eNews April 20, 2021

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

How is COVID-19 affecting your business, your people, your customers? IMDA is a membership organization, and in times like these, we can all use some camaraderie. If you have a COVID story to share, advice to offer, or a warning to sound, send it to Mark Thill, IMDA’s communications director, at mdthill1913@gmail.com, with the subject line “IMDA COVID story.” We’ll compile them and send them back out to you.

Long-term outcomes for CPAP?

Continuous positive-airway pressure (CPAP) therapy has traditionally been judged in terms of its effect on the apnea-hypopnea index, which indicates the severity of sleep apnea. But a report by the Agency for Healthcare Research and Quality says that available evidence “mostly does not support” a link between CPAP therapy and long-term, clinically important outcomes for obstructive sleep apnea, including all-cause mortality, stroke, myocardial infarction or composite [cardiovascular] outcomes, reports MedTech Dive.

Smart infusion pumps need human help

The Joint Commission issued a Sentinel Event Alert describing actions healthcare organizations can take to reduce the risk of errors caused by the misuse of smart infusion pumps, especially errors that can be avoided by the optimal use of DERS (i.e., built-in dose error reduction software). Most United States hospitals have invested in smart infusion pumps with DERS, which have demonstrated their safety potential and have been on the market for 15 years, says Joint Commission. Still, many errors occur because healthcare organizations and clinicians are not optimizing their use of DERS technology.

Medline reported for sale

Medline Industries is exploring a sale that could value the Northfield, Illinois-based company as much as $30 billion, the Wall Street Journal reported on April 10. The family-owned company was reported to have hired Goldman Sachs Group Inc. to run the process. There is no guarantee the company will ultimately be sold. The process is at an early stage, according to sources, with some adding that an IPO or minority investment is also a possibility.

ZOLL acquires Respicardia

ZOLL® Medical Corporation announced on April 12 that it had acquired Respicardia, Inc., a provider of implantable neurostimulators for the treatment of moderate to severe Central Sleep Apnea (CSA), a condition that is often associated with heart failure, coronary artery disease, and certain cardiac arrhythmias. Respicardia’s remedē® system is the only implantable device approved by the FDA to treat moderate to severe CSA in adult patients with reduced cardiac function, according to Zoll.

HHS reverses Jan. 15 notice

The Biden administration reversed a Trump-era decision to exempt certain medical devices — including infusion pump controllers and fetal monitors — from regulatory review, reports Medical Design & Outsourcing. In mid-January, the Department of Health and Human Services had published a notice permanently removing from regulatory review 83 Class II devices and one Class I device, including home ventilators, cardiopulmonary bypass pressure gauges, fetal cardiac monitors, long-term extracorporeal support systems, certain imaging software, ethylene oxide sterilizers and aerators, and certain masks (including N95 respirators), gloves and gowns. “Upon review, HHS and FDA have determined that the proposed exemptions in the Jan. 15, 2021, Notice were published without adequate scientific support, that the Notice contained errors and ambiguities, and that the Notice is otherwise flawed,” wrote HHS Secretary Xavier Becerra and acting FDA Commissioner Janet Woodcock.

Registration open for IMDA/HIRA Conference

Registration is now OPEN for the 2021 IMDA/HIRA Annual Conference, which will be held onsite at the Eaglewood Resort in suburban Chicago, Sept. 27-29. The theme for the conference is “ROI: More Than Just Money.” Why? Because HIRA and IMDA members know that the value they bring – the ROI – is greater than dollars saved. It rests with the training, the efficiencies and the patient outcomes we help our customers achieve. For manufacturers, it’s about market share.