Countermeasures to medical errors and relation with ISO9000 (2000,Aug-4w)
1. America:[T0 ERR IS HUMAN]
"TO ERR IS HUMAN: BUILDING A SAFER HEALTH SYSTEM", written by Committee on Quality of Health Care in America: INSTITUTE OF MEDICINE, says more people (estimation 98,000) die in a given year as a result of medical errors than from motor vehicle accidents (43,458), breast cancer (42,297), or AIDS (16,516).
Using a detailed case study, the book reviews the current understanding of why these mistakes happen.
Comprehensive and straightforward, this book offers a clear prescription for raising the level of patient safety in American health care.
In the chapter 8, it says 5 principles for Key Safety Design Concepts.
Among the principles there is a principles that Respect Human Limits in Process Design. This concept is similar to POKAYOKE.
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In Japan, in order to prevent medical errors, recently hospitals that have installed near misses reporting systems are increasing.
But countermeasures taken to prevent medical errors often do not base the Respect Human Limits. Often countermeasures, which are relied on human awareness, are noticed.
2. Medical services and Process Design
Products of hospitals are medical services. But design activities of hospitals are Process Design, not Product Design. This differs from manufacturing companies.
In hospitals, Process Design is vital and effective if done properly. 4.4 clause: Design Control of ISO9001 can be applied to this Process Design.
Design review, design verification, design validation of Process Design in medical services in hospitals are effective.
Some auditors say that Process Design is not a design and Product Design is only a design work in ISO9001. The auditors cannot contribute to raising quality of medical cares in hospital.
3. uality assurance and Quality management of medical cares in hospital
Quality assurance will generate from good Quality management that will decrease medical errors.
Some say that the purpose of ISO90001 is to assure Quality system, not improve Quality. To improve Quality, ISO9004 should be used.
But without improving medical cares effectively in hospitals, Quality assurance of hospitals cannot be attained.
If a hospital gets ISO90001 certification with heavy documentation and no prevention of medical errors, demoralization and meaningless workload will increase medical errors in the hospital.
Installation of an effective ISO9001 is necessary to a hospital.