Intended applicable time frame and scope:
This statement is intended as a recommendation for the use and re-use of pediatric tracheostomy tubes during acute materials and/or distribution shortage of available tracheostomy tubes for children, in both inpatient and outpatient settings. This statement should ONLY be used during the current acute shortage across the US and is NOT intended to serve as recommendation for long-term standard of care for tracheostomy dependent patients. This statement should NOT replace manufacture instructions for use (IFU), once tracheostomy tube supply shortage is no longer in place.
Statement of Clinical Context:
Beginning in 2021, raw material shortages and supply-chain constraints have resulted in an unprecedented national and international shortage of tracheostomy tubes for both adults and children. The shortage has created risk of life-altering and inarguably life-threatening sequelae related to discrepancies between manufacturing use and re-use recommendations against caretaker realities. With few contingencies available for this fragile population, tracheostomy-dependent children and the clinicians who care for them have been required to receive or provide care that creates “work-arounds” to accommodate for supply shortages, limited by product availability as well as manufacturing and IFU constraints.
In October of 2022, this working group surveyed the membership of the American Society of Pediatric Otolaryngology to assess the impact of this shortage. The survey had 150 respondents – each response solely representing a single hospital or institution. The respondents collectively care for and represent an estimated range of 33,500-54,900 tracheostomy-dependent children in the United States. 96.62% of these institutions reported being affected by the shortage across a range of tracheostomy tube sizes. Documented consequences of the impact include the use of an inappropriate or suboptimal tracheostomy tube for the child (78.38%), hospital and family re-use beyond IFU guidelines (62.84%, 84% respectively), delays in hospital discharge (47.3%), increased Emergency Room and outpatient visits due to tracheostomy-related complications (29%), delays in surgical placement of new tracheostomies when indicated (14%) and the absence of a backup emergency tracheostomy tube due to lack of tube availability (76%). Documented complications directly related to the shortage of tracheostomy tubes and the contingencies implemented included but are not limited to: airway obstruction and mucus plugging, increased infection rate, difficulty ventilating, pulmonary complications, tracheal injury, stoma breakdown, acute hypoxia, and respiratory arrest.
The purpose of this document is to provide consensus recommendations for safe tracheostomy tube re-use, applicable ONLY for the duration of the tracheostomy tube supply shortage.
The following recommendations are NOT intended to supersede the recommendations of the patient’s physician(s) who specifically care for a child’s tracheostomy dependence and use.
- There are three major tracheostomy brands utilized in children: Bivona (ICU Medical), Shiley and Tracoe. While traditionally physicians, clinicians and patient families may have used a preferred brand/type of tube, during crisis-level times of shortage, it is acceptable to use an alternative brand of tube of comparable size. The alternate size and type of tube should be confirmed with the clinician to ensure an appropriate fit for each patient.
- There are traditionally two types of tubes used in children; tubes containing a cuff (or “balloon”) at the end of the tracheostomy tube to seal air leakage, and uncuffed tubes. Cuffed tubes may be at higher risk for earlier degradation, specifically at the cuff site.
- Reuse of tracheostomy tubes should be performed with the following parameters:
a. Prior to re-use of a tracheostomy tube, the tube should be inspected carefully, looking specifically for the following:
i. Degradation of the cuff or failure for the cuff to remain inflated (leak) after addition of sterile water or air in the pilot line
ii. Yellow discoloring of the tube that does not improve with the cleaning process
iii. Cracking anywhere along the flange or shaft of the tube, paying particular attention to the location where the shaft of the tube meets the flange and where the shaft meets the cuff of the tube
iv. Crusting inside the lumen of the tube that will not come off during a routine cleaning
v. Alteration or deviation in standard shape or appearance
vi. Obturators should also be inspected to ensure they are intact and may also be safely re-used
- Any of the findings above should be addressed with the clinical team caring for the child and should prompt an attempt to find a new tube or a suitable replacement.
- Children with known immunocompromise or altered immune responses should be treated with special caution, as infection from tracheostomy tubes may have more significant
- Biofilm formation (development of a bacterial layer on the tracheostomy tube itself) is an especially difficult problem. Biofilms are typically identified by changes in color, development of rapid mucous plugging or early discoloration of the tracheostomy tubes. Suspicion of biofilm formation should encourage earlier change of tubes, as well as a thorough disinfection of the old tube.
Cleaning of the tubes should involve washing in a mild, fragrance-free clear detergent, with attention to cleaning the lumen of the tube using a tube cleaner or similar device along with the obturator. Tubes should be thoroughly rinsed after cleaning and allowed to completely air dry before re-use. Re-inspection of the tube should take place before and after cleaning of the tube. Please follow manufacturer’s IFU.
Endorsed by AAO–HNS (American Academy of Otolaryngology–Head and Neck Surgery)
Endorsed by ASPO (American Society of Pediatric Otolaryngology)
Endorsed by SENTAC (Society for Ear, Nose, and Throat Advancement in Children)
Endorsed by ABEA (American Bronchoesophagological Association)