The U.S. FDA said the class I recall of the Alaris infusion pumps by Carefusion 303 Inc., of San Diego, is due to “multiple system errors, software errors, and use-related errors.” These issues can lead to delays in infusion, as well as slower- or faster-than-expected infusion of medication. The agency said it has received notification of serious adverse event for each of the three error types, as well as one death. The recall affects 744,000 units distributed in the U.S. under five different model designations that were distributed between 2004 and January 2020.
The U.K. National Institute of Health and Care Excellence (NICE) said the evidence for safety in the use of MRI-guided interstitial laser thermal therapy for drug-resistant epilepsy suggests “serious but well-recognized safety concerns.” NICE said the procedure should be used only with consent and audit/research, and that patient selection should be handled by a multidisciplinary team. The agency called for randomized, controlled studies, registry studies or large case series to answer questions, such as the impact of the procedure on long-term neurodevelopmental outcomes in pediatric patients.
The U.S. Centers for Medicare and Medicaid Services said it has developed a second code under the Healthcare Common Procedure Coding System (HCPCS) for testing for the novel coronavirus, a follow-on to the U0001 code released by the agency last month. The U0001 code is for billing for tests conducted in labs operated by the U.S. Centers for Disease Control and Prevention (CDC), while the U0002 code is for COVID-19 testing in non-CDC labs.