Make an intelligent and thorough evaluation of whether or not to reprocess EP catheters and other devices in your EP Lab. Written by Steve Miller, RN, a past EP/Cath Lab Coordinator who has been involved in reprocessing decisions. He has worked in three different EP Labs over the last 17 years, has visited both reprocessing facilities and presents an objective roadmap for making your decision.
The decision for a hospital to participate in EP catheter reprocessing (referred to as re-manufacturing in the UK) is a challenging one. Historically, reprocessing took place within the hospital, but in 2003 the FDA instituted new requirements for a hospital, manufacturer, or third party company that reprocessed single use devices called the Medical Device User Fee and Modernization Act of 2002 (5). These stringent requirements caused hospitals to cease this practice. (1) Since then third party reprocessors, who were able to satisfy these requirements have successfully increased the number of devices they can reprocess and the number of hospitals they are servicing.
In researching the decision of whether or not to reprocess and which company to use, we recommend you include the following steps in your evaluation process:
1. With any plan that affects an entire department it is strongly recommended that you use a team approach during the evaluation and implementation process. This gives you the best chance of coming to a good decision and having a successful outcome as compliance with the EP Lab collection team is increased if they have input during the decision making process. Include the following team members: the Cath/EP Lab Department Manager, Materials Management, Medical Director of the EP Lab, and representatives from the EP staff (a nurse and a tech).
2. Research EP catheter reprocessing on the internet and in the medical and materials management literature as there are a number of articles that provide useful information.
3. Create a prioritized list of factors that you want to evaluate.
4. Meet with sales persons from all companies to compare pricing, service and other factors you have prioritized.
5. Check with nearby and/or sister hospitals about their experiences with each of these companies, as a large degree of your satisfaction depends upon how well your local rep takes care of your department.
6. Combine all of the information you have collected and review it with you team and ask for comments.
7. Have your Materials Manager lead in the negotiations for a contract with the company you have selected. If you have determined that reprocessing is not the best option for you or you do not reprocess all items, consider EPreward's Catheter Buy Back program.
The Process: EPreward provides a special collection kit that safely stores and ships the devices your collect. It is provided free of charge and shipping is covered as well. In the UK, EPreward utilizes STOK UK to assist with the pick up of the used EP Catheters. As a reminder EPreward is not a reprocessor/re-manufacturer but rather a collector that helps earn additional income for your department.
If your facility determines that reprocessing ( known as re-manufacturing in the UK) is not appropriate at this point in time or you are not reprocessing all your items, there is a second option far better than Platinum Recovery from the EP catheter tips!
St. Jude Agilis Sheaths with Blue Dilators $15
Select Category I Catheters
Fixed curve Quad through Decapolar $8
Select Category II Catheters
Steerable Quad through Decapolar $14
Category III EP Catheters.
Ablation Catheters receive Platinum Value.
Select Category IV Catheters
Steerable DuoDeca, Halo, Lassos, etc. $18
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