eNews Dec 23, 2021

The latest news affecting you and your customers… from the Independent Medical Specialty Dealers Association

Agitation code response teams

It is estimated that 1.7 million instances of agitated patients occur in acute care settings every year. A recent article in the Annals of Emergency Medicine describes the design and implementation of an agitation code response team in the emergency department at Yale-New Haven Hospital in New Haven, Connecticut. The team has three essential members: a team lead, who is a clinician, a primary nurse, and a lead protective services officer, according to a report in HealthLeaders Media. Any nurse or clinician can activate the code response team based on several criteria, including if more than one staff member is required to manage an agitated patient. Yale-New Haven Hospital’s agitation code response team was developed in three phases over a five-year period, resulting in a 27.3% decline in the physical restraint rate.

Light-based device reduces appearance of post-surgical incisions

Laval, Quebec-based Klox Technologies Inc. received FDA De Novo clearance for LumiHeal®, a fluorescent-light-energy-based (FLE-based) system currently indicated to provide fluorescent and blue light to post-surgical incisions for scar management. The system is a non-invasive, non-thermal treatment that employs FLE to reduce the appearance and feel of acute post-surgical incisions. The De Novo request provides a marketing pathway to classify novel medical devices for which there is no legally marketed predicate device.

AARC helps tornado victims

The American Association for Respiratory Care has activated its Disaster Relief Fund for members affected by the Dec. 10 tornadoes in Arkansas, Illinois, Kentucky, Missouri, Mississippi and Tennessee. Click here for more information.

Watch out for cybersecurity vulnerability

The FDA issued an alert on Dec. 17 regarding a cybersecurity vulnerability in Apache’s Log4j software library, which is used in a variety of consumer and enterprise services and applications, including medical devices. “These vulnerabilities may introduce risks for certain medical devices where the device could be made unavailable, or an unauthorized user could remotely impact the safety and effectiveness of device functionality,” according to the agency. As of Dec. 17, the FDA was not aware of any confirmed adverse events affecting medical devices related to these vulnerabilities. Nevertheless, the agency urged manufacturers to assess whether they are affected by the vulnerability, evaluate the risk, and develop remediation actions.

Pediatric innovations cited

Five awardees from the National Capital Consortium for Pediatric Device Innovation “Make Your Medical Device Pitch for Kids” competition will share grant funding from the FDA to support the advancement of pediatric medical devices. This year’s awardees are: PeriCor, for a catheter grip tool for use during pediatric cardiac interventional procedures; Inkspace Imaging, for a pediatric cardiac and vascular MRI coil; Karios Technologies, for Tissue Shield, a technology to prevent scar tissue formation (adhesions) on the heart after surgery; Sibel, for ANNE™ One, ICU-grade wireless sensors for cardiopulmonary monitoring in neonates with congenital heart defects; and Starlight Cardiovascular, for Project Lifeline, a less-invasive way to maintain sufficient circulation in newborns with ductal-dependent circulation.