Situation:
· All Medtronic DUET spinal drain systems have been removed due to safety recall.
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Background:
· Inadvertent disconnections of the Medtronic DUET spinal drain system have been reported, leading to CSF leakage and potential infection risk. As such, there has been a world-wide recall of the product since Jan 2024.
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Assessment:
· There are only 2 known alternatives currently on the market. Quantities are also extremely limited due to the world-wide demand – all products are currently on allocation.
1. Medtronic Becker – instructions attached
§ Already in use as a sub throughout the hospital.
§ Last month Sunnybrook’s usage ~20 each.
§ 1 disconnection at the drainage bag noted locally, peer hospital (TWH) noted 5 disconnections.
§ No current recall notice for this product.
2. Integra Codman EDS3 – instructions attached
§ Sunnybrook is currently allocated only 1 system per week, totaling 11 systems in hospital.
§ TWH has already switched exclusively to this product due to concerns over the Medtronic Becker system.
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Recommendation:
· Remove all Medtronic DUET systems (already in place since Feb 2024).
· Switch over to Integra Codman EDS3 to mitigate potential issues with the Medtronic Becker system; however, the hospital does not currently have a sustainable supply.
· Additional in-services for the Integra Codman EDS3 will be provided to all clinical areas this week.
· Medtronic Becker systems will continue to be used once the hospital’s supply of the Integra Codman EDS3 is depleted.
· As the supplies are extremely limited and uncertain, all available stock are being stored centrally in A2-10e, Margaret (Max) Lo Dico’s office. During off hours, call the CrCU Team Leader for access to supplies. There will be a sign-out sheet to log the date, patient name, and location to track usage. During this time, only 1 system at a time will be released as patient need arises.
SUPPLY ACCESS
Room: A2-10e (turn left at CrCU entrance doors)
M-F 0800-1600
Max Lo Dico
x88110 or 437-229-6307
All other times
CrCU Team Leader
x88116
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