[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS

[S. Manz]

Not sure about the UK but nothing that the incompetent Liberal government of Trudeau would say about my health, will make me feel more comfortable.
From their disastrous vaccine rollout to telling people to go ahead and continue to use a CPAP device that the manufacturers themselves say is "DANGEROUS" to use, the cartoonish government of Canada really doesn't know what they are doing.....which is why I moved south a long time ago and now I have to deal with the same ilk here...No peace for the wicked, I suppose:-)

[btreger]

After reading some posts over the past several days I thought it important to remind everyone of the rules of this forum:

"INFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED AS MEDICAL ADVICE. ALWAYS SEEK THE ADVICE OF A PHYSICIAN BEFORE SEEKING TREATMENT FOR MEDICAL CONDITIONS, INCLUDING SLEEP APNEA. INFORMATION POSTED ON THE APNEA BOARD WEBSITE AND FORUMS ARE PERSONAL OPINIONS ONLY AND NOT NECESSARILY A STATEMENT OF FACT"

 There are no points awarded for the number of posts you submit or for trying to prove you are right and another person is wrong. These past posts seem to me to be very childish and do nothing to add to the body of knowledge we have been able to assemble. 

The American College of Chest Physicians® (CHEST)  

In response to the voluntary recall announced by Philips on June 14, 2021, for certain Philips Respironics devices used to treat OSA, including CPAP, BPAP devices, and mechanical ventilators, the American College of Chest Physicians® (CHEST), along with the American Academy of Sleep Medicine (AASM), American Academy of Neurology (AAN), American Thoracic Society (ATS), Alliance of Sleep Apnea Partners (ASAP), and the American Sleep Apnea Association (ASAA), submitted the following request to the Centers for Medicare and Medicaid Services (CMS) and private insurance payers.

The societies are seeking support from CMS to temporarily suspend the 90-day adherence rule, to allow patients to have existing equipment repaired or receive new equipment from durable medical equipment (DME) suppliers. Additionally, they are seeking an exception to the 5-year reasonable useful lifetime (RUL) for L33718, which requires documentation of a new clinical evaluation, sleep test, or trial period before a device is replaced. Read the CMS statement in its entirety below.

“The recalled positive airway pressure (PAP) devices are subject to the CMS Local Coverage Determination (LCD) PAP Devices for the Treatment of Obstructive Sleep Apnea (L33718), which has specific requirements for continued coverage of a PAP device beyond the first 3 months of therapy. This requirement states that ‘no sooner than the 31st day but no later than the 91st day after starting therapy, the treating practitioner must conduct a clinical reevaluation and document that the beneficiary is benefiting from PAP therapy.’ Our society members are concerned that the Philips Respironics recall will disrupt treatment for patients with OSA, and many will not meet the CMS adherence requirements before their device can be fixed or replaced. Given that many patients will be affected by the recall, we are requesting support from CMS and private payers to temporarily suspend the 90-day adherence rule, to allow patients to have existing equipment repaired or receive new equipment from DME suppliers. Although Philips has not provided estimates of how many patients and products are affected by this recall, we anticipate significant delays in equipment repairs and replacements and want to ensure that patients, who are no longer able to use their device due to the recall, are not penalized or required to have a new sleep test performed."

“Additionally, L33718 includes requirements for replacing PAP equipment. The LCD states, ‘If a PAP device is replaced during the 5-year reasonable useful lifetime (RUL) because of loss, theft, or irreparable damage due to a specific incident, there is no requirement for a new clinical evaluation, sleep test, or trial period.’ Although these devices have not been lost, stolen, or damaged due to a specific incident, AASM, AAN, CHEST, ATS, ASAP, and ASAA urge CMS to allow for an exception to the RUL requirements for the equipment repairs or replacements that will result from the Philips recall. Our societies believe that it is both reasonable and necessary to allow DME suppliers to repair or replace the recalled equipment without requiring documentation of a new clinical evaluation, sleep test, or trial period, and do not think patients should be responsible for the repair or replacement costs."

In anticipation of significant delays in equipment repairs, the societies also reached out to private payers with a request to “temporarily suspend any time-specified adherence rules, to allow patients to have existing equipment repaired or receive new equipment from DME suppliers” and “allow for an exception to coverage requirements for only replacing PAP equipment after a certain number of years to account for the equipment repairs or replacements that will result from the Philips recall.”

[WakeUpTime]

The Philips recall notice is clear for people in my situation -- STOP USING the machine.  

That's certainly the advice of the manufacturer.  It's amazing how some governments (U.K., Canada) or government agencies are advising to continue, contrary to the advise of the manufacturer, possibly because (in their public system) they don't want the cost of 100,000 patients urgently booking doctors' appointments and the government needing to purchase (or subsidize) 100,000 replacement devices (which likely don't exist now on the open market at the moment).  None of those governments (or government agencies) have done their own real-life studies of the faulty foam in older recalled devices or devices regularly cleaned with SoClean.  

So, would I trust my country government or government agency, who neither wishes to urgently spend the medical cost of additional doctors' visits and replacement PAP device costs, for a replacement device that's now very difficult to acquire?  Not so much.  They want "their customers" to wait a year or more for their replacement foam.  It's very sad that there will be a significant number of people that will continue to use their faulty-foam machine, composed of proven cancer-causing chemicals, for a lengthy period of time.  

As the old expression goes:  "Be Careful Who You Take Advice From".
Ask yourself, "what's their motivation?" and "are they looking out for my best interests?".
If you should develop a significant illness several years from now, possibly related to the ingestion of cancer-causing faulty-foam particles, you may be looking back at your decision to wait-out receiving the "fix" from Philips.  At that time, the manufacturer will say, "don't blame us, we immediately and urgently told you not to".

[btreger]

Over the past several days there has been an exchange of posts concerning what Canadian officials have said or not said. I am not sure why this would be considered so important one way or the other. We are where we are and nothing posted here has changed that fact. With that being said I went back and found this:

Position Statement from the Canadian Thoracic Society, Canadian Sleep Society, and the Canadian Society of Respiratory Therapists Phillips Respironics Device Recall

CTS_CSS_CSRT-Phillips-Recall-Statement_final-07_09_2021.pdf (cts-sct.ca)

 

[WakeUpTime]

Re: < above >

As a discussion paper, that's a great document.  It was previously placed in the Wiki by Gideon.  It has good web-links at the end too.  It doesn't add any new information though from what's already known or advised.

It's a good read for everyone, though the essence of the original Philips directive stays the same - consult your doctor before changing therapy.  Those associations don't want people stopping therapy altogether until a "fix" is available from Philips.  They also acknowledge the shortages for replacement products within the industry that will be occurring.

[btreger]

Philips has another Class 1 recall to worry about:

Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to Risk of Receiving Reduced Oxygen

I know not our problem, but it does reflect on Philips and its health care products and safety concerns.

[btreger]

AASM guidance in response to Philips recall of PAP devices

Some takeaways from this article:

Regarding foam degradation, Philips indicated that foam particle sizes down to 2.69 microns had been observed. However, Philips stated that the majority of particulates were of size (more than 8 microns) that are unlikely to penetrate into the deep lung tissue. Philips concluded, “Based on the test data and information available to date, Philips believes that most degraded foam particulates are too big to be deeply inhaled.”

Philips also tested for chemical emissions by running new devices at a high temperature (i.e., 95 degrees Fahrenheit) for 7 days (i.e., 168 hours). Philips indicates that two compounds of concern were emitted during testing. Testing results to date suggest that the emission of one compound dissipates to below detectable levels after the initial 24 hours of use of a new device. Results also suggest the emission of the other compound tapers off during the initial days of use of a new device.

Philips has reported that the complaint rate in 2020 was low (0.03%). However, the company also has stated, “Philips acknowledges that the low complaint rate may not fully reflect the probability frequency or severity of the occurrence, because users may not detect the particulates and/or report the event to Philips.” 

You can read the complete article here. It contains many additional links.

AASM guidance in response to Philips recall of PAP devices

[SingingSam]

"Philips has another Class 1 recall to worry about"

Right, the ventilator recall isn't our problem.

But I wonder. Like our recall, this is a Class 1 recall. I assume you mean FDA Class 1.

Canadian authorities regard our FDA-Class-1 recall as a type II hazard classification. Meaning that Canada regards the problem as being either temporary in nature or as having a remote possibility of serious adverse health consequences.

It isn't helpful when government authorities aren't on the same page about the same recall.

The safest interpretation for us is the most conservative. Especially when PR, like the FDA, regard the problem as serious.

It is reasonably clear from available authoritative documentation that PE-PUR foam emits particles under the best of conditions. The majority of particles are individually invisible to the naked eye which at best can see a 40 micron particle. What these particles do in the respiratory tract will not remain a mystery to us forever. When we learn what PR and the FDA already know, we will agree with them.

[hegel]

"It is reasonably clear from available authoritative documentation that PE-PUR foam emits particles under the best of conditions."

actually that's not clear at all. Which documentation are you referring to? You just mentioned in the same post that the Canadian govt. sees little risk; and the complaint rate is miniscule.

the idea that all foam in everyone's machine is and has been emitting a continuous stream of invisible cancerous particles is exactly NOT what's been documented. that's a frightening picture. Which credible source does it come from?

[btreger]

Canadian authorities regard our FDA-Class-1 recall as a type II hazard classification. Meaning that Canada regards the problem as being either temporary in nature or as having a remote possibility of serious adverse health consequences.

Who cares, this is the real information provided by the FDA:
Due to the risk to the patients who rely on the ventilator to provide high flow oxygen therapy if the system pressure reaches the default maximum limit. This can occur if the oxygen flow is partially blocked for any reason. If the issue causing maximum system pressure is not resolved by the health care provider, the ventilator will continue to provide the patient with a lower oxygen flow rate and issue a low priority alarm. This could lead to serious adverse events, including death. 
 
There have been 61 incidents, 25 injuries, and no deaths reported for this issue.

Who May be Affected

• Health care providers using affected Respironics ventilators
  
  
• Patients who require care using affected Respironics ventilators
  

You can read the full article here:

Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to Risk of Receiving Reduced Oxygen | FDA