Good afternoon everyone. Thank you for attending this session.
In this session we will explore the “Role and Evolution of AAMI/ANSI Standards for Dialysis Fluids.”
Objectives for the session are:
1) To identify AAMI/ANSI dialysis standards and how they have evolved over time, and 2) To recognize how AAMI/ANSI standards are used by CMS to audit dialysis clinic operations.
There will be a question and answer period at the end of the session. During that time period, please share any questions you may have.
Copyright RPC - Vern Taaffe, 2012, 2013
What exactly is AAMI and what do the letters A-A-M-I stand for?
AAMI - is the acronym for “The Association for the Advancement of Medical Instrumentation.”
It’s a nonprofit organization that was founded in 1967.
AAMI is a diverse community of nearly 7,000 healthcare technology professionals united by one important mission - supporting the healthcare community in the development, management, and use of safe and effective medical technology.
Copyright RPC - Vern Taaffe, 2012, 2013
AAMI is the primary resource for industry, the professions, and government for national and international standards.
The AAMI standards program consists of over 100 technical committees and working groups.
These committees and working groups product Standards, Recommended Practices and Technical Information Reports for medical devices, including dialysis devices and dialysis fluids.
The AAMI working group for dialysis is called the Renal Disease and Detoxification Committee. The RDD committee meets in the spring and fall of each year to update existing standards, and to produce new standards, recommended practices, and Technical Information Reports.
Copyright RPC - Vern Taaffe, 2012, 2013
...and what is ANSI?
ANSI, is the acronym for the “American National Standards Institute”. It is a federation that has served as coordinator and watchdog of the U.S. private sector voluntary standardization system for more than 90 years.
ANSI also accredits qualified organizations - whose standards development process meets all of ANSI’s requirements - to develop American National Standards. However, ANSI itself does not develop standards.
It’s important to note that, technically speaking, all AAMI/ANSI standards are voluntary guidelines.
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In general, a Standard contains recommendations to the medical device manufacturer. However, it may also be helpful to device purchasers or users to get an understanding of safe and effective device use and current technologies in a clinical environment.
A Recommended Practice is a set of guidelines mainly directed to the healthcare professional for the safe and effective use, care, and processing of a medical device.
Standards and recommended practices are subject to a formal process of committee approval, public review, and resolution of all comments. This process of consensus is supervised by the AAMI Standards Board and, in the case of American National Standards, by the American National Standards Institute.
A standard must be acted on—reaffirmed, revised, or withdrawn—and the action formally approved usually every five years, but at least every 10 years.
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An AAMI Recommended Practice that is accepted by ANSI becomes an ANSI/AAMI Standard.
All standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI are voluntary, and their application is solely within the discretion and professional judgment of the user of the document.
Often, voluntary technical documents are adopted by government regulatory agencies or procurement authorities, in which case the adopting agency is responsible for enforcement of its rules and regulations.
Copyright RPC - Vern Taaffe, 2012
A technical information report or TIR is an AAMI publication that addresses a particular aspect of medical technology. A dialysis related example is the recently released TIR on ultrapure dialysate.
Although the material presented in a TIR may need further evaluation by experts, releasing the information is valuable because the industry and the professions have an immediate need for it. A TIR differs from a standard or recommended practice.
A TIR is not subject to the same formal approval process as a standard.
However, dialysis related TIRs are produced by and approved for distribution by the AAMI Renal Disease and Detoxification Committee and the AAMI Standards Board.
For a dialysis related TIR, AAMI consults with its Renal Disease and Detoxification Committee about five years after the publication date for guidance on whether the information in the document is still relevant or of historical value. If the information is not useful, the TIR is removed from circulation.
Unlike a standard, a TIR permits the inclusion of differing viewpoints on technical issues.
Copyright RPC - Vern Taaffe, 2012, 2013
Ok. Now that we know AAMI produces guidelines and standards, why is it that we should have standards for hemodialysis fluids?
We need the standards because patients are at risk of injury from contaminants in water and in the final dialysate. Some of these contaminants include aluminum, chloramines, fluoride, and microbial impurities.
In addition, contaminants are associated with morbidities. Some of these morbidities include anemia, bone disease, dialysis dementia, clinical complications such as pyrogenic reactions, septicemia, and inflammatory state associated with loss of kidney function.
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Acknowledgement of these and other patient risks associated with dialysis fluids led to the development of the AAMI standards.
ANSI/AAMI RD5 for hemodialysis systems was the first dialysis standard. It was published in the United States in 1981 and was intended for dialysis equipment manufacturers. RD5 included dialysis machines, water treatment systems, concentrate and more.
Copyright RPC - Vern Taaffe, 2012
After multiple revisions for the purpose of updating RD5 over time, RD5 was ultimately revised to divide it into three separate standards.
In the year 2000, the hemodialysis concentrate part of RD5 was released as a separate standard identified as RD61. In 2001, the water and water treatment equipment part of RD5 was released as a separate standard identified as RD62…. and in 2003 RD5 was changed to address only hemodialysis equipment.
Copyright RPC - Vern Taaffe, 2012
This slide shows the first release of the RD62 water treatment document and the RD5 document after RD5 was divided into three separate standards.
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In addition to the separation of RD5 into three different standards, in 2002 – the RD47 standard for Reuse of Hemodialyzers was updated.
During the same time period, the AAMI Renal Disease and Detoxification Committee began work on a standard to address dialysate for hemodialysis. Because the final fluid the patients are treated with is dialysate not water, the RDD committee recognized that the quality standard for water alone was not enough to fully protect the patient.
The dialysate standard was identified as RD52 and it was released in 2004.
Copyright RPC - Vern Taaffe, 2012
This slide shows the 2002 update of the RD47 Reuse of Hemodialyzers document and the 2004 first release of the RD52 Dialysate for Hemodialysis standard.
Copyright RPC - Vern Taaffe, 2012
As stated earlier, AAMI standards are intended by AAMI to be voluntary.
The goal of the standards is to increase the safety and effectiveness of existing technologies and to support the development of new technologies.
The standards can provide device manufacturers with recommendations regarding basic safety and performance criteria and provide end users with guidelines for safe and effective device use.
Copyright RPC - Vern Taaffe, 2012
In the United States, outpatient hemodialysis is regulated by the Centers for Medicare and Medicaid Services.
In 2008, in their ESRD Condition for Coverage, CMS adopted by reference the entire ANSI/AAMI RD52:2004 and RD47:2002 standards, and sections of RD62:2001..
As a result, compliance with all of the recommendations and guidelines in the respective AAMI standards is no longer voluntary; it is mandatory.
For clarity, selected parts of these standards were incorporated, along with other CMS requirements, within the CMS “Interpretive Guidance” document used for ESRD surveyor training.
Copyright RPC - Vern Taaffe, 2012, 2013
This slide shows the CMS Interpretive Guidance document and the website address you can use to download it.
It’s likely that most of you already have this document.
If you do not have it, this slide is in your handouts…so there is no need to write down the website address.
AAMI related sections that are included by CMS in the Interpretive Guidance cover water treatment equipment, water quality, dialysate quality, reuse practices, and monitoring practices for ensuring proper equipment operation and fluid quailty.
Copyright RPC - Vern Taaffe, 2012, 2013
Inpatient hemodialysis usually falls under the authority of The Joint Commission…formerly known as the Joint Commission on Accreditation of Healthcare Organizations.
The Joint Commission does not regulate inpatient hemodialysis in the same way as CMS regulates outpatient dialysis; however, it does expect its accredited organizations to follow applicable industry guidelines such as those provided by AAMI standards and recommended practices.
Copyright RPC - Vern Taaffe, 2012
In 2009 and 2010, RD52, RD61, and RD62 - the AAMI standards that focus on hemodialysis fluids – and dialysis fluid standards from the International Organization for Standardization - all went through a major review. After these reviews and significant input from AAMI to ISO, AAMI adopted a set of five dialysis fluid standards developed by the ISO.
These new ISO standards now serve as replacements for the previous AAMI standards.
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This table and the tables on the next two slides provide a summary comparison of the AAMI adopted ISO standards and how they correlate with the previous AAMI standards.
Water quality was addressed in the prior AAMI RD62 standard and it is now being addressed in the new ISO 13959 standard.
Water treatment equipment was addressed in the prior AAMI RD62 standard and is now being addressed in the new ISO 26722 standard.
Production of concentrates was being addressed in the prior AAMI RD61 standard and it’s now being addressed in the new ISO 13958 standard.
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Dialysate preparation and quality was addressed in the prior AAMI RD52 standard and is now being addressed in the new ISO 11663 standard.
User guidance on compliance with fluid quality standards was also being addressed in the prior AAMI RD52 standard and it’s now being addressed in the new ISO 23500 standard.
Copyright RPC - Vern Taaffe, 2012
In addition to the five dialysis fluid standards just discussed, there are two other AAMI dialysis standards to consider. As mentioned earlier, RD5 evolved to cover only hemodialysis equipment.
Rather than an ISO standard, RD5 has now been replaced by the 60601 standard developed by the International Electrotechnical Commission…or IEC for short.
AAMI RD47 covers user guidance and recommendations for an optimal dialyzer reuse program. The RD47 standard is not replaced by any other standard and the latest revision to it was in 2008.
This year (2013), the AAMI RDD Committee will evaluate RD47 to determine if it needs to be revised or reaffirmed.
Copyright RPC - Vern Taaffe, 2012, 2013
How do the new AAMI/ISO standards differ from prior versions? Most of the content in the newly adopted ISO standards should be familiar to anyone who has worked with the previous AAMI standards.
There are, however, some important differences. In the new AAMI/ISO 13959 standard, the maximum allowable level of chemical contaminants in dialysis water is the same as in RD62:2006 except that free chlorine and chloramines have been combined into a single contaminant, total chlorine. The maximum allowable level of total chlorine is set at 0.1 ppm. This is the same value that RD62 listed for chloramines. In most dialysis facilities, total chlorine tests such as test strips are already being used to determine the level of chloramines in the pretreatment water. Therefore, this change in the new standard will have little or no impact.
The more important differences are primarily in relation to the microbiological quality of fluids. Let’s go to the next few slides to examine these differences.
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AAMI’s adoption of ISO 13959 reduces the allowable level of bacteria and endotoxin in dialysis water. The specification for bacteria is reduced from less than 200 CFU/mL to the new standard of less than 100 CFU/mL. Endotoxin is reduced from 2 EU/mL to the new standard of 0.25 EU/mL.
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In addition, AAMI’s adoption of ISO 11663 acknowledges three levels of dialysate microbial quality: standard, ultrapure, and on-line prepared substitution fluid. Standard quality dialysate is considered to be the minimum acceptable for clinical use.
To align the United States with other countries such as Europe and Japan, the ANSI/AAMI /ISO 23500 standard recommends the use of ultrapure dialysate for all treatments. Substitution fluid prepared on-line is intended for use in therapies such as hemofiltration and hemodiafiltration.
This slide shows that – in the new ISO standard - the allowable level of bacteria in dialysate has been reduced to less than 100 CFU/mL for standard dialysate and less than 0.1 CFU/mL for ultrapure dialysate. Substitution fluid is required to be sterile and non-pyrogenic.
Also, the allowable level of endotoxin in dialysate has been reduced to less than 0.5 EU/mL for standard dialysate and less than 0.03 EU/mL for ultrapure dialysate.
Copyright RPC - Vern Taaffe, 2012
As shown on this slide, the new standards also specify different media, incubation time, and incubation temperature for bacterial cultures.
When compared with the RD52 method, the new culturing conditions are thought to provide better recovery of bacteria from low nutrient fluids, such as dialysis water.
This might seem like it could make compliance with the new standard more demanding.
However, the difference in recovery is small and some labs have found no discernible difference. Facilities that routinely complied with the microbial provisions of RD62 and RD52, should have minimal difficulty complying with the new standard.
Because of the increase in incubation time from 2 days in the previous AAMI standards to 7 days in the new standard - and the effect it would have on implementing corrective action - AAMI RDD committee members had differing opinions on whether or not to accept this provision. By consensus, it was accepted based on the concept in the new AAMI/ISO 23500 standard that a facility’s quality management plan for fluid systems must be periodically re-validated for performance…and that approach will help define the requirements for a successful, systematic and proactive disinfection program.
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Does CMS require compliance with the new AAMI/ISO dialysis standards? The answer to that question is one of the most important elements of this presentation.
Dialysis clinical and technical managers have been asking that question from the day the new standards were released…… So what is the answer?
In short, the answer is no, not at this time. CMS will continue to enforce the existing Conditions for Coverage for the foreseeable future. Therefore, until CMS updates its regulations, compliance will continue to be tied to the RD52:2004, RD62:2001, and RD47:2002 AAMI standards The lag time between release of new AAMI standards and their probable adoption by CMS can be long. This interim time period offers dialysis providers an opportunity to implement procedures that enable compliance with more stringent quality standards.
The lag time between release of new AAMI standards and their probable adoption by CMS can be long. This interim time period offers dialysis providers an opportunity to implement procedures that enable compliance with more stringent quality standards.
Copyright RPC - Vern Taaffe, 2012, 2013
So, just when will CMS require compliance with the new standards? The current focus for CMS is a project called “CMS Quality Assurance Efficiency and Effectiveness Initiative” and at this point CMS has yet to commit to or state a time frame for incorporating the new standards.
The development process for the current regulations took more than 14 years.
It’s probable that an update to the current Conditions for Coverage would take somewhat less time; however, it is likely that it would be at least a year and perhaps two or more years before we see the change.
It is important to note that, in the interim, CMS does not discourage compliance with the more stringent new standards. Also, tag V181 in the Interpretive Guidance has the ultrapure dialysate requirements of RD52, which are the same as the ISO standards. While use of ultrapure dialysate is not currently a requirement, if a facility states that they are delivering ultrapure dialysate, surveyors could hold that facility to those standards
Copyright RPC - Vern Taaffe, 2012, 2013
Because of the historical reliance by CMS on AAMI standards as a function of the dialysis facility survey process, I thought it would be appropriate to share with you some information about the CMS Quality Assurance Efficiency and Effectiveness Initiative. The initiative is fluid and subject to change; therefore, CMS has asked that only general information be shared.
A new ESRD Core Survey is considered to be the first in a series of CMS Quality Assurance Efficiency and Effectiveness initiatives.
It utilizes survey resources most efficiently by focusing surveyors on those elements of dialysis care and technical operations that most impact patient safety and quality care.
It was developed, piloted, and refined in 2012, included consultation with the AAMI RDD Committee, and it’s being rolled out nationally during 2013.
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The new survey process will have an increased focus on ESRD survey findings which link to mortality, hospitalization and infections.
CMS goals for the initiative are to improve patient outcomes and the efficiency of the survey process. Objectives for meeting these goals include development of a more focused core survey process, a focus on surveyor education, and implementation of a change management strategy.
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This slide shows the AAMI RDD committee action items that are in process as of today.
The RDD committee has developed and is following up on the position that the five new AAMI/ISO dialysis fluid standards need to be revised to better harmonize - across all five documents - the requirements language and terminology.
In addition, several Technical Information Reports are under development. The TIR reports in process include: water testing methodologies, electrolytes in concentrate, sorbent based systems, and risk management…
And the committee has been in discussion on whether or not to lower the current maximum allowable residual level for ozone in dialysis water.
Copyright RPC - Vern Taaffe, 2012, 2013
Let’s conclude and summarize this presentation:
AAMI produces voluntary Standards, Recommended Practices, and TIRs for medical devices.
Prior versions of AAMI standards for dialysis fluids have been adopted by CMS as regulatory requirements
Current AAMI standards for dialysis fluids are now harmonized with ISO standards
Compliance with the new AAMI/ISO standards is not yet required by CMS, and
AAMI continues its unending work of updating existing standards, while developing new standards and TIRs
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In the last two years, Dr. Jo-Ann Maltais, Glenda Payne, and I - all members of the RDD committee - have contributed to the development and presentation of AAMI webinars designed to address AAMI dialysis standards.
AAMI has recorded these dialysis related webinars - and other webinars - on CDs.
To determine what webinar CDs are currently available, visit the webinar section of the AAMI website as shown in yellow at the bottom of this slide.
In May of 2012, Jo-Ann and Glenda developed and presented a webinar that specifically addresses the AAMI/ISO 11663 and 23500 standards. The CD for that webinar can be obtained by visiting the website as shown in yellow and white at the bottom of this slide.
Copyright RPC - Vern Taaffe, 2012, 2013
One last note:
AAMI is also working on a publication entitled “AAMI Dialysis Water and Dialysate Recommendations: A User Guide,”
This book is intended to help users understand the similarities and differences in RD:52, currently adopted by CMS, and the documents (23500, 11663, and 13959) adopted by AAMI as replacements. It will provide a cross walk from the familiar requirements to the new guidance and define changes in practice necessary to meet the new guidance.
The projected release date for the publication is sometime in the first half of this year (2013).
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Thank you very much for attending this session.
If you wish to download this presentation and other educational presentations, visit the technical support section of the RPC website at the address shown on this slide.
At this time, please feel free to ask any questions that you may have.
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