When medical devices prove to be defective, put the health of patients in jeopardy, or both, a recall is issued. However, recalls do not always require healthcare professionals to return medical devices; devices sometimes just need to be fixed or adjusted. Medical device recalls can be slow, trying experiences, but technological innovations are helping hospitals discover new and more efficient ways of operating. Let’s take a look at four ways technology is helping to increase the effectiveness of medical device recalls:
1. Improve the quality of medical devices
More and more medical devices are being sold each year, and the competition for sales has led to the production of devices with questionable or poor quality and reliability. With so many companies vying for footholds within the industry, patients are beginning to experience the effects of cost-cutting processes. The medical device industry is growing fast, but the number of medical device related hospitalizations and deaths is increasing even more swiftly. There is a lot to be gained for the regulation and adoption of quality best practices. Companies will soon be forced to focus on reliability and quality throughout the supply chain from design to manufacturing and marketing.
Quite a few technologies exist that would benefit companies as they work to improve the quality of medical devices. Statistical tools, like Quality Function Deployment (QFD), and risk-assessment tools, like process failure mode and effects analysis (FMEA), can both be used to monitor quality.
2. Properly analyze recall information
Device recalls are important in the short term because they protect patients from faulty medical devices – but companies can’t just stop there. In order to truly understand what went wrong and how to avoid the same issues in the future, companies must properly analyze recall information. This can be done with Unique Device Identification (UDI), which helps improve the quality of information received during recalls. The additional recall data can potentially help businesses save money by preventing history from repeating itself. Analyzing recall information can help better identify product problems, make future recalls, and also benefits the safety of patients.
3. Speed up the recall process
Medical device recalls are expensive and can take quite a long time to complete. The longer a recall is, the longer patients are at risk. At this time, most product recalls are handled manually. Processes that require data entry are prone to human error; with medical device recalls, data entry errors can greatly lengthen the recall process and may even cause devices to be lost in the process.
UDI, which utilizes barcodes to record and transmit data, greatly improves the efficiency of the recall process. On average, humans make mistakes every 300 keystrokes; barcode scanners make mistakes once in five to 10 million scans. UDI streamlines the recall process and it does it without making any errors.
4. Establish better visibility throughout the supply chain
Recalls cannot be successful or streamlined if the whereabouts of the faulty devices are unknown. UDI will provide visibility into the source, current location, and flow of medical devices by providing real-time data; this data can be integrated across different IT systems, providing even greater visibility for important device data.
The landscape of medical device recalls is set to change in the coming years. Companies will soon be forced to improve the quality and reliability of their medical devices, and UDI will expedite the recall process.
