The South African Health Products Regulatory Authority 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.
“As the source of the contamination of the product is still under investigation and has not confirmed, all batches of Lubri-A are being recalled. Future manufacture and distribution of the product will be subject to review and authorisation by Sahpra,” the regulator said in a statement on Wednesday.
In a letter to provincial heads of health, acting director-general in the national health department, Jeanette Hunter, said the National Institute for Communicable Diseases detected the fungus Wickerhamomyces anomalus (W.anomalus) as an emerging pathogen which is causing “serious infection” among immunocompromised and critically ill patients, including babies admitted into neonatal units.
“In over a quarter of the cases, the fungus was cultured from normally sterile patient specimen such as blood. The number of cases and the clustering of cases in time and location is very unusual as this yeast is rarely found in patient specimen,” Hunter said.
The letter, which Business Day has seen, was sent to provinces on December 18.
Health department spokesperson Foster Mohale said the fungus may have entered the bloodstream or into other body sites in some patients.
“There is no need for members of the public to panic as the situation is under control,” Mohale said.
“Healthcare professionals who have used this 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.”
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