Development of a Risk-Based Methodology for Improvement of Health Technologies: Pilot Application to Orthopaedic Surgery. D. Charles and A. Bardsley, AEA Technology plc, Culham, Abingdon, Oxfordshire, UK; P. Joice and I. D. Learmonth, University of Dundee, UK; and E. J. Smith, Department of Orthopaedic Surgery, University of Bristol, UK
The objective of this study is to develop and undertake a predictive,
a priori analysis of the critical factors which influence
the success of complex surgery, initially total hip replacement
(THR). This is intended to highlight the individual steps of
surgery most prone to human error, and hence direct the focus
of outcomes studies, as well as the practical measures that could
be implemented to reduce the likelihood and severity of errors.
In the light of the recent focused examination of the factors
influencing the quality of health care, the study capitalises
on the opportunity to transfer appropriate experience of human
reliability assessment to the health care field.
The study has looked at a small number of different approaches
to THR. Training videos of typical hip replacements were used,
supported by discussions with consultant surgeons. The THR procedures
were first resolved into discrete conceptual steps (Task Analysis),
and in close consultation with clinicians, a systematic identification
of credible, potential errors was conducted using a formal human
error identification technique. Input from clinicians
was used to predict the consequences of the errors thus identified,
and these were then screened to leave only those which if committed,
could conceivably lead to a failure of the replaced joint within
its design or target life. A human error quantification methodology
was then used to rank each remaining error, both in terms of its
likelihood of occurrence, taking into account existing procedural
controls or other safeguard mechanisms, and its consequence (i.
e. the likelihood if committed to necessitate a revision).
A consideration of the impact of the dependence of potential
errors on prior events and errors was included, as were the steps
intended to check that previous actions had been undertaken adequately.
An overall risk profile for the studied procedure was then produced,
indicating which steps are likely to present the greatest contribution
to the overall risk of failure. Recommendations of practical
measures that could reduce the overall risk of long or short term
failures of THR necessitating revision are then presented.
A second surgical replacement was studied using the same methodology
in order to investigate the relative strengths and weaknesses
of particular overall approaches to THR from a human
reliability perspective, together with the impacts of individual
surgical techniques.
It is hoped that this work will stimulate a wide-ranging discussion
on the value of the approach, and elucidate the views of research
fending bodies on its potential role in improving the performance
of orthopaedic, and other emerging techniques, such as key-hole
surgery.