In March 2024, the AASM hosted a webinar that includes an interactive panel dialogue addressing uncertainties stemming from the announcement by Philips Respironics that it’s discontinuing varied sleep and respiratory care gadgets within the U.S. The dialogue additionally addressed the consent decree between Philips, the U.S. Meals and Drug Administration (FDA), and U.S. Division of Justice (DOJ) associated to the continuing recall of Philips constructive airway stress (PAP) gadgets.
Representatives from the AASM, American Faculty of Chest Physicians (CHEST), American Thoracic Society (ATS), American Academy of Neurology (AAN), American Affiliation for Respiratory Care (AARC), and American Affiliation of Sleep Technologists (AAST) mentioned the implications for sleep facilities. A video recording of the webinar is out there for viewing on the AASM YouTube web page.
The webinar generated a number of questions from contributors, and the AASM Public Security Committee has offered the next responses to handle frequent inquiries. Sleep medication professionals ought to attain out to your Philips Respironics gross sales consultant or Buyer Service at 800-345-6443 with further questions.
Questions and Solutions
How does the consent decree influence sufferers and labs?
The consent decree is a legally binding efficiency enchancment plan. It has outlined a roadmap of what actions and milestones Philips Respironics should meet to show regulatory compliance and restore its enterprise in respiratory and sleep providers within the U.S. The construction outlined within the decree contains prioritizing remediation of sleep and respiratory gadgets recalled in June 2021, establishing impartial consultants concerned within the recall remediation, and guaranteeing impartial evaluation of compliance. No additional sale of BiPAP or CPAP gadgets inside the U.S. is allowed till Philips meets these necessities. For additional info, learn the AASM abstract of the ultimate settlement.
What’s concerned within the Philips announcement of sleep and respiratory portfolio adjustments?
Based mostly on the announcement, for the U.S. and U.S. territories, Philips Respironics will shift its focus to the sale of consumables and PAP equipment, together with masks, and won’t return to the sale of hospital air flow merchandise, sure dwelling air flow merchandise, transportable and stationary oxygen concentrators, and sleep diagnostic merchandise. As well as, a portion of non-U.S. gross sales will compensate the FDA for fines levied by the recall. Extra particulars can be found within the Philips portfolio replace. See the desk beneath for an inventory of discontinued merchandise.
What defines the “finish of service” for Philips merchandise within the portfolio change?
After Philips discontinues a product on the market and discontinues shipments, there will likely be a specified variety of years of service to help all related restore components and equipment needed to make use of or service the system pending half availability. Past the top of service date for a particular system, Philips will not help or present service. Bear in mind that the service, substitute components and equipment are topic to availability for listed gadgets. In different phrases, if they’re unavailable, entry to components and equipment is probably not offered. See the desk beneath for particular finish of service dates.
A lot of our Philips titration gadgets (i.e., OmniLab Superior+) proceed for use since there may be restricted availability of an alternate. How do I cowl the fee? Is there any help?
In January 2024, Philips Respironics discontinued gross sales and cargo of the OmniLab Superior+ within the U.S. Based mostly on the consent decree, Philips can proceed to service current gadgets and supply equipment and substitute components primarily based on availability. Philips signifies that the end-of-service date for these gadgets is Jan. 25, 2029. See the desk beneath.
What are the choices if a discontinued Philips product has failed inside its guarantee interval and is non-repairable?
Philips will present refunds as articulated within the guarantee phrases and circumstances however will likely be unable to offer a substitute product.
A lot of my sufferers have restricted assets and clinically profit from their CPAP. They’re afraid in regards to the ongoing use of a Philips product and can’t afford an alternate. Are there any assets or options for these sufferers to obtain an alternate therapy?
Relying on the system getting used, your sufferers’ choices following registration of their system might embody monetary fee. This will likely help the price of new therapy, however full therapy substitute or help of an alternate is just not a part of the consent decree. Extra info is out there from Philips on the remediation pathway webpage. You will need to be aware this registration deadline: Registration for affected CPAP and BiPAP gadgets within the U.S. and Canada ends at 11:59 p.m. EST, Dec. 31, 2024. To obtain a substitute system or monetary fee, the system have to be registered with Philips previous to the top of the 12 months.
What are some issues for sufferers who’ve restricted assets and are depending on a Philips Respironics system?
Some sufferers are financially unable to acquire new gear (together with upkeep merchandise) or transition to different remedy. Additional, payers might not have modified or accommodated their well being care insurance policies to permit a transition to a different PAP system or respiratory help system (RAD). Though remediation will likely be offered by Philips, a full transition could also be incomplete in some instances. As well as, there are conditions during which DME firms are not servicing Philips gadgets. This has created challenges that will permit for unexpected difficulties for these sufferers.
Because of the menu of gadgets which were impacted, and sufferers’ dependence on Philips Respironics gadgets (in some instances for years), sleep and respiratory professionals ought to take into account sufferers’ consolation stage and challenges in transitioning (e.g., system distinction, retesting), acknowledge weak inhabitants views (e.g., lack of belief), and particular wants (e.g., training, language) in addition to intensify collaboration with native and regional DME suppliers.
What points are being encountered by sleep labs, sleep and respiratory practices, and DME suppliers who’re making an attempt to coordinate care?
Because of the dimension and scope of the Philips recall, and the present useful resource limitations throughout the broad array of merchandise, it’s anticipated that this announcement is broadly felt by:
Sleep labs: Transitioning from a Philips titration system to a different entails different prices together with equipment (e.g., interface cables), technician coaching, and different unmeasured bills.
Sleep and respiratory practices: On account of insurance coverage necessities, practices are realigning affected person merchandise, coordination of care, and different approaches to medical gear.
DME suppliers: To offer entry to gadgets, DME suppliers sought options from nontraditional, overseas, and home manufactures with unknown or unclear (or not totally vetted) high quality assurance applications.
What are among the challenges from having too few producers making gear?
For the reason that recall, new therapies and producers have entered {the marketplace}, partially filling a spot in a quick interval. Since these new therapeutics didn’t have time to mature, and provide chains had been restricted, there have been mounting considerations about high quality challenges. Nevertheless, larger competitors goes to be useful for sufferers sooner or later.
What does the Philips announcement imply for the system market; is it enough to serve sufferers? What’s the outlook for the longer term in sleep and respiratory care?
For the reason that preliminary Philips recall announcement in 2021, and their portfolio adjustments in 2024, there was a progress of conventional and different producers within the sleep and respiratory market. Beforehand, there was restricted product availability adopted by an intermediate restoration. It’s anticipated that with an enhanced regulatory atmosphere, longitudinal expectations help an improved provide of sleep and respiratory care gadgets and higher look after sufferers. A name for higher care has led to the pursuit of extra head-to-head trials evaluating therapeutics and gadgets, and there’s a larger understanding of the gaps in look after our most weak sufferers who depend on sleep and respiratory gadgets.
