NKTI asks FDA to verify finding that fluids caused dialysis chills | Inquirer News
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NKTI asks FDA to verify finding that fluids caused dialysis chills

/ 06:11 PM June 09, 2014

MANILA, Philippines — With the partial opening of the National Kidney and Transplant Institute (NKTI) Hemodialysis Center on Monday, the NKTI also announced that they have sought the help of the Food and Drug Administration (FDA) in verifying their finding that the fluids used in dialysis caused the chills experienced by 44 patients during the last week of May.

NKTI’s hemodialysis unit, which closed early June due to patients experiencing chills, was reopened on Monday with 20 out of the 31 machines operated and used again by some 40 patients who showed up for treatment at the transplant center in Quezon City.

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Dr. Ricardo Jose Quintos II, head of the NKTI Information Office, told the media during a press conference at the Department of Health office in Manila that after investigating and replacing all the machines at the dialysis center, NKTI finally ruled that it was safe to resume operations.

The Hemodialysis Center shut down operations on June 30 after 44 out of the more than 800 dialysis patients of NKTI experienced chills while undergoing treatment. Quintos noted that they had to close the hemodialysis unit because of the increasing number of patients experiencing chills.

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“We voluntarily closed it to contain the number of cases and to avoid other patients from suffering from the same,” he added.

But he noted that with the shutdown of operations in the Hemodialysis Center, the NKTI made sure that the patients were able to continue treatment at other dialysis centers.

“All of the 44 patients were properly monitored and all of them are doing well now, with some even sent home after some tests and monitoring,” Quintos said.

As for the cause of the chills in the affected patients, Quintos said they have already arrived at results after investigating the incident for more than a week. But the head of the NKTI Information Office said they could not divulge their findings yet as they have tapped the FDA to verify the results.

He reiterated that no damage was found in the dialysis machines as the contamination tests run on the filters, pipes and lines yielded negative results. The water source and dialyzer were also clean, he added.

Despite withholding the investigation results, Quintos hinted  that the FDA has been verifying if the two brands of fluid solutions used in the dialysis procedure was indeed the cause of the chills experienced by the patients.

He, however, refused to reveal more details saying that the FDA would release the results hopefully within the week.

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The NKTI Information Office head explained that they have been using eight brands of fluid solutions for dialysis and that they have been planning to have the other six brands checked upon the recommendation by the FDA.

According to Dr. Jose Dante Dator, NKTI executive director, the Hemodialysis Center will resume full operations, after the FDA release the verified and final results

He also noted that during Monday’s partial operations, there were no reports of chills among the patients who underwent medication.

Dator added that the public should not worry that the situation would worsen because the cases have been contained. Neither are the cases contagious, according to Dator.

“For now, we have an alternative supply of fluid solutions used in dialysis treatments,” he added.

When asked who would be held liable for the problem, Dator said appropriate sanctions would be imposed after release of the FDA results.

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TAGS: chills, dialysis machines, Food and Drug Administration, Health, Health Service, Hemodialysis Center, Jose Dante Dator, National Kidney and Transplant Institute, NKTI, public hospitals, Ricardo Jose Quintos II
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