HTM-RenalNET-UK

[Chris Pearson]

http://www.egypttoday.com/article.aspx?ArticleID=7175

"Further investigation into Haidylena’s dealings has allegedly unearthed a forged license submitted to the ministry validating the company’s claims that it owns a state-of-the-art production line for blood bags and dialyzers, sources claim."

Interestingly we were prevented from supplying their haemodialysis blood tubing sets into the UK via their EU subsidiary Allmed (http://www.allmedgrp.com/polyether.html) after a complaint to them by a large UK haemodialysis product supplier who's own label products were actually manufactured in Egypt by Haidylena.


Allmed product warnings:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=726071

HAIDYLENA "ALLMED" HAIDYLENA, ALLMED MEDIUM FLUX POLYSULFONE DIALYZER POLYSULFONE MEDIUM FLUX DIALYZER Back to Search Results
Model Number ALL LOW, MEDIUM AND
Event Date 04/28/2006
Event Type Death Patient Outcome Death; Life Threatening Disability Other
Event Description

One of the patients used hollow fiber dialyzer manufactured by company "allmed medical gmbh", where the label stated that the dialyzer was manufactured in germany. The dialyzer was polysulfone and it was completedly filled with water vapour and the label stated the dialyzer was steam sterilized. As soon as the patient connected to dialyzer, severe reaction and cramps occurred to the patient. Later the patient suffered from hemolysis and hypotension. Unfortunately the patient died during dialysis. Investigation to other not used dialyzer revealed that the dialyzer is not sterilized and there was a microbial growth inside the dialyzer. By review fda web site it was confirmed that the original manufacturer is "haidylena-egypt" the company which is famous with "sheating and killing patient around the world. " i wonder how bsi-ce 0086- and germany ministry of health approve to this company to state "manufactured in germany. ".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=726093

FDA Warning letter:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2005/ucm075517.htm
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"There is hardly anything in the world that someone cannot make a little worse and sell a little cheaper." John Ruskin

[Chris Pearson]

http://news.egypt.com/en/index.php?option=com_content&task=view&id=1304&Itemid=52
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"There is hardly anything in the world that someone cannot make a little worse and sell a little cheaper." John Ruskin

[Chris Pearson]

http://weekly.ahram.org.eg/2007/849/eg6.htm

MP Hani Sorour has been referred to Criminal Court after being accused of fraud and profiteering in supplying 300,000 blood transfusion bags last year which apparently did not comply with international standards.

On Tuesday, Sorour, who is also CEO of the Hayedelena Advanced Medical Industries Company (HAMIC), which produced the blood bags, was referred to the court by Prosecutor-General Abdel-Meguid Mahmoud.

Joining Sorour was his sister and partner Nivan Sorour, three HAMIC employees and two Health Ministry officials

Supreme Public Funds Prosecution Attorney Ali El-Hawari announced in a press conference that the defendants list includes Hayedelena factory manager Wafaa Abdel-Rehim El-Zorqani, production manager Ashraf Ishak, quality manager Fatheya Ahmed Abdel-Rehim, general manager of the Blood Department at the Ministry of Health Salaheddin Helmi and head of technical guidance of the Blood Department Mohamed Shokri.

According to the prosecutor-general's report, blood bags produced by HAMIC violated 14 provisions governing Egyptian and international standards. A forensic report proved that the bags may cause bacterial poisoning which may lead to death. Leakage in an anti- coagulant liquid inside the bags was another violation. The report said customs officials at Hayedelena had imported raw material for the bags prior to a tender, meaning the company had submitted to the Ministry of Health samples produced by other companies, then added its own sticker.
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"There is hardly anything in the world that someone cannot make a little worse and sell a little cheaper." John Ruskin