X-ray Inspection Becomes More Crucial as Medical Device Recalls Rise in 2023

January 18, 2024 – For the first time, manufacturing defects have outpaced non-manufacturing issues for medical device recalls in 2023. Typically, non-manufacturing issues such as sterility, quality, or malfunctioning parts are cited as the leading causes of product recalls. However, according to the “U.S. Product Safety and Recall Index Report”, manufacturing defects are surging forward.

The noticeable increase in medical device recalls underscores the heightened importance of quality control. It plays a crucial role in safeguarding not only manufacturers but also the integrity of the healthcare industry and the well-being of patients. And the data underscores this necessity. Specifically, in the initial quarter of 2023, there was an almost 5% increase in the occurrences of medical device recalls. The staggering total for each impacted device involved in these recalls is 83.3 million, rising by more than 34%.

“Facing just one recall could hit a manufacturer’s pockets hard, with costs up to $600 million.” Said Steve Zweig, VP of Sales, Glenbrook Technologies. “With X-ray inspection, you’re not just cutting recall costs; you’re also keeping a tight grip on quality, which benefits both patients and the whole healthcare system.”

“The uptick in recalls signals a need for manufacturers to prioritize quality assurance through X-ray inspection.”

The uptick in recalls signals a need for manufacturers to prioritize quality assurance through X-ray inspection to minimize risks. Timely detection of issues through X-ray inspection can prevent expensive recalls, which not only incur direct costs but also potentially save a manufacturer’s reputation.

Glenbrook offers a variety of X-ray machines designed for medical device inspection that can:

• Detect discrepancies, anomalies, or indications of substandard manufacturing
• Strengthen supply chain security by conducting thorough inspections
• Enhance overall quality control specific to medical device manufacturing

Each X-ray system is versatile, capable of inspecting a diverse array of medical devices including Catheters, Packaged Transcatheter Devices, Biopsy Needles, Drug Delivery Devices, Heart Valves, Pacemakers, Vena Cava Filters, Biopsy Markers, Surgical Staples, Stents, Robotic Surgical Arms, Microelectronic Implants, and other critical components.

Glenbrook Technologies provides a range of X-ray systems for medical device inspection, such as The JewelBox Series known for ultra-high resolution, powerful microfocus X-ray tubes, and five-axis positioners. The Cath-X offers detailed views of critical needle device components, and The Bench-X is a compact option with high resolution at relatively low radiation levels. Custom configurations are also available that can meet your requirements.

For more information about Medical Device X-ray Inspection Systems at Glenbrook, click here.