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IV Bags: Is there an end in sight to IV bag recalls/supply issues?

Intravenous (IV) solution bags are in high demand in our healthcare system, and quality control is one of the key success factors driving this market. Intravenous solution bag recalls due to defects and leaks are one of the most disruptive issues in the industry.

Biomed Security
Suzie Dufour
Date  January 2020

Recalls result in undesired costs for manufacturers (up to $5 billion according to a BCC search) and shortages throughout the supply chain for caregivers. Not only are these recalls expensive but they also present complex logistical challenges and potential risks to patient safety. Improved solutions for intravenous bag quality inspection are needed to help solve recall and shortage problems.

IV solution bag integrity can be compromised in different ways. Defects can include micrometric holes, irregularities in the seal around the bags, stretched material over ports and connectors at junction points, friction points, fragile points, and port insertion errors. Bags are made of clear material and often contain a clear solution. As a result, most of these flaws are hard to detect with the naked eye and even sophisticated inspection systems can fail to identify them. To add to these difficulties, bag inspection systems must be integrated into quality controlled high-volume production chains. More often than not, inspection is performed by humans and, unfortunately, everyone gets tired at some point. And this increases the risk of a defect slipping through the production line and potentially causing a recall.

Generally, if a defective product reaches healthcare providers, the entire production lot must be recalled, leading to substantial costs due not only to the recall itself but also to production interruptions, product replacement, and associated logistical issues. In addition to those monetary costs, IV bag producers also face the risk of losing the trust of their clients and the general public. Ultimately, the biggest challenge of inline inspection difficulties is the risk of exacerbating IV bag shortages. Given that about 200,000 people around the world need IV bags daily, these shortages are a big concern to the FDA. In 2014, it started working with major companies to reduce these shortages.   

Over the years, INO has developed multiple quality inspection systems based on our imaging, image fusion, optical design, and image processing expertise. We developed a video rate imaging technology for small leak detection. Our robust technology has been shown to be effective at identifying small solution leaks in different environments and with different bag samples. The method is robust and, more importantly, compact, making it a preferred solution for integration into existing production and inspection protocols.

 

Isn't it obvious?

Isn't it obvious?

Our engineers and researchers have developed more than 6,000 custom solutions. INO guides its customers through five easy development phases:

  • Requirement phase
  • Custom solution blueprint
  • Prototyping phase
  • Integration of a complete solution
  • Transfer and production scaling phase

Reducing product recalls and the associated costs is possible. If assessing the integrity of intravenous solution bags is a challenge for you, contact us to find out how we can use our technology to develop a custom solution to your quality inspection challenges.

 

About the author

Suzie Dufour

Solutions Manager

Solutions Manager since 2019, and part of the INO team since 2015, Suzie has strong expertise in biophotonic, neurophotonic, ophthalmology, biomedical imaging and in vivo experimentation.  As a researcher, she participated in projects related to ophthalmic laser surgery, ophthalmic imaging and sensing, and printable photonics.  She’s the author and co-author of more than 20 peer reviewed journal publications and she’s participated in more than 30 conference scientific presentations.

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