Reprocessing Program Overview

The service offered by MEDISISS encompasses the cleaning, testing, refurbishing, sterilizing and packaging of both re-usable surgical devices and a growing number of devices that have traditionally been considered disposable (or single use) at half the original purchase cost on average. Our protocols ensure that your devices meet the highest standards in terms of quality, functionality and safety before being returned to your facility.

Our pursuit of excellence is an enormous driving force, which we achieve by serving our customers with quality and efficiency. We continually explore new and improved technologies and methods to enhance the services we provide and we offer a broad and complete product line that is reliably and safely reprocessed to FDA standards.

Our comprehensive reprocessing program
begins with the customer.

 

Your staff first conducts a simple cleaning and rinsing (with recommended enzymatic solution such as Metrex's EmPower) and then places the devices in our bin. Once the bin is full, we pay to have Fed-Ex deliver your single use devices to our facility.

From there the following steps take place:

1	Notification We send you an email that alerts you when your devices have been received and are in process. The email will also contain a lot identification for your orders.
2	Decontamination Devices are thoroughly cleaned through a series of disinfection, enzymatic cleaning, hand washing and steaming steps.
4	Identification We identify and label each device with the Original Manufacturer’s part number and description to allow for easy traceability into your inventory system. We can also label your devices with your facility’s internal tracking number to make inventory management even easier.
5	Reprocessing Cycle Tracking Each time a device is reprocessed, we permanently mark it to indicate the number of reprocessing cycles it has undergone. When the device has reached the maximum number of cycles, we will discard the device at no additional cost to you.
6	Refurbishing Our technicians inspect devices for defects and conduct device functionality testing. If any devices fail to pass our scrutiny we reject them and take responsibility for the cost of their disposal. We document the reason for rejection so that you always know why a device will not be returned for an additional use.
7	Final Wash and Primary Inspection Devices are thoroughly washed a final time and inspected microscopically tip-to-tip for any defects.
8	Packaging and Labeling Devices are double pouched, labeled and prepared for Ethylene Oxide sterilization.
9	Final Inspection and Sterilization Once we’re 100% satisfied that each device has met all acceptance criteria, it’s subjected to an ethylene oxide- sterilization process, validated using the FDA recognized standard: ANSI/AAMI/ISO 11135-1. Our devices are sterilized to a 10-6 sterility assurance level, and all sterilization documents are reviewed by Quality Assurance prior to release to ensure that all validated parameters have been met. Devices meet ISO 10993-7 biocompatibility requirements for safe levels of ethylene oxide residuals prior to shipment back to the facility.
10	Packing List Notification We then email you the official packing list that includes: The full listing of the devices being shipped back to your facility Device reclamation rates which denote how many devices had to be rejected Projected shipping dates, with a FedEx tracking number Itemized pricing (provided in advance of the final billing to help with your budgeting)
11	Product Release Typically we have a 2-3 week turnaround time to ship devices back to you, which is the fastest in the industry. And once we reprocess a device we guarantee it 100%.