There are substantial changes in the third edition of IEC 60601-1, and understanding all aspects of them is the key to turning the standard into a benefit for medical-device manufacturers.

Japanese vehicle manufacturer, Toyota, is well-known for developing the principles of lean manufacturing. Research published in the International Journal of Technology Management suggests that the lean approach might also be beneficial to medical procedures, making hospitals more efficient and cutting waiting lists.

I recently attended the annual forum of the Institute for Healthcare Improvement (IHI), which is probably the leading health improvement organization in the world. The forum has grown from under 100 attendees in 1989 to almost 6,000 this year—half of whom were there for the first time—with now thousands more virtual participants. It has become a cliché that invokes my gag reflex when participants say, “Oh, I go to get my batteries charged.” And I always wonder, on hearing this, Why were they drained?

A nurse refuses to help an ailing alcoholic who is upset to find a hospital detox unit closed. A hospital clerk brushes off a deceased woman’s grieving family as they try to pay her bills and claim her belongings. A charge nurse keeps the mother of gunshot victim from seeing her son, saying the emergency room is “too busy.”

To improve quality, the most effective hospitals and leaders focus on processes and systems, instead of just lecturing and cajoling their employees and physicians to do better. W. Edwards Deming famously stated that the problem with posters and exhortations was that “they take no account of the fact that most of the trouble comes from the system.” His words still ring true today.

Hospital-acquired infections, ventilator-acquired pneumonia, patient falls, and similar events are (hopefully) rare enough to promote discussion of control charts for rare events. A Google search will, for example, turn up the application of u charts to falls per 1,000 patient days (u being defect density, such as defects per unit or defects per time period).

As a 2011 recipient of the Malcolm Baldrige National Quality Award, the Henry Ford Health System in Detroit has achieved recognition as a top-performing organization for excellence in innovation, efficiency, and quality improvement. The highest priority of our quality improvement work is to become a harmless organization. As a member of the Institute for Healthcare Improvement (IHI)’s “100,000 Lives” and “5 Million Lives” campaigns, we used IHI’s 12 evidence-based interventions as well as other initiatives to reduce harm.

Story update 12/13/2011: Additional information was added to the first paragraph pointing out the connection between FDA requirements and statistical tools.

A first-of-its-kind framework released Dec. 6, 2011, offers recommendations to food and food packaging companies on how to identify and evaluate nanomaterials in products. Not only is this technology unregulated and untested for its implications on public health but companies may not even be aware if they are using products made with nanomaterials.

(ASQ: Milwaukee, WI) -- The results of ASQ’s 25th annual Salary Survey show strong average salaries for quality professionals in 2011 and fewer lay-offs as companies continue to see the value of quality and its positive impact on an organization.

The survey results also show that experience and obtaining ASQ certifications can significantly boost earning power for both U.S. and Canadian respondents.