Tracheostomy Supply Shortages are Threatening Patient Health

Instant Pots, duct tape, and tracheostomy tubes from people who didn’t survive COVID-19: These are the tools patients and families are using to navigate persistent tracheostomy supply shortages exacerbated by the pandemic.

Jenny McLelland started sterilizing her son James’ trach tubes in her Instant Pot in late 2019 after reading a 2018 PLOS One paper that concluded that self-contained electric pressure cookers “are a viable alternative for steam sterilizing laboratory items when an autoclave is unavailable” (PLOS One. 2018;13:e0208769). Her son’s supply was impacted by the 2019 closure of an oxide sterilization facility in Illinois that triggered a shortage of pediatric Bivona tubes. Three years later, McLelland, a California resident, is still sterilizing and reusing trach supplies—the family currently receives just four trach tubes per year, down from their allotted 50—and her social media posts outlining her sterilization technique have been shared hundreds of times by other desperate families.

Crystal Evans, a Massachusetts-based adult who has been ventilator dependent since 2016, is using a UV baby bottle sterilizer to maintain her stash of limited supplies. Evans started stockpiling equipment almost as soon as COVID-19 began circulating, but her foresight wasn’t enough to forestall harm. Unable to obtain adequate numbers of ventilator circuits and trach tubes, Evans developed tracheitis and bacteremia. When her ventilator circuit ripped in December 2020, Evans patched it with duct tape, as new supplies hadn’t been delivered. By January 2021, she was struggling to breathe against an inflamed airway. Her durable medical equipment (DME) provider, health insurance company, Congressman, and Senator provided little help; Evans is still getting only one ventilator circuit per month instead of the five she needs and is using trach supplies shipped to her “from friends who have lost their kids.”

To say the COVID-19 pandemic interrupted the supply chain, creating shortages of necessary tracheostomy supplies, is not entirely accurate. Yes, years of COVID-related shutdowns (not to mention COVID-related deaths and disability) have led to a global shortage of medical-grade silicone, shipping delays, and workforce shortages. But those who rely on tracheostomy tubes say the supply chain has always been precarious, with few factories manufacturing the necessary equipment and their personal supply dependent on Medicaid rules that vary from state to state and DME providers who have little financial incentive to deliver the proper number of supplies.

Unfortunately, tracheostomy supply shortages are likely to continue for a while. “This isn’t going to be over until the end of 2023,” said Andrew Georgilis, president and CEO of Bryan Medical, a Cincinnati-based manufacturer of tracheostomy tubes and speaking valves, noting that his company currently receives only about 25% of the raw material they order, while demand has increased nearly 50%. “It’ll get better and better as we go forward, but this isn’t going away anytime soon.”

Supply Chain Challenges

Well before the COVID-19 pandemic upended global commerce, consistent access to necessary tracheostomy supplies was a challenge.

“Managing the practicalities of tracheostomy supplies has never been a simple matter for patients, or for hospitals,” said Michael Brenner, MD, president of the Global Tracheostomy Collaborative and associate professor in the department of otolaryngology–head and neck surgery at the University of Michigan in Ann Arbor.

Products from different manufacturers aren’t necessarily interchangeable. If a hospital or health system cannot obtain their preferred equipment from their regular supplier, they can usually order from another supplier. But using less familiar products complicates care and introduces safety concerns.

Patients and families in the community lack the buying power of health systems and may not be able to obtain supplies at all if the manufacturer of their equipment is unable to continue production for any reason, as their DME provider may be locked into a contract with a particular company.

“Hospitals and large healthcare systems can often be agile in terms of negotiating purchasing contracts, making bulk equipment purchases, or navigating supply chain shortages, but that versatility and agility simply doesn’t exist for patients and families,” Dr. Brenner said.

Insurance-imposed limitations are another long-standing problem. Access to trach supplies varies greatly depending on geography and insurance coverage. In some states, children on Medicaid who have tracheostomies are entitled to five tracheostomy tubes per month; in others, children covered by Medicaid get just two tubes per year, although the tubes are not intended to be used for longer than 30 days.

“These devices haven’t been tested for longer periods, and their safety and fidelity over longer periods is unknown,” Dr. Brenner said. “Manufacturers designate these devices to be used for 30 days,” he said, because “otherwise the devices would be required to meet standards for implantable devices. Yet payers will only pay for them to be replaced every 90 days. So, you have a perverse situation where people’s only option is to use the devices in a manner that’s inconsistent with manufacturers’ instructions.”

To cope, families have “historically had online peer support exchanges where people post what they need and what their kids have outgrown,” said McLelland, a former police officer turned nurse and disability advocate. “There has always been a massive transfer of supplies.”

DME companies, which charge insurance companies a global billing rate for tracheostomy supplies, don’t always deliver the supplies ordered by patients’ physicians or the correct number of inner cannulas, heat moisture exchangers (HMEs), speaking valves, or ventilator circuits.

McLelland’s son uses several HMEs every day to maintain lung moisture, but “going back as long as 10 years ago, we had to constantly fight with the DME over getting more than 30 a month,” she said. “The DME provider has every incentive to shortchange the patient on items that are less profitable to provide.”

Many healthcare providers aren’t aware of these long-standing issues. “Doctors have this assumption that people are getting what they need,” McLelland said. “They don’t realize the level of battle that it takes.”

COVID-19 Complications

When SARS-CoV-2 started spreading around the globe, Evans, the ventilator-dependent adult, thought, “My supplies are going to be gone.”

Shortages of personal protective equipment underscored the fact that medical supplies were limited, and Evans realized that increased demand for ventilators and tracheostomy supplies in hospital settings would likely decrease the quantities available to people in the community.

“A lot of the same supplies that are used in hospital settings are also things that you use if you have a ventilator at home as well. Patients are basically competing with the hospital,” Dr. Brenner said.

The hazards of just-in-time (JIT) manufacturing and supply chain management soon became apparent. “There’s so much downward pressure to try to provide better pricing year in and year out that companies went to JIT so that they’re not paying for supplies to sit on a shelf,” Georgilis explained. In retrospect, he said, “that was the perfect thing to do if you wanted an organization to totally implode.”

“No one’s tracking infections, pneumonias, and deaths from routine reuse of disposable medical equipment.” —Jenny McLelland, patient caregiver

Some hospitals and healthcare systems were inadvertently better prepared than others. Henry Ford Health, in Detroit, was in the process of updating its inventory and transitioning from one product line to another when shortages hit, said Ross Mayerhoff, MD, a Henry Ford laryngologist.

“As a large healthcare system, we had a fair bit of back stock, so we’ve been relatively insulated,” he said. People in the community, however, struggled to get proper supplies. “I’ve had people show up with the wrong tube, for example,” Dr. Mayerhoff said.

Stymied by shutdown orders and silicone shortages, tracheostomy supply manufacturers were unable to meet demand. With no new stock available, patients were forced to make do with significantly fewer supplies. Evans’ supply of ventilator circuits dropped from four per month to one. The McLelland family received just two new trach tubes per month instead of their usual four; that number eventually declined to one, and then to zero.

Physicians advised patients to reuse supplies for as long as possible. “We told parents, ‘Don’t throw away any trach tubes until you’ve gotten a replacement. Keep cleaning them as you’ve been taught to clean them, according to manufacturers’ instructions,” said Romaine Johnson, MD, MPH, professor in the department of otolaryngology–head and neck surgery and director of quality and safety for the Department of Otolaryngology at UT Southwestern Medical Center in Dallas.

As the pandemic continued, COVID- 19 patients who’d had tracheostomies placed during hospitalization were discharged into the community, sometimes with little support.

“In some cases, ENT teams weren’t even consulted,” said Jonathan Bock, MD, an assistant professor, division of laryngology and professional voice in the department of otolaryngology and communication sciences at the Medical College of Wisconsin in Milwaukee. “The trachs had been done by the pulmonary team or trauma surgery, and patients were sent home without a supply hookup or follow-up for trach care.”

With no system in place to prioritize silicone for medical needs over other usages, manufacturers can still produce only a fraction of the needed tracheostomy supplies. Adding to the crisis is the 2021 recall of Philips Respironics ventilators. Although the company initially planned to complete the repair and replacement program by December 2022, a more recent report said they expect to complete “around 90%” of the production and shipment to consumers in 2022.

Real-World Impact

Kimberly Holmes didn’t know there was a pervasive shortage of tracheostomy supplies until a few months after her medically complex daughter underwent a tracheotomy in January 2022. The Shiley trach her daughter received in the hospital “rubbed her chin raw,” Holmes said, and the ventilator circuit kept popping off. When she reported these difficulties to her daughter’s pulmonary/ otolaryngology team, they ordered a custom Bivona trach for her.

Months passed. Holmes looked online and connected with another mom whose child’s trach tubes were the exact diameter Holmes’ daughter needed. The mom had a few extras and sent them to Holmes. The tubes were too long, but with few other options, Holmes “carefully snipped them down to the appropriate length” and began using them.

Her daughter’s custom trach arrived six months after it was ordered.

“Just the one,” Holmes said. “No backup trach to change it out and no emergency size down trach either.” The family is currently getting only half of the suction canisters they’re allotted and washing and reusing trach tubes well past the manufacturer’s recommendations.

“I’ve been forced to spend a lot of money I don’t have out of pocket to try to obtain the things I can’t get from the DMEs,” she said. “It’s absolutely absurd that life-saving equipment is in short supply.”

Making do with available supplies increases the risk of harm. Tubes—especially older ones that have developed microfractures—can develop bacterial biofilms, increasing the risk of infection. Mucus can build up, causing inflammation, and ill-fitting equipment can trigger coughing and interfere with communication.

Evans has already suffered numerous infections and is tremendously concerned about the “lifelong impact” of supply shortages. She’s currently working with a local agency to obtain a communication device in case she’s forced to switch to a bigger trach that will inhibit airflow to her vocal cords.

“None of this would be happening if I simply had access to ventilator supplies,” Evans said.

Dr. Bock said he’s recently seen “at least three patients who came in nine to 12 months or more after a hospital discharge without any plan for trach care or trach supply management.” He had to perform surgery on one woman to remove significant granulation around her tracheotomy and insert a new trach tube.

Nobody knows the extent to which patients and families are experiencing adverse consequences. Rebecca Brooks, RN, an advanced practice registered nurse/pediatric clinical nurse specialist with CHAMP (Children’s Health Airway Program) who works with Dr. Johnson, said, “We haven’t had anybody with complications,” as patients can contact the office or ventilator clinic for help.

McLelland, the California mom, suspects the true human cost of tracheostomy supply shortages will never be fully known. “No one’s tracking the infections, pneumonias, and deaths that come from routine reuse of medical equipment that’s supposed be disposable,” she said.

---

Jennifer Fink is a freelance medical writer based in Wisconsin.