12 Nov SAHPRA CONFIRMS BEDHEAD SERVICE SYSTEM IS A MEDICAL DEVICE
With the recent pronouncement by South African Health Products Regulatory Authority’s (SAHPRA) Acting CEO, Portia Nkambule, confirming that a bedhead service system is in fact a medical device, this leaves many customers and consumers within the South African market wondering how this affects them and their non-compliant bedhead service system suppliers.
It is, in fact, quite straightforward in terms of legislation.
As per the Medicines and Related Substances Act, 1965 (Act 101 of 1965), in the regulations relating to medical devices, all medical device manufacturers, importers, exporters, distributors and wholesalers are required to obtain a licence from the SAHPRA. The licence allows for the regulation and control of medical devices to ensure patients are protected against harmful or ineffective medical devices.
One of the mandatory licencing requirements is that the licensee is required to provide SAHPRA with a valid and acceptable certificate to a quality standard.
South Africa’s current situation is such that billions are spent on medical malpractice claims. These malpractice claims are caused either by the Healthcare Practitioner, or by the Healthcare Facility itself. To curb these expenses, stricter measures will be applied from the insurance provider, as no insurance company will settle any claim if the equipment used is non-compliant.
A condition of Insurance is that the Insured must always “take all reasonable steps and precautions to prevent accidents or losses, included but not limited to, compliance and adherence to laws and regulations which are material to the risk” The Insured must also “ warrant that all laws, regulations, by-laws and rules that apply to the business or any other matter for which cover is provided” is adhered to at all times.
Even if the Hospital was unaware that the equipment did not comply, it would be their duty to ensure that it did, as all policies exclude cover in respect of non-conformity or disregard of any SANS or legal regulation.
At Hutz Medical and Hutz Hospi-Tec we adhere to the most stringent processes and have the necessary quality systems in place. Both Hutz Medical and Hutz Hospi-Tec are ISO 13485:2016 (Medical Devices: Quality Management Systems) certified and are holders of SAHPRA licences. Our customers and their patients can be assured of only the highest standards of quality and compliance when utilising the Hutz brand of products.
Can you be guaranteed that your suppliers are compliant?