Risk Mitigation with Implementation of 2-D Barcoding

Medical Device Recalls at their Highest in a Decade; Implementation of 2-D Barcoding in Phasium Power’s Manufacturing Execution System (MES) Mitigates Risk

Recent analysis of U.S. recall data shows that the second quarter of 2018 saw the largest number of medical device recalls during a single quarter since at least 2005. Product recall management company Stericycle Expert Solutions releases a “recall index” quarterly. The report, details the frequency and causes of recalls in the food, pharmaceutical, automotive, medical device and consumer product industries. The firm identified 360 recalls in the medical device sector during the second quarter of 2018, up 5 percent from the first quarter. Top causes for medical device recalls included mislabeling issues and quality issues, which can be largely prevented with quality management and document control systems.

OEMs must have more than just the fundamental insurances afforded by ISO 13485 certified suppliers. Phasium Power by Megmeet has implemented a robust manufacturing execution system (MES) in a large ISO 13485 medical power electronics manufacturing environment, where we manufacture medical power supplies, Li-ion battery packs and chargers. This custom 2-D barcoding system tracks parts to the material, machine, process, technician and test level allowing for complete traceability in the event of a quality issue or recall.

The system provides assembly-level data collection and operator and equipment performance indicators and provides custom reporting to a production dashboard allowing for improved planning control for material, production equipment and quality. Before and after data from our factory shows an improvement in quality yielding improved patient safety in addition to improvements in efficiency. As seen in the graph below, key metrics of inventory and material preparation accuracy rates improved from 92% to ~100%. On time delivery improved from 80% to 95% and warehouse staff requirements decreased by 25%. These changes result in tangible benefits to the Medical OEM and patient.

To download Stericycle’s full report, click here

Written by Robin Schneider, Ph.D.

Dr. Robin Schneider is responsible for market expansion in her role as Director of Marketing. She has an expertise in translating market drivers into technical solutions in the battery, charger, and power supply industries and her primary focus has been in medical applications, from surgical to imaging and diagnostics. Dr. Schneider brings almost fifteen years of marketing experience within the portable power industry to Phasium Power, from companies such as Micro Power Electronics, Electrochem Solutions (Greatbatch/Integer) and Inventus Power. She has presented at many technical conferences, has published in peer-reviewed technical journals and is a regular contributing editor to Electronic Design Magazine. Dr. Schneider received a Ph.D. in Materials Science and Engineering from the University of Texas at Austin under the tutelage of Professor John Goodenough, where her research involved li-ion battery and fuel-cell cathode chemistry. Her undergraduate degree is from Columbia University in New York.