Supporting healthcare heroes on the frontlines
GOODS
& BECTON DICKINSON
Project Type
Services
Industry
Becton Dickinson and Company (BD) is a global medical technology leader, driving innovation in healthcare through groundbreaking products and solutions that improve diagnostics, care delivery, and support for healthcare providers worldwide.
Highlights
Goods has worked closely with BD since 2014, providing extensive support in their medical initiatives- Provided quality management and testing of BD’s infusion pumps
- Worked with BD to ensure the availability of essential healthcare resources to patients
- Goods aided BD in reintroducing solutions to the market and securing FDA approval
Goods and BD joined forces in 2014 as BD sought a partner who understood the importance of quality management and could assist with their initial 510K filing. Goods has been working closely with BD in medication management for more than 10 years, primarily focusing on testing infusion pumps. With the acquisition of CareFusion, BD now dominates the global infusion pump market. It's highly likely that, if one has received medication through an infusion, they have benefited from a pump made by BD.
As a leading manufacturer of devices and infusion pumps, BD is committed to enhancing connectivity in hospitals and healthcare facilities. Their unique BD Alaris Infusion System securely links patient modules, providing care teams with a comprehensive patient perspective. This innovative platform seamlessly integrates with the most widely used electronic medical record (EMR) systems, ensuring scalability and interoperability.
In May 2019, BD initiated a Class 1 recall of more than 150 million Alaris Pump Model 8100 infusion sets produced from May 2016 to March 2019 due to potential issues causing rapid medication delivery or operation while not in "running status." The recall resulted from non-uniform silicone thickness in the tubing, leading to tubing failure or blockage, associated with reported injuries, including serious ones. These recalls had a significant impact on the healthcare industry due to the market share BD has on devices and infusion pumps.
In response to the recalls, BD prioritized taking action to increase engagement and ensure the safe reprogramming of these devices.
Ensuring the safe reintroduction of BD's solutions
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Supporting multiple 510K filings
From that point, Goods's main goal was to assist BD in reintroducing their solutions to the market. We played a crucial role in resolving issues and facilitating the release of these solutions by supporting multiple 510K filings. This partnership has had a significant impact on the availability of essential healthcare resources by ensuring that only quality and safe devices enter hospitals.
“From day one, we've tried to embed in our employees what important work they're doing. It’s more than just testing and coding. It impacts not only community health, but it actually helps to save lives.”
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On-going assistance and support
Goods's dedication to this project is evident as they have supported BD in three other 510K filings, addressing concerns raised by the U.S. Food and Drug Administration (FDA) regarding their devices. These actions were necessary to meet quality standards and ensure the safety of the devices in healthcare settings. Throughout the years, Goods has consistently provided assistance and support whenever needed, solidifying their commitment to BD and the success of their solutions.
“Since 2014, we've proudly supported BD on mission-critical devices and projects, creating solutions that advance the world of health™. Our team deeply respects the importance of working with medical devices and approaches each project with innovation and care.”
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Achieves FDA Approval
Recently, the hard work of the Goods and Services team paid off by securing FDA approval to reintroduce Alaris pumps to the market. The 510K clearance from the FDA paves the way for the system's comprehensive infusion capabilities to reenter commercial operations and deliver an optimized standard of care. This news holds a special significance to Apodaca, whose own father and uncle relied on these pumps for their survival while in the hospital.
“It's a wonderful thing to be able to work on something that helps drive an outcome in people's lives. If my dad and my uncle did not have those pumps, neither of them would be here. And those are just two cases, but there are hundreds of thousands of people that those pumps are supporting on a daily basis,” Apodaca said. To address open recalls, BD will engage closely with customers to ensure remediation or replacement of devices in the field, prioritizing compliance and patient safety. The company's operational capacity investments will facilitate rapid distribution and comprehensive support for the BD Alaris Infusion System.
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