Phillips Respironics Medical Device Recall

RECALL NOTICE: PHILIPS RESPIRONICS CPAP AND BIPAP DEVICES

 

Philips está implementando una medida correctiva permanente. Para obtener más información sobre este Aviso de seguridad en campo, visite: https://www.philipssrcupdate.expertinquiry.com/?ulang=es

 

Dear Patients,

Philips Recall

We understand the Philips Medical Device Recall has caused our patients some concerns. We are doing our best to keep you updated with the most recent information we have.

Philips Device Remediation Update May 2022

Please take a look at the most recent Patient Journey Infographic that Philips has given us:   Understanding the recall process | Philips Healthcare

Some patients have been receiving replacement machines. If you do receive a replacement machine from Philips please note it will be pre-programmed with your current pressure setting. Once the machine is plugged in, and you begin using it, the machine will automatically send us your data. There is no need for an SD card. If you are on our auto supply program, please notify us so we can update your supply order with the new filters. You can reach us at [email protected]

If you are having issues with your replacement machine from Philips please see Resources for your Philips Replacement DreamStation page. You can contact Philips at 833-262-1871 if you have any questions with your new replacement machine.

Looking for a summary of the clinical studies that have been conducted over the past several months?  Take a look at this summary of  the External studies that have been done around the foam degradation and patient safety.  (link)

Testing results can be confusing and clinical! Philips developed a patient friendly update page that talks about what has been tested, how and the results to those tests.  (link)

 

WHAT DO I DO ABOUT MY MACHINE?

Please note that in terms of a replacement machine, the best option is to register with Philips to receive a replacement machine or have your current machine repaired.  This would be at no cost to you. Unfortunately, currently, Philips does not have a timeline for the recall. Please register your machine at Philips website  www.philips.com/SRC-update. Philips Respironics also set up a phone number for the recall process.  Their recall hotline number is 877-907-7508. Please note there are extended wait times, so we recommend you register online. You can also visit the Philips Update FAQ page here.

The PAP replacement options are:

  1. Register device with Philips for repair/replacement
  2. Check with your insurance company to see if you are eligible for a new machine
  3. Purchase a machine out-of-pocket

If you would prefer to receive a new machine through insurance, please check with your insurance company if you are eligible for a replacement machine due to recall or due to the purchase date of your current machine.  Please confirm any associated costs you may incur based on your deductible or co-insurance.  If you are eligible and decide to replace your machine via insurance, please let us know so we can make arrangements for a new machine for you. You can email us at [email protected] or call 703-729-3420 extension 280. Please leave your full name and date of birth and insurance information so we can start the eligibility process. If we do not answer, please leave your full name and date of birth. We are experiencing a high call volume but will get back to you as soon as we can.

MEDICARE / MEDICAID Patients – If you have had your machine greater than 5 years or you have changed insurance you may qualify for a replacement device. It will require an office visit with your sleep medicine physician and new prescription.

DO I NEED TO STOP USING MY MACHINE?

As of yet, there are no published scientific articles about the Phillips Respironics problem or the health risks that are outlined in the Philips recall website information.

Philips Respironics recommends: “For patients using BiLevel PAP and CPAP devices, consult with your physician on a suitable treatment plan”

We would like to give our patients some important information for use of your PAP therapy –

According to American Academy of Sleep Medicine and the Medical Team here at Comprehensive Sleep Care Center recommends that patients consider continuing to use their device until it is replaced/repaired by Philips please use the below guidelines in making your decision.

Please note this was a voluntary recall and the discontinuation of treatment may potentially be associated with even greater health risks than the low rate of complaints associated with this recall.

If you have:

  • Severe Sleep Apnea
  • COPD
  • Hypoventilation
  • Pulmonary Hypertension
  • Neuromuscular Disease Related Respiratory Problems (Parkinson’s, ALS)
  • Past or present cardiac arrhythmia
  • Heart Failure

If any of these apply:

  • DOT license requiring treatment of OSA
  • Occupation with operational safety requirements
  • Extreme sleepiness or drowsy driving prior to using CPAP or BiPAP
  • Recent hospitalization for breathing problems
  • Discontinuation of PAP therapy would lead to substantial deterioration of functional status or quality of life
  • If you have mild or moderate sleep apnea and you feel significantly symptomatic without using the machine

 

Please follow these important guidelines

  • Immediately discontinue use of any ozone-based cleaning system. Go back to basic cleaning with soap and water.
  • Do not use or keep your equipment in a hot, humid environment

If you are still uncomfortable using your PAP machine here are some Alternative Treatment Options to consider:

  • Alternative Treatment Option: If you have mild to moderate sleep apnea you may be a candidate for the oral appliance. Visit our OA webpage at https://comprehensivesleepcare.com/our-services/cpap-alternative-oral-appliance-therapy-for-sleep-apnea/  for more information, email us at [email protected] or call the OA Department at 703-729-3420 extension 509. If we do not answer, please leave your full name and date of birth. We are experiencing a high call volume but will get back to you as soon as we can.
  • If there is a strong positional component to your apnea, specifically the majority occurring while you sleep on your back, then use of a body positioning device to maintain a side sleep position may be an alternative.
  • If you own a travel device, other than the Philips Respironics Dream Station Go that is included in this recall, then you may try switching to your travel device for nightly usage until you receive your replacement.

If you have additional questions, please recheck our website for the most current information that we have. We will be updating it frequently as we learn more. You may also email us at [email protected] with specific questions. Please be understanding as there are thousands of patients in our practice on PAP devices and similarly affected. We can manage your questions best by email.

Sincerely,

Comprehensive Sleep Care Center Medical

Updated 5/17/22