EBME Forums Forums Maintenance Technical Assistance PB 840 Exp. Filter Autoclave standards.

Hi all
We are having a problem getting Puritan Bennett (Covidien) to grant assurances that the British standard HTM2010 methods of autoclaving are acceptable when autoclaving the Re/X800 expiratory filter.
Our CSSD dept have been autoclaving these filters for 10 years without any problems however we recently purchased 11 new vents (pandemnic) and the filters (along with autoclave instructions) were delivered to CSSD who having read the instructions noted that they differ from UK standards and therefore will not process these new filters until the Manf./ Supplier gives assurances that HTM2010 is ok.
This has posponed our getting these ventilators into service.
CSSD encounter this issue with most equipment but usually companies resolve the issue quickly by giving written assurance that their products are compatiable with British standards, after all these products are marketed here.
It is obvious to me that we are not the only Trust in the UK who use these filters and therefore it is a big issue that most must not be aware of.
Has anyone managed to resolve similar issues or does anyone have any suggestions where the company have failed to deliver this assurance?
Topper

Any suggestions? Yes, send the vents back!

How is the "pandemic" coming along these days, by the way?

Also, I can't help but wonder if your CSSD staff read instructions quite so keenly ten years ago!

Dare I ask. Did anybody get a PPQ before they were purchased. There ia a whole section with questions on decontamination. If you have one, remember it's a legally binding document.

It's encouraging to note that I'm not the only one thinking along those lines, Graham.

I hope (but I must admit, suspect otherwise ... and would be more than pleased to be proved wrong) this wasn't yet another case of "short-cuts" being taken, using the "pandemic" as the er, excuse (what other word can I use - reason, perhaps).

I also can't help but wonder what form these "written assurances" take (that is, what do they say), and what value they actually are. In practical terms, that is. Surely the "bottom line" is that the filters need to be autoclaved. So, do the manufacturer's instructions differ (at all) from what normally takes place in the CSSD? And, if they do (and the recommended technique is valid - and why wouldn't it be), why not adjust the CSSD procedures accordingly?

What matters most here ... getting the ventilators into service, or "following the rules" (or whatever else it is causing the hold-up)?

But on a positive note, let's hope that it all ends up being sorted out ... and soon!

Hi Topper have you resolved this issue? we solved our Expiratory Filter problem by going over to Diposable Filters. This might not be the answer you were looking for but would get your Machines up and running. Our issue with the reusable was leakage.

Hi John
Unfortunately, Covidien have gave us an inadequate response. . Having waited weeks for the required assurance, the official reply was a regurgitation of the U.S. standards with the comment "my take is that the methods of Autoclave used in HTM2010 should be okay". This was stated by a salesperson! In a nutshell, Covidien will not endorse UK Sterilization standards for these products they are selling in the UK!
We have a consignment of disposables here already just in case.
We have never had a problem with Reuseables leaking. Were they mounted in the ventilator correctly before pushing the lock down? Were they possibly used past their 100 autoclave cyles limit maybe?
As of yet, our 11 new Vents are yet to be released into service pending the filter issue.

Don't worry, the "pandemic" will be over by the time they're in service.

No Topper the Filters were installed correctly but were found to be cracking or the glue giving up where the top is stuck to the main filter body. Also had some issues with the cup section cracking, add to this the occasional gasket between the two.Although expensive the users appear to be happier with the Disposable type at least no failed SST's due to leaks.

Hi all
I am trying to gauge how many NHS hospitals make use of the Re/X800 reuseable expiratory filter for the PB 840 Ventilator.
Additionally how is your CSSD (Sterile Services) department getting around the fact that Covidien will not endorse the autoclaving standards used in all NHS hospitals, for these devices. Is it a case that your CSSD departments are not aware / ignorant of this fact? Does anyone have any written agreement, document or PPQ (no matter how old) from Covidien / Tyco / Nellcor / PB that these filters are compatiable with Autoclaving standards HTM2010? This hopefully would appease our CSSD dept.
Any information would be greatly appreciated.
Topper