How does the performance of a reprocessed device compare to a new device?
Each device goes through an inspection procedure to ensure that its performance is equivalent to a new device. We reprocess the device and recertify it for an additional single use per each reprocessing cycle. Reprocessed devices must be cleared by the FDA.
Why should I use Smith & Nephew over a third party reprocessor?
When you use a reprocessed device from a third party reprocessor, you lose the original manufacturer’s warranty. During normal use, fatigue loading affects all components differently. As the original manufacturer, we ensure all product specifications are met.
Also, products reprocessed by other companies cannot be inspected to the Original Equipment Manufacturer (OEM) guidelines we follow for patient safety. This can potentially put both the patient and hospital at risk.
Do you have FDA clearance to reprocess JET-X External Fixator clamps?
Yes, we have 510(k) clearance to reprocess our JET-X clamps. The reprocessing industry is regulated by the FDA so companies that choose to reprocess devices must have clearance to do so.
What products do you reprocess?
Our JET-X clamps. We recertify all of the clamps in the JET-X system for an additional single use. We do not reprocess our half pins, drills or carbon fiber bars. Carbon fiber bars risk structural damage during reprocessing due to the threaded carbon fibers that make up the design.
Half pins and drills cannot be re-sharpened after initial use. Plus they have been inside a patient, similar to an implantable device. We feel that reprocessing these devices results in too great of a risk for potential patient harm or surgery delay.
Do you reprocess other Smith & Nephew external fixation devices such as TAYLOR SPATIAL FRAME◊ External Fixator?
At this time, we do not reprocess any of our other external fixation systems such as TAYLOR SPATIAL FRAME◊ or ILIZAROV™ External Fixator. We do not feel it is safe to reprocess these systems because they undergo more extreme conditions for longer periods of time.
How does the Smith & Nephew Recertification Program work?
It is a simple and straightforward process:
1. The hospital signs an annual agreement with Smith & Nephew to reprocess.
2. We require a minimum of 50 clamps per shipment.
3. We provide the hospital with a collection container for collecting clamps until they are ready for shipment.
4. Once recertification is complete, we notify the hospital. Then the hospital issues a PO to us for the clamps.
How am I billed for recertified products?
When recertified products are ready to ship we notify the hospital contact. The hospital issues a PO to Smith & Nephew.
Do you guarantee products that you reprocess?
Yes, we offer the same warranty and guarantee on our recertified products that we offer on new devices.
Do you guarantee products from third party reprocessors?
No, we do not offer any guarantee or warranty on products from third party reprocessors. They do not have access to original specifications. Plus we cannot guarantee the third party reprocessors are inspecting parts to the same standards we require as the OEM.
When I send in products to be reprocessed is the same product returned?
Yes, you are guaranteed to receive the same product that you sent. Unlike some of the third party reprocessing companies, we will not send you a product that was sent in from another account to be reprocessed. This is added assurance that the products have only been handled by your hospital and Smith & Nephew.
What is the average turnaround time to reprocess clamps?
The average turnaround time is 10 days per 50 clamps.
How many times can a device be reprocessed? How do you track it?
Devices can be reprocessed a total of two times. This allows for a total use of three times for the device. The number of uses was determined based on our mechanical testing and what we concluded to be a safe number of uses.
The devices are marked each time they are recertified – so the number of uses for each device is visibly tracked. We also keep records for individual lot numbers.
What happens to the device after it has been used the maximum amount of times?
Devices should be disposed of when they reach their maximum number of uses.
Why must we decontaminate products before sending them in for recertification?
Shipping devices that have not been decontaminated fall under the shipping classification for biohazards. These special shipping requirements add additional costs to the overall recertification program.
Do you provide device collection containers?
Yes, we do have collection and shipping materials available for use with our recertification program. Ordering information for these containers is in your Product Recertification Agreement
Where can I find out more about the recertification program?
Speak with your Smith & Nephew sales representative.