Lubricant used in medical procedures recalled after fungus link in 380 patients
The South African Health Products Regulatory Authority (Sahpra) has issued a countrywide recall of a suspected contaminated sterile lubricant, Lubri-A, linked to fungus infections in 380 patients.
Sahpra said the source of the contamination is still under investigation.
The health department said on Thursday it would assist in the recall of the product, which was used in public and private health facilities for medical procedures such as insertion of urethral catheters and ultrasound-guided insertion of venous catheters.
The recall follows an investigation by the National Institute for Communicable Diseases (NICD) into an unusually high number of patients in hospitals in South Africa with positive cultures of a fungus called wickerhamomyces anomalus (previously known as candida pelliculosa). The fungus is recognised as an emerging pathogen causing serious infection in immunocompromised and/or critically ill patients and babies admitted to neonatal units.
The department said while evidence suggests a potential source of the fungus may have been the lubricating jelly, it is not yet certain if all cases in this outbreak represent true infections.
A proportion of these cases may represent pseudo-infections. “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,” the department said.
The government, Sahpra, the NICD and manufacturer Electro-Spyres are working together to ensure the product is no longer used and all unopened lubricant sachets or batches are returned through the distribution channels.
Sahpra CEO Dr Boitumelo Semete-Makokotlela said recalling medical products is a crucial measure to address safety concerns or quality issues to protect the health of the public.
“Future manufacture and distribution of the product will be subject to review and authorisation by Sahpra.”
Healthcare professionals who have used this product have been urged to monitor their patients for 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 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 affected.
The recall is limited to Lubri-A (2.5g and 50g sachets) and does not affect other lubricating gel products authorised for sale in South Africa.
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