eNews April 12, 2022The latest news affecting you and your customers… from the Independent Medical Specialty Dealers Association
Fixed endcap duodenoscopes must go: FDA
Given the cleaning concerns and contamination data with fixed endcap duodenoscopes and the increasing availability of duodenoscopes that facilitate or eliminate the need for reprocessing, hospitals and endoscopy facilities should complete their transition to duodenoscopes with disposable components, such as disposable endcaps, or to fully disposable duodenoscopes, says the FDA. The use of a removable component to facilitate cleaning leads to significantly less contamination. Fixed endcap duodenoscopes still in use at healthcare facilities should be replaced with newer models.
Pleural drainage system receives CE Mark
Bearpac Medical, LLC received CE Mark certification for use of the Passio Pump Drainage System for the intermittent drainage of recurrent and symptomatic pleural effusions and malignant ascites. The system consists of the Passio Catheter, a Handheld Control Unit (pump) and a Disposable Collection Kit, which includes a redressing kit. The pump is attached to an implanted Passio catheter using the disposable collection kit and is activated to begin the evacuation of fluid into the collection bag. The CE Mark enables the Moultonborough, New Hampshire-based company to market Passio in Europe.
System identifies brain aneurysm with AI
Aidoc, a provider of healthcare artificial intelligence (AI) solutions, received FDA 510(k) clearance for triage and notification of brain aneurysm. The system allows providers to analyze medical images directly after the patient is scanned. One out of 50 people suffer from a brain aneurysm in the U.S. each year, according to New York City-based Aidoc. Overlooked 10 percent of the time, incidental positive cases often go unnoticed due to their small size and complexity of blood vessels in the brain. If ruptured, patients face a 50% chance of fatality.
New executive director for AARC
Daniel Garrett was named executive director of the American Association for Respiratory Care. Most recently, he served as the executive director of the American Society of Transplant Surgeons (ASTS). Prior to that, he was executive director/CEO of the American Academy of Cosmetic Surgeons, for whom he oversaw a financial turnaround. In addition to ASTS and AACS, he led the Iowa Chiropractic Society and Foundation as executive director, the National Society to Prevent Blindness as senior vice president, the American Red Cross as national marketing manager, and the Illinois CPA Society and Foundation as their director of member services.
Hernia mesh reduces infection risk
Ariste Medical, a pre-commercial drug+device company, received FDA 510(k) clearance to market its drug-embedded, synthetic hernia mesh in the United States. The mesh aims to reduce the risk of microbial colonization during surgical implantation. Mesh-related infection following surgical repair of ventral hernia can range from 8%-40%, depending on patient risk factors and the complexity of the surgical case, according to the Salt Lake City, Utah-based company. The polypropylene mesh carries antibiotics minocycline and rifampin to prevent mesh contamination by bacterial pathogens associated with surgical site infections, such as MRSA and E. coli.
See and be seen at the IMDA/HIRA Annual Conference
We look forward to welcoming you to the IMDA/HIRA Annual Conference, July 25-27, in suburban Chicago. Sponsoring a session or event will heighten your profile and enhance your networking opportunities among the professionals of IMDA and HIRA – the people who can help you build your market. Unable to attend in person? Don’t be forgotten! Display your support of IMDA and HIRA by becoming a sponsor. We’ll make sure your name is in front of all attendees. Click here to learn more about sponsorship opportunities.