Ivenix, a medtech company based in North Andover, Massachusetts, has developed the Ivenix Infusion System for intravenous drug infusions. More than 90% of hospital patients receive intravenous infusion therapy, yet infusion errors remain a significant challenge. In the U.S. alone, these errors are estimated to cost approximately $2 billion annually. Strikingly, more than 50% of adverse drug events involve drug infusion errors. The ECRI Institute, a patient-safety watchdog group, named infusion errors the No. 1 technology hazard in 2017.
Drug infusion systems can suffer from issues such as inconsistent fluid delivery, complexity of use, and nuisance alarms. It can also be extremely difficult to monitor older systems remotely, or integrate them with existing hospital information systems. Ivenix has developed its infusion system to address these persistent problems.
Medgadget asked Ivenix CEO Stuart Randle some questions to find out more about the company’s technology and the issues it’s addressing.
Conn Hastings, Medgadget: Please tell us a little about infusion errors and the healthcare issues they create.
Stuart Randle, Ivenix: The majority of patients who are admitted to a hospital today receive an infusion during their stay, which ranges from simple fluid replacement to very complex, high-risk drugs. Infusion-related errors can be harmful to the patient and can have a significant financial impact on the hospital. Infusion-related errors account for more than 50 percent of the 1.5 million adverse drug events reported annually to the FDA, and infusion-related adverse drug events account for more than $2 billion in annual costs. More than 23,000 pump malfunctions and subsequent injuries have been reported to the FDA’s MAUDE database between 2015 and 2017.
Medgadget: Can you give us some background on the challenges facing healthcare staff in delivering infusions using traditional systems?
Stuart Randle: Clinicians are faced with continually evolving demands in today’s complex healthcare environment. They are managing multiple patients, often with multiple devices attached to them – each with a unique user interface and workflow, which can be challenging and result in patient harm and workflow inefficiencies. On top of that, many of these devices are now integrating with the electronic medical record (EMR) and other hospital information systems, compounding the amount of data – and decision points – that clinicians must manage. At an institutional level, cybersecurity is an overarching concern, and a fleet of infusion pumps can represent a potentially large attack target for cyber threats.
With current infusion systems, outdated technology and poor user interfaces have led to persistent use errors, pump recalls and cybersecurity threats. Today’s pumps interoperate with hospital information systems, but not well, and infusion data is not being used to its full potential. Incremental improvements to legacy infusion systems have not addressed the safety and efficiency needs of our modern healthcare system. We believe this industry is long overdue for a new, innovative alternative for providers.
Medgadget: Please give us an overview of the components of the Ivenix Infusion System.
Stuart Randle: At Ivenix, we are rethinking infusion delivery to set new standards in safety, simplicity and interoperability. The Ivenix Infusion System consists of the following:
Medgadget: How does the system help to avoid infusion errors?
Stuart Randle: We took a holistic approach to the infusion delivery process with the guiding principles to simplify every step, eliminate unnecessary work, and inform every decision to streamline delivery with the goal of improving patient safety and clinician efficiency.
For example, programming errors are one of the leading use errors associated with potential infusion-related adverse events. The Ivenix Large Volume Infusion Pump (LVP) features a smartphone-like user interface that encourages programming safety and accuracy, guiding clinicians through their workflow with a touchscreen interface rather than presenting clinicians with different buttons and workflows that may lead to programming errors.
Hospitals’ best practices attempt to avert programing errors, but they are often difficult to navigate by the clinician and can be bypassed. We designed a drug library that is in the pump itself for automatic opt-in by the clinician and provides real-time feedback on the infusion medications’ compliance with the hospitals’ formularies.
Medgadget: Can the system be integrated with existing hospital information systems? Can clinical staff remotely monitor and control the system?
Stuart Randle: The Ivenix Infusion System architecture begins with interoperability and security at the onset, which allows for quality, secure data communicated in a way that’s designed to make infusion delivery safer and more efficient.
The pump’s remote monitoring through a mobile clinical viewer allows staff to access a patient’s infusion status from anywhere. For example, if there’s an alarm or if a critical infusion is coming to the end of the delivery, clinical staff can monitor remotely and know what to do next. We are turning data into real knowledge to streamline patient care and clinician communication.
Medgadget: How does the system improve on the accuracy and consistency of pre-existing systems?
Stuart Randle: Large volume pumps typically report flow accuracy of plus or minus 5 percent, but this is in controlled laboratory conditions. In the real world, clinical conditions often differ significantly from lab results for a variety of reasons, such as height of the bag in relation to the pump or the viscosity of the fluid being delivered.
An adaptive pumping system that automatically compensates for external factors impacting flow will help administer infusions as the clinician intended. For example, medications delivered as a secondary, or intermittent infusion, are required to be hung at a particular height above the pump with the majority of pump technology today. If this isn’t performed correctly, it can result in under-infusion, or no infusion, of these medications. With an adaptive pumping system, this secondary medication bag does not need to be hung at a particular height, which eliminates this potential source of error and ensures these infusions are administered as programmed by the clinician.
Note on the Ivenix Infusion System: 510(k) pending. The Ivenix Infusion System is not commercially available in the U.S.
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