March 7, 2022
Dear valued patients and caregivers, We are writing to inform you about the Bivona trach back-order issue. As of right now, your Bivona trach may have inventory shortages for several weeks or months per the manufacturer. Apple is working diligently with our suppliers to ensure that we have as much of a surplus of Bivona trachs as possible. You will continue to receive your trach if we have it in stock. If your trach is on back order due to material shortages there may be a delay, but as soon as we receive your trach you will receive it immediately. If you need a custom trach, we will continue to place the order, but we cannot guarantee a delivery time right now. Apple will continue to monitor this issue with the manufacturer weekly and we will update you as we receive new information. In the meantime, please use the following guidelines for cleaning and disinfecting your Bivona trach to extend its use.
PLEASE DO NOT THROW ANY TRACHS AWAY
What you can do to prolong trach use
Carefully following these instructions from the manufacturer will allow you to use your child’s tracheostomy tube many times. In addition to these instructions, please read the instructions listed on the IFU provided with your child’s tracheostomy tube.
Some Bivona neonatal/pediatric tubes have a removable swivel. Before cleaning, remove the swivel by inserting the disconnect wedge between the plastic swivel and base of the silicone neck flange. This allows you to clean in and around the swivel. Before storing the tube in a clean plastic bag, re-attach the swivel by positioning the flange on the swivel toward the patient.
Adults can be reused up to 10 times.
Pedi and Neo can be reused 5 times.
Supplies needed for cleaning after removing the tracheostomy tube from your child:
Mild, fragrance-free clear detergent solution
Soft bristled brush
Clean plastic bag
Trach cleaning procedure:
Wash hands with soap and water.
Set up supplies.
Gently wash the inside and outside of the tube in a mild, detergent solution using a soft bristled brush. Be careful! Too much scrubbing, scraping, or stretching may damage the tube.
Rinse the tube with water and set aside to air dry.
Gently wash the obturator with clean water and detergent as described in step 3.
Rinse the obturator and set aside to dry.
When the tube and obturator are completely dry, sore the tube with the obturator in place in a clean plastic bag.
Supplies for disinfection before inserting the tracheostomy tube into your child:
Storage bag with used tube
Pan of rapidly boiling distilled water, with lid
Disinfection procedure immediately before reuse:
Immediately before the next use of the tube, remove the tube and obturator from the plastic bag and place them side by side in a pan of rapidly boiling distilled water. Cover the pan, turn off the heat and let cool. Once cool, remove the tube and obturator from the water, holding the tube by the neck flange and the obturator by its handle.
Inspect the tube prior to use. Do not use a tube that is cut or damaged.
If you have any questions, you can reach us by email at firstname.lastname@example.org or by phone at 866-332-7753 during office hours. Thank you for your understanding as we work to resolve this supply issue.
Below you can read the letter on this issue from the manufacturer, ICU Medical.