The U.S. Food and Drug Administration (FDA) recently posted the following updates:
On March 21, 2022, the FDA issued a Letter to Health Care Personnel to provide recommendations, including conservation strategies, for prefilled 0.9% sodium chloride IV lock/flush syringes. The FDA is aware that the U.S. is experiencing interruptions in the supply of prefilled 0.9% sodium chloride (saline) intravenous (IV) lock/flush syringes due to an increase in demand during the COVID-19 public health emergency. The FDA has added prefilled 0.9% sodium chloride IV lock/flush syringes to the device shortage list and the device discontinuance list.
On March 21, 2022, the FDA issued a recall notice that Philips Respironics is recalling certain V60 and V60 Plus ventilators because a subset of these devices had parts that were assembled using an expired adhesive. If the adhesive fails, it could cause the ventilator to stop providing oxygen to the patient. This failure may cause an alarm to notify the healthcare provider, or it may not sound any alarm at all. The FDA identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences or death.
On March 18, 2022, the FDA approved Ztalmy (ganaxolone) to treat seizures associated with cyclin-dependent kinase-like 5 deficiency disorder (CDD) in patients aged 2 and older. This is the first treatment for seizures associated with CDD and the first treatment specifically for CDD. Ztalmy is associated with certain risks, which are described in the prescribing information.
U.S. Food and Drug Administration (FDA). FDA Roundup: March 22, 2022. Available at: click here. Accessed March 23, 2022.