A STRUCTURED SAFETY CHECKLIST FOR INTRATHECAL PUMP REFILLING: DEVELOPMENT, 12-MONTH IMPLEMENTATION AND PRELIMINARY EXPERIENCE IN 21 PATIENTS

M. Cuomo, C. Barbieri, D. Tammaro | UOC terapia del dolore presidio ospedaliero Monaldi, Napoli, Italy

Background. Refilling totally implantable intrathecal drug delivery systems is a routine but potentially high-risk procedure. Errors in patient identification, device recognition, reservoir access, drug preparation, concentration calculation, residual volume assessment, refill technique or pump programming may result in underdose, overdose, withdrawal syndromes, infection or pocket fill. Standardized safety documentation is particularly relevant in pain medicine units managing different generations of implantable pumps and complex intrathecal drug regimens.
Objective. To develop and implement a structured, paper-based safety checklist for intrathecal pump refill procedures, aimed at improving standardization, traceability and early recognition of procedural red flags.
Methods. A multidisciplinary conceptual review of the refill pathway was performed in a tertiary Pain Medicine Unit. The procedure was divided into sequential safety domains: patient identification, clinical pre-procedural screening, device recognition, pump interrogation, sterile field and material preparation, drug and mixture preparation, residual volume aspiration and verification, reservoir refill, pump reprogramming, post-procedural observation, documentation and scheduling of the next refill. The checklist was designed as a front-and-back A4 landscape form, suitable for different pump systems, including SynchroMed, Archimedes, MedStream and other legacy or currently used models. Specific stop points and alert indicators were incorporated, including suspected infection, unclear prescription, mismatch between expected and aspirated residual volume, difficult port access, suspected pocket fill, uncertain drug concentration and programming discrepancies.
Results. The checklist was used over a 12-month period in 21 patients undergoing refill of totally implantable intrathecal pumps. Its implementation supported a more reproducible procedural workflow and improved documentation of key safety steps, including double checking of drug concentration, residual volume, refill volume, programmed flow and next refill date. The compact front-and-back format was suitable for routine outpatient use and facilitated rapid completion without losing the essential safety structure. Overall, the implementation was associated with a favourable final outcome in terms of procedural organization, traceability and perceived safety of the refill pathway.
Conclusions. A structured checklist for intrathecal pump refilling is feasible in routine clinical practice and may represent a simple, low-cost tool to improve procedural safety, standardization and documentation. This approach appears particularly useful in centers managing multiple pump models and individualized intrathecal drug regimens. Larger prospective evaluations are warranted to quantify its impact on refill discrepancies, near misses, pocket fill prevention and procedure-related adverse events.