Sahpra announced a recall of Lubri-A, otherwise known as Sterile Lubricating Jelly.
The national Health Department says it is working with the South African Health Products Regulatory Authority (Sahpra), the National Institute for Communicable Diseases (NICD) and the manufacturer of a suspected contaminated medical product called Lubri-A, to ensure the product is no longer used and is recalled with immediate effect.
The department said it was also working to ensure that all unopened lubricant sachets or batches are returned through the usual distribution channels.
Sahpra announced a recall of Lubri-A, otherwise known as Sterile Lubricating Jelly.
An independent outbreak investigation conducted by the Western Cape government had revealed earlier this year that clusters of cases at two Cape Town hospitals may have been linked to the use of contaminated batches of lubricating jelly sachets.
“This product has been used in public and private health facilities for medical procedures such as insertion of urethral (urinary) catheters and ultrasound-guided insertion of venous catheters,” the department said.
“This follows an investigation by the NICD into an unusually high number of patients in hospitals across South Africa with positive cultures of a fungus called Wickerhamomyces anomalus.”
The fungus is recognised as an emerging pathogen causing serious infections among immunocompromised and/or critically ill patients and among babies admitted to neonatal units.
According to the NICD, evidence suggests that contaminated medical lubricating jelly could have introduced the fungus into the bloodstream or other body site 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 if there was fungal contamination of the patient’s skin by contaminated lubricating jelly before collection of a specimen,” the department said.
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 department said.
The NICD reviewed public-sector laboratory records from January 1, 2022, through to December 4, 2023.
During this period, 380 patients with W. anomalus-positive specimens were identified in seven provinces.
“Although there are no reports of fatalities linked to this contaminated product, the continued use of the product may place the health of patients at risk.”
Health-care professionals who have used the product have been urged to monitor their patients for any signs of an infection and to liaise with their local laboratories to check if any of their hospitalised patients have had a positive fungal culture after use of this product. This type of fungal infection can only be diagnosed in a laboratory.
The signs or symptoms will depend on the body site that is affected.
In a statement on Tuesday, Sahpra CEO Dr Boitumelo Semete-Makokotlela said: “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.”
The future manufacture and distribution of the product will be subject to review and authorisation by Sahpra.
Cape Times
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