Durban — Health authorities have issued an immediate recall of a sterile lubricating jelly Lubri-A, linked to the development of a fungal infection which could have serious implications for the health of vulnerable patients.
The South African Health Products Regulatory Authority (Sahpra) put out an urgent alert to public hospitals, retail outlets, health-care professionals and authorised prescribers, as well as individual customers and patients last week.
“Sahpra has been informed of multiple complaints received from health institutions, public and private, across the country. The complaints are from a number of patients who became ill due to developing a fungal infection, caused by exposure to the fungal species Wickerhamomyces anomalus (previously Candida pelliculosa) associated with use of Lubri-A (sterile lubricating jelly).”
Sahpra CEO Dr Boitumelo SemeteMakokotlela said: “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 said the Class 1, Type A recall was associated with serious product quality concerns that might have severe consequences.
“Considering the wide usage of the product for lubricating purposes in medical and surgical procedures, the regulator has taken a decision to urgently recall this product from the market because there are multiple contaminated batches, with the potential to cause serious and widespread nosocomial infections.”
Nosocomial infections, also referred to as health-care-associated infections, are infections acquired during the process of receiving health care.
The issue came to light when the National Institute of Communicable Diseases (NICD) was alerted to an increased detection of a yeast-like fungus from sterile and non-sterile specimens at a microbiology laboratory in KwaZulu-Natal.
It said an independent investigation by two hospitals in the Western Cape revealed their cases were possibly linked to the use of sachets of Lubri-A supplied by Electro Spyres Healthcare.
The NICD said Lubri-A was used as a skin lubricant in ultrasound-guided central venous catheter placements, potentially introducing the fungus directly into the patient’s bloodstream.
“Health-care professionals who have used this product are urged to monitor their patients for any signs of an infection and to liaise with their local microbiology laboratories to check if any of their patients have had a positive fungal culture after use of this product. This fungal infection can only be diagnosed in a laboratory and the signs or symptoms of an infection will depend on the body site that is affected,” the NICD said.
While Wickerhamomyces anomalus constituted a minor portion of the human body’s normal microflora, it was also recognised as an emerging opportunistic pathogen, occasionally causing serious infections among immunocompromised individuals, critically ill patients and infants in neonatal units, according to the NICD.
“The continued use of this product may place the health of vulnerable patients at risk.
“Though no deaths have been reported to date, the NICD continues to work with hospitals to collect clinical information from case patients to assess the clinical significance of positive cultures and patient outcomes. Infection prevention and control teams should initiate or continue surveillance of W anomalus-positive specimens.”
Between January 2022 and December 14, 2023, 392 cases were identified in all provinces except the Free State and Eastern Cape.
Sahpra urged everyone to immediately stop using the product, remove it from their inventory and return it through normal distribution channels.
It also urged health-care professionals who had used Lubri-A to contact their patients to determine if there were any symptoms of infection after its use.
Independent on Saturday