Special to CONTRACTOR
ARLINGTON, VA. — The International Association of Plumbing and Mechanical Officials is sorting out differences with the Association for the Advancement of Medical Instrumentation Renal Disease and Detoxification Committee over water supplies to kidney dialysis machines.
AAMI contends that IAPMO standards for backflow prevention equipment may pose a safety risk for dialysis patients. Part of the problem may hinge on how local code officials interpret the Uniform Plumbing Code.
In several localities, a plumbing code provision published in the 2000 UPC 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 in 2001 from facilities in several states where plumbing inspectors were coming into facilities wanting them to install backflow prevention devices on the back of each dialysis machine,” said Matthew Arduino of the Centers for Disease Control and Prevention.
The medical instrumentation group objected.
“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,” said Lee Fischbach, co-chair of the Renal Disease and Detoxification Committee.
Placing a backflow prevention device in the purified supply line of an individual hemodialysis machine could be hazardous to the patient, AAMI committee members said. AAMI 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. The committee wrote U.S. Food and Drug Administration officials requesting a determination on the issue.
Timothy Ulatowski, director of the FDA Center for Devices and Radiological Health 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.”
IAPMO has responded by asking the medical device group and the government to contribute to the writing of an appropriate standard.
“Anytime we receive comments of concern from an organization as highly respected as AAMI we take them seriously and give it our utmost attention,” explained Jay Peters, senior director of codes and education for IAPMO. “We invite their cooperation and input in our code development process and look forward to working with them to resolve their issues.”
Peters requested in a letter to Ulatowski that IAPMO receive all technical information that the FDA has on public health concerns with backflow preventers and dialysis.
“After receiving the information and supporting documentation, it will be presented to the IAPMO Answers and Analysis Committee for their review and analysis,” he said.
Peters also noted that the code does not specifically assert that a backflow prevention device is required at every unit, and that local authorities might have amended the UPC in some cases.
Another option that was offered was possibly issuing a tentative interim amendment, or TIA. This enables the proponent of a code change to try to prove that an emergency correction needs to be addressed. It is then considered by the IAPMO Technical Committee, voted on and, if approved, added as an amendment to the 2003 edition of the code.
AAMI President Michael Miller wrote to IAPMO that the FDA has the legal authority to pre-empt “inconsistent plumbing code requirements.” He added that his group believes that “it is in everyone’s interest to work cooperatively to repeal (or prevent passage of) plumbing code provisions requiring backflow prevention devices in individual hemodialysis machines and prohibiting PEX tubing in water purification systems for hemodialysis.”
Fischbach added, “If IAPMO finds concerns with the design of a water system used for hemodialysis, the issue should be brought before organizations such as AAMI, FDA, CDC or other standards organizations that deal with water treatment systems before regulations or rules are put into place.”
Peters noted that IAPMO looks forward to AAMI becoming proactive in the development of the UPC and Uniform Mechanical Code in the future.