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 millions of IV bags are used daily around the world, these shortages are a big concern to the FDA. Since 2014, they 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.
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.