Plumbing codes put dialysis patients at risk
The Food and Drug Administration has put the nation's plumbing code body on notice that it will take action, if necessary, to address provisions in state and local plumbing codes that conflict with federal requirements for medical devices used to purify water for kidney dialysis...
ARLINGTON, VA, Oct. 14, 2004 (PRNewswire) -- The Food and Drug Administration has put the nation's plumbing code body on notice that it will take action, if necessary, to address provisions in state and local plumbing codes that conflict with federal requirements for medical devices used to purify water for kidney dialysis.
One provision in question -- related to backflow equipment -- poses significant safety risks for dialysis patients, according to members of the Association for the Advancement of Medical Instrumentation (AAMI) Renal Disease and Detoxification Committee, who wrote FDA officials requesting a determination on the issue.
"International Association of Plumbing and Mechanical Officials [IAPMO] should not have responsibility for the design of a water system for hemodialysis," explains Lee Fischbach, committee co-chair. "I believe that protection to the potable water source by IAPMO standards should end with a backflow prevention device placed at the inlet to the water systems pretreatment."
In several localities, a plumbing code provision published in 2000 has been interpreted to mandate the use of a backflow prevention device preceding each hemodialysis machine -- in addition to backflow devices routinely placed between potable water supplies and hemodialysis water purification systems.
"I began getting calls from facilities in several states in 2001 where plumbing inspectors were coming into facilities wanting them to install back flow prevention devices on the back of each dialysis machine," recalls Matthew Arduino of the Centers for Disease Control (CDC).
Placing a backflow prevention device in the purified supply line of an individual hemodialysis machine could be hazardous to the patient, AAMI committee members warned.
Members cited four risks: bacterial contamination in internal flow paths, chemical germicides trapped in internal flow paths, copper and zinc leaching from brass construction, and pressure reduction caused by the devices.
Timothy Ulatowski, director of FDA Center for Devices and Radiological Health (CDRH) Office of Compliance, confirmed that hemodialysis machines, water treatment systems, and distribution loops used in dialysis clinics are medical devices as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act.
In the past, FDA has "chosen to use enforcement discretion and not actively regulated the distribution loop," Ulatowski said. He added, however: "If the IAMPO proceeds with the requirement that backflow prevention devices be installed in the distribution loop, FDA would reconsider this decision since this would appear to increase the risk that these devices pose to dialysis patients."
In response, the IAPMO has suggested that interested parties submit a request for code amendment to the technical committee of industry experts responsible for developing standards applicable to dialysis facilities -- which the AAMI committee intends to do.
AAMI President Michael Miller has expressed reservations about the proposed solution, however, because the amendment process will "not provide immediate resolution of a major public safety issue." Miller has requested that IAPMO officials "suggest other avenues of resolution."
AAMI (www.aami.org) is a unique alliance of more than 6,000 members united by the common goal to increase the understanding and beneficial use of medical instrumentation.