HME Industry and TexMEP News and Updates
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Philips Respironics Trilogy Evo, Evo O2, EV300, and Evo Universal ventilators provide continuous positive airway pressure (CPAP) and intermittent positive airway pressure breathing support for people who need mechanical ventilation. They are intended for pediatric through adult patients weighing at least 2.5 kg and are used in hospitals and health care settings and for patient nonemergency transport. The Trilogy EV300 and Trilogy Evo may also be used by people requiring mechanical ventilation in their homes.
Philips is recalling Trilogy Evo, Evo O2, EV300, and Evo Universal ventilators after detecting dust and dirt from the environment in the air path of some devices. Extended exposure to environmental contaminants such as dust and dirt can lead to buildup that may block air vents and cause the device to stop delivering the right amount of air pressure, or air volume/flow.
If the ventilator fails to provide the right level of breathing support, patients may not receive enough oxygen (hypoventilation) and may experience a build-up of carbon dioxide or other gas pressure, which can lead to serious injury or death.
Philips has received 542 reports about this issue. There are currently two reported injuries and one death.
On April 17, 2023, Philips sent affected customers and patients an Important Product Notice with the following actions:
Locate the part number on the bottom of the device and verify it against the impacted part numbers noted in the letter.
Prevent accumulation of debris on the machine flow sensor:
For questions and support, contact your local Philips representative or Philips Respironics Customer Service.
Medical Device Recall Database entry: Trilogy Evo O2 EV300
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using the online form or call 1-800-332-1088 for more information on how to mail or fax the form.
The nationwide durable medical equipment (DME) provider continues to advocate for making items like diapers and breast pumps tax-free on a state by state basis
Aeroflow Healthcare, a nationwide provider of durable medical equipment through insurance, today celebrated the passage of Texas SB 379 after directly advocating and lobbying for the change in the state. This piece of legislation will benefit hundreds of thousands of families and individuals by eliminating taxation on numerous care products such as diapers and breast pumps, starting September 1, 2023.
Aeroflow Healthcare has been active across numerous U.S. states this year to advocate for changes in accessibility to care and health supplies. The DME provider directly lobbied with the Texas House and Senate on the diaper tax elimination (HB 300), and pushed for adding breast pumps to the exemption, resulting in its inclusion in SB 379. As a result, Texas residents will now be able to obtain the following products, tax free: adult and child diapers, breast pumps, bottles, baby wipes, feminine hygiene products, maternity clothing and wound care dressing.
“We are encouraged to see SB 379 pass, yet another reflection of the work our government relations team has conducted to ensure more patients and caregivers can access medically-necessary products and resources to live a healthier life,” said Ryan Bullock, COO at Aeroflow Healthcare. “Both Texas and the recent addition of Florida this past May are two significant additions to the growing number of states our team has successfully lobbied in to enact important legislation changes. We look forward to continuing our mission of breaking down legislative barriers that currently block patients from obtaining products and care in other states.”
For over a decade, Aeroflow Healthcare has been committed to providing high-quality medical products and services to patients across the country. The passing of Texas’s HB 379 comes at a time when the provider is taking further steps to bolster their government relations efforts in order to improve equitable access to care. The recently announced program will shine a spotlight on policies at both the state and federal levels to make critical healthcare products like breast pumps and diapers more affordable, prioritizing quality of life for all.
Source: Globe Newswire
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