Dilation/Sizing System Sterilization and Reuse Instructions
INSTITUTION STERILIZATION AND REUSE INSTRUCTIONS
The following devices of the Blom-Singer® Dilation/Sizing System may be cleaned and sterilized for reuse between patients to a limit of 60 uses: Puncture Dilator, Dilator-Sizer, Voice Prosthesis Sizer (NOT the sizer inserter stick).
Prior to sterilization, manually hand clean the device:
1. Rinse the article under running water. While rinsing, use a soft bristled brush to brush the device. Use an appropriately sized lumen or channel brush to brush the lumen of the device, as applicable.
2. Immerse the device in a prepared enzymatic detergent solution for 1 minute (following manufacturer's instruction for dilution). While immersed, use a soft bristled brush to brush the device. Use an appropriately sized lumen or channel brush to brush the lumen of the device, as applicable.
3. Remove the device from the bath of detergent solution and rinse under running utility water for 1 minute.
4. Dry the articles using pressurized air.
To sterilize after manual cleaning:
Device to be sterilized must be placed in a single sterilization pouch.
Two separate parameters using pre-vacuum steam sterilization autoclave have been validated to a limit of 60 uses:
1. Sterilization at 132°( for 4 minutes after performing 4 preconditioning pulses OR
2. Sterilization at 134°( for 3 minutes after performing 4 preconditioning pulses.
After sterilization cycle is complete:
1. Device requires a minimum drying time of 20 minutes.
2. Inspect the device routinely for structural damage. If there are tears, cracks, or structural damage, discontinue use and replace device.
<span style="color:#00a6e2;font-weight: 600;">What is a UDI marking?</span>
The Unique Device Identifier (UDI) marking gives hospitals and clinics a way to identify each item's lot number, item number, and expiration date. This is important for items that are reprocessed and used again, as the information on the box or package labels is not often kept or easily tracked otherwise.
<span style="color:#00a6e2;font-weight: 600;">Which items will have a UDI marking?</span>
The same items that have updated sterilization guidelines will also feature a UDI marking:
BE 2036: 20 Fr Blom-Singer Voice Prosthesis Sizer
BE 6036: 16 Fr Blom-Singer Voice Prosthesis Sizer
BE 2051: 18 Fr Blom-Singer Dilator-Sizer (for 16 Fr prostheses)
BE 2052: 22 Fr Blom-Singer Dilator-Sizer (for 20 Fr prostheses)
<span style="color:#00a6e2;font-weight: 600;">How does this affect how I use these items?</span>
No change exists in how listed items are used, only in how they are sterilized/reprocessed.
<span style="color:#00a6e2;font-weight: 600;">Why did the number of users drop from 100 uses to 60 uses?</span>
In validation testing, the UDI marking shows signs of wear and may not be reliably scanned beyond 60 uses.
No, any of the above items that do not have UDI markings can still be reprocessed and used up to 100 times. The change in the number of uses is strictly based on the UDI marking.
