Medical authority under pressure to re-use costly single-use devices
The SA Health Products Regulatory Authority (SAHPRA) has come under pressure this week to formulate a clear directive concerning the use of single-use medical devices as more voices join the call for regulation of these apparatuses.
A Johannesburg-based company, Medi-Q, and the Association of Medical Device Reprocessors (AMDR) are the latest to join the debate on re-use of medical devices.
This week the international trade association, which represents commercial single-use processors and promoting specialised cleaning of these medical devices, said, “We strongly encourage SAHPRA to revisit its guidance on this matter.”
Medi-Q, the country’s first commercial medical device-reprocessing company to be recognised by SAHPRA after it got its licence from the former Medicines Control Council (MCC) in 2017, is also in agreement for a more formal regulation of these devices.
Their call follows that of leading academics and surgeons, who recently said SA’s strict stance of not reusing some single-use medical devices is not only wastage, but a threat to the environment.
In a letter published in the SA Medical Journal, the experts urged SAHPRA to reconsider its guidelines relating to the use of these medical devices, labelling the early discard of some of these expensive devices as misuse.
Prof John Lazarus, head of urology division of the University of Cape Town, and colleagues argued that in a country such as SA that battles with a shortage of essential medical equipment and surgical devices, the country needs workable solutions and one of them is the sterilisation of these devices.
Despite the widespread practice of reprocessing of single-use devices across the globe and strong evidence that shows they can be safely sterilised, the experts argue that the country’s regulator has been unwilling to consider their re-usage.
Some of the single-use devices include specialised cardiac catheters, patient transfer mats, pulse oximeters, blood pressure cuffs and other devices such as endoscopic prostatectomy, which costs up to R5,000.
This week AMDR’s president Daniel Vukelich told TimesLIVE that in its 22-year history of monitoring reprocessing of single-use devices around the world, “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.”
The association said despite millions of single-use devices commercially reprocessed and used again on patients, “not a single regulatory authority in the world has found an increased risk to patient safety”.
“In fact, the opposite appears true. Many medical devices are labelled for single use because they should not be used on more than one patient. But hundreds of types of devices are labelled for single use simply because manufacturers want to sell more devices.
“Their profit model is built on volume sales. This business model has resulted in billions of rand wasted unnecessarily at hospitals worldwide. It has generated tonnes of medical waste and contributed to greenhouse gas emissions that contribute to global warming and human sickness.”
SAHPRA wouldn’t be drawn into the debate, with spokesperson Yuven Gounden not giving direct answers. “I shall ask Dr (Theresa) Mathibe to clarify whether we are able to respond now or wait until after May 25,” he said on Thursday. In a previous response he said Mathibe, who is a manager responsible for medical devices, “will be discussing the matter” on May 25 and only after this day will SAHPRA respond to media questions.
Despite the 2016 amendment of the South African Medicines and Related Substances Act of 1965 to include reprocessing as a manufacturing activity, the regulation of this industry remains a grey area after SAHPRA issued a directive in 2019 stating that medical devices intended by the original manufacturer for single use may only be used once and must be disposed of after use.
A year ago Medi-Q almost became a victim of SAHPRA’s ambiguous policy on these devices. The company, which reprocesses among others, biopsy forceps and specialised catheters used in the examination of the heart, almost had its licence revoked after SAHPRA questioned its work.
SAHPRA CEO Dr Boitumelo Semete-Makokotlela initially told the company in 2020 SA health regulations did not permit the reprocessing of single-use medical devices. The regulators later took a decision “not to revoke the licence issued to Medi-Q, but to suspend the licence until all the requirements relating to microbiological and sterility testing are addressed”.
Vukelich said his association will soon be releasing global regulatory standards for single-use devices processing and remanufacturing. The document will be “the first document to list, in one place, the federal and international regulatory standards used to ensure that commercially reprocessed devices are as safe and effective as new devices”.
“We hope that SAHPRA will see fit to explore this information when we share it globally in the coming days. We strongly encourage SAHPRA to revisit its guidance on this matter.”
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