Lubricant Gel, Lubri-A
The Department of Health in South Africa has recently welcomed the recall of the medical lubricant gel known as Lubri-A, also referred to as Sterile Lubricating Jelly, after at least 380 patients developed a fungus infection following its use. This was discovered following an investigation by the National Institute for Communicable Diseases (NICD) from January 2022 to December 2023, which found an unusually high number of patients with positive cultures of a fungus called Wickerhamomyces anomalus, previously known as Candida pelliculosa.
The Health Department has commended the NICD and the South African Health Products Regulatory Authority (SAHPRA) for this decision to recall the contaminated health product, which has been used in both public and private health facilities for medical procedures such as insertion of urinary catheters and ultrasound-guided insertion of venous catheters.
The NICD’s investigation suggests that the source of the fungus may have been a contaminated batch of the medical lubricating jelly used by health professionals across the health system in South Africa. It is not yet certain if all cases in this outbreak represent true infections, as a proportion of these cases may be pseudo-infections. However, an independent outbreak investigation conducted by the Western Cape provincial government indicated that clusters of cases at two Cape Town hospitals may have been linked to the use of contaminated batches of lubricating jelly sachets.
During the period of investigation, 380 patients with Wickerhamomyces anomalus positive specimens were identified in seven provinces. While there are no reports of fatalities linked to this contaminated product, the continued use of it may place the health of patients at risk.
The Department of Health is working closely with SAHPRA, the NICD, and the manufacturer Electro-Spyres to ensure the immediate recall of the product and the return of any unopened lubricant sachets or batches through the usual distribution channels. Healthcare professionals who have used this product have been urged to monitor their patients for any signs of infection and to liaise with their local laboratories to check if any of their hospitalised patients have had a positive fungal culture after using this product.
The recall is limited to the product called LUBRI-A (2.5g and 50g sachets) and does not affect other lubricating gel products authorized for sale in South Africa. The department reassures the public that the situation is under control and that the health of the population remains a priority, with the aim to use safe and effective medical products to improve health and prevent illness and disease.
Lubricant Gel, Lubri-A
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