IMDA eNEWS 071823

The latest news affecting you and your customers…

from the Independent Medical Specialty Dealers Association

Manufacturers: Clean up your IFUs

Manufacturers of complex medical devices often treat Instructions for Use (IFUs) and labeling as an afterthought, but IFUs should be given the same consideration as the device they accompany, according to Korey Johnson at Bold Insight, speaking with Medical Device & Diagnostic Industry. It can be easy to overlook IFUs and labeling associated with medical device or combination products because the focus during product development is on the design of the device, says Johnson. According to research, 70% of human-factors practitioners cite IFU design and content as common drivers of FDA requests for information when reviewing human-factors protocols and submissions.

Respiratory support for preterm infants

The type of noninvasive respiratory support – nasal continuous positive airway pressure (NCPAP) or heated humidified high-flow nasal cannula (HHHFNC) — does not directly influence feeding tolerance in preterm infants, according to a recent study published in JAMA Network. In a randomized clinical trial involving 247 preterm infants with respiratory distress who were randomized to either the NCPAP or HHHFNC arm, no differences were observed in the median time (14 days in both groups) to achieve full enteral feeding or in the evaluation of the signs of feeding intolerance. Researchers concluded that clinicians may tailor respiratory care by selecting and switching between the two NRS techniques based on respiratory effectiveness and patient compliance, without affecting feeding intolerance.

Room monitor detects SARS-CoV-2 in minutes

Researchers at Washington University in St. Louis combined recent advances in aerosol sampling technology and an ultrasensitive biosensing technique to create a monitor that can detect any of the SARS-CoV-2 virus variants in a room in about five minutes. The inexpensive, proof-of-concept device could be used in hospitals and healthcare facilities, schools and public places to help detect CoV-2 and potentially monitor for other respiratory virus aerosols, such as influenza and respiratory syncytial virus (RSV), they say. Results of their work on the monitor, which they say is the most sensitive detector available, were published July 10 in Nature Communications.

Healthcare M&A activity approaches pre-pandemic levels

Healthcare merger and acquisition (M&A) activity has increased, bringing the number of deals closer to pre-pandemic levels, according to the newest Kaufman Hall M&A Quarterly Activity Report, according to HealthLeaders. From April through the end of June 2023, 20 hospital and health system M&A transactions were announced — the highest number of transactions announced since Q1 2020. Three “megamergers” involved entities in which the seller or smaller party had an annual revenue of more than $1 billion: Froedtert Health and ThedaCare, Kaiser Foundation Hospitals and Geisinger Health, and BJC HealthCare and St. Luke’s Health System

It's Orlando in March for 2023-2024 conference

Rosen Shingle Creek in Orlando, Florida, will be the site of the 2024 IMDA/HIRA Conference. Golfers will tee off Monday morning, March 4, and the conference will begin that afternoon. We’ll finish at noon on Wednesday, March 6