REGULATION OF MEDICAL DEVICES IS SET TO BECOME A REALITY IN SA

By Julie Oppenheim Wednesday, September 09, 2020
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Medical and health apps are catching on fast in South Africa, if mobile store rankings are anything to go by. From blood sugar and blood pressure trackers to heart rate monitors and apps that help relieve ringing in the ears, they are appearing thick and fast on the internet for anyone to download.

And while some of them may have respectable healthcare provenances, such as the apps that medical schemes have for their members, others come from sources that seemingly have little to do with healthcare.

There’s a mobile app, for instance, that a video game and mobile app developer in Spain has designed to remind women when to take their contraceptive pills. That might seem harmless enough, but is it suitable for South African users? Was it designed with a clear understanding of how contraception works? Are there any health risks associated with using it?

Over the past few years, a multitude of medical and health apps have become available and appear to be operating in South Africa, with little or no regulatory oversight. That might be about to change.

Wheels of new regulatory regime set in motion

Now that South Africa’s Minister of Health has appointed the board of the new South African Health Products Regulatory Authority (SAHPRA), we can expect the wheels to start turning on the implementation of the country’s new regulatory regime for medical devices and in vitro diagnostics (IVDs).

SAHPRA will be a souped-up version of the Medicines Control Council (MCC), which it is replacing, and will have wide powers over the licensing and distribution of medicines, scheduled substances, clinical trials, medical devices and IVDs.

The definition of a medical device and IVD is extremely broad, potentially bringing hundreds of ordinary-seeming consumer and health products into the regulatory net.

For example, condoms are now considered medical devices, along with insulin pumps, breast implants, surgical gloves, pregnancy tests, thermometers, catheters, HIV home test kits and surgical gauze. Even toothpaste can be a medical device if its function fits the definition.

Interestingly, the definition also includes within its ambit software that is part of, or an accessary to, a medical device or IVD.

How and what is it used for?

The acid test of whether something is or is not a medical device or an IVD is: what is it used for and how does it work?

The “how” is important because for something to be a medical device, it cannot achieve its primary intended action by pharmacological, immunological or metabolic means (so a medical device is not a drug or vaccine, for instance). These processes could support the intended functioning of a medical device, but would not be the main activity.

This narrows down the possibilities somewhat, but the potential range is still extremely wide.

If the function of an instrument, apparatus, implement, machine, implant, software and the like is intended by the manufacturer to diagnose, prevent, monitor, treat or alleviate disease, then it is a medical device.

If it is intended to diagnose, monitor, treat, alleviate or compensate for an injury, it is a medical device.

The same applies if it is intended to control conception, disinfect medical devices, or support or sustain life.

It is also a medical device if it is meant to investigate, replace, modify or support the anatomy or a physiological process.

And finally, it is a medical device if it is intended to provide information for medical or diagnostic purposes through in vitro examination of specimens from the human body. This refers to processes done in a test tube, culture dish or elsewhere outside the body, such as would be the case with HIV tests and pregnancy tests.

All in all, the definition of a medical device is so wide that it has some industry watchers wondering whether it includes devices such as fitness trackers, which measure the wearer’s personal fitness by monitoring various factors such as heart rate, steps walked and calories consumed.

Chances are that such items are not medical devices as long as they only provide data for the edification of the wearer.

If used for any form of diagnostics or treatment, however, then it arguably crosses the line into medical device or IVD territory. An item that almost certainly is a medical device is a blood-glucose monitor that people with diabetes might use to inform them when to take their medication. Another example is an app that sends an emergency signal in the event of a stroke, heart attack or other health crisis.

These do not simply passively record information but alert the user to take action of some kind. A device such as this could therefore present a health risk to the user if it has a defect or were to malfunction.

From low risk to high risk

The risk to health that medical devices and IVDs potentially pose is of course the reason why the new regulatory regime has been put in place. Four levels of risk – to the patient’s health or to the health of the general public – have been identified for medical devices. These are low risk, low-moderate risk, moderate-high risk and high risk (or A, B, C and D, according to the guidelines on the classification of medical devices). The highest risk devices are those that are implantable or invasive, and are used in the long-term.

Except for the low-risk category (class A), manufacturers, importers, exporters, distributors and wholesalers i of medical devices and IVDs must be licensed with the new South African Health Products Regulatory Authority.

It is worth noting that the deadline for licensing applications has already come and gone (on 24 August 2017), although wholesalers still have until February 2018 to apply for licences.

Medical devices and IVDs will also have to be registered with the new regulator, which will issue call-up notices for the registration of particular types of devices, starting with the highest risk devices.

It will be interesting to see what stance the SAPHRA will take on medical and healthcare apps and, if it finds regulation is needed, how this could be achieved.

In the United Kingdom, the National Health System is busy trialling two new medical apps in collaboration with the developers, and hopes to roll them out in 2018 to help people manage their own health, cutting down on doctors’ visits while remaining connected to their hospitals. According to the New Scientist, the deployment of one app reduced hospital admissions by 17% and visits to general practitioners by 40% over a year.

Commentators have praised the UK approach of trialling medical apps in this way, but also cautioned that the use of apps that interface with patient records may raise privacy concerns.

In short, regulation in the healthcare industry is complex at the best of times; in terms of health technology, societies are treading new ground. The next few months will be interesting times for the medical devices industry.