eNews May 10, 2022

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

Risk of airway obstruction

The FDA is evaluating the potential risk of airway obstruction from silicone-based electromyogram (EMG) endotracheal tubes (Medtronic NIM Standard Reinforced EMG Endotracheal Tube and Medtronic NIM Contact Reinforced EMG Endotracheal Tube). The agency has received reports describing serious adverse events and deaths for these devices after airway obstruction and ventilation failure. At this time, the root cause and incidence rate of obstruction and ventilation failure with use of these devices is not known. The FDA is encouraging providers to report adverse events related to the endotracheal tubes to the manufacturer and the FDA.

 

Clarity needed on ‘remanufacturing’

MITA – which represents manufacturers of ultrasound, CT, X-ray and nuclear imaging systems — has voiced support for legislation that calls for clarity on activities that fall under medical device remanufacture. Improper servicing of equipment that alters the action or efficacy of devices edge into the realm of device manufacture, an FDA-regulated activity, says the association. Significant changes to devices or energy output could pose harm to operators and patients, and could reduce the accuracy of diagnostics. Currently, the definition of “remanufacture” could be misinterpreted and could lead to some devices being improperly changed without oversight, says MITA. A bill, H.R. 7253, “The Clarifying Remanufacturing to Protect Patient Safety Act of 2022,” was introduced earlier this month.

 

Startup offers onsite anesthesia for medical practices

Columbus, Ohio-based OFFOR Health, which offers onsite clinical services for dental and medical practices, recently landed $9 million in a Series A funding round, reports MedCity News. OFFOR already serves practices in Tennessee, Kentucky, and Illinois. The company provides anesthesiologists, registered nurses, medications, and equipment needed for procedures so medical practices can do procedures in-house. Separately, OFFOR is the parent company of SmileMD, which provides in-office anesthesia services to dental practices. To date, the company has raised $15 million.

 

Medical industry should be first in line for semiconductor chips: AdvaMed

Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), led a meeting last week of medical technology CEOs and leaders with Secretary of Commerce Gina Raimondo to discuss semiconductor chip supply chain issues. The group urged the Biden administration “to send a clear and unambiguous message to chips manufacturers and distributors that our health care system must be prioritized, and ensure full transparency for future allocations to our industry.” Whitaker was joined by leaders from Hologic, BD, ResMed, Royal Philips, GE Healthcare, Boston Scientific, Stryker, and Varian.

 

Mace Horoff to keynote IMDA/HIRA conference

Author, trainer, podcaster and speaker Mace Horoff has agreed to deliver the keynote presentation at the IMDA/HIRA Annual Conference in July. Author of Mastering Medical Sales, Horoff is the founder of Medical Sales Academy, a program designed to help sales managers and reps understand their personal and business challenges, and uncover and leverage opportunities that others might overlook. His Medical Sales Guru podcast is available on iTunes and most podcast platforms. Register by May 31 for the annual conference, “Winning Through Collaboration: Finding Opportunities Through Collaboration,” July 25-27 at the Eaglewood Resort in Itasca, Illinois, and take advantage of an advanced-registration discount.