May 28, 2022

Mawazo Writing Africa

Writing about the main

Medical authority under pressure to re-use costly single-use devices

The South African Healthcare Products Regulatory Agency (SAHPRA) came under pressure this week to formulate a clear policy on the use of single-use medical devices, as more voices joined the call for these devices to be regulated.

A Johannesburg-based company, Medi-Q, and the Association of Medical Device Reprocessors (AMDR) are the latest to join the debate on medical device reuse.

This week, the international trade association, the commercial single-use processors and promotes the special cleaning of these medical devices, said, “We strongly encourage SAHPRA to reconsider its guidance on this issue.”

Medi-Q, the country’s first commercial medical device – Reprocessing company to be recognized by SAHPRA after receiving its license from the former Medicines Control Council (MCC) in 2017 n also agrees to more formal regulation of these devices.

Their reputation follows that of leading academics and surgeons, who recently said SA strict sta The fact that some single-use medical devices are not reused is not not just waste, but also a threat to the environment.

In a letter published in the SA Medical Journal, the experts urged SAHPRA to reconsider its policies on the use of these medical devices, noting the early disposal of some of these expensive ones devices is referred to as misuse.

Prof. John Lazarus, head of the Department of Urology at the University of Cape Town, and colleagues argued that in a country like SA, which is struggling with shortages of basic medical and surgical equipment, the country needs workable solutions, and one of them is the Sterilization of these devices.

Despite the widespread practice of reprocessing single-use devices around the world and strong evidence showing they can be safely sterilized, experts argue the country’s regulator wasn’t ready to consider re-using them.

Some of the disposable products include special cardiac catheters, patient transfer mats, pulse oximeters, blood pressure cuffs and other devices such as endoscopic prostatectomy which cost up to R5,000.

< p>This week, AMDR President Daniel Vukelich told TimesLIVE that in its 22-year history of monitoring the re processing single-use products around the world “we know that millions of single-use products are reused, regardless of the regulations in this country.”

“They are either cleaned in the hospital under poor regulatory oversight and reused, what known to result in serious safety problems, or they are commercially reprocessed off-hospital under the watchful eye of a strict government regulator, as is the case in Canada, the US, the UK and many European countries.”

The Association said that despite millions of single-use devices being commercially processed and reused on patients, “not a single regulatory body in the world has identified an increased risk to patient safety”.

“In fact, the opposite appears to be the case . Many medical devices are labeled for single use, as they should not be used on more than one patient. But hundreds of device types are marked for one-time use simply because manufacturers want to sell more devices.

“Their profit model is based on volume sales. This business model has resulted in billions of Rands being wasted unnecessarily in hospitals worldwide. It has generated tons of medical waste and contributed to greenhouse gas emissions that contribute to global warming and human diseases.”

SAHPRA did not participate in the debate as spokesman Yuven Gounden did not provide direct answers. “I will Dr. (Theresa) Mathibe to clarify whether we can respond now or wait until after May 25,” he said Thursday. In a previous reply, he said Mathibe, a manager in charge of medical devices, will “discuss the matter on May 25” and only after that day will SAHPRA respond to media questions.

Despite the 2016 change of the South African Medicines and Related Substances Act 1965 to include reprocessing as a manufacturing activity, regulation of this industry remains a gray area after SAHPRA issued a 2019 directive stating medical devices intended by the original manufacturer for single use only Single use devices are used once and must be discarded after use.

A year ago, Medi-Q almost fell victim to SAHPRA’s ambiguous policy on these devices. The company, which reprocesses biopsy forceps and special catheters for heart examinations, almost had its license revoked after SAHPRA questioned its work.

Sahpra CEO Dr. Boitumelo Semete-Makokotlela said the company initially in 2020, South American health regulations did not allow the reprocessing of single-use medical devices. Regulators later made a decision “not to revoke the license granted to Medi-Q, but to suspend the license until all requirements related to microbiological and sterility testing are met”.

Vukelich said his association will do so soon do publish global regulatory standards for the processing and remanufacturing of single-use devices. The document will be the first document to list, in one place, the federal and international regulatory standards used to ensure that commercially remanufactured products are as safe and effective as new products.” p>< p>“We hope that SAHPRA will see fit to investigate this information as we share it globally in the coming days. We strongly encourage SAHPRA to reconsider its guidance on this issue.”

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