Statistical evidence suggests that one or two measures of a patient's heartbeat per hour are not a statistically adequate sample for decision making. Especially since more reliable procedures, based on statistical process control are available. Current clinical practice can be compared to industrial procedures used in Japan prior to Dr. Deming's quality revolution. In the authors' opinions, the only reason the one point outside a judgement specification limit works in medicine is the extra effort that is put forth by high skill caregivers. Current clinical practice is to search for a cause when one measurement is beyond the specification limits.
Medial devices produce raw data.
Some medical schools are trying to address this problem by integrating new technology into the traditional medical courses. One of the greatest obstacles to applying industrial quality practices to healthcare is the legal system, which threatens caregivers to follow the accepted practice to avoid litigation. In addition, the FDA protects the public by limiting the use of new untested technology. It is impossible to establish the benefits of SPC in a health care setting without testing the benefits. When SPC is utilized, patient treatments are likely to change and the user is consequentially changing the practice of medicine.