Keywords
arthroplasty - implant - osteoarthritis - wrong-site - knee - replacement
Procedures performed at the incorrect anatomical site are commonly perceived as being
relatively rare. However, they can be a devastating event for patients and doctors.
Evidence from the United Kingdom and North America suggests that wrong-site, wrong-procedure,
and wrong-patient events occur more commonly than we think. In previous studies in
North America, orthopaedic surgery has been found to be the worst-offending specialty.
Wrong-site surgery is considered a devastating event to the patient, treating physician,
and the institution. This event may occur in the form of wrong side, wrong level,
wrong patient, wrong procedure, or wrong implant.[1] It has been termed as “never events” and refers to operating on incorrect side,
incorrect level, or incorrect patient. It is estimated that these events occur 1 in
every 100,000 surgical procedure.[2] Although the prevalence varies from one study to another, however, orthopaedic surgery
has gained most of the attention as one of the specialties that has the highest number
of wrong-site surgeries along with spine and dentistry. This occurs in orthopaedics
due to the large number of cases in this specialty and working on symmetrical extremities.[3] According to a study that analyzed data from National Patient Safety Agency and
National Health Services Litigation Authority on 292 cases, it was found that the
most offending specialty is orthopaedics and ranked as number 1 in 2006 to 2007 in
England and Wales. Wrong-site surgery is believed to be under-reported and is more
common than what we think.[4]
Discussion
One case report has been found in the literature describing wrong-site femoral component
in total knee arthroplasty that has ended up with symptomatic patellar maltracking.[5] Sigma system is commercially available in the United Kingdom from August 1997. It
has separate left and right femoral components. In our case, a right femoral component
was correctly positioned in the right knee but a right femoral component was wrongly
placed in the left knee ([Fig. 2]). However, no complications have been observed in our reported case so far. During
her follow-up in the clinic, WOMAC was shown to be 84 indicating very good result.
Several studies have shown that the root cause of such events is miscommunication
among staff, surgical team members, ignoring members questioning the laterality of
the procedure, or staff not speaking up when they notice wrong-site surgery. Other
factors that may contribute are lack of time-out, lack of standardization, or lack
of clear policies. It is of utmost importance to notice that proper communication
inside and outside the operating room among all staff involved in the patients' care
cannot be overemphasized.
The operating room is similar to an airplane cockpit, where improvements in communication
through “crew resource management” have demonstrated improved safety. All members
of the surgical team should feel valued and are emboldened to “speak up” and actively
participate. It is the responsibility of all surgical team members to monitor and
report potentially harmful situations before patient harm is caused. As with pilots
and their crews' use of standardized flight procedures, the use of standardized surgical
systems, including the use of checklists, is critically important to keep the patients
safe. The proper implant, including the correct side, size, and implant type, compatibility,
and expiration date must be confirmed before being surgically implanted to avoid medical
errors and wasted implants which can exhaust the health care system budget. Implants
must be opened individually during the procedure and confirmed by the entire surgical
team prior to opening the package by reading the implant package label directly from
a distance that allows each one of the surgical team members to properly identify
the implant type, laterality, size, and expiration date. The use of large size wall
mounted monitors in the operating room can help overcome the distance problem between
the person presenting the package and the confirming team member. Recent novel study
has presented the use of electronic labeling system has shown to improve the identification
of the implants in regard to type, size, site, expiration date, and resulted in less
wasted implants and can reduce the chance of wrong-site surgeries.[6]
The surgeon should lead the process of procedure confirmation. If the planned surgery
involves multiple surgical sites, procedures, and implants, each should be individually
identified during the initial surgical “brief,” the surgical “time-out,” and the final
“de-brief,” as well as confirmed individually with a “time-out” before each planned
separate site, procedure, and implant. The use of a separate implant “time-out” supports
focused team communication and reduces surgical errors.
Conclusion
Wrong-site surgery is devastating event and is preventable by many measures even if
it does not result in direct harm to the patient. The use of clear policies, standardization,
and time-out is important. Communication must be encouraged and the slightest suspicion
must be taken seriously even if it comes from a junior staff. Miscommunication is
by far the commonest root cause for wrong-site surgery. New strategies should be implemented
to prevent “never events.”