Additional Information
Kidney Health Australia, The Home Dialysis Advisory Committee and the NSW Renal Services
Network of the NSW Agency for Clinical Innovation (ACI) committee are all independently, but
consultatively acting to ensure that home dialysis, both home haemodialysis (HHD) and home
peritoneal dialysis (APD) are accessible and effective treatment options within Australia and NZ.
Kidney Health Australia (KHA) is the peak body for those in Australia with kidney disease. Their
mission related to home dialysis, is to remove any barriers that prevent all of those with kidney
failure having the opportunity for home dialysis. Kidney Health New Zealand has the same function
within New Zealand.
The Home Dialysis advisory committee (HDAC) is an official national (Australia and NZ) committee
comprising renal specialist doctors, renal nurses, allied health, and importantly consumer
representation. This committee reports to the Dialysis, Nephrology and Transplant committee. It
also actively pursues the removal of barriers to home dialysis, and has a strong education focus.
The NSW Agency for Clinical Innovation (ACI) committee has a high priority to develop flexible,
evidence-based patient-focused models of care. This includes determining any barriers to this care.
Goals and Objectives
The goal is to ensure that standard regulation is appropriate compared to the level of risk and the
functionality of the machines related to home dialysis therapies.
Net benefit of standard revision to the community
About Home Dialysis
Kidney failure requires treatment with either transplant or dialysis to prevent death. Home dialysis
was introduced in the 1960s with the aim of reducing the inconvenience of travelling to a hospital or
dialysis centre and increasing autonomy of patients. Home dialysis, either home haemodialysis
(HHD) or automated peritoneal dialysis (APD) are the only feasible option for people living in rural or
remote locations unless they wish to relocate closer to a satellite centre or renal unit. It is
imperative that home dialysis remains a viable option for dialysis. The current standard has
requirements that are a disincentive for home dialysis.
Peritoneal dialysis is a daily treatment. It involves intermittent filling and emptying of the peritoneal
cavity with fluid that can remove the wastes and fluids that build up during kidney failure.
Automated peritoneal dialysis uses overnight treatment, controlled by the dialysis machine.
Haemodialysis is the direct cleansing of the blood by a dialyser on a haemodialysis machine. It is
completed at minimum, three times a week for 4 hour treatments. This treatment can be done at a
specialised centre or within the home. Haemodialysis in the home can now use standard machines
or portable new technology.
30% of patients are trained and supported to manage their own dialysis at home. The average time
at home is 2-4years.
Automated Peritoneal Dialysis
Home Haemodialysis (standard)
Nxstage – new technology
Social and Community impact
Home Dialysis is the preferred choice of health professionals because the advantages include:
• ability for those on automated peritoneal dialysis and portable home haemodialysis to travel.
•
•
•
•
•
longer survival times
decreased risk of exposure to hospital infections
improved quality of life
enhanced opportunities for rehabilitation and return to employment
greater independence and flexibility to perform dialysis at a time that suits the individual with
CKD and their families/carers
• no time and cost issues associated with transport to dialysis
Public Health and Safety
Evidence suggests that the current standard may not be adhered to because of both financial factors
and staff time factors that would be required for the current standard of automated peritoneal
dialysis installation. If the standard is refined to an appropriate level there is commitment from
health departments to adhere to the standard.
Environmental impact
Standard haemodialysis regimes at a satellite centre involve travel to 3 appointments every week.
The average travel costs were estimated as $24 per week in 2009.
National results – metropolitan
National results – regional
National results – mean
100%
Proportion of respondents (%)
90%
80%
70%
60%
50%
40.0%
38.8% 37.4% 38.4%
40%
27.4%
30%
26.5%
23.7%
15.8%
20%
20.3%
13.4%
11.4%
6.8%
10%
0%
0–10
11–20
21–30
> 30
Round trip distance travelled to dialysis (km)
Economic Impact
Cost of Dialysis
International costing data for dialysis programs in high income countries generally arrive at the same
conclusion, that in-centre or hospital haemodialysis is the most expensive form of dialysis1. The
costs associated with dialysis treatment per person per year are:
•
•
•
•
$79,072
$65,315
$53,112
$49,137
Hospital
Satellite
Home – Peritoneal dialysis (PD)
Home – Haemodialysis (HHD)2
The savings to the commonwealth are from $12 000- $30 000 per annum per patient managing their
treatment at home rather than in a hospital or satellite
Additional to health department costs, those funded by the patients are one identified barrier to
home dialysis, and this includes machine installation, ongoing water and electricity costs and other
miscellaneous costs.
AS/NZS 3003 installation requirements are estimated to be between $800-$1200 per patient for
HHD, and would be similar per patient for PD. This may be paid by the patient or by the health
department depending on the jurisdiction of the patient. Therefore it is important to ensure the
cost is justified.
1
Kidney Health Australia, 2006, The Economic Impact of End-Stage Kidney Disease in Australia, p. 78.
2
Kidney Health Australia, 2010, The Economic Impact of End-Stage Kidney Disease in Australia, Projections to 2020, p. 27.
Need for the proposed work
Please identify and provide evidence of the problem to be addressed, the goals and objectives of the
proposed Standard(s), and demonstrate that it is justified and implementation is likely.
Machines affected by standard, section 5.2.1/2
There are two machine options for home dialysis: automated peritoneal dialysis and home
haemodialysis.
The machine suppliers for automated peritoneal dialysis include Fresenius Medical Care, and Baxter
Healthcare. Both are classified home care medical electrical equipment having Type B parts and are
therefore subject to AS/NZS:3003, section 5.2.1or2.
The current machine suppliers for home haemodialysis include Fresenius Medical Care and Gambro
Pty Ltd.
Nxstage is a new generation portable haemodialysis machine which indicates a requirement for
compliance with section 5.2.1 although the parts are classified Type BF. Both Fresenius Medical Care
and Baxter Healthcare are currently developing new portable home haemodialysis technologies,
which are anticipated to be on trial in Australia within 2 years.
AS/ANZ:3003 Evaluation related to Home Dialysis
Within the renal profession, KHA, the HDAC, the NSW renal ACI there is growing concern that the
mandatory requirements within this standard may be unnecessarily prohibitive to patients choosing
to go home. Therefore advice to confirm or refute this has been sought from experts in the industry,
both electrical experts, dialysis technicians and dialysis nurses, lawyers and the Ministry of Health in
NSW. It is of note that for HHD many of these standards have been partially implemented since
2003, but the same had not applied for APD, indeed no one was initially aware it even implicated
APD.
In depth analysis of the standard has occurred, particularly to seek the interpretation of the
rationale for the separate electrical circuit requirement 5.2.1(c) and 5.2.2.2(b). Electricians have
advised that these points intend to prevent power failure to the machine, caused by a power issue
elsewhere in the home. Expert home dialysis nurses, and Fresenius and Baxter clinical experts, have
agreed that this is not a safety essential for a number of reasons:
•
•
•
•
Both HHD and PD machines have battery back-up, which allows the patient adequate
time to disconnect themselves from the machine
all HHD and PD patients are taught how to disconnect if there was complete power
failure
the majority of patient dialyse accompanied at home
HHD and PD machines do not maintain life in the way that a ventilator or oxygen
therapy might and treatment can be safely delayed to the following day.
Additionally advice indicates that for those living in a unit, or an old property the installation of a
separate circuit may be cost-prohibitive or practically impossible to achieve. This will lead health
services to limit these treatment options to those whose properties can easily be adapted.
Importantly as a patient on APD, these therapies already has a high treatment burden and the
flexibility of using the machine in multiple places has always been one area of freedom.
In pursuing information about the development and the consultation process related to this
standard it appears the consulted renal industry expert was not aware of all implications of the
standard, and also did not consult widely for opinion about the standard. It has also become clear
that other key players in the development were not aware that the standard now implicated APD
machines. Additionally the new generation of HHD machines entering the market, currently Nxstage
are planned to be portable and were not known about during guideline development.
Current Industry practice
In 2003 AS/ANZ 3003 standard incorporated home haemodialysis machines, but was not classified as
mandatory. A number of dialysis units adopted this standard, but a number independently assessed
the risks and determined that they would only implement certain aspects of the standard.
AS/NZS 3003 became mandatory in 2011, and at this point the introduction of the standard for all
haemodialysis and automated peritoneal dialysis was identified. Industry confusion however and
indeed standard board confusion led to a delay in confirming that APD machines were now indeed
subject to the standard. During meetings it also became apparent that there are barriers to the full
implementation. It has been established that all home dialysis for both haemodialysis and
peritoneal dialysis machines are protected by an RCD or LPD device, and health departments will
continue this practice.
The measures that prevent patient electrocution are not in dispute and all experts consulted agreed
that many points are considered safe practice. Expert electricians and technicians have however
raised other concerns that may also require future clarification.
Current Standard proposal for change:
Priority 1: It is proposed that the current standard, section 5.2.2 be modified to allow simple
installation of automated peritoneal dialysis with a leakage protection device rather than a
dedicated circuit.
Priority 2: It is proposed that portable technology home haemodialysis machines are subject to the
regulations of other home care installations 5.2.2 rather than home haemodialysis 5.1.1.
Priority 3: It is proposed that ultimately home haemodialysis installations 5.2.1 be assessed and
updated to match modern dialysis technology and home-care practice to develop practical and
achievable installation standards that are financially appropriate and fit with dialysis industry
practice.
Appendix 1.
Copy of content of letter to machine providers. Baxter Healthcare and Fresenius medical care
both provided agreement to the pursuance of this matter.
Re: Electrical Installations – patient areas – AS/NZS 3003:2011
Kidney Health Australia, on behalf of the Home Dialysis Advisory Committee (HDAC) is preparing a
submission to the standards board related to the April 2011 standard: electrical installations –
patient areas. The intent is to request modification to the guideline in relation to the dedicated
circuit for APD.
Interpretation of this standard, section 5.2.1 regarding home haemodialysis determines the
requirements for dedicated circuits, the use of residual current devices, and the specific use and
marking of all sockets within three metres of the dialysis machine. As home haemodialysis was
regulated in AS/NZS 3003:2003 these recommendations appear to be standard practice in most
jurisdictions. The HDAC are accepting of this part of the standard is preparing documentation to
ensure all units are aware that this regulation is now mandatory rather than optional.
Guideline section 5.2.2 considers machines other than haemodialysis. This new section specifies the
machines, which by classification are subject to the regulations. The affected machines require
dedicated circuits and electricity modifications as above.
Rationale for the regulation is a key issue. It is acknowledged that the use of residual current devices
has an important role in the prevention of accidental electrocution, in the event of machine failure.
The rationale for the dedicated circuit has been interpreted by industry specialists as being to
prevent accidental power-loss to the machine, caused by electricity issues elsewhere on the
property. Whilst this is known to be a more difficult issue for HHD, because of the more complex
disconnection process, specialists and the HDAC agreed that it is an insignificant issue with an easy
solution for PD.
How the regulations pertain to the peritoneal dialysis machines is therefore issue the HDAC would
like the standards board to review. Whilst it is understood that consultation regarding the new
guideline occurred related to haemodialysis, it is thought that the consideration of the inclusion of
peritoneal dialysis was not assessed. The HDAC and KHA also recognise that if a PD installation
becomes prohibitive then this will impact on the uptake of home peritoneal dialysis.
Prior to a submission however KHA and the HDAC need to confirm the classification of the peritoneal
dialysis cyclers, used on the Australian market. It is understood that the Baxter Home-choice cycler
is rated as Class 1 (uses an earthed mains connection) and the patient circuit is Type B (non-floating).
If so this renders the machine subject to the classification. Please can Baxter Health-care confirm
the classification of the sleep-safe cycler.
KHA and the HDAC would appreciate any further comments relating to this standard and your
support, or not, regarding their intent to request alterations to the standard.
Please contact me for further clarification.
Warm regards