Warranties on medical devices could save the country – and taxpayers – millions in negligence claims
South Africa has a unique opportunity to become the global leader in the regulation of warranties for medical devices.
Legal cases against pharmaceutical companies in South Africa that manufacture medical devices such as implants for treatment of specific conditions are on the increase, as patients are not always properly informed about how the device works, what its intended purpose is, and, most importantly, how long it will work effectively. Globally, the same trend is evident.
South Africa is on the brink of launching a new public health system, the National Health Insurance (NHI). The NHI Bill was presented to the public for comment on 21 June 2018 by the Minister of Health. This is an ideal opportunity to take the lead and come up with a legal framework that would set a new global standard for managing warranties in the medical device industry.
A major problem leading to the increasing law suits stems from a lack of information given to patients on what to expect from a product and the patient’s own, sometimes unrealistic, expectations.
Medical devices are designed and implanted by highly trained medical personnel and often require costly and painful surgery to implant. The patient – as the consumer – has no way to know what to expect from the implanted medical device. If things go wrong, patients can experience discomfort or further health problems, which may require further surgery to correct. As a result, some patients may sue the medical practitioner and the device manufacturer.
“The difficulty with warranties for medical devices is that no single device works exactly the same for every person,” says Martha Smit of the law firm Fasken’s Life Sciences practice group. “Due to the complex nature of the human body – and the physical and physiological differences between people, a device that works for 10 years in one person, might work for only five years in another. This makes it difficult for a manufacturer to accurately spell out what a patient can expect from the device.”
The situation can be further complicated when a doctor implants a device for a purpose other than what it was designed for. This has happened under strictly controlled conditions and led to great success for many patients – and to the development of a number of great new medical inventions. But when it goes wrong, the patients usually point a finger at the device manufacturing company.
Having warranties in place would be useful in setting out the specific conditions and reasonable expectations for use of a device. It will ensure that there is clear understanding about responsible use and who will be liable in specific circumstances should the product be defective. When a doctor uses the implant for a purpose that it is not designed for, the onus should be on him or her to fully inform the patient of what he or she is doing, and why.
Warranties could be established according to each risk category a medical device is registered in. The risk category would determine the type of warranty required for that device. This will link with the current requirement for a medical device’s safety and performance which form part of the Conformity Assessment of the South Africa Health Products Regulatory Authority.
“A patient needs to be able to give ‘informed consent’ to any procedure done. If they do not understand what the device is intended for and what the potential side effects or associated risks of the implant procedure is, it is impossible for them to be said to have made an informed decision,” says Smit.
The introduction of a warranty in the regulatory requirements under the Medicines and Related Substances Act could have many benefits.
“It would be a win-win for all parties involved and can save the country, the manufacturers and doctors millions of rands in legal costs,” says Smit.
“Health authorities and practitioners in South Africa already face significant numbers of law suits, due to negligence claims. If we do not carefully consider regulations on the requirements of warranties for these products, we can expect these claims to drastically increase in the future – at great expense to the taxpayer.”
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