(07-07-2021, 11:40 PM)hegel Wrote: Packtheknife, you don't know that for sure.

Quote:Actions to be complete by 17 December 2021

Identify whether you have any of the affected devices in your organisation, or if you have provided them to patients under your care.

Send the FSNs to all relevant departments. Ensure clinicians read and follow the manufacturer’s FSNs for each device within 2 days.

Implement and document a risk assessment process to determine the suitability of the continued use of these devices within 1 month. Refer to additional information section below for more information. Clinicians should: a) Determine whether risk assessments should be based on individual patients or patient groups and b) Contact affected patients and have a risk–benefit conversation about continued use. Advise that they can register their devices on the manufacturer’s website.

Source alternative devices where clinically appropriate. Guidance will be available through NHS Supply Chain in England (or national procurement services for Devolved Administrations).

Train staff and patients, and verify competency, in using the alternative devices. Ensure training records are updated.

Quote:Biological safety risk assessment (based on the currently available data)

The available evidence suggests:

• Volatile organic chemicals of concern (Dimethyl Diazine and Phenol, 2,6-bis (1,1-dimethylethyl)-4-(1-methylpropyl) are not detectable 24 hours after the first ‘out of box’ use of the device.
  
• Levels of diethylene glycol detected were within an acceptable margin of safety.
  
• The degradation by-products Toluene Diamine and Toluene Diisocyanate are classified by IARC as Group 2B carcinogens. This category is used for chemicals where there is limited evidence of carcinogenicity in humans and less than sufficient evidence of carcinogenicity in experimental animals.
  
• Laboratory analysis found that as the foam degraded it tended to stick to nearby surfaces as well as itself. This reduces the risk of respirable particles entering the breathing circuit.
  
• Degradation of the polyurethane foam can be accelerated by off-label use of ozone decontamination or use in environments with high humidity and temperature, neither of which apply in the UK.
  
• Available evidence suggests that most degraded foam particles are too big to be inhaled.
  
• Diisocyanate is associated with isocyanate-induced asthma in a very small number of patients. For sensitised patients even low concentrations can cause adverse effects.
  

(07-08-2021, 01:58 PM)hegel Wrote: paradox, have you never heard tv commercials for drugs? They all list a ton of possible side effects, including death, at the end. They don't say "this drug will cause liver damage' because in the vast majority of cases it doesn't. But they're required to state the warning.

(07-08-2021, 03:36 PM)btreger Wrote: Earlier this week I mentioned that I found one DME in Europe that was selling Phillips now recalled products.
... Now there is a notice you get when you click on info regarding a Philips DreamStation. 

(07-08-2021, 01:08 PM)paradox551 Wrote: https://www.philips.com/c-dam/b2bhc/master/landing-pages/src/update/documents/philips-recall-letter-2021-05-a-2021-06-a.pdf

We all have the foam in our machines and the air goes through it. We're all getting exposed to this crap.

Quote:
[Philips Letter: URGENT Medical Device Recall Philips Respironics CPAP and Bi-Level PAP Devices ]

Permanent Corrective Action to be Taken by the Company: Philips is deploying a permanent corrective action to address the two (2) issues described in this Recall Notice. 

As part of the registration process above, you will be provided information on the next steps to implement the permanent solution.