HTM-RenalNET-UK

[Chris Pearson]

Just the facts!
_________________
"There is hardly anything in the world that someone cannot make a little worse and sell a little cheaper." John Ruskin

[Joker]

Hi Chris
In your professional opinion do you think that reuse in the uk etc was stopped not because of clinical risk or cost, but on the possible risk to the staff involved in the cleaning /sterilising process etc with the involement of the chemicals used?

Regards
Joker

[Chris Pearson]

Joker,
I'm not sure what staff risks you're elluding to given the fact that the only chemical used was PAA which is in common useage for dialysis machine and ring main disinfection.

However,I do know exactly why it was stopped,the DOH ,through the MHRA (and CHAI) put pressure on our customers in the form of a Device Alert because they were using dialysers labelled up for single use on the Renatron.

DA2002(06)

We tried to argue the fact that this was irrelevant because CE marking isn't applicable to NHS customers unless they place the product back on the market but to no avail.

This was despite the fact that in nearly 8 years whilst I was involved we never had a single patient or staff incident reported either to the MHRA or ourselves whilst at the very same time scores of patients were killed in a very short period of time whilst using a Baxter single-use dialyser.

Story here

Device Alert on single use dialysers

NDT Editorial

At the time Gambro,Fresenius and Baxter were lobbying the DOH through the auspices of the ARI arguing that re-use was the cause of high mortality and morbidity and also claimed that their dialysers in the EU couldn't be used more than once so they couldn't be re-labelled for multiple use despite evidence presented that they were using a completely contrary argument in submissions to the FDA.

This recent submission (below) rather confirms what we were claiming in correspondance with the DOH at the time,ie.the dialysers were safe to re-use and only labelled "single-use" for marketing rather than scientific or medical reasons.

http://www.fda.gov/cdrh/pdf4/K043342.pdf


Mortality study

No difference in mortality risk was found between patients treated with reuse compared with single use in an intent-to-treat approach (hazard ratio, 0.98; 95% confidence interval, 0.94 to 1.02; P = 0.266) after adjusting for chain affiliation, for-profit status, year of dialysis inception, age, sex, race, renal diagnosis, comorbidity, and hospitalization days. Findings were similar in an as-treated approach (hazard ratio, 0.97; 95% confidence interval, 0.93 to 1.01; P = 0.136). No survival advantage associated with single use was found for subgroups. Conclusion: No overall survival advantage or disadvantage is associated with dialyzer reuse compared with single use in incident hemodialysis patients in the United States; however, continued monitoring is advised.

However,hopefully shortly, a new multiple use labelled dialyser will be available CE marked for sale in the UK,given that there is NO evidence whatsoever to support the previous argument's in relation to morbidity and mortality then surely the DOH must rethink its previous strategy given the enormous overspends in most Foundation Trusts and the financial savings and clinical benefits which could be realised by putting patients back on multiple use high flux dialysers.
Health Trusts facing bankruptcy


I hope that answers any questions you may have had?
_________________
"There is hardly anything in the world that someone cannot make a little worse and sell a little cheaper." John Ruskin

[Joker]

Hi Chris,
I see the points your getting at, I just couldn't understand why that was the intial reason as petty as it was at the time, I personally thought there must be some other reasons, as a senior renal tech I personally didn't see any problem with re-use.

regards
Joker

[Chris Pearson]

The effects of reprocessing on haemodialysis membranes
_________________
"There is hardly anything in the world that someone cannot make a little worse and sell a little cheaper." John Ruskin

[Guest]

Hi Chris/Joker
As a relitivley new tech (five years) I have no concept of the reuse of dialysers, I have never seen a unit that opporates this system and would be interested in learning about it, I think it is used more in America but to be honest its something thats never talked about or explored at work, it almost seems a dirty word!, I can only suppose the dialyser is cleaned and sterilised in some kind of washer/disinfector but as to its storage/use after that i'm at a loss.It does seem a terrible waste to throw away the dialyser if it can be used again and again especialy in our present national mission of recycling and cutting costs,
If you would be so kind as to point me in the right direction on the net or spare some of your own thoughts i would be very greatfull.

[Chris Pearson]

Hi Guest,
I was just about to post this as you popped up.
STOP spending
Am I the only one who feels that its amazing that whilst the NHS is in probably it's worst ever state in terms of funding,every day thousands of dialysers are being thrown away prematurely when there is absolutely no evidence whatsoever that re-using them has any negative clinical consequences.

At its height we had 18 units reprocessing dialysers and for nearly 7 years before the DOH intervened, we never had a single reported patient or staff Adverse Incident Report.
The last customer to give up following pressure from the DOH on the Chief Exec. was The Northern General in Sheffield who had some patients who only used 3 dialysers a year!
The average right across the board was probably about 12 uses which means that most patients were only using 12 dialysers a year.
On top of that the Trust is also making enormous savings by reducing the volume of its clinical waste.

How does it work,basically the new dialyser is pre-processed and logged into the database,it is then allocated to a patient and labelled with the patients name(and in some units a photo).
Once used it is immediately rinsed and pre-cleaned to remove any blood and clots and then stored in a peracetic acid sterilising solution until the next treatment when it is rinsed prior to use and the process starts again.
The whole process is very carefully controlled and recorded so that traceability is assured.
Hope this helps to give you a small insight into the background of re-processing.
_________________
"There is hardly anything in the world that someone cannot make a little worse and sell a little cheaper." John Ruskin

[Chris Pearson]

This is the FDA database for adverse incident reporting which is mandatory in the US.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM

It is very interesting to compare Non-Reuse dialyser reactions i.e. "1st use reactions" with Reuse reactions by punching in the relevant manufacturers in the search box.
_________________
"There is hardly anything in the world that someone cannot make a little worse and sell a little cheaper." John Ruskin

[Chris Pearson]

FOR IMMEDIATE RELEASE
February 2, 2006

Contact:
Lynne Snyder, Marketing Associate
B. Braun Medical, Inc.
Phone: 610-691-5400

Announcement – MAKY™ Dialyzer Reprocessing System

BETHLEHEM, PA - B. Braun Medical Inc. announces the addition of the MAKY Dialyzer Reprocessing System to their hemodialysis product line. The Renal Therapies Division of B. Braun in partnership with HDC Medical, Inc. will be a distributor for the MAKY dialyzer reprocessing system and ancillary reprocessing products including Peracidin™. The MAKY employs advanced technology and state-of-the-art electronics, resulting in greater efficiency for dialyzer reprocessing. The MAKY is a self-sufficient unit that does not require an ancillary computer or peripherals. MAKY features include multiple programming options, various report selections, and interactive on-screen menus. For more information, contact the Renal Therapies Division at 800-848-2066.

About B. Braun
Since its founding in 1839, B. Braun has built an unparalleled store of knowledge and expertise in delivering innovative healthcare products, medical devices and programs that enhance both patient and health-professional safety. Its 30,000 employees worldwide are proud of their commitment to translating customer needs into products with unmatched quality, superior technology, cost-effectiveness and environmental responsibility. Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. For more information about B. Braun or the renal therapy products, call 800-848-2066, or visit B. Braun at www.bbraunusa.com.

Contact:
Lynne Snyder, Marketing Associate
B. Braun Medical, Inc.
Renal Therapies Division
824 Twelfth Avenue
Bethlehem, PA 18018
Phone: 610-691-5400
Fax: 610-691-1547
_________________
"There is hardly anything in the world that someone cannot make a little worse and sell a little cheaper." John Ruskin