The new infection control guideline standards were released: ‘AS 5369:2023 Reprocessing of reusable medical devices and other devices in health and non-health related facilities’. Here’s what it means for podiatrists
In December 2023, the new standard (AS 5369) was released. This standard has superseded, and is a merger, of previous reprocessing standards AS/NZS 4815 and AS/NZS 4187.
The NHMRC guidelines for the Prevention and Control of Infection in Healthcare were updated to reflect reference to the AS 5369 standard in February 2024.
Whilst at this current point in time, this new standard hasn’t been accepted into legislation, there is direction from governing bodies, regulatory bodies, codes of practice and standards that require clinics be implementing AS 5369.
AS 5369 specifies the requirements for reprocessing, storing, handling and transporting reprocessable medical devices and other devices in human healthcare settings. Implementation of this new standard is required by all healthcare settings (and non-healthcare settings) where reprocessable medical devices (and other devices) are in use.
Note that there are additional infection control requirements not covered in this article (such as hand hygiene).
The Podiatry Board of Australia provides regulatory guidance, with this pre-existing two page document available online.
This document notes:
“The Board adopts the National Health and Medical Research Council Australian guidelines for the prevention and control of infection in healthcare (NHMRC) guidelines as amended from time to time. The NHMRC guidelines were developed using the best available evidence at the time they were written and they aim to promote and facilitate the overall goal of infection prevention and control.’
While not an exhaustive list, key updates include the following:
Emma Coombes, the presenter in the Australian Podiatry Association webinar on this topic, suggests the following considerations are kept in mind.
We asked two podiatrists for their thoughts on the impact of these changes; shared below.
Note that the following anecdotal accounts are not intended to constitute advice. Always independently refer to the relevant guidelines for information that relates to your own practice.
Emma Coombes is a co-director and podiatrist at NSW-based Twinkle Toes Podiatry, which consists of two podiatrists and one part time reception staff member. Emma presented in the August 2024 webinar on this issue.
“The main impact of the Infection Control Guidelines on my business is the additional documentation requirements. Our practice has previously undergone and achieved accreditation and whilst we do have strong policies and procedures in place already, the change requires additional policies and procedures to be generated and implemented. This requires valuable time from myself, either out of clinical hours or by reducing clinical hours to ensure that these documents are generated and meet requirements.
Our sterilisation procedures previously were compliant and with minor changes in the water quality requirements there has been little impact (other than financially) in this area.
We have had a reverse osmosis system installed in our practice as our water does not meet the guideline recommendations and this will reduce our clinic’s environmental footprint. In addition to this we are purchasing quality distilled water for our steriliser. Our reverse osmosis system cost $2200 to install and this does have financial implications with ongoing testing, however this pathway was the most financially viable for our clinic.
The big concern for us as a small clinic is the recommendation for ventilation and temperature/humidity controlled environments. For our clinic, strong documented risk assessments and considerations moving forward will be necessary to ensure that we are aiming to be compliant in this area to the best of our ability.
My advice to fellow podiatrists is to put strong policies and procedures in place to comply with the standard and the transitional guidance. I would highly recommend podiatrists utilise the great resources that the Australian Podiatry Association has available (and will have more available soon at the time of writing). These resources will tick almost all of the documentation boxes required of us in the space of infection prevention and control.”
Mary Ellen Redmayne is the founder and director of Queensland-based mobile podiatry service, The Foot Stop. It has over 20 employees, which consists of clinical (podiatrists and an allied health assistant) and administrative roles.
Here are Mary-Ellen’s thoughts on the impending changes and how they might affect her practice.
The primary impact of the new Infection Control Guidelines on our business is the increased cost of purchasing distilled water for reprocessing podiatry instruments, rather than distilling our own water.
We are now using bottled distilled water in the ultrasonic cleaner (or for scrubbing and rinsing instruments). This approach eliminates the need for regular water testing; instead, we request water testing reports from the manufacturer at regular intervals for auditing purposes, in line with the guidelines for all instrument uses.
This will add over $5000 per annum in costs for distilled water, alone, due to operating over multiple sterilisation sites. However, this is still more cost-effective for our practice than installing reverse osmosis systems and conducting regular water testing at each sterilisation site.
Another change involves establishing a procedure for transporting instruments, given our mobile nature. This has posed some challenges, but we updated procedures and have adopted the use of airtight containers for instrument sets during transport.
A lot of these updated standards are very relevant to us, but some sections (such as ventilation and humidity) seem like they’ve been written for a hospital-based sterilisation unit and may need to be altered to be less prohibitive in the podiatry sector.
I appreciate that there is a lens on public safety but am aware that these changes will likely have an immense impact on podiatry practices across Australia, to the extent where the feasibility of reprocessing instruments comes into question. We may be pushed to utilise disposable instruments and increased use of plastic bottles, which has an unnecessary and unsustainable environmental impact.
The flow-on effect would include raising podiatry consultation fees, which could further the gap for those who already struggle to afford podiatry and for the health equity of our podiatry clients who often come from vulnerable populations.
I believe that most podiatrists across Australia already have excellent sterilisation procedures in place. With minor adjustments, such as purchasing bottled distilled water, we can largely comply with the updated water standards.
Standards regarding humidity control and ventilation are more challenging to achieve. By utilising risk assessments and updating policies and procedures, we will be able to show we are transitioning to meet the new standards, but some of us may really struggle to get there. The APodA are creating guidelines and resources, starting with this webinar by Emma Coombes, to support us through this transition; which we will be utilising at The Foot Stop Podiatry.
The new NHMRC guidelines uniquely impact our profession, unlike many other allied health fields. This alignment with the medical profession underscores podiatry’s evolving role. If managed effectively, this can enhance future funding allocations, boost community awareness, and elevate professional respect for podiatry.
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