BD Bounces Back with Alaris 510k Approval

Published 08/08/2023

The BD Alaris System is all set to make its comeback with its recent 510K approval. This follows significant remediation efforts after BD’s voluntary Class I recall of the device in March 2020. After what has indubitably been a long and cumbersome process, BD has received the greenlight to proceed with the redistribution of the Alaris System across the US as of July 2023. Reintroduction of this device is likely to be well received from hospitals looking to capitalise on and broaden their patient visibility and integration capabilities.

BD’s Remediation Efforts Deemed Successful by FDA

Becton Dickinson (BD) issued a voluntary Class I recall on the Alaris System Infusion Pump, in which the company warned customers of the device’s operational errors. A myriad of software errors resulted in a distribution halt for the company. Issues pertaining to software errors, delays in programming, and alarm failures, were associated with serious injury and death. The recall affected 774,000 units sold in the United States.

Thankfully, three years after the initial non-conformance order, BD’s efforts to remediate software errors have placed the Alaris Infusion Pumps System back in the US market. BD is expected to regain previous customers and potentially expand its client base. The remediation efforts and reintroduction of the Alaris System comes with additional software benefits as the newly issued devices will have clinical, operational, and cybersecurity updates. As the infusion pump market becomes increasingly digitalised BD has been smart to revitalise its solution off this recall and integrate additional and highly desirable features within the device.

The Long-Awaited Return of the Alaris Infusion Pump System

The Alaris platform was the leading infusion pump device in the United States due to its comprehensive system. It has a broad range of capabilities including EMR (Electronic Medical Record) interoperability, auto-identification, drug error reduction software and respiratory monitoring. Its all-encompassing patient view provides smart and connected care, which is increasingly sought by healthcare professionals. However, uncertainty regarding safety concerns may be hard to shake for some buyers. BD noted in an assuring release to stakeholders that all initial capacity investments required for remediation and subsequent FDA approval are expected to fall within its 2023 financial guidance range, as the company does not foresee undergoing any negative financial impact.

As the only infusion system commercially available in the US with a centralised user interface that provides visibility of up to four infusion types, customer demand for connected solutions is likely to drive further uptake of the Alaris pump system. Furthermore, brand loyalty and the need for innovative solutions to tackle the staff crisis is expected to allow BD to remain comfortable in its position as market leader. The Alaris Infusion System has an impressively robust customer base, which BD claims to have the largest number of nurses trained to use and the greatest number of customers with EMR interoperability. It is therefore likely that hospitals will be unwilling to undergo time intensive training of new devices and will readily receive the updated Alaris pump with open arms. Despite brand loyalty evidently intact, rigid product replacement cycles and restricted hospital budgets may limit the full potential uptake of the device in the short-term. While, this is not expected to negatively impact BD’s market share, it may pose an obstacle in further broadening its customer base.

Recalls Continue to Plague the Infusion Pump Market

Software errors have proven to be a common theme in recalls within the Infusion Pump market, and BD is certainly not alone in its remediation efforts. The infusion pump market has seen a frequent influx of recalls in the past few years. The table below outlines recalls that have specifically impacted the US infusion pump market.

Table 1

Regulatory Bodies Provide Guidance Amidst the Struggle

With many recalls pertaining to software errors with the potential to cause patient harm, the US Food and Drug Administration has updated its medical software compliance regulations. Further documentation is required for all companies, with requirements increasing in line with software complexity. The update in regulations is expected to reduce the risk of non-compliant software entering the market and encourage the safe manufacture and development of software. Internationally, regulatory bodies have also taken steps to mitigate risks to patient harm. The UK’s Medicines & Healthcare products Regulatory Agency has issued an AI and Digital Regulations Service providing guidance to manufacturers and software developers on current digital health regulations.

It is the hope that regulatory initiatives will shine light on how emerging and established manufacturers can promote the digitalisation of infusion pumps and wider clinical solutions, without jeopardising patient care. As connectivity, software, and artificial intelligence developments become increasingly important, priorities must shift to ensuring patient care is not only revolutionised, but safe and effective.

Related Research

Signify Research is due to publish its Infusion Pump – World – 2023 report. The report builds on our 2022 edition of the research and provides a data-centric and global outlook of the market. The report blends primary data collected from in-depth interviews with healthcare professionals and technology vendors to provide a balanced and objective view of the market.

About Tosin Alex-Duduyemi

Tosin joined Signify Research in 2022 as a Market Analyst within the Clinical Care team. She holds a bachelor’s degree in Biological Sciences from the University of Birmingham & has prior experience working in primary and secondary education.

About the Clinical Care Team

The clinical care team provides market intelligence and detailed insights on the clinical care equipment and IT markets. Our areas of coverage include patient monitoring, diagnostic cardiology, infusion pumps, ventilators, anaesthesia devices, and high-acuity IT. Our reports provide a data-centric and global outlook of each market with granular country-level insights. Our research process blends primary data collected from in-depth interviews with healthcare professionals and technology vendors, to provide a balanced and objective view of the market.

About Signify Research

Signify Research provides healthtech market intelligence powered by data that you can trust. We blend insights collected from in-depth interviews with technology vendors and healthcare professionals with sales data reported to us by leading vendors to provide a complete and balanced view of the market trends. Our coverage areas are Medical Imaging, Clinical Care, Digital Health, Diagnostic and Lifesciences and Healthcare IT.

Clients worldwide rely on direct access to our expert Analysts for their opinions on the latest market trends and developments. Our market analysis reports and subscriptions provide data-driven insights which business leaders use to guide strategic decisions. We also offer custom research services for clients who need information that can’t be obtained from our off-the-shelf research products or who require market intelligence tailored to their specific needs.

More Information

To find out more:
T: +44 (0) 1234 986111