The Importance of Human Factors in Patient Safety

  • Posted on 06.07.2016

The Importance of Human Factors in Patient Safety


Goran Ribaric

Director, Regional Safety Officer EMEA J&J Medical Devices


“All men make mistakes, but a good man yields when he knows his course is wrong, and repairs the evil. The only crime is pride.”— Sophocles, Antigone

Just two decades ago, in the late ‘90s, the Institute of Medicine presented shocking statistics, comparing the death occurring from medical errors to the equivalent of a jumbo jet crashing every day. As a result, patient safety came into sharper focus and was recognised as a global challenge that requires skills and knowledge in many areas, including human factors. In Europe, the statistics are similarly worrying and fuelled by cases where surgeons implant wrong organs into the patient, or even worse – bring the wrong patient into surgery.

Recognizing the significant risk to surgical patients, the topic has received attention from international organizations, such as the World Health Organisation (WHO), which published guidelines to improve patient safety in the operating theatre. A 19-item checklist was designed with the goal of reducing the rate of major surgical complications during three time-critical checkpoints: sign-in, timeout, and sign-out. Briefings carried out by operating theatre teams provide an opportunity to identify and resolve issues before a case starts. Debriefings at the end of the theatre list support reflective learning on what went well and what could be done better tomorrow. The checklist also helps to improve the reliability of essential surgical processes by prompting the surgical team to anticipate and prepare for potential problems. It forces a brief period of reflection (the ‘time out’) in which the theatre team works through a series of questions aimed at highlighting potential problems.

Indeed, the checklist has contributed to the overall reduction of mortality in surgery and enhanced communication among theatre staff. From the medical device standpoint, its implementation is critical as it allows demonstrating potentially avoidable adverse events when it comes to:

– Instrument sterility (sterility indicator not checked preoperatively).
– Inadequate anesthesia equipment safety check (inactivation or muting of monitor alarms).
– Lack of preoperative confirmation of the availability and size of implantable devices.
– Equipment function (not addressing equipment deficiencies).

Where do we stand with the implementation of the checklist? Despite the growing evidence demonstrating the effectiveness of the checklist in improving patient safety, the question still remains how to overcome the barriers to its implementation. We don’t believe it is possible to foresee every possible risk, but an organisation that has gone through the process of demonstrating that hazards have been identified, controlled and monitored will be more resilient in the face of unexpected events.

Such an active approach requires a shift in mindset about the ways in which safety is monitored and measured. The checklist must become part of an overall healthcare ethic within the organization, which is a challenging task as it takes a truly collaborative effort to make the change. However, implementing the surgical checklist could be the right step into a future where fewer patients are harmed because of avoidable medical errors.


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