Sahpra vs medical company: would you want a used catheter in your heart?
An SA medical manufacturer is at loggerheads with the SA Health Products Regulatory Authority (Sahpra) after its licence to clean medical equipment such as biopsy forceps and heart catheters for reuse was suspended.
The saga has placed the debate around the specialised cleaning of sophisticated medical equipment in the spotlight, with those in favour of the practice saying it has huge costsaving benefits for patients, while those against it believe it poses a high risk.
It started in 2017 when the then Medicines Control Council (MCC) gave the South African company Medi-q a medical device manufacturing licence.
It opened a factory in Vereeniging after receiving a R71m investment from US medical device manufacturer Northeast Scientific.
This licence was valid until October 2022.
But now, after Saphra took over from the MCC, the licence has been suspended as its owners and SA authorities argue over whether it includes and allows specialised cleaning, which is known as reprocessing.
Devices Medi-q was to reprocess include biopsy forceps and specialised catheters used in the examination of the heart.
This means it wanted to do specialised cleaning on what are usually called single-use devices (SUD), which would normally be destroyed after operations.
The reuse of such equipment after it has undergone specialised cleaning is at the heart of the controversy.
It is permitted in the US and Europe but not in SA.
Medi-q’s licence was suspended when Sahpra CEO Dr Boitumelo Semete-makokotlela told the company in a July 2020 letter that SA health regulations did not permit reprocessing of medical SUDS.
Semete-makokotlela’s letter was issued several months after Sahpra officials conducted an unannounced inspection of Medi-q’s factory.
She admitted in her letter that while Medi-q had disclosed its intention to reprocess SUDS when applying for its licence, it was wrong to give Medi-q the licence because SA health regulations did not permit the reprocessing of SUDS.
“Sahpra has concerns about Medi-q’s ability to conduct the microbiological and sterility testing indicated.
“Failure to conduct such testing on reprocessed single-use equipment poses a significant risk to the public.
“Sahpra has therefore taken 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.”
Medi-q managing director Ebrahim Jappie expressed shock at the suspension.
“When we applied for our licence, we said we would be reprocessing single-use devices. We were transparent about that.
“When we questioned whether they issued the licence in error, Saphra demanded we redo our microbiological testing to a certain standard.
“The same standard they want now is the standard at which we originally conducted our sterilisation tests.”
He claimed the company obtained its licence because it showed it could safely reprocess complex medical devices.
“Reprocessing is not about changing a device’s functionality. We do not reprocess syringes. We want to reprocess items like catheters used in heart operations, biopsy forceps and drill bits used by orthopaedic surgeons.”
Jappie said they had invested R6.7m in the business, with Northeast Scientific investing R71m.
“Our pushback is to make people aware of the benefits from reprocessing, especially cost saving for patients.”
Sahpra spokesperson Yuven Gounden said SUDS were not permitted for reuse or reprocessing due to safety and quality concerns.
“Sterilisation and decontamination processes are complex.”
He said Medi-q was issued a licence to manufacture SUDS.
Asked about Semete-makokotlela’s letter, Gounden said Medi-q had been asked to address certain issues. “They have not responded.” Anita Hamilton, Netcare’s general manager procurement services, said there was room for companies in SA to reprocess such devices, “provided such companies and the reprocessed products comply with all SA medical device regulatory requirements”.
“Cost reduction will be an advantage. The reduction of waste will also be a significant advantage.”
Dr Gerrit de Villiers, chief clinical officer of Mediclinic Southern Africa, said very strict international protocols and standards needed to be applied to reprocessing, which could have cost-saving benefits for patients.
“Reprocessing comes with a number of risks and cannot be viewed from a financial perspective in isolation.
“The complexity of reprocessing will depend on the grade of medical device, the design and the purpose for which the device was intended to be used.”
Dr Mark Ferreira, Life Healthcare group chief medical officer, said: “While the reuse of singleuse products would seem to make economic sense, patient safety remains foremost.
“Any changes to SA’S regulations would require the regulators to consider ethical, medical, legal and economic factors, and will involve considerable engagement with all industry stakeholders supported by scientific evidence that the reused device is safe and effective.”
Noluthando Nematswerani, Discovery Health’s clinical policy head, said they had been approached by some medical suppliers to seek funding for reprocessed single-use devices.
“Safety and clinical effectiveness of reprocessed SUDS need to be established first and regulatory authorisation granted before we can consider funding.”
Dan Vukelich, president of the international Association of Medical Device Reprocessors, said he interpreted SA’S regulations as permitting reprocessing.
“In 2019, collectively hospitals across the globe were saved an estimated $544m through using reprocessed devices, with 7,000,000kg of potential waste diverted from landfill sites.”
Reprocessing is not about changing a device’s functionality. We do not reprocess syringes. We want to reprocess items like catheters used in heart operations, biopsy forceps and drill bits used by orthopaedic surgeons