Root cause analysis of epidural spinal cord stimulator implant infections with resolution after implementation of an improved protocol for surgical placement.

BACKGROUND

Placing a spinal stimulator for the purpose of restoring paralysed function is a novel procedure; however, paralysis predisposes people to infection. Preventing surgical site infections is critical to benefit this population.

OBJECTIVE

The objective of this study was to review the root cause analysis of postoperative wound infections by a hospital epidemiology team following implantation of epidural spinal cord neurostimulators in patients with chronic spinal cord injury.

METHODS

A team was assembled to review the case of every individual who had been enrolled to receive a neurostimulator at the facility. A root cause analysis was performed evaluating five categories: the patient; equipment; facility/environment; procedure; and personnel.

FINDINGS

The root cause analysis included 11 patients. Two patients became infected. Three others dehisced their wound without becoming infected. All patients were given preoperative antibiotics on time. A mean of 17 personnel were in the operating room during surgery. Vancomycin powder was used in the patients who either dehisced their wound or became infected.

CONCLUSIONS

The root cause analysis provides guidance for other institutions performing the same novel procedure. This analysis did not reveal a direct association, but did generate several areas for improvement including increasing pre-surgical screening, cleaning transient equipment (e.g., computer screens), limiting traffic in the operating room, using new sterile instruments for each stage of the procedure, not reopening the back incision, not applying vancomycin powder, and using an antimicrobial envelope for the stimulator.

Déclaration de conflit d'intérêts

Declaration of conflicting interests: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The following two authors report conflicts of interest: CA reports grants from The Leona M. and Harry B. Helmsley Charitable Trust, grants from US National Institutes of Health, NIBIB, grants from Christopher and Dana Reeve Foundation, grants from Kessler Foundation, grants from Craig H. Neilsen Foundation, non-financial support from University of Louisville Hospital, non-financial support from Medtronic plc, during the conduct of the study. In addition, CA has a patent High Density Epidural Stimulation for Facilitation of Locomotion, Posture, Voluntary Movement, and Recovery of Autonomic, Sexual, Vasomotor and Cognitive Function after Neurological Injury issued, a patent Methods for Applying Epidural Electrical Stimulation pending and a patent Methods for Detecting and Mapping Spinal Cord Epidurally-Evoked Potentials pending. CF reports grants from The Leona M. and Harry B. Helmsley Charitable Trust, grants from US National Institutes of Health, NIBIB, grants from Christopher and Dana Reeve Foundation, grants from Kessler Foundation, grants from Craig H. Neilsen Foundation, non-financial support from University of Louisville Hospital, non-financial support from Medtronic plc, during the conduct of the study. FA, SB, DJ, LS, CH, LO, TB, MS, YC, SH and MB do not report conflicts of interest.