regulated in other countries where they hold valid qualifications that are recognised in those countries. Sonographers or ultrasonographers in other countries have their own regulatory body that approves qualifications and licences them to practice their profession.
In other countries, sonographers or ultrasonographers are recognised professionals that are legally allowed to perform diagnostic medical procedures such as ultrasounds under the direct supervision of a registered medical professional. Even in most of these other countries, sonographers or ultrasonographers are not allowed to practice independently.
As it stands, currently in Malaysia, there is no MOH-recognised sonography/ ultrasonography course that certifies an individual without a medical license to perform diagnostic medical procedures on members of the public within MOH, let alone in the private sector for a fee.
Overseas qualifications for sonographer/ ultrasonographer training are NOT recognised by MOH or by any regulatory body. There is currently NO regulatory body for sonographers/ ultrasonographers in Malaysia.
There is no piece of legislature that recognises or regulates their practice or profession. Sonographers/ ultrasonographers fall under the purview of allied health professionals in other countries, however in Malaysia, they are not listed as a recognised allied health profession under the Allied Health Professionals Act and they are not regulated by the allied health professions division of MOH.
Most sonographers/ ultrasonographers in the private sector in Malaysia have not undergone any formalised medical or clinical training. Some have basic degrees in health care-related fields, but no actual medical or clinical training.
However, there are many courses available locally that “certify” individuals with absolutely no medical or clinical qualifications to perform diagnostic ultrasound. These courses range from a duration of one year with limited hands-on training under the supervision of another unlicenced sonographer or even a six-week internet course that offers a certificate at the end of the programme.
None of these certifications are recognised by MOH. The current structures of these courses are glaringly insufficient to accredit someone with no medical or clinical experience to provide diagnostic medical services.
To put this into context, diagnostic radiographers, who are a licensed allied health profession, undergo an extensive four-year degree programme to get recognised certification but even then, they do not practice independently.
Sonographers/ ultrasonographers in Malaysia have neither any MOH-recognised qualification, nor are they even licensed by any regulatory body to perform basic diagnostic ultrasounds on members of the public, let alone complex diagnostic ultrasound procedures.
Yet, they are performing such complex medical procedures for a fee on members of the public. They are performing these procedures in standalone sonography centres, some general practitioner (GP) clinics, and even some private hospitals despite being unlicensed.
Sonographers/ ultrasonographers freely advertise their services to members of the public on social media despite being unlicensed. These advertisements obviously do not have the approval for medical advertising under KKLIU.
Some have even branched out in providing full pregnancy care, including offering “medical advice”. More worrying is that recently, brochures of these sonography centres were provided to members of the public during their visits to a few government health clinics (Klinik Kesihatan).
There have already been multiple cases of missed and erroneous diagnosis made by sonographers/ ultrasonographers on members of the public, including pregnant mothers and their unborn children. This has resulted in severe psychological and even physical detriment to members of the public and their unborn children.
As sonographers/ ultrasonographers are not a legally recognised profession with a practicing certificate, they have no professional indemnity either. The harm done to members of the public also cannot be adequately compensated, only to be conveniently disregarded as a misadventure on the part of the patient should there be a complaint.
The irony of the whole situation is that a licensed registered medical practitioner – after years of study and clinical practice with professional indemnity – is so stringently regulated by rules and guidelines, whereas any individual with no medical background or professional indemnity can attend a six-week online course and claim not only to perform the same diagnostic procedures as a registered doctor on members of the public for a large fee, but even more advanced diagnostic procedures that can be performed by the average specialist registered on the National Specialist Register (NSR).
With the exponential rise of sonographers/ ultrasonographers, sonography centres and sonography “training” programmes, the public is exposed to greater risk. The number of catastrophic errors in diagnosis is bound to rise if this pertinent issue is left unaddressed.
Some sonographer training programmes proclaim their Malaysian Qualifications Agency (MQA) approval and freely confer diplomas after a one-year course. However, these courses are yet to be properly assessed, let alone be approved by MOH.
Other sonographer training courses have applied for occupational skills recognition under the Ministry of Human Resources. These are mere red herrings to distract from the real pertinent fact that these qualifications are NOT recognised by MOH.
These proclamations of MQA or National Occupational Skills Standard (NOSS) accreditations are mere smoke screens to mask the real issue that these sonographers/ ultrasonographers are unlicensed and are not legally allowed to utilise a registered medical device on a third party, let alone charge fees for performing complex diagnostic procedures with these devices that they haven’t undergone MOH-accredited training for.
With the landmark Federal Court judgment in the case of Siow Ching Yee regarding the extent of damages that private medical facilities are liable for, I hope that the owners or managers of private medical centres understand their extent of exposure to liability by hiring these unlicensed sonographers/ ultrasonographers in their facility.
So far, nothing has been done to address this issue of unlicensed individuals performing diagnostic procedures on members of the public in the private sector. Despite numerous official complaints by many, including myself, absolutely NO action has been taken by the regulatory authorities.
Regardless if the service provided was free or for a fee, public safety is being compromised. If these errant practices are allowed to carry on, then the integrity of private health care services in Malaysia will be in tatters.
There are plans to make Malaysia a hub for medical tourism. What confidence would foreigners have in our private health care system if such illegal practices are allowed to continue?
I hope this letter will help shed some light on this rampant malpractice. The practice of unlicensed sonographers/ultrasonographers infringes the following laws and regulations:
- Section 43(2), Medical Devices Act 2012: They have no recognised qualifications or licensing to use a registered medical device (ultrasound) on a third party.
- Sections 16 and 17, Allied Health Professions Act 2016: They are performing allied health activity without licensing and registration.
- Section 33, Medical Act 1971: They do not fall into the exemptions of Section 36 either.
- Section 31, Private Healthcare Facilities and Services Act 1998: GPs and private hospitals that hire unlicensed sonographers are in direct breach of this provision.
- Code of Professional Conduct, Malaysian Medical Council (MMC): Doctors who sign off ultrasound scan reports by unlicensed sonographers are in violation of this code.
Dr Kuharaj Balasubramaniam is a consultant obstetrician and gynaecologist.
- This is the personal opinion of the writer or publication and does not necessarily represent the views of CodeBlue.
