The Association for the Advancement of Medical Instrumentation (AAMI) has adopted the FDA-recognized ANSI/AAMI/IEC 60601-2-16—which replaces the AAMI standard RD5. The standard is for dialysis machine manufacturers, and requires them to perform a risk analysis in addition to safety type testing.
In a risk analysis, the manufacturer must identify what could go wrong with the machine, as opposed to type testing, when the manufacturer has a defined risk and must verify that the equipment has a safety system to avoid the risk.
“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.
“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.