Dialysis industry news

Stories from the dialysis comunity across the globe.



Study to Improve Bloodstream Infection Detection - Renal Business Today PDF Print

NASHVILLE, Tenn.—Dialysis Clinic, Inc., (DCI) is partnering with local nephrology practice groups, the Tennessee Department of Health (TDOH) and the Centers for Disease Control and Prevention (CDC) to improve detection of bloodstream infections in hemodialysis patients.

The study, which started in March 2011, aims to compare data in the local nephrology practice office and DCI medical information system to infections identified through intensive public health surveillance of hemodialysis patients conducted by the Tennessee Department of Health.

This study will help determine how well dialysis facilities are identifying bloodstream infections in their patients, including infections that are diagnosed outside of the dialysis facility, in places like hospitals and urgent care centers.

Infection is a leading cause of sickness and is second only to cardiovascular disease as the leading cause of death for hemodialysis patients.

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Ill Nigerian woman could die if she is deported from UK, doctors warn - The Guardian PDF Print

Doctors have warned that a woman who is facing deportation to Nigeria could die within a month if the Home Office goes ahead with plans to remove her from the UK, where her life expectancy is good.

Roseline Akhalu, 48, a Nigerian university graduate, came to the UK in 2004 on a Ford Foundation scholarship to do a masters degree in development studies at Leeds University.

Soon after arriving she was diagnosed with renal failure and began treatment the following year. In 2009 she had a successful kidney transplant but needs regular hospital check-ups and immunosuppressant drugs for the rest of her life.

The Home Office tried to remove her last month but her solicitor, Hani Zubeidi, launched judicial review proceedings, which are ongoing. The removal was halted pending the outcome of the legal action. She is currently detained in Yarl's Wood immigration removal centre in Bedfordshire.

Reliance, the UK Border Agency subcontractor, has launched an investigation into the way Akhalu was treated en route to Yarl's Wood. She claims that she was refused permission to use the toilet despite her medical condition and despite the presence of a medic alongside the escorts in the van. Zubeidi has requested CCTV from the van but has not yet received it.

"If the Home Office send me back to Nigeria there is definitely no way I can survive," said Akhalu. "I'm a widow, with no children. I have very few family members and even if treatment was available in Nigeria I would have no means to pay for it.

"One part of your country – the NHS – gave me my life back. But now another part – the Home Office – wants to take my life away. I'm feeling very low and know that I'm approaching my death bed if they send me back."

Akhalu is a prominent member of St Augustine's Catholic church in Harehills, Leeds. She has the backing of both the Catholic and Anglican bishops of Leeds, as well as the city's lord mayor, the Rev Alan Taylor, and her MP, Greg Mulholland.

Mulholland and the bishop of Leeds, the Right Rev John R Packer, have written to the immigration minister Damian Green urging him to intervene in Akhlau's case.

Her doctors have tried to make contact with renal specialists in Nigeria to ask what treatment would be available for Akhalu but according to Zubeidi they have received no response.

"Roseline's consultants at St James's hospital in Leeds have warned that if she is sent back to Nigeria where she cannot get appropriate treatment she could lose her renal transplant within one month, leading to premature death," said Zubeidi. "They say that if her transplant fails she will die."

Akhalu said the way she was treated by Reliance escorts after her arrest was "humiliating and degrading".

"Because of my medical condition I am not supposed to delay urinating. The Reliance escorts who were taking me to Yarl's Wood stopped in Manchester. I begged them to take me to the toilet when we stopped but they refused. Instead I was given a small plastic bag and told to urinate in that in the van instead."

A UKBA spokesperson said: "We do not routinely comment on individual cases. The UK Border Agency expects the highest standards of integrity and professionalism from contractors and will take action if these expectations are not met. As the escort agency is investigating this matter we cannot comment further."

In 2008, Ghanaian Ana Sumani, who had cancer, died after being forcibly removed to her home country by the Home Office. The medical journal the Lancet said of the case: "The UK has committed atrocious barbarism."

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Renal Denervation Outcomes for Resistant Hypertension Persist at 3 Years - Family Practice News Digital Network PDF Print
Family Practice News Digital Network
CHICAGO – Selective renal denervation for the treatment of resistant hypertension continues to rack up impressively large and durable blood pressure reductions and a solid safety profile 3 years post-procedure, according to the latest update from the

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High blood pressure, diabetes are primary risk factors in chronic kidney disease - The Mercury PDF Print
The Mercury
Dr. Zia Umruddin is a member of the active medical staff, department of Internal Medicine – Nephrology, at Pottstown Memorial Medical Center. Dr. Umruddin is a graduate of the JJM Medical College, Davangere, India. An internal medicine residency was

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FDA announces plans to pilot end-stage kidney disease technology in new program - FDA.gov PDF Print
FDA NEWS RELEASEFor Immediate Release: April 9, 2012
Media Inquiries: Erica Jefferson, 301-796-4988,
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Consumer Inquiries:888-INFO-FDA

FDA announces plans to pilot end-stage kidney disease technology in new program
Innovation Pathway aims to reduce time and cost of bringing safe and effective, breakthrough technologies to patients

Three products for patients with end stage renal disease (ESRD) have been chosen to participate in the FDA’s Innovation Pathway, an evolving system designed to help medical devices reach patients in a safe, timely and collaborative manner.

The FDA selected three from 32 product applications ranging from an artificial kidney to devices that assist kidney function that were submitted in response to a January 2012 request from FDA’s device center.

The three products are:

  • An implantable Renal Assist Device (iRAD) being developed by the University of California, San Francisco.
  • A Wearable Artificial Kidney (WAK) in development by Blood Purification Technologies Inc. of Beverly Hills, Calif.
  • A Hemoaccess Valve System (HVS) that has been designed by Greenville, S.C.-based CreatiVasc Medical.

The majority of the 32 applications came from small, start-up business or academic institutions. 

 “The response from innovators exceeded our expectations and demonstrates that there is a desire from developers of innovative technologies for earlier and more collaborative agency interaction,” said Jeffrey Shuren, M.D., director of the Center for Devices and Radiological Health (CDRH).

The ESRD products will be the focus of the second version of the Innovation Pathway, first announced in 2011, to shorten the time and cost it takes for the development, assessment and review of medical devices, in particular breakthrough medical devices.

ESRD is the progressive loss in kidney function over a period of months or years. The kidneys play an essential role, filtering and removing waste from the body and producing hormones that are responsible for calcium absorption and red blood cell production.

The FDA chose ESRD because more than half a million Americans suffer from the disease. Management of the disease is largely dependent upon medical device technology, such as hemodialysis (process for removing waste products) equipment. Most dialysis patients spend long hours in specialized outpatient clinics, impacting their quality of life and reducing productivity. Medicare alone covers some 75 percent of ESRD health care costs, which in 2009 topped $29 billion.

 “We found ESRD a natural fit given that patients have few options. We think this process could impact the lives of patients by providing access to innovative new technologies they so desperately need. In turn, this could also have a positive impact on health care, encouraging innovation through smarter regulation that could potentially save companies time and money,” said Shuren.

Developers who participate in what FDA now calls Innovation Pathway 2.0 have an opportunity to collaboratively discuss their technology with FDA, work with the agency on the development of a benefit-risk profile for their product that will help guide future studies and map out a regulatory path forward for their product.

This approach is intended to deepen collaboration between FDA and innovators early in the process, prior to pre-market submission, with the goal of making the regulatory and product development process more efficient and timely.
CDRH constructed the Innovation Pathway with help from the Entrepreneurs in Residence (EIR) program, which brings together professionals with diverse talents from inside and outside government to work together as a team on solution-oriented outcomes in a short and focused time frame. These outside experts worked alongside agency staff and leadership to address impediments to efficient and timely review processes and construct Innovation Pathway 2.0.

For more information:

Innovation Pathway

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


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