Tackling Infusion Supply Shortages with Innovation and Alternative Delivery Solutions

In the wake of COVID-19, hospitals are experiencing a marked shortage of medical supplies. Notably, infusion pump supplies—used to deliver fluid and medication critical in treating complex patients—are also growing short. In April, the Institute for Safe Medication Practices (ISMP) concluded that health care organizations were indeed having trouble accessing enough infusion supplies or expecting shortages. [1]

Preparing against potential shortages requires transparency, and the CARES Act signed into law in March 2020 grants the FDA authority to help prevent or mitigate medical supply shortages during a public health emergency. This law requires manufacturers to notify the FDA of a meaningful disruption in the medical device supply chain. [2] Additionally, the FDA and ISMP have provided pointed solutions and alternatives in anticipation of infusion pump shortages.

Innovation: A Solution to Shortages

Manufacturing solutions required to fix the stockpile shortage entail changes in the design and production of infusion pumps and accessory devices. As a response, the FDA is allowing infusion pump makers to make low-risk or moderate-risk changes to the devices without submitting a new 510(k). [3]

This policy encourages device manufacturers to propose modifications to design, indication, material, energy source, or manufacturing process with a goal of increasing availability of medical supplies, as well as to create better remote monitoring capabilities. [3] And the industry as a whole has been granted flexibility to add production lines or manufacture at alternative sites with different equipment. [3]

Examples include changes to motors or other components used in infusion pumps, which may be provided by an alternate supplier; use of infusion pumps for patient populations not referenced in the device labeling (e.g., adults may use pumps indicated for pediatric patients); and adapting pumps not originally intended for ground or air transport for use in emergency or ambulatory care. [3] The FDA is further advocating a push to modify current infusion technology to be operated and monitored remotely. [3]

Smart Pump Alternatives

Health care organizations experiencing or anticipating a shortage of infusion pumps should consider alternative setups such as gravity flow infusion and syringe pumps and allocate smart pumps on a basis of specified medication and patient criteria.

The ISMP recommends taking inventory of all pumps, searching on and off-site settings, including interventional radiology departments, perioperative units, ambulatory care/procedural areas, and surgery centers. [4] In addition, due to the postponement of many elective procedures, unused anesthesia supplies can be found, including syringe pumps. [4]

Health care organizations should furthermore identify medications that rely on smart infusion pumps for delivery and outline patient requirements (e.g., age, comorbidities, vascular access). [4] Careful allocation of equipment should be based on these criteria; patients may be switched to oral therapies if appropriate. [4]

Smart pump alternatives may include gravity infusions (for IV hydration, some IV antibiotics, and medications that are not high alert), tubing with IV flow rate regulators (such as DIAL-A-FLOW), or available add-on regulators. [4]  Consider using an electronic drop counter with an alert system in tandem with a standard rate regulator to augment monitoring.  This pairing will provide an alternative to the primary pump features of rate regulation and monitoring that traditional unassisted gravity infusions lack. Other infusion devices that may be adapted in an emergency setting are volumetric burette tubing, elastomeric devices, and non-electronic-rate controllers. [4]

However, all these supplies may run short in the future, and ensuring access to infusion pumps relies on collaboration between health care organizations, manufacturers, and the national stockpile to plan and guide production for emergency preparedness.

References:

  1. https://www.medtechdive.com/news/the-latest-coronavirus-shortage-hospital-infusion-pumps/575891/
  2. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/medical-device-shortages-during-covid-19-public-health-emergency
  3. https://www.medtechdive.com/news/coronavirus-fda-infusion-pump-modifications-to-prevent-shortages/575511/
  4. https://ismp.org/resources/planning-anticipated-shortage-smart-infusion-pumps-and-dedicated-administration-sets

Leave a Reply

Your email address will not be published. Required fields are marked *

You may use these HTML tags and attributes:

<a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <s> <strike> <strong>