IMDA eNews 082923

The latest news affecting you and your customers…

from the Independent Medical Specialty Dealers Association

Weight-loss drugs and pulmonary aspiration 

Patients who take blockbuster drugs like Wegovy or Ozempic for weight loss may face life-threatening complications if they need surgery or other procedures that require empty stomachs for anesthesia, reports STAT. Some anesthesiologists in the U.S. and Canada say they’ve seen growing numbers of patients on the weight-loss drugs who inhaled food and liquid into their lungs while sedated because their stomachs were still full — even after following standard instructions to stop eating for six to eight hours in advance. The drugs can slow digestion so much that it puts patients at increased risk for the problem, called pulmonary aspiration, Dr. Ion Hobai, an anesthesiologist at Massachusetts General Hospital in Boston, was quoted as saying. 

Class 1 ventilator recall 

The FDA has identified Draeger Medical’s recall of its Carina ventilators a Class I recall, the most serious type. During testing, the firm found polyether polyurethane (PE-PUR) in the airpath of the Carina ventilator. This results in the emission of contaminant 1,3-Dichloropropan-2-ol, a potential carcinogen. There have been no reported deaths, complaints, or incidents associated with this issue. The contaminants exceed acceptable levels if used by pediatric patients for more than 30 days. 

Hospitals cutting back on VC investments 

Before the pandemic, many sizable health systems embraced venture capital offices, investing in new technologies and devices while offering hospitals as testing grounds for startups, reports STAT. That premise seems to have evaporated for some systems as they close venture offices, halt new investments, or choose private equity instead. Among them: NewYork-Presbyterian, Advocate Health Enterprises in Charlotte, North Carolina, and Providence Ventures in Seattle. That could be bad news for entrepreneurs who rely on hospitals to be their keystone customers. 

Unique device identifiers remain scarce 

In September 2013, the FDA issued its Unique Device Identification System Rule, requiring unique device identifiers (UDIs) on the label and packaging of nearly all medical devices authorized for use in the US, according to a commentary in JAMA Network. Over the past decade, supply chain, health system, and payer infrastructure to support a UDI system have begun to be built. Even so, UDIs are not routinely or comprehensively captured, integrated as structured data within patients’ electronic health records, or available for clinicians, patients, and others to use. 

Has your business been scammed yet? 

The FBI receives 300,000 email scam filings each year. Business scams are a large part of them. Is your company protected? Are your employees aware of the risk they can put your company in when receiving and sending emails? At the upcoming 2024 IMDA/HIRA Annual Conference and Manufacturers Forum, March 4-6, in Orlando, Florida, IMDA Executive Director Don Sizemore will show you how a common scam can cost you money. He should know, as his business was a victim of one. At the conference, learn how such scams work, how to spot them, and what to do once you are in the scam situation. Click here for more information about the 2024 IMDA/HIRA Annual Conference and Manufacturers Forum.