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UCT call on SAHPRA to revisit single-use medical device ruling

A group of medical professionals from the University of Cape Town (UCT) has appealed to the South African Health Products Regulatory Authority (SAHPRA) to reconsider its mandate regarding single-use only of medical devices. In the SA Medical Journal, they write that this is the second attempt to engage SAPHRA, and that nearly 9,000 hospitals around the world use reprocessed devices safely, without harm to patients. The practice has been also acknowledged by the US Food & Drug Administration.

They write:

African countries face a well-recognised shortage of essential medical equipment and surgical devices. To meet this challenge, we will need context-specific solutions. On 29 November 2019, the acting chief executive officer of the South African Health Products Regulatory Authority (SAHPRA) issued a directive that contained the following instruction: “Medical devices intended by the original manufacturer for single use may only be used once, may not be reprocessed and must be disposed of after use.”

A letter from the first author (JL) to SAHPRA (4 February 2020) appealing this mandate was unacknowledged, and later, after multiple attempts to engage, SAHPRA said that the matter was non-negotiable. Following this new rule, Groote Schuur Hospital has banned any reprocessing of medical devices.

The practice of reprocessing single-use devices (SUDs) is widespread across the globe. Many countries have specific regulations in this regard. The widely recognised draft US Food and Drug Administration (FDA) statement (2000) on reprocessing describes a risk-prioritisation scheme that addresses the combined risks of infection and device performance.

The FDA states that many SUDs “are low risk when used for the first time and remain low risk after reprocessing, provided that the reprocessor conducts cleaning and sterilisation/disinfection of the SUD in an appropriate manner”.

A review of FDA oversight reiterated the safety of reprocessing in a 2008 article that stated: “Available information indicates that their use does not present an elevated health risk.”

More than 8,800 hospitals use reprocessed devices in the USA, Canada, Israel, Europe and Japan alone. Yet the practice is outlawed by SAHPRA in South Africa, when the cost/risk benefit may be far more advantageous in less developed economies, and especially in the cost-constrained public sector in SA.

A recent editorial in the Annals of the Royal College of Surgeons of England recognises that “the amount of single use equipment in the operating theatre can be phenomenal … a simple tonsillectomy can generate over 100 pieces of disposable plastic”.

Estimates suggest that as much as 7,000kg of landfill waste could be reduced annually by reprocessing at a 200-bed hospital. Reprocessing SUDs is also a way to reduce the carbon footprint of healthcare, which is 4.4% of global emissions or equivalent to the annual greenhouse gas emissions from 514 coal-fired power stations.

Operating theatres have a particularly huge environmental impact. For example, “a typical cataract operation in the UK generates 182kgCO2, but in India the same operation generates only 6kgCO2 … [while] a robotic hysterectomy [generates] over 800kgCO2”.

A Commonwealth Fund report has looked at the cost savings inherent in reprocessing of SUDs. It is estimated that in the USA alone, reprocessing would reduce healthcare costs by USD540m annually.

We call on SAHPRA to engage with stakeholders and to reconsider its 2019 directive. Our hope is that this process would result in the drafting of guidelines to allow quality-controlled reprocessing of selected SUDs to ensure patient safety by mandating strict cleaning, functionality and sterility specifications. Such guidelines would lead to substantial financial and environmental savings for SA, without compromising patient safety.

John Lazarus, Professor and Head, Division of Urology, Faculty of Health Sciences, University of Cape Town
Salome Maswime, Head and Associate Professor, Global Surgery Division, Department of Surgery, Faculty of Health Sciences, University of Cape Town
Graham Fieggen, Professor and Chair, Division of Neurosurgery, and Head, Department of Surgery, Faculty of Health Sciences, University of Cape Town
Lydia L Cairncross, Chair and Head, Division of General Surgery, Faculty of Health Sciences, University of Cape Town
James Irlam, Division of Environmental Health, School of Public Health and Family Medicine, University of Cape Town; Chair, Climate Energy and Health Special Interest Group, Public Health Association of South Africa
Anthony Reed, Level 2 Head: Anaesthetics, Metro West and New Somerset Hospital, Cape Town; Senior Lecturer, Department of Anaesthesia and Perioperative Care, University of Cape Town
Shrikant Peters, Executive Management, Manager Medical Services, Peri-operative and Critical Care Services, Groote Schuur Hospital, Cape Town; Honorary Senior Lecturer and Public Health Medicine Specialist, Division of Public Health Medicine, Faculty of Health Sciences, University of Cape Town
Johannes Fagan, Professor and Chair, Division of Otolaryngology, Faculty of Health Sciences, University of Cape Town

 

SA Medical Journal letter – Call for SAHPRA to revisit regulations on single use devices (Open access)

 

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Medical device regulation in SA is a 'tangled web'

 

COVID-19 exposes SA's 'covert' crisis in the medical device sector

 

Medical device industry rejects Discovery's planned fees

 

 

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