Elite Medical Experts Weighs in on Philips’ Recall of Breathing Machines That May Emit Toxins

AlixPartners Forecasts: Household Products Could Cost U.S. Manufacturers and Consumers 15% More This Year Due to Resin Shortage

While companies can’t control the market forces at play, they can take action to mitigate the risk and impact of supply chain disruption.

How To Control a Radio Frequency (RF) Process

The radio frequency welding and manufacturing process uses electromagnetic energy and pressure to fuse and permanently bond vinyl, thermoplastic, and coated materials to produce a specific product - all according to customer requirements. Using this RF sealing process, a distinct, one-piece perpetual bond is formulated that is both solid and resistant to ripping or tearing. But how is this process controlled, and with what specific tools? Read on.

Cartessa Aesthetics’ Innovative Multi-Modality Treatment Leads Demand for Non-Invasive Body Procedures

PHYSIQ is a novel, dual-modality system that offers deep heat to target tissue and electrical muscle stimulation (EMS) to re-educate muscle – all from one device and in one session.

On June 30, 2021, the U.S. Food and Drug Administration (FDA) alerted the public about a voluntary recall of specific Philips Respironics ventilators, BiPAP, and CPAP devices due to the risk of exposing users to particulate matter and off-gassing from polyester-based polyurethane (PE-PUR).

FDA warned that degraded PE-PUR, a component of the foam used to dampen noise and vibration, may inadvertently enter the device’s airflow pathway where it can be inhaled or ingested during therapeutic use of the machine. The recall notice followed Philips’ April 2021 announcement that they had internally “identified a quality issue in a component that is used in certain sleep and respiratory care products.”

“Direct exposure to foam particulates and chemicals can be dangerous for several reasons,” said Dr. Venktesh Ramnath, an Associate Clinical Professor of Pulmonary Medicine at UC San Diego Health. “Inhalation of particulate foam can lead to difficulty breathing and frank respiratory failure, and bacteria or fungus carried into the body can cause infection in the respiratory tract and lungs.” Regarding off-gassing, Dr. Ramnath added, “inhalation of isocyanates and other gases associated with polyurethane can cause lung irritation, and some may be carcinogenic in their own right. Prolonged exposure to these chemicals is worrisome, particularly since many people using CPAP and BiPAP already have underlying asthma and other respiratory diseases.”

“The complex issues in this recall will necessitate expert witnesses from a variety of disciplines,” says Dr. Burton Bentley II, an Emergency Medicine specialist and CEO of Elite Medical Experts. “We anticipate the need for experts in Pulmonology, Toxicology, Epidemiology, Biomedical Device Engineering, and Polymer Science. Physician experts in Occupational & Environmental Medicine will also have a role since they are frequently involved in human exposure to toxic compounds.” Regardless of the trajectory of litigation, Dr. Bentley added, “the most important thing right now is to focus on the health and safety of the millions of people affected by the recall. That means seeing a doctor and assuring that you have a safe device.”

Full article can be found here.

spot_img

DON'T MISS

Mediclinic Appoints 2 New Independent Non-Executive Directors

Natalia Barsegiyan and Zarina Bassa will bring significant and diverse skills and experience, complementing those of existing Board members. I am confident they will both be great additions to our Board of Directors.”

Asensus Surgical Appoints Two New Board Members

Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced the expansion of its Board of Directors, appointing...

Our Sister Publication: Biotechnology News Magazine

Subscribe to Medical Device News Magazine here.