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.

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, at this time, Philips does not have a timeline for the recall.  Please register your machine at Philips website  https://www.usa.philips.com/healthcare/e/sleep/communications/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.

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 PhilipsRecall@LMGDoctors.com 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: “Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks.”

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
  • Philips is recommending the use of an in-line bacterial filter if you opt to continue to use your device. This will filter out particulate matter but will not filter gasses. We have ordered a supply of these to have some on hand for purchase, but you can also obtain these online.  Please note the filters cannot be used in conjunction with heated coil tubing.

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 for more information, email us at CSCCOA@LMGDoctors.com or call the OA Department at 703-729-3420 extension 523 or 535. 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 PhilipsRecall@lmgdoctors.com 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 7/1/21