Next COVID-19 device shortage? ‘Smart’ infusion pumps

Severely ill COVID-19 patients may need multiple medications delivered by infusion pumps. Manufacturers and hospitals are planning on how to avoid shortages of these pumps and the associated tubing.
You’ve likely seen the videos of ICU hallways lined with medical devices that would normally be in patient rooms.
Among them are machines that are ubiquitous throughout any hospital — “smart” infusion pumps that are programmed to deliver controlled doses of medication. The effects of COVID-19 on patients’ organs heighten the need for these pumps — made by companies including Becton Dickinson (NYSE:BDX), B. Braun, Baxter (NYSE:BAX), ICU Medical (NSDQ:ICUI) and Ivenix.
The pumps’ medication administration sets and the extended tubing that allows them to operate in hallways to reduce nurses’ exposure to COVID-19. Some patients even need multiple pumps.

‘The rules were thrown out a while ago’

Reports of pump shortages began popping up on nurses’ listservs in March as the volume of critically ill COVID-19 patients began to increase, according to the ECRI Institute and the Institute for Safe Medication Practices (ISMP). In acute-care settings, these smart pumps deliver vasopressors, antiarrhythmic agents, opioids, anesthetic agents, neuromuscular blocking agents, antithrombotics and insulin, many of which COVID-19 patients need.
The volume of patients is what’s taxing the system in terms of the availability of pumps, according to Michelle Mandrack, a nurse and the director of consulting services at ISMP.
“Some hospitals have to face choices in where they will use smart pumps when the patient need exceeds their available supply,” Mandrack told Medical Design & Outsourcing. “I think the availability of smart pumps is not as stressed as probably the ventilators, but we are hearing conversations where organizations are trying to figure out how they’re going to make these kinds of decisions.”
Nurses must carefully titrate highly concentrated drugs and, to ensure proper dosing, want the pumps supplying those medications to be as close to the patient as possible, according to Susan Niemeier, chief nursing officer for smart infusion pump manufacturer Ivenix (North Andover, Mass.). Niemeier said she started noticing nurses positioning the pumps outside patient rooms in early March.
“It was a very creative way to accommodate a challenging situation. It’s not ideal. The rules were thrown out a while ago,” Niemeier said. “If you’re delivering a drug that is highly sensitive and to be delivered at a very low rate you now have extra feet of tubing.”
The use of extended tubing also raises issues of infection control and tripping hazards, not to mention the possibility of shortages. The drug propofol, used for sedation, contains lipids that raise the possibility of bacterial contamination if the tubing is not changed regularly. For propofol, the standard of care is to change the tubing every 6 to 12 hours, Niemeier noted.

Bracing for shortages

Healthcare providers, hospitals and pump manufacturers are all bracing for the possibility that the pumps and their accessories may go into more widespread shortage as the virus spreads across the country and the world.
ECRI and ISMP have been planning for such a shortage for weeks and advising health systems on how to maximize the infusion pumps they already have. That advice includes scouring their other departments and clinics for unused pumps as care focuses on COVID-19 patients.
Hospitals have been using smart infusion pumps for about 20 years, according to Mandrack. They tend to stick with a single manufacturer because they can program the pumps’ built-in software library with infusion rates for different medications. The software can also potentially intercept the programming of a mistaken entry that could jeopardize a patient’s health, Mandrack said.
Those infusion rates are also stored in a central library for reference throughout the hospital. If the hospital needs more of those pumps and they are not available, it’s not easy to switch to another manufacturer’s device, Mandrack said.
But unlike the ventilator shortage, ECRI doesn’t expect researchers and others to feel the need to make do-it-yourself infusion pumps, according to the organization’s health devices group engineering manager, Erin Sparnon. Some suppliers are moving away from automatically delivering on every order to allocating supplies to the hardest-hit areas, she added.

Planning ahead

Infusion pump manufacturers are keeping a close eye on the situation as well. Becton Dickinson B. Braun, Baxter, ICU Medical and Ivenix each reported their various efforts to monitor and target inventory as well as boost production of pumps, administration sets and extended tubing to ECRI and ISMP.
Melsungen, Germany-based B. Braun, for instance, told ECRI it has increased infusion set production for critical items and added long extension sets to its inventory. BD said it has ceased automatic shipments of its Alaris infusion sets in order to target shipments to highest-need areas. None of the companies reported shortages of pumps or infusion sets or extended tubing.
“While we are seeing unprecedented increases in demand for pumps coinciding with existing and emerging COVID-19 hot spots, we have been able to meet customer needs through available inventory and by increasing production,” Baxter spokeswoman Colleen Weber told MDO in an email. “We track hot spots based on objective research sources, government data reporting and academic data, such as Johns Hopkins University & Medicine Coronavirus Resource Center.”
Deerfield, Ill.–based Baxter has also seen significant increases in orders for its extension sets, including sets with longer tubing. To ensure patient safety, the company simultaneously reinforced guidance on proper extension-set usage, according to Weber.
“We are working with our manufacturing facilities to increase production of these product codes, and in the interim, have implemented a protective allocation above historical ordering levels to help ensure fair distribution of supply,” she added. “During the pandemic, we are also allocating additional product based on specific criteria that help deliver our life-saving products where they are needed most.”
San Clemente, Calif.-based ICU Medical has reviewed its inventory, including the raw materials originating from COVID-19-affected countries, and confirmed that it has sufficient stock on hand to support its production plan, according to company medical director Dr. John Beard.
That plan includes an across-the-board increase in the manufacturing of IV pumps, consumables and solutions to meet the anticipated surge in demand, Beard noted. ICU Medical has also increased the supply of key infusion set configurations and components used in the treatment of COVID-19 patients, including long tubing sets, he added.
“We review regular supplier updates to identify any supply risks and are taking appropriate measures to mitigate any such risks,” Beard told MDO in an email. “In addition, we conduct an ongoing review of potential impacts caused by constraints that may exist at sub-tier suppliers.”
ECRI and ISMP will also keep an eye on supplies and continue to help guide hospitals and healthcare systems as the coronavirus continues its spread.
“There are areas that are not experiencing that surge but they are preparing for it,” Mandrack said. “It’s definitely an evolving process.”

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