Why the Safety Question About Remanufactured Devices Has Already Been Answered
When hospital teams first encounter remanufactured medical devices, the first question is rarely about cost.
It is about safety.
That is the right question to ask. And it is one the TGA regulatory framework has been designed specifically to answer.
Hospitals that have worked through this question, and there are now over 160 of them across Australia and New Zealand, consistently reach the same conclusion:
The safety case is clear, the regulatory standard is rigorous, the same as for all other devices, and the clinical experience is operationally identical to using a new device.
The following is an account of why that is the case, and what it means for hospital teams considering this option.
What TGA Regulation Actually Means
Remanufacturing of medical devices in Australia is regulated by the Therapeutic Goods Administration as a manufacturing activity. This is a specific and important distinction.
It means devices Medsalv supplies for clinical use are supplied under an ARTG inclusion and must meet the Essential Principles, the same baseline regulatory requirements that apply to new devices.
Clinical performance must be substantially equivalent to the original. The essential principles, governing infection control, microbial contamination, labelling, tracking, and tracing all apply in full.
Remanufacturing is enshrined in statute, as a manufacturing activity.
Whether it be called remanufacturing, refurbishing, reconditioning, or reprocessing (of a device labelled as single-use, as opposed to reprocessing of a reusable device) is beside the point.
The most important fact is that every device supplied for clinical use in Australia must comply with TGA’s essential principles.
This is not a lighter regulatory standard applied to a secondary category of product. It is the same standard, applied to a different sourcing model.
The TGA framework exists precisely to ensure that remanufactured devices can be evaluated on their merits, consistently and objectively. Devices that meet the standard are devices that can be used with confidence.
The Difference Between Single-Use Labelling and Clinical Safety
One of the most common points of confusion is the relationship between a device being labelled single-use and that same device being clinically safe to use a subsequent time following remanufacture.
Single-use labelling reflects the original manufacturer's product and commercial model.
It does not, in itself, determine whether a device can be safely remanufactured under a separate regulatory process.
This has been thoroughly investigated by the United States Government Accountability office, which found in this report that:
"a device may be labeled as single-use because the manufacturer believes that it cannot be safely and reliably used more than once, or because the manufacturer chooses not to conduct the studies needed to demonstrate that the device can be labeled as reusable"
TGA-regulated remanufacturing exists because the clinical and technical evidence supports safe reprocessing of qualifying device categories - these are the categories where the manufacturer has chosen not to do the studies required to label the device as reusable, as opposed to devices that are damaged during use.
Each category Medsalv works with has been assessed against that evidence.
Devices that do not qualify are not included in the program.
It's important to remember, all remanufacturing conducted by Medsalv is conducted in the same market the device is used in, not in the lowest labour cost country on the other side of the world - the ability to see where and how devices used in Australasia are produced is unique, as both New Zealand and Australia import the majority of their medical products.
For hospital infection control and clinical governance teams, the practical implication is straightforward.
A remanufactured device returning to clinical use has been through a documented manufacturing process, individually tested and inspected up to 9 times, and returned to a standard that meets the same essential principles as a new device.
What this means for hospitals, is that the same framework used to assess and buy ‘new’ devices can be applied directly to remanufactured devices, without adjustment.
What Changes Operationally, and What Does Not
This is where the clinical and operational picture becomes particularly clear.
Staff use remanufactured devices exactly as they would any equivalent new device.
Clinical use is the same as the original device.
Hospitals may still complete local governance steps (infection control review, procurement review, staff communications) as part of their normal introduction process.
The prerequisite for using a remanufactured device is simply that the hospital is already using the original. Nothing about clinical practice changes.
The one operational addition is collection. Used devices are placed in dedicated receptacles for return to Medsalv's remanufacturing facilities in Geelong and Christchurch.
This is a logistics step, not a clinical one, and it is managed by Medsalv's collection network across Australia and New Zealand.
Nothing changes operationally, except that the device gets collected. - and not by a landfill.
What the Hospitals Running This Program Have Found
The best evidence on this question is the track record of the program itself.
Across more than 160 hospital partners since 2017, from large metropolitan health networks to regional standalone facilities, the clinical experience has been consistent.
Clinical staff report no difference in use.
The process behind that consistency is worth understanding in detail.
Every device is individually tested and inspected up to 9 times before it is returned to clinical use.
Not as a batch assessment. Every single device, every single cycle. This includes the functionality being tested.
Every device returned to clinical use is ARTG-listed.
The documentation trail is digital, complete, auditable, and independently audited on site (all sites) annually by SGS, a leading international notified body responsible for quality systems all over the world.
Nearly a million devices have gone through that process.
Each one collected, remanufactured, inspected, listed, and returned. The scale reflects the confidence hospitals have placed Medsalv programs, and the outstanding track record.
Medsalv has an exceptional track record when it comes to quality.
With nearly a million devices remanufactured and returned to hospitals, Medsalv’s complaint rates related to it’s remanufactured medical devices are amongst the lowest in the world.
While it is normal for Medical device manufacturers to target a complaint rate of ~less than 1.5% for Consumable devices, Medsalv’s complaint rate is less than 0.0009%.
No complaints have been related to any potential or actual patient safety issues.
Up to 60% cost reduction on qualifying device categories.
That is what procurement teams are reporting to their CFOs.
But the number that makes it possible is not a paper based price negotiation.
It’s a smarter business model, built from the ground up to deliver what health really wants.
The savings are real. They are a consequence of the safety question being answered well.
Why This Matters for Clinical and Procurement Teams Together
A device that meets the standard and has ARTG approval is clinically appropriate and financially accessible at a lower price.
Hospitals with strong clinical governance and forward-thinking procurement leadership have found that working through and understanding the regulatory detail together, rather than sequentially, shortens the path to implementation considerably.
The question that tends to unlock the conversation is a simple one: if the regulatory standard is the same, and the clinical performance is equivalent, what is the basis for the cost difference?
The answer is business model, and operational efficiency, not a compromise in quality.
And that is a procurement decision, not a clinical one.
A Practical Starting Point
For clinical teams considering this for the first time, the most useful starting point is often a review of the device categories currently in use and whether any qualify for Medsalv's program.
Where they do, the regulatory documentation and device approvals is available via the ARTG, and your hospitals infection control protocols for device use will be fully specified.
Cost savings vary from device to device, and are based on the complexity and size of the device as that contributes to the manufacturing cost - we adjust for freight cost - which is subject to distance - and incorporate in the device price unless we invoice for freight separately.
For hospitals that have already made the decision, the onboarding process is straightforward.
Medsalv's cost-free collection network covers facilities across all of Australia and New Zealand, and implementation does not require a procurement overhaul.
In many cases, hospitals introduce remanufactured devices within the existing flexibility of their supply arrangements.
No compromise on safety. No compromise on clinical standards. No compromise on infection control. The regulatory framework ensures all three. The savings are a direct result of the same framework working as intended.
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