IMDA eNews 110723
The latest news affecting you and your customers…
from the Independent Medical Specialty Dealers Association
PVA in critically ill kids is subject of study
A research team led by Robinder Khemani, M.D., MsCI, attending physician in pediatric intensive care at Children’s Hospital Los Angeles, received a $3.4 million grant from the National Institutes of Health to examine the frequency and risk factors for common types of patient-ventilator asynchrony (PVA) in critically ill children. PVA is a mismatch between the patient’s breathing efforts and the rhythm delivered by the ventilator. Working with hospitals in Canada and the Netherlands, the researchers will investigate whether PVA is independently associated with poor clinical outcomes and determine the effects on the body when breathing doesn’t match the flow of air provided by the ventilator.
Virtual OR/sales rep communication tool is dropped
Avail Medsystems shut down its business, presumably because of difficulty raising capital. The Santa Clara, California-based company was born during the pandemic to connect medical device sales reps with operating room teams virtually. Recently the ORtelligence Rep+ software was made available to surgical teams and medical device professionals collaborating via the Avail platform. Avail had also intended to add more third-party applications to its platform, which would have leveraged cameras, audio, monitor and computing on the Avail console without the need for additional equipment.
Pandemic policy for medical devices extended by FDA
The Food and Drug Administration will continue to allow medical device manufacturers to make alterations to certain products or manufacturing processes without prior authorization if the changes are due to production limitations or supply chain challenges, reports MedTech Dive. The policy is a continuation of COVID-19 pandemic-era changes that eased some requirements on device makers. An FDA guidance document released Nov. 2 offers examples of when companies would not be required to file a premarket application (PMA) or humanitarian device exemption (HDE) supplement, or a 30-day notice, before making changes.
New recommendations for CAUTI reduction
As many as one-fourth of all hospital inpatients may have a short-term, indwelling urinary catheter placed during their hospital stay. However, use of catheters can lead to urinary catheter complications, including catheter-associated urinary tract infection (CAUTI). Updated recommendations — developed by five medical societies and published in the journal Infection Control & Hospital Epidemiology — identify alternatives to indwelling catheters, demonstrate how to safely insert and maintain catheters, and prompt healthcare personnel to initiate timely removal. Rayal Patel, M.D., an infectious diseases physician at Intermountain Health, was lead author of the new recommendations.
2024 Conference: Registration is open!
There’ll be plenty of learning inside and outside the meeting rooms at the 2024 IMDA/HIRA Conference in Orlando, Florida, March 4-6. In general sessions, you’ll receive updates on issues like how to deal with the threat of cyberattacks, how to navigate the world of contracts, and how to meet the clinical and financial needs of your customers. And outside the meeting rooms you’ll exchange ideas with peers during cocktails and shared meals, the Manufacturers Forum, and, of course, the golf course for those of that persuasion. Come to the 2024 IMDA/HIRA Conference. There’ll be a whole lot of learning going on. And it’s all for just $750 for IMDA members. Click here for registration information.