EFHSS Questions and Answers - Question Q00507

We have St. Jude Medical's prosthetic heart valves, which are beyond their expiry date. The company recommends re-sterilization through steam. We would like to know how long we can keep the valve after re-sterilization / or rather what is the expiry date of these re-sterilised items?
Please reply to me on my email id:

Thank You

ShivaKumar Kotne
Technical Officer
Sri Sathya Sai Institute Of Higher Medical Sciences
Bangalore
India

This answer is copied from St. jude's website (www.sjm.com)

How are St. Jude Medical mechanical valves resterilized?
St. Jude Medical mechanical valves are supplied sterile and ready for use. If resterilization is necessary, use only the recommended steam cycles and follow the instructions below. The St. Jude Medical mechanical valve must not be resterilized more than once (1 time).

1. Remove both the inner tray containing the valve and the inner tray seal.
2. Place the inner tray inside a sterilization bag for sterilization. Exercise extreme care when handling the valve assembly to avoid structural damage to the valve.
3. Follow these recommended sterilization cycle parameters for St. Jude Medical mechanical heart valves:

   	Pre-Vacuum Steam	Pre-Vacuum Flash
   Purge Time	6 minutes	6 minutes
   Pulses	2	2
   Maximum Pressure	15 PSIG	15 PSIG
   Minimum Pressure	23 mmHg	23 mmHg
   Sterilize Time	28 minutes	7 minutes
   Sterilize Temperature	122° C (250° F)	132° C (270° F)
   Post-Vacuum Dry	26 mmHg	26 mmHg
   Vacuum Dry Time	10 minutes	10 minutes

St. Jude Medical does not validate ETO sterilization methods.

Hospitals are encouraged to return valves to St. Jude Medical for resterilization rather than resterilizing the valves themselves. Contact your local St. Jude Medical sales representative for further information. For more information, go to Locations.

To answer your second question: shelf life is event related and therefore you should define it according to your facility/packaging conditions.

Hope it helps
Yaffa Raz

Dear,

On the EFHSS Education pages under Articles you find a paper of Tim Galekop: "European expert condemns the re-use of sterilization packaging".
Herein he gives a lot of information on event related sterility and also describes the Dutch point system to determine sterile shelf life.

Best regards,
Wim Renders