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

[Ratchick]

First thing I noticed that their web site was infected with java script. I had to use chrome incognito to register as my ad blocker  did not like their site. I have to wonder if this is intentional to stop as many people as they can from registering as it sure looks like it.

I'm not sure if you're intentionally describing it this way, but I just wanted to clarify that javascript isn't a virus, it's a programming "language" that is neither good nor bad. It can be used maliciously, but lots of legitimate websites used javascript for very valid reasons. I, too, run an adblocker (among other things) and monitor for malicious javascript, but I just wanted to clarify that (as someone who has built websites and server-side apps).

Just to be sure, I hopped on over to the page to register a recalled device and checked out under the bonnet. As far as I can see, the only javascript involved is to do with making the page work correctly. It also worked for me with and without my Adblocking extension, but I guess it depends if your ad blocker disables all JS by default.

[btreger]

ISO

INTERNATIONAL STANDARD FOR MEDICAL DEVICE TESTING UPDATED

Patient safety is a key focus in the update of ISO 14155, the industry reference for good practice in clinical trials.

Clinical investigation of medical devices is naturally highly regulated, with numerous national and regional rules and requirements that must be adhered to by manufacturers and investigators, as well as other parties involved in clinical trials.

https://www.iso.org/news/ref2535.html

[ST Dog]

ISO

INTERNATIONAL STANDARD FOR MEDICAL DEVICE TESTING UPDATED

Patient safety is a key focus in the update of ISO 14155, the industry reference for good practice in clinical trials.

Clinical investigation of medical devices is naturally highly regulated, with numerous national and regional rules and requirements that must be adhered to by manufacturers and investigators, as well as other parties involved in clinical trials.

https://www.iso.org/news/ref2535.html

So they updated the testing standard last year.

I assume it's like other updates and previously approved devices don't have to meet the new standard. 

That blurb says nothing meaningful about what changed let alone why. And it's not a free standard. Have to pay for a copy to even see a changelog.

[Moriarty]

That blurb says nothing meaningful about what changed let alone why. And it's not a free standard. Have to pay for a copy to even see a changelog.

There is a bit more at https://www.iso.org/obp/ui/#iso:std:iso:...ed-3:v1:en 

I don’t think it actually informs the questions around technically testing the equipment and it’s components on a bench…

It seems to be more about safely and ethically conducting therapeutic value tests involving live patients.

[btreger]

Philips Respironics 

Has stated that its new round of testing is using the new ISO 18562 guidance, VOC toxicological risk assessments were performed by certified testing laboratories and a qualified third-party expert based on the initial and new VOC testing performed to date. Philips Respironics has made this data available to the FDA and other competent authorities and is in the process of sharing this data with healthcare providers and patients.

https://www.yahoo.com/now/philips-provid...00075.html


ISO 18562-1:2017

Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process

 Scope

This document specifies:
— the general principles governing the biological evaluation within a risk management process of the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments;
— the general categorization of gas pathways based on the nature and duration of their contact with the gas stream;
— the evaluation of existing relevant data from all sources;
— the identification of gaps in the available data set on the basis of a risk analysis;
— the identification of additional data sets necessary to analyze the biological safety of the gas pathway;
— the assessment of the biological safety of the gas pathway.

https://www.iso.org/obp/ui#iso:std:iso:1...ed-1:v1:en

[WakeUpTime]

My issue isn't necessarily with the quality of lab testing, but with Philips' sweeping broad conclusions based on the specific controlled-environment simulated results.  For example, for Philips to conclude that "Test results prove that Philips ventilators pose no significant risk" is a gross overstatement, in my opinion.  Recalled Philips defective faulty-foam ventilators may indeed pose a significant risk to someone who has additional health conditions who's been using several different Philips ventilators over the past 20 years.

What's the longer-term (or short-term) health impact on someone with pre-existing lung, kidney or other illnesses who has inhaled/ingested a portion of the Philips faulty foam?  Philips, or the Philips testing lab, can't predict that.  I'd go even further to suggest that the current lab results can't effectively predict long-term results on healthy individuals who have inhaled/ingested Philips faulty foam.

[hegel]

My issue isn't necessarily with the quality of lab testing, but with Philips' sweeping broad conclusions based on the specific controlled-environment simulated results.  For example, for Philips to conclude that "Test results prove that Philips ventilators pose no significant risk" is a gross overstatement, in my opinion.  Recalled Philips defective faulty-foam ventilators may indeed pose a significant risk to someone who has additional health conditions who's been using several different Philips ventilators over the past 20 years.

And you know all of this...how? "In my opinion". Frankly you're also making sweeping generalizations based on speculation. But I agree that common sense suggests that the foam should never have been used, at least once it's propensity to break down became apparent. Way back at the start of this thread I think I recall reading that the foam had passed spec. In other words PR assumed that it was safe. I imagine that they were relying on the word of the foam's manufacturer. But I may be mis-recalling all of this.

[btreger]

Regarding my post # 1855

Philips published statement only covers VOCs:

Volatile organic compounds (VOCs) are emitted as gases from certain solids or liquids.

There has been no new reported testing done on the original foam.

To date, the FDA has made no comments regarding the results of the test Philips said they turned over for review.

[Fletch]

I'm not sure if you're intentionally describing it this way, but I just wanted to clarify that javascript isn't a virus, it's a programming "language" that is neither good nor bad. It can be used maliciously, but lots of legitimate websites used javascript for very valid reasons. I, too, run an adblocker (among other things) and monitor for malicious javascript, but I just wanted to clarify that (as someone who has built websites and server-side apps).

Just to be sure, I hopped on over to the page to register a recalled device and checked out under the bonnet. As far as I can see, the only javascript involved is to do with making the page work correctly. It also worked for me with and without my Adblocking extension, but I guess it depends if your ad blocker disables all JS by default.

Sorry I disagree. JavaScript is a big part of what is wrong with the web today and yes it is a virus the way it is often used/abused.- . I could not even register on that site without going incognito (disabling my ad blocker). There is zero excuse for them to use JavaScript on a registration site for a safety recall without some hidden motive. I don't think JavaScript was invented for ill intent but that is what it is often use for today. The internet worked just fine without it and that is coming from someone that has been on the net in one form or another since the late 80's.

[Crimson Nape]

Please keep this thread on topic. Any further JavaScript discussion should be in its own thread in the Off Topic Forum.