SAHPRA recalls Lubri-A, sterile lubricating gel after fungus outbreak.
By Lehlohonolo Lehana.
The South African Health Products Regulatory Authority (SAHPRA) has recalled Lubri-A sterile lubricating jelly across all health facilities in the country after 380 patients contracted a yeast-like fungus stemming from use of the product.
The lubricating jelly is used in medical and surgical procedures such as inserting urinary catheters and ultrasound guided insertion of venous catheters.
Lubri-A is available in two presentations, the 2.5 g sachets and 50 g tubes.
The recall is limited to the product called LUBRI-A (2.5g and 50g sachets) and does not affect other lubricating gel products authorised for sale in South Africa.
Between January 2022 and 4 December 2023, 380 patients from seven provinces tested positive for the fungal infection.
According to the NICD, current evidence suggests that a potential source of this fungus may have been a contaminated medical lubricating jelly used by health professionals across the heath system in the country. This could have introduced the fungus into the bloodstream or into other body sites in some patients. However, it is not yet certain if all cases in this outbreak represent true infections. A proportion of these cases may represent pseudo-infections. A pseudo-infection (a positive culture in the laboratory without a true infection in the patient) may occur, for example, if there was fungal contamination of the patient’s skin by contaminated lubricating jelly before collection of a specimen.
An independent outbreak investigation conducted by the Western Cape provincial government earlier this year revealed that clusters of cases at two Cape Town hospitals may have been linked to the use of contaminated batches of lubricating jelly sachets. Most of the cases at one Western Cape hospital were assessed to be pseudo-infections. This product has since been confirmed to be used by facilities with clusters of cases in several other provinces.
The provincial government is working closely with SAHPRA, the NICD and the manufacturer (Electro-Spyres) to ensure the product in question is no longer used and is recalled with immediate effect and that all unopened lubricant sachets or batches are returned through the usual distribution channels.
"As a national regulatory authority, the recalling of medical products is a crucial measure to address safety concerns or quality issues so that we protect the health of the public. SAHPRA is recalling this product from the market as there are multiple suspected contaminated batches with the potential to cause serious and widespread nosocomial infections, " says SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.
The recall is being classified as a Class 1, Type A recall, which is associated with a serious product quality concern that may have severe consequences.
The product is being recalled from hospitals, retail outlets, health care professionals, authorised prescribers and individual customers or patients.
Healthcare professionals that have used this product should contact their patients to determine any symptoms of infection after use of product.