AAMI has adopted a 2008 international standard for dialysis equipment manufacturers that introduces a risk management component. ANSI/AAMI/IEC 60601-2-16 — which replaces the AAMI standard RD5 — is for dialysis machine manufacturers, and requires them to perform a risk analysis in addition to safety type testing. The standard has been recognized by the U.S. Food & Drug Administration (FDA).
“With a risk analysis, the manufacturer has to sit down and ask what could go wrong with the machine,” says Richard Ward, a professor of medicine at the University of Louisville in Louisville, KY, and the co-chair of AAMI’s Renal Disease and Detoxification Committee, which adopted the standard.
In type testing, the manufacturer has a defined risk and the machine must have a safety system to head off that risk. RD5 included certain tests the manufacturer had to perform to demonstrate the safety system worked, Ward says.
In a risk analysis, the manufacturer must identify what else could go wrong with the machine. In addition, the standard includes a number of references to risks that should be covered in a manufacturer’s risk management process.
“That is a little bit different than a type test because instead of having a defined list of risks and safety systems, it is now open-ended,” Ward says. The risk analysis is supposed to show if additional testing, mediation, or redesign of the device is needed, according to the standard.
“Risk analysis and risk management are important components of safe medical product development”, says Conor Curtin, senior vice president of research and development for Fresenius Medical Care NA, a dialysis machine manufacturer and provider based in eastern Massachusetts, and the other committee co-chair.
Curtin says that Fresenius already does risk analyses on its devices, so he doesn’t anticipate it will face any difficulty in complying with the standard. He adds that risk analysis was required under the 2005 edition of the electrical equipment standard IEC 60601-1. “It is a natural progression to incorporate this approach into the particular standard for dialysis machines,” Curtin says.

Saving Patients Through Better Dialysate
In an effort to improve patient safety, the AAMI Renal Disease and Detoxification Committee adopted another international standard for the users of dialysis machines that includes more stringent requirements for the quality of dialysate, the fluid used during dialysis.
The standard, ANSI/AAMI/ISO 11663, replaces the AAMI standard RD52. It sets a stricter limit on the levels of bacteria and endotoxins allowed in dialysate.
“There is a growing body of evidence that even low levels of bacterial contaminants result in a chronic inflammatory state within patients,” Ward says. He adds that this chronic inflammation is thought to contribute to some of the long-term complications associated with dialysis.
The allowable bacteria level in the new standard—which is 100 bacteria colony-forming units per milliliter — is half the allowable amount in RD52. The endotoxin level — 0.5 endotoxins per milliliter — is a quarter of RD52’s limit, Ward says.
The replacement of both RD5 and RD52 is part of a larger effort by the AAMI committee to replace AAMI standards with a comparable set of international standards, Ward says.
AAMI News: February 2011, Vol. 46, No. 2

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