Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Medical device manufacturer, Fresenius Medical Care AG & Co. KGaA, has issued a medical device safety alert concerning its stay safe Disinfection Cap [Article no.: 2845091] [HKMD No.: 120081].
The manufacturer is updating the labeling to stay safe Disinfection Cap. Label updates include adding additional warnings and contraindications for potential side effects for the use of stay safe Disinfection Cap.
Based on current literature, it has been recognized that an increased exposure to povidone-iodine, a potent antiseptic present in the stay safe Disinfection Cap used to close the peritoneal dialysis (PD) catheter extension could lead to iodine-induced hypothyroidism and associated clinical sequelae. This is especially a concern for infants and children with smaller peritoneal fill volumes in which iodine overload could result in secondary hypothyroidism.
The manufacturer is aware of one pediatric-related event of hypothyroidism during PD treatment, and recommends close monitoring of thyroid function in patients with small peritoneal fill volumes, typically infants and children, when using iodine containing products.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 4 Oct 2023