The international trade association, a commercial representative of single-use processors and promotor of specialised cleaning of said devices, strongly encouraged SAHPRA to formulate clearer directives.
Medi-Q is standing behind the above, as it calls for a formal regulation on single-use medical devices. The calls have followed leading academics and surgeons stating that it is a threat to the environment.
This is with regard to South Africa’s strict stance on not reusing certain single-use medical devices. The groups believe this is a waste. The experts have urged SAHPRA to reconsider its guidelines relating to single-use medical devices.
In a letter published in the South Africa Medical Journal, the experts labelled th4e early discarding of some of the expensive devices as a misuse. The experts have argued that SAHPRA has been unwilling to consider the re-use of these devices.
Which medical devices are experts talking about?
This is despite the practice of reprocessing single-use devices across the world and strong evidence that shows these devices can be safely sterilised. Some of the single-use devices include:
- Specialised cardiac catheters;
- Patient transfer mats;
- Pulse oximeters;
- Blood pressure cuffs and;
- Endoscopic prostatectomy (which has a price tag of up to R5 000)
AMDR’s president Daniel Vukelich spoke with TimesLIVE about the reprocessing of single-use devices.
“We know that millions of single-use devices are re-used regardless of the regulation in that country. They are either cleaned in the hospital with poor regulatory oversight and used again, which is known to lead to serious safety problems, or they are commercially remanufactured outside the hospital under the watchful eye of a strict government regulatory authority, as is the case in Canada, US, UK and many European countries,”
Daniel Vukelich, AMDR’s President.
SAHPRA’s Spokesperson Yuven Gounden did not provide sound answers. He stated that he would ask Dr Theresa Mathibe to clarify a response date.