Methotrexate, a common medication used to treat rheumatoid arthritis, has a newly recognised useful secondary effect to lower blood pressure and potentially reduces the risk of heart disease in people with this condition.
A new study, led by Flinders University and Southern Adelaide Local Health Network (SALHN) researchers, has shown that methotrexate significantly lowers blood pressure when compared to another arthritis drug, sulfasalazine. The findings, published in Annals of Medicine, mark the first clear evidence of this effect in newly diagnosed patients.
Occurring in about one in 100 people, rheumatoid arthritis (RA) is a common autoimmune disease which leads to inflammation and pain in the connective tissue of a patient’s joints.
Over six months, the South Australian and Italian researchers followed 62 newly diagnosed adults who had not yet started treatment.
Half were given methotrexate and the other half received sulfasalazine. Researchers then measured their blood pressure, joint inflammation, and stiffness in their arteries at the beginning of the study, then again after one and six months.
Lead author of the study, Professor Arduino Mangoni, from Flinders University’s College of Medicine and Public Health, and SALHN’s Department of Clinical Pharmacology, says they wanted to see if methotrexate could lower systolic blood pressure, which indicates how much pressure your blood is exerting against artery walls when your heart beats.
“We found that methotrexate lowered systolic blood pressure by an average of 7.4mmHg compared with people taking sulfasalazine,” says Professor Mangoni, Strategic Professor of Clinical Pharmacology.
“This kind of reduction is considered meaningful because even a small drop in blood pressure can lower the risk of serious heart problems like heart attacks and strokes.”
Interestingly, this benefit did not seem to be linked to changes in either arthritis symptoms or the stiffness of arteries, suggesting that it might be helping the heart in other ways, like calming inflammation or improving how blood vessels work.
Professor Arduino says the findings are exciting because they show methotrexate might do more than just treat rheumatoid arthritis.
“We’ve known for a while that methotrexate helps with inflammation, but now we’re seeing that it may also help lower blood pressure, which is a major risk factor for heart disease,” he says.
“This could be a big step forward in how we care for people with rheumatoid arthritis.”
The researchers also looked at how genetics might play a role in how well methotrexate works and found that certain genetic traits made some people more likely to experience a drop in blood pressure while taking the drug.
“In short, if someone has specific gene variants, methotrexate might add a heart health benefit to its usual role in treating rheumatoid arthritis by the positive effect on blood pressure,” he says.
The researchers say that this opens the door to more personalised treatment options, where doctors could use genetic testing to predict who might benefit most from methotrexate’s heart-protective effects.
Study coordinator and medical scientist, Dr Sara Tommasi, says that although more research is needed to confirm these findings and understand exactly how methotrexate lowers blood pressure, the results are promising.
“The results suggest that this well-known arthritis drug could also play a role in protecting heart health, especially in people who are at higher risk due to inflammation,” says Dr Tommasi from the College of Medicine and Public Health and South Adelaide Local Health Network.
Pretoria, 28 September 2025 – The South African Health Products Regulatory Authority (SAHPRA) wishes to reassure the public that paracetamol remains a safe and recommended option for the relief of pain and fever during pregnancy, when used short-term at recommended doses.
Paracetamol is one of the most widely used medicines globally and has been extensively studied for decades. There is currently no scientific evidence that using paracetamol in pregnancy causes attention-deficit hyperactivity disorder (ADHD) and autism.
SAHPRA will continue to monitor emerging evidence on the safety of paracetamol.
Advice for healthcare professionals
Paracetamol remains a recommended safe treatment for pain or fever in pregnant women. Pregnant women should be reassured that there is no evidence that taking paracetamol during pregnancy causes autism or ADHD in children. Healthcare professionals are encouraged to provide counselling to patients about the side effects of paracetamol, as detailed in the product’s professional information and patient information leaflet (https://pi-pil-repository.sahpra.org.za/).
Advice for healthcare professionals to provide to patients
Pregnant women and those planning a pregnancy should be advised to use paracetamol only when needed and at the lowest effective dose for the shortest possible time. Untreated fever and pain may pose risks to the unborn baby, and it is therefore important to seek treatment if recommended by a healthcare professional. Pregnant women should consult a healthcare professional if pain or fever persists or if they have any concerns about medicine use during pregnancy. Pregnant women should also be advised to avoid combining paracetamol with other medicines without first seeking medical advice.
Report any suspected adverse drug reactions
Healthcare professionals and members of the public are urged to report any suspected adverse drug reactions (ADRs) related to the use of paracetamol and other health products to SAHPRA via the eReporting link available on the SAHPRA website (www.sahpra.org.za) or complete an ADR reporting form accessible via the SAHPRA website and email it to adr@sahpa.org.za. Alternatively, reporting can be done via the Med Safety App, downloadable through Google Play or the Apple App Store.
SAHPRA remains committed to ensuring the safety of medicines available in South Africa and will update the public if new scientific evidence changes current recommendations.
Rooibos, South Africa’s beloved herbal tisane, with proven benefits for the heart, diabetes management and brain health, is now revealing even more potential in preliminary breast cancer research led by Dr Nicky Verhoog, senior lecturer of biochemistry at Stellenbosch University.
Caption: Dr Nicky Verhoog, senior lecturer of biochemistry at Stellenbosch University.
Oestrogen’s role in breast cancer
While the research is still in its early stages, initial findings suggest that Rooibos extracts may counteract the activity of oestrogen in breast cancer cells – a discovery that has prompted the South African Rooibos Council (SARC) and the Department of Science, Technology and Innovation (DSTI) Sector Innovation Fund Programme to continue to support the work of Dr Verhoog with further studies in animal models scheduled to begin next year.
Oestrogen is often described as a kind of driver of breast cancer growth, because many breast cancer tumours carry receptors that respond to it. Although oestrogen doesn’t always start the cancer, it can speed up its growth once the disease has developed. Some newer studies also show that it may sometimes play a more direct role in triggering changes in cells that lead to cancer. Because so many breast cancers are sensitive to oestrogen, the possibility that Rooibos might help block its effect makes these findings especially significant.
Breast cancer in South Africa
Breast cancer remains a major health concern in the country. According to the latest statistics, between 11 000[1] and 15 000[2] women are diagnosed with breast cancer annually and the disease accounts for approximately 24% of all cancer cases in South African women. Early detection is critical – when identified at an early stage, breast cancer survival rates can exceed 90%, highlighting the importance of regular screening and self-examination.
Caption: Warning signs of breast cancer. Source: CANSA (cansa.org.za)
Rooibos under the microscope
Against this backdrop, Dr Verhoog’s team conducted an in vitro (cell) study to examine whether Rooibos could influence oestrogen receptor-positive breast cancer cells. In the past, there has been some uncertainty about whether Rooibos might interact with oestrogen in ways that could affect women with hormone-sensitive breast cancer. This study set out to clarify its role – whether Rooibos could potentially act like estrogen or conversely, help block its activity – and to assess whether it influences cancer cell behaviour.
“To better understand how Rooibos interacts with natural hormones like estrogen, our team wanted to gather clearer scientific evidence,”
Dr Verhoog explains. “We also looked at whether Rooibos could influence the growth and spread of cancer cells, which is especially important for women with hormone-sensitive breast cancer.”
In the laboratory, the researchers worked with well-known breast cancer cell models that carry two types of estrogen receptors: one that can encourage tumour growth (ERα) and another that helps to suppress it (ERβ). They then added Rooibos extracts to see how the cells would respond – in terms of growth, movement and spread.”
The results were encouraging. The extracts acted against oestrogen, in a way similar to fulvestrant, a treatment commonly used to block oestrogen activity in breast cancer treatment. Rooibos slowed down oestrogen-induced cell growth and prevented the cells from spreading. Interestingly, the extracts showed a preference for activating ERβ, the receptor associated with tumour suppression.
“Rooibos appears to act in a protective way against oestrogen-driven breast cancer cells in the lab. It doesn’t mimic oestrogen, but rather inhibits its action. Importantly, we also found that it didn’t interfere with the effect of tamoxifen, a standard breast cancer therapy, which suggests Rooibos could be safely consumed by women undergoing treatment. Of course, this needs confirmation through in vivo (animal) studies.”
Next steps: pre-clinical trials in 2026
While the findings are promising, Dr Verhoog stresses the limitations of in vitro research.
“Lab studies involve single cell types and don’t replicate the complexity of the human body,” she says. “We need to see how Rooibos behaves when metabolised in the body, which is why our next step is pre-clinical trials planned for 2026.”
The next phase of research will move beyond cell studies to look at how Rooibos behaves in a pre-clinical model system. This step is important to confirm its safety for women with oestrogen-sensitive breast cancer and to better understand its effects in the body. The aim is not to test Rooibos as a treatment, but to ensure that it can be safely enjoyed alongside conventional therapies.
Rooibos’s broader health benefits
Rooibos is already celebrated for its wide range of health benefits. Rich in antioxidants and free from caffeine and added sugars, it is a popular alternative to sugary drinks, contributing to overall hydration and general wellness. Previous studies have also highlighted its potential protective effects against other cancer types, including prostate, liver and colon cancers, thanks to its potent antioxidant properties.
“While we are still in the early stages, our research adds to the growing evidence of Rooibos’ multifaceted biological actions. It’s a step toward understanding how this uniquely South African tisane may support health in a variety of ways,” emphasises Dr Verhoog.
Experts stress that these findings should not be interpreted as evidence that Rooibos can prevent or treat breast cancer. Rather, they reinforce its safety for consumption and provide a foundation for future research.
With October recognised as Breast Cancer Awareness Month, the study also underscores the urgent need for continued scientific investigation into the disease, while reminding women that regular screening, awareness of family history and early detection remain the most effective strategies for reducing breast cancer risk and improving outcomes.
[1]https://www.nicd.ac.za/wp-content/uploads/2025/04/NCR_ASR_tables_2023.pdf According to the National Cancer Registry (NCR), 10 980 cases of breast cancer were recorded in 2023. However, CANSA has highlighted significant underreporting, particularly in rural and under-serviced communities, suggesting that the actual number of cases is likely much higher. The available figures are based on pathological diagnoses.
The statistics provided by the International Agency for Research on Cancer (IACR) differ from those reported by the South African NCR, with the number of new breast cancer cases in 2020 being much higher in the IACR data than in the NCR data (15,491 versus 9259). These differences are due to the different strategies used to tally the statistics. The NCR is a collection of pathology-based cancer surveillance figures based on the curation of cancer diagnosis data from histology, cytology and bone marrow aspirate and trephine samples; these samples have been collected, analysed and then reported on annually [4]. The IACR data are based on the South African NCR and Eastern Cape Province Cancer Registries.
Women who miss their first mammogram run a higher risk of being diagnosed with advanced breast cancer and dying from the disease. This is shown in a new study from Karolinska Institutet published in The BMJ.
Since the early 1990s, women in Sweden have been offered regular mammograms, which has contributed to a decrease in breast cancer mortality. Despite this, a significant proportion choose not to attend their first examination. The researchers behind the new study wanted to investigate the long-term consequences of this.
The study is based on data from the Swedish mammography screening program and national health registries, and covers almost 433 000 women in Stockholm between 1991 and 2020, with follow-up for up to 25 years.
The results show that 32% of all women who were invited to their first screening declined. These women were also less likely to participate in future examinations, which often led to a later diagnosis and poorer prognosis.
“Skipping the first mammogram is a strong indicator of who is at risk of late detection and higher mortality. Our results show that missing the first mammogram is not just a one-time choice, but often marks the beginning of a long-term pattern of not attending check-ups,” says the study’s first author, Ziyan Ma, a doctoral student at the Department of Medical Epidemiology and Biostatistics, Karolinska Institutet.
Were detected at a more advanced stage
When women who skipped their first screening were later diagnosed with breast cancer, the disease was more often detected at a more advanced stage. The risk of developing stage III cancer was approximately 1.5 times higher, and for stage IV, the risk was as much as 3.6 times higher compared to those who participated in the first mammogram. Over a 25-year follow-up period, almost 1 percent of those who did not participate had died of breast cancer, compared with 0.7 percent among the participants – a difference that corresponds to a 40 percent higher risk of dying from the disease.
However, the total proportion of women who developed breast cancer was almost the same in both groups, approximately 7.7%. According to the researchers, this shows that the increased mortality is mainly due to delayed detection rather than more cases of the disease.
“Family history is a well-known, unchangeable risk factor for breast cancer. Our study shows that missing the very first screening examination carries a similar mortality risk – but unlike family history, this is a behaviour that we can change. Since over 30 percent of women skip their first screening, increased participation could save many lives. Since this group can be identified early, decades before deaths occur, healthcare providers have a chance to intervene with reminders or support to encourage participation, says the study’s last author, Kamila Czene, professor at the Department of Medical Epidemiology and Biostatistics, Karolinska Institutet
A new study suggests adding microscopic particles to vinegar can make them more effective against dangerous bacterial infections, with hopes the combination could help combat antibiotic resistance.
The research, led by researchers at QIMR Berghofer, Flinders University and the University of Bergen in Norway, has resulted in the ability to boost the natural bacterial killing qualities of vinegar by adding antimicrobial nanoparticles made from carbon and cobalt.
Wounds that do not heal are often caused by bacterial infections and are particularly dangerous for the elderly and people with diabetes, cancer and other conditions.
Acetic acid (more commonly known as vinegar) has been used for centuries as a disinfectant, but it is only effective against a small number of bacteria, and it does not kill the most dangerous types.
The findings have been published in the international journal ACS Nano.
Flinders University and QIMR Berghofer molecular biologists Dr Adam Truskewycz and Professor Nils Halberg found these particles could kill several dangerous bacterial species, and their activity was enhanced when added to a weak vinegar solution.
As part of the study, Dr Truskewycz and Professor Halberg added cobalt-containing carbon quantum dot nanoparticles to weak acetic acid (vinegar) to create a potent antimicrobial treatment.
They used this mixture against several pathogenic species, including the drug-resistant Staphylococcus aureus, Escherichia coli (E. coli) and Enterococcus faecalis.
Dr Truskewycz says the acidic environment from the vinegar made bacterial cells swell and take up the nanoparticle treatment.
“Once exposed, the nanoparticles appear to attack dangerous bacteria from both inside the bacterial cell and also on its surface, causing them to burst. Importantly, this approach is non-toxic to human cells and was shown to remove bacterial infections from mice wounds without affecting healing,” he says.
The anti-bacterial boost in vinegar found in the study could potentially be an important contribution towards the ongoing battle against the rising antimicrobial resistance levels worldwide, with an estimated 4.5 million deaths associated with a direct infectious disease.
Professor Halberg adds this study shows how nanoparticles could be used to increase the effectiveness of traditional bacterial treatments.
“Combination treatments such as the ones highlighted in this study may help to curb antimicrobial resistance. Given this issue can kill up to 5 million people each year, it’s vital we look to find new ways of killing pathogens like viruses, bacteria and fungi or parasites,” he says.
The article, ‘Cobalt-Doped Carbon Quantum Dots Work Synergistically with Weak Acetic Acid to Eliminate Antimicrobial-Resistant Bacterial Infections’ (2025) by Adam Truskewycz, Benedict Choi, Line Pedersen, Jianhua Han, Melanie MacGregor and Nils Halberg has been published in ACS Nano.
A microneedle patch captures cancer biomarkers in the top-most layer of skin to detect melanoma in animal tissue samples
The newly designed ExoPatch being removed from a sample of mouse skin successfully distinguished melanoma from healthy skin in mice. A gel coating the microneedles picks up cancer indicators from the top-most layer of the skin. Dissolving the gel releases exosomes into a solution, which is then used on a two-lined test strip, similar to an at-home COVID-19 test. Image credit: Jeremy Little, Michigan Engineering.
Melanoma testing could one day be done at home with a skin patch and test strip with two lines, similar to COVID-19 home tests, according to University of Michigan researchers. Developed with funding from the National Institutes of Health, the new silicone patch with star-shaped microneedles, called the ExoPatch, distinguished melanoma from healthy skin in mice.
The patch and test move toward rapid at-home melanoma testing, helping patients catch the most aggressive form of skin cancer early without a biopsy or blood draw.
“The star-shaped needles make puncture easier and less painful, but they are so small that they only go through the top-most layer of the skin, the epidermis, and do not draw blood,” said Sunitha Nagrath, the Dwight F. Benton Professor of Chemical Engineering at U-M and co-corresponding author of the study published in Biosensors and Bioelectronics.
The ExoPatch microneedles, at just 0.6mm long with a width of less than 100 nm (0.0001 mm) at the tip, are coated with a gel that picks up exosomes, tiny packages released by cells, from the interstitial fluid that fills the spaces between cells in the epidermis.
Once thought to be trash ejected from cells for cleanup, exosomes actually contain DNA and RNA fragments that cells use to communicate with each other. Cancer cell exosomes can help tumours spread by preparing tissues to accept tumour cells before arrival, and detecting them can catch cancer earlier than past methods.
The gel that coats the ExoPatch contains a protein called Annexin V that attracts and sticks exosomes to the microneedles’ surface. Once removed from the skin, placing the patch in an acid dissolves the gel, which releases the exosomes into a solution. After dipping a test strip into the solution, two lines form if the sample contains melanoma exosomes, and one line forms for a negative test – the same way an at-home COVID-19 test strip works.
“A fair-skinned person with moles must go to the doctor about every six months to send off a biopsy to see if they’re malignant or benign. With this test, they could instead test at home, get the results right away and follow up with a dermatologist for a positive result,” Nagrath said.
As a first step in the proof-of-concept study, the researchers tested the ExoPatch on a tissue sample of pig skin, which closely resembles human skin in thickness and composition. Using a microscope, they found the microneedles penetrated about 350 to 600nm into the skin. For scale, the epidermis on the human forearm is about 18 300nm thick.
To test whether the ExoPatch could capture melanoma exosomes from skin tissue, the research team tested tissue samples of mouse skin, half from healthy mice and half from mice injected with a fragment of a human melanoma tumour. After a 15-minute application, the ExoPatch was placed under a powerful microscope.
“When looking at microscopy images, I was happy to see how nicely the exosomes adhered to the microneedles and were within the 30 to 150 nanometre size range we expect,” said Scott Smith, U-M doctoral student of chemical engineering and co-lead author of the study.
After confirming the exosomes stuck to the ExoPatch, the researchers dissolved the gel and ran the sample through the test strips. The test successfully distinguished between melanoma and healthy tissues with a 3.5-fold darker line in melanoma samples.
The ExoPatch isolated 11.5 times more exosomal protein from melanoma tissue samples compared to healthy tissue, showing it can specifically target cancerous exosomes.
A pilot study in humans followed by a series of clinical trials will be the next steps to move the technology toward use. Beyond melanoma, the ExoPatch gel coating could be modified to detect exosomes released by other cancers with a solid tumour, including lung, breast, colon, prostate and brain cancer.
“This is the first patch designed to capture disease-specific exosomes from fluid under the skin. The potential applications are huge,” said Nagrath.
Flavoured marijuana vaping is now the most common form of use among American teenagers who vape cannabis, according to new findings from the University of Michigan.
The research, published in the Journal for Adolescent Health, found particularly sharp increases among younger teens between 2021 and 2024. Among eighth graders who vaped marijuana, the percentage using flavoured solutions jumped from 47% in 2021 to 63% in 2024. The trend was similar for older students, with use climbing from 41% to 53% for 10th graders and from 36% to 50% for 12th graders.
“The findings suggest that these products are gaining traction among youth; in fact, since the pandemic onset in 2020 youth appear to be turning toward these products while reducing their use of all other drugs,” said Richard Miech, principal investigator of the Monitoring the Future study at U-M’s Institute for Social Research.
The overall percentage of marijuana users who chose to vape the drug also grew over the study period. Among eighth graders who had used marijuana in the past 12 months, the percentage who vaped it increased from 48% to 57%. In 10th grade, the number went from 60% to 66%, and among 12th graders, it rose from 58% to 67%.
“Flavoured vaping solutions offer a discreet mode of cannabis use, with flavours apparently enhancing their appeal,” Miech said. “The study results suggest that a growing proportion of youth find the newly available flavours – especially fruit flavours – more attractive than the standard cannabis taste.
“Vaping does not produce the distinctive odor that comes from smoking cannabis, and vaping devices can be quickly concealed if an authority figure appears unexpectedly.”
More addictive?
This increase in those who vaped highlights growing public health concerns about changing patterns of substance use among teens.
“As for health consequences for cannabis use, one of the most potentially serious is addiction,” Miech said. “Should cannabis use become more popular among youth in future years, then a greater number will end up with an addiction that can impair their social and academic life. Many people may not realize that more adolescents meet the criteria for cannabis use disorder than for alcohol use disorder, with 5% affected by cannabis compared to 3% for alcohol.”
These results point to flavored marijuana vaping solutions as a critical area for future research and policy development. The study’s authors suggest that these findings underscore the need for targeted policies, interventions and educational campaigns to address and mitigate this escalating concern among young people.
“Our survey includes questions on both cannabis’s perceived risk and its social acceptability,” Miech said. “Interestingly, perceived risk among adolescents actually increased over the study period from 2021-24, and social acceptability has gone down. That being said, our questions so far have been about cannabis use in general, and not flavoured cannabis solutions, which students may view differently.”
Would restricting flavoured vapes work?
Recent trends in adolescent cannabis vaping raise concerns about the best way to protect youth. Restricting flavors may seem like an easy solution, but it is by no means a guaranteed success, researchers said.
Teens who seek flavored cannabis products could easily shift to unflavored options or return to smoking cannabis in traditional forms. At the same time, adults in states with legal cannabis may resist limits on flavor choices, and industry lobbying could block such policies.
“An alternative approach to restricting supply of cannabis flavours is to restrict demand,” Miech said. “That is, to reduce teens’ interest and willingness to use cannabis, including flavoured vaping solutions. A demand reduction approach has been very effective for cigarettes.”
Evidence from previous studies on cigarette use supports this approach. In 1998, 35% of 12th graders had used cigarettes in the past month. By 2024, that number dropped to 3%. Cigarettes remained legal and available, but broad-based media campaigns, public education and tighter rules on marketing to youth drove the change.
As the complexities of global healthcare evolve, the need for collaborative, values-driven investment in health systems has never been more urgent. Rand Mutual Assurance’s (RMA) recent completion of the Welkom Sub-Acute Rehabilitation Hospital upgrade offers more than a modern facility; it stands as a bold statement of intent on how the private sector can participate responsibly as a vehicle of driving universal healthcare coverage that addresses the disparities in access to quality healthcare.
General health inequities in South Africa are well-documented and mirror the persistent income inequalities of an unequal society. Bridging these inequity gaps demands multilateral thinking that transcends siloed programme implementation and that sees rehabilitation as a core component of the healing journey. RMA’s approach exemplifies how a private occupational healthcare insurer can work hand-in-hand with regulators, multi-disciplinary clinical teams and local stakeholders, to construct a shared vision for rehabilitation and wellness.
Hospital upgrade
Established in 2016 to provide basic wound care for injured workers and assisted living for disabled ex-miners (RMA pensioners), the Welkom Sub-Acute Hospital has undergone a major upgrade. It now features:
• Specialist wound management and vocational rehabilitationunits
• Assisted living units for ex-workers injured and/or disabled in the line of duty
• A multidisciplinary clinical team of occupational therapists, physiotherapists, sessional medical officers and urologists• 24-hour nursing support and dedicated case management, and
• An in-house orthotics and prosthetics centre developed via a joint venture.
These enhancements speak to RMA’s core values of serving with care and compassion and its aspirations of being a pioneering social insurer. Patients benefit from seamless care journeys that prioritise functional recovery and long-term wellness. More broadly, the facility serves as a tangible blueprint for what future-focused healthcare investment can achieve in injury and disability management by integrating wound care, rehabilitation and custodial care with vocational reskilling infrastructure, all under one roof.
Inclusive innovation
Innovation, too, must be inclusive. RMA’s willingness to integrate independent joint-venture partners in key clinical areas, such as orthotics and prosthetics, demonstrates how ethical investment can fuel niche specialisations that were previously inaccessible in under-resourced regions. As private and public sectors increasingly intersect, providers who prioritise equitable collaboration will shape the standards for occupational health, post-acute care and sustainable rehabilitation pathways.
The Welkom upgrade also delivered tangible socioeconomic benefits. Construction created temporary jobs for local labourers, artisans and suppliers. As the hospital transitions to full operation, it will sustain roles in clinical services, administration, facilities management and auxiliary support – all drawing from the surrounding community.
Building equitable, resilient healthcare
Crucially, the project demonstrates that ethical healthcare investments need not be confined to metropolitan hubs. In a world where access to healthcare and especially rehabilitation services is driven primarily by affordability more than by need, RMA raises the banner of corporate citizenship by investing in the community where the health-insured population resides, and that mainstream healthcare providers might otherwise overlook, so as to promote health equity goals. By situating a cutting-edge sub-acute hospital in Welkom, Free State, RMA created a ripple effect, attracting specialised talent, strengthening referral networks and inspiring similar initiatives in other underserved areas. This industry influence signals a turning point where sub-acute care is no longer an afterthought but a strategic pillar of resilient health systems.
Looking ahead, RMA remains committed to scaling these principles, thus advocating for policy frameworks that foster public-private collaboration, driving research into cutting-edge rehabilitation modalities and championing community-centred care models. In doing so, it positions itself as a social insurer that is invested in shaping a more equitable, resilient future for South Africa and beyond.
Media enquiries: Gopolang Peme, Group Communications Manager, Rand Mutual Assurance
Author: Dr Tryphine Zulu, Head Healthcare, Rand Mutual Assurance
Most medical devices are used in healthcare settings but some like bandages, thermometers, condoms, and blood pressure monitors are used at home. Photo by Mockup Graphics on Unsplash
By Catherine Tomlinson
Unlike with medicines, and with a few exceptions, South Africa’s regulator does not assess whether diagnostic tests and other medical devices on the market are safe and work as they are supposed to. The regulator has however started down a road that should eventually lead to the regulation of all medical devices in the country.
From scalpels to surgical robots, finger-prick diagnostic tests to MRIs, thermometers to wearable AI-powered health monitoring devices, bandages to prosthetics: the range of products classified as medical devices is vast.
Some medical devices are used briefly and then disposed of after a single use, while others are designed to stay in our bodies for long periods of time, such as implants to prevent pregnancy and pacemakers to help the heart beat regularly.
While most medical devices are used in medical settings, some, like bandages, thermometers, condoms, and blood pressure monitoring devices, are used at home.
The World Health Organization estimates that there are more than two million different types of medical devices used around the world. Given the enormous diversity of medical devices, it can be tricky to see what links all these products together.
One answer, and essentially the one used in South African law, is that it is the intended use of the device. A medical device is thus simply any device that is intended to be used to prevent, diagnose, monitor, or treat a disease, injury, or other medical condition.
Because medical devices are sold for medical purposes, they require regulatory oversight to ensure that they are safe to use and work as intended. But in South Africa, this regulatory oversight is not yet fully in place, and you can’t always trust that devices do what they claim to do, or that tests are accurate.
‘Inaccurate readings’
On a recent webinar hosted by FIND, an international non-profit engaged in the development of diagnostics for low resource settings, the chairperson of NGO SA Diabetes Advocacy, Kirsten de Klerk, told participants that “a lot of people assume that if a medical device is available for purchase, it has been correctly tested and approved for use” but “unfortunately, that’s not the case”.
De Klerk added: “I have unfortunately had community members sharing stories of life-threatening situations because of inaccurate readings” from continuous glucose monitors (CGMs). These are medical devices used by people with diabetes to monitor their blood sugar level.
To address the challenge of poor-quality CGMs on the market, South African diabetes advocates and FIND launched a tool to assist people with diabetes and healthcare providers to identify and use monitors that have been properly assessed for safety and functioning.
But what role does the South African Health Products Regulatory Authority (SAHPRA) play in ensuring the safety and effectiveness of medical devices used in the country, and what steps is it taking to better protect the public?
A mandate to regulate
Though medical devices aren’t yet registered, SAHPRA does have a legal mandate to regulate medical devices. The relevant legal requirements were introduced in the 2015 Medicines and Related Substances Amendment Act 14. Before the 2015 Amendment Act came into force in 2017, only electromagnetic or radiation-emitting medical devices were regulated in South Africa.
The 2015 amendments provided for the establishment of SAHPRA to replace the Medicines Control Council as the country’s health products regulator and expanded SAHPRA’s regulatory scope to cover all medical devices.
SAHPRA’s first big move towards regulating the medical device industry was to introduce requirements for medical device companies to be licensed as medical device establishments. Medical device companies were informed that they would need a medical device establishment license to operate in the country in a government gazette notice issued in 2017. (Manufacturers of the lowest risk products – Class A medical devices that don’t have a measuring function and/or are not required to be sterile – are currently exempt from the licensing requirements.)
Today, over 2 500 companies hold active medical devices establishment licenses from SAHPRA. In their applications for these licenses, companies must list the medical devices that they will manufacture, import, or wholesale in South Africa and the establishment licenses that they are granted are specific to the class of products that they are manufacturing or handling.
Medical devices are classed in four groups from lowest to highest risk products, based on the risk posed by the product to patients and the broader public health. Bandages for example are classed as low risk, while heart valves are classed as high risk. Using a risk-based approach allows SAHPRA to harmonise how medical devices are regulated in South Africa with international norms and will allow the regulator to prioritise review of high-risk products as it phases in requirements for registration of medical devices used in the country.
In addition to listing the devices that they manufacture, distribute, or wholesale, companies seeking medical device establishment licenses from SAHPRA are also required to provide a declaration regarding the quality management systems that they have in place.
Critically, however, the devices themselves are not yet being assessed by SAHPRA.
Dr Dimakatso Mathibe, senior manager of SAHPRA’s medical device unit, told Spotlight that more than 200 000 different medical devices are used in South Africa. While over two thousand companies hold active medical device establishment licenses, she explained that a single company may be importing over a hundred products. She noted that as SAHPRA has increased the regulatory requirements for operating in South Africa, some medical device companies have voluntarily withdrawn from the market.
ISO 13485 certification
SAHPRA’s second big move, which is now being rolled out, is the introduction of requirements for medical device companies to gain ISO 13485 certification verifying that they meet international quality management standards.
Medical device companies operating in South Africa can receive certification that they meet ISO 13485 standards from an international or local conformity assessment body that has been accredited to provide this certification.
When SAHPRA first introduced medical device establishment licenses, it did not require companies to have ISO 13485 certification, as it was concerned that enforcing this too quickly could disrupt access to medical devices in the country. This was in part due to the lack of local conformity assessment bodies accredited by the South African National Accreditation System (SANAS) to grant this certification at the time.
John Ndalamo, accreditation manager for SANAS’ certification programme, told Spotlight that six local conformity assessment bodies have now been accredited to provide ISO 13485 certification.
SAHPRA now requires that companies renewing their five-year medical device establishment licenses provide either proof of ISO 13485 certification or evidence that the company has begun the process of seeking this certification.
What about regulation of the actual devices?
While important strides have been made by SAHPRA toward regulating the medical device industry, medical devices themselves still remain mostly unregulated in South Africa.
What this means is that, as pointed out by SA Diabetes Advocacy, medical devices may currently be marketed in the country without an independent regulator confirming that they are safe to use and perform as advertised.
The registration of the over 200 000 medical devices in use in the country is a mammoth job. Mathibe said that when SAHPRA introduces requirements for the registration of medical devices, it will do so in a phased and transitional manner. She explained that the call-up of medical devices for registration will likely be phased by product risk classes and conditions. Presumably, SAHPRA will start with the highest risk products and work down from there.
Assessing feasibility
SAHPRA is conducting a feasibility study of its intended approach to register medical devices. Companies holding medical device establishment licenses have been asked to voluntarily participate in the study.
In documentation published for the feasibility study, SAHPRA indicated it plans to include 32 medical devices used for HIV and TB in the study. These will cover in vitro diagnostic tests, condoms, and X-ray devices used for TB screening.
SAHPRA also aims for half of the products included in the study to be manufactured locally and the other half to be imported. In doing so, SAHPRA can use the study to test its approach for registering products that are evaluated locally, as well as products assessed in other countries with which it has a regulatory reliance mechanism in place (meaning it can rely on regulatory evaluations performed in these countries).
How will safety and performance be assessed in the feasibility study?
Mathibe said that SAHPRA will not directly assess the safety and performance of medical devices in the feasibility study. Instead, this will be done by accredited conformity assessment bodies, which is the same approach used by regulators in Europe. The assessment made by the conformity assessment bodies will then be used by SAHPRA in determining whether a product should be approved for use in the country.
For medical devices already registered in jurisdictions with which SAHPRA has a reliance mechanism in place, like the European Union, Australia, and Japan, companies can submit evidence of such conformity assessments and marketing approval. SAHPRA can then use this information to help make its own registration decisions.
Devices that are not approved by a regulatory authority recognised by SAHPRA, must undergo a safety and performance assessment by a locally accredited conformity assessment body.
Mathibile said insights from the study will be shared with stakeholders next year, and the lessons will help inform how SAHPRA introduces medical device registration in South Africa.
Emergency authorisation of COVID-19 and Mpox medical devices
While SAHPRA has not yet registered medical devices, it introduced rules in 2020 for emergency authorisation listings for certain medical devices used for COVID-19 in South Africa, and it announced in 2024 that diagnostic tests for Mpox required approval from SAHPRA before they could be used in the country.
SAHPRA has thus “listed” multiple COVID-19 tests and two Mpox diagnostic tests as approved for use in South Africa. Khanyisile Nkuku of SAHPRA’s medical devices unit told Spotlight that the diagnostic products for COVID-19 and Mpox received interim Section 21 authorisation.
Section 21 authorisation allows for the use of unregistered products under certain conditions, including public health emergencies. This mechanism has been used by SAHPRA both to respond to the public health needs posed by COVID-19 and Mpox and to prevent the use of substandard products, which was a challenge faced in the early days of COVID-19.
Nkuku added while South Africa has had a relatively low number of Mpox cases, South Africa is a leading supplier of in vitro diagnostics to the rest of the continent, including countries facing large Mpox crises, and so SAHPRA shares the responsibility of ensuring that Mpox diagnostics used on the continent work properly and is working with the African Medicines Regulatory Harmonisation programme to review Mpox diagnostics.
A new project led by Oxford University aims to develop a novel breathing test that could detect asthma and COPD earlier, more accurately, and closer to home – reducing pressure on the NHS and improving outcomes for patients.
This work is included in a portfolio of research funded by the Engineering and Physical Sciences Research Council (EPSRC), part of UK Research and Innovation, to make diagnostic testing more accessible by designing simple, affordable tools that can be used in everyday settings. The project, called ACCESS (A Community-based diagnostiC for early airwayS disease), focuses on airway diseases, and will receive £1.3 million over three years.
Chronic respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD) affect more than half a billion people worldwide and cause over four million deaths every year. In the UK, these conditions hit disadvantaged communities hardest, with people in areas of socioeconomic deprivation facing particular challenges in accessing hospital-based diagnostic care.
A volunteer undertaking a computed cardiopulmonography based breath test. (The volunteer is Dr Nick Smith, a member of the research team developing the CCP technology). Credit: Department of Chemistry, University of Oxford.
Currently, asthma and COPD diagnosis relies on a test called spirometry. This measures how much air a person can forcefully breathe out, but it is difficult for many patients to perform and often fails to detect disease in its earliest stages. By the time spirometry picks up abnormalities, damage to the lungs is usually irreversible, resulting in late diagnoses, missed chances for early treatment, and poorer outcomes.
The project is enabled by the strong ethos for collaborative and innovative research in this University and will be delivered by a multi-disciplinary team, working across university departments and the NHS.
To address these issues, Oxford researchers have developed a new test, known as computed cardiopulmonography (CCP), that could transform the way lung diseases are diagnosed. CCP is performed while a patient breathes normally for 12 minutes through a mouthpiece linked to a highly accurate gas analyser. Using cutting-edge laser technology and advanced mathematical modelling, the test captures a detailed picture of how evenly air flows through the lungs. This “fingerprint” of lung function changes early in the course of disease, making CCP a powerful tool for spotting subtle problems that spirometry can miss.
Early studies in people with asthma, COPD, and even in otherwise healthy smokers suggest CCP is a highly sensitive marker of small airways damage. But while the results are promising, the test currently takes too long and requires specialist gas supplies, restricting its use to hospitals and research labs.
The goal of the ACCESS project is to adapt CCP for community use, for instance in GP surgeries, pharmacies, and community diagnostic hubs. Specifically, the research team will work to reduce the time duration and volume of gas needed for each test, and speed up the data analysis so that results can be shared with the patient during the same appointment. Towards the end of the project, CCP will be trialled in a community diagnostic centre to gather feedback from patients and healthcare professionals.
The long-term goal is to support earlier diagnosis and treatment, helping reduce hospital visits and tackle health inequalities. By enabling earlier intervention and delivering care closer to home, CCP has the potential to improve outcomes for millions of people living with lung disease.
