Frequently Asked Questions

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What is remanufacturing?
Remanufacturing of medical devices involves inspecting, cleaning, functional testing, and packaging previously used single-use devices to ensure they meet clinical and safety standards for reuse.  

This process offers sustainable and cost-effective solutions while maintaining patient safety.
How can devices labelled single use be remanufactured?
The decision to label a device as single use or reusable lies with the manufacturer:

“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”
– US Government Accountability Office, 3 March 2008

Many devices are labelled single-use because the manufacturer chooses not to validate or distribute cleaning instructions to hospitals. As the legal manufacturer of all devices it remanufactures, Medsalv carries out the necessary studies and validation to ensure the safe return of each device back into the market.
How does Medsalv remanufacture devices to make sure they are substantially equivalent to new devices?
Collected devices undergo a thorough initial inspection, followed by cleaning and further inspections.

Every device is functionally tested to ensure it performs as intended during clinical use.

Cleaning removes bio-burden and preserves appearance before devices are appropriately disinfected.

Clean devices are sorted and undergo suitable disinfection as required.

Throughout each stage of our process, and between each step, every device goes through multiple inspections to guarantee that remanufactured devices match the quality of a new device.
How can we tell if a device has been remanufactured by Medsalv?
All devices remanufactured by Medsalv are permanently marked with a Medsalv branded barcode or mark, in a way that cannot be removed without destroying the device. Barcodes or marks are put on the devices themselves, as opposed to the packaging.

Barcodes uniquely identify each device and allow for tracking of both remanufacturing and distribution of the devices.

This system allows Medsalv to record valuable data about the quality of devices from different manufacturers, and feed this back to your hospital.
How much can a hospital expect to save with Medsalv?
Medsalv’s remanufactured devices are sold directly to customers at up to 60% off the cost of a new device, a clear and significant saving.

Waste savings from landfills range from 80% to 100% of target devices, with end-of-life devices being recycled through other sustainable initatives.
What happens to devices once they can no longer be remanufactured?
Devices that fail Medsalv’s strict quality standards are broken apart into their individual materials and recycled where possible. 

We are continually pursuing avenues for the reuse and recycling of end-of-life devices.
What input will be required by my hospital?
All  devices for remanufacture are placed into reusable Medsalv collection bags. Devices are regularly collected by Medsalv staff in urban areas. Rural or regional hospitals use a simple online portal to notify us when their collection bags are full. Medsalv handles the rest. 

This includes providing staff education, device collection, counting, sorting, remanufacturing and re-delivery of the devices to your hospital. 
How are the collected devices transported to Medsalv? Who pays for it?
Medsalv has been designed to suit your hospital with collection points in suitable hospital areas and provides education to staff collecting devices.

Medsalv is responsible for picking up, remanufacturing, and returning devices to the facility.

Medsalv does not collect devices that are soiled or have bodily fluid contamination and does not collect devices from patients in isolation.

Medsalv covers the collection costs and the returning costs, which are built into the price of returned devices.

Medsalv’s collection system meets healthcare waste requirements and uses fully reusable collection bags and containers.
Which standards do processes for non-invasive devices follow in disinfection?
Remanufacturing single-use medical devices is a manufacturing activity, governed by the Essential Principles of Safety and Performance of Medical Devices, as with any other Medical Device Manufacturing activity. 

While there are no specific standards for remanufacturing, guidelines from relevant standards for disinfection of devices of similar levels of complexity are directly relevant.
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