Vanguard is all about sustainability
Sustainability is at the core of the Vanguard business model. It is our goal to enable the circular economy in the medical device industry. The responsible use of raw materials in the production and use of medical devices is an absolute requirement for a sustainable medical system.
Using pioneering processes, we give new life to single-use medical devices and increase the reach of your financial resources so that your commitment to sustainability also pays off financially. Medical remanufacturing restores a used medical device to “as new” functional and safety standard:
- The device is disassembled
- All components and separate parts are tested
A technological upgrade may be involved through the replacement of individual components. Subsequently, the device is reassembled and tested for functionality and then cleaned and sterilised so it can be safely used again.
We set global standards
Medical Remanufacturing also includes:
- The creation of technical documentation
- Reverse engineering specifications (including construction and material analysis)
- Requirements for post-market surveillance
- Procedures for recognising changes to the design of the original product
- A system for reporting any incidents that may occur
- A product tracking system that monitors the product throughout the remanufacturing process and over its lifetime
- A compulsory certification
What is the difference between remanufacturing and reprocessing?
Reprocessing typically refers to a process focused primarily on cleaning and hygiene. However, since reprocessors of single-use medical devices are increasingly regulated as manufacturers and the regulated activity also comprises process steps that go beyond cleaning many experts, including the Association of Medical Device Reprocessors (AMDR), refer to these activities as (medical) remanufacturing. We have adopted this designation.
Medical Remanufacturing is safe
We ensure that all our remanufactured products are restored to “as new” functional and safety standards and fully comply with EU regulatory requirements.
Complex medical devices can only be remanufactured with state of the art remanufacturing processes. To ensure that a remanufactured device is substantially equivalent to the original product our research and development group develops the technical specifications for each remanufactured device using advanced re-engineering processes. The data required for the validation procedures is generated in our dedicated testing laboratories.
On this foundation we develop our medical remanufacturing procedures and validate these processes. This enables us to ensure the functional, hygienic and biological safety of our products and substantial equivalence to the original device.
The Vanguard process of medical remanufacturing for single-use-devices
From collection to delivery, we maintain the highest standards of excellence throughout our remanufacturing process. In our state-of-the-art production facilities, we use product-specific validated processes to remanufacture your devices.
Medical facilities place pre-cleaned medical devices into the Vanguard collection box. These are collected according to a mutually agreed schedule by the Vanguard logistics service. The medical devices can be tracked and traced through the entire logistics chain.
2. Inspection and identification
An IT based incoming goods inspection and product inspection is followed by laser marking with a unique identification number so the device can be tracked through the entire production and logistics processes all the way back to the medical facility. Devices which are not suitable for reprocessing or defective are rejected.
The device is then disassembled, cleaned and subsequently reassembled. To ensure the highest standard of hygiene of our products, they are subjected to rigorous and extensive testing. We do not rely on batch testing – 100% of our products are checked for safety and performance. This process includes visual checks, a mechanical inspection of all moving parts and Vanguard Product Verification, which guarantees the electrical functionality of the remanufactured device.
4. Sterile packaging & sterilisation
The remanufactured products are then packaged in high-quality Tyvek sterilisation bags and visually inspected after sealing. The result is an effective sterile barrier system. All products are treated by low-temperature sterilisation to protect thermolabile devices/components. The sterilisation process is carried out in accordance with strict protocols. All our devices must pass microbiological testing before they are approved for release.
5. Shipment of remanufactured devices
After sterilisation, the medical devices are placed in protective packaging and labelled. The products are then sorted according to customer requirements and shipped to our customers.