Risk-Based Qualification of Cellular Starting Material Collection Sites: Tools to Determine Scope of Manufacturer Audits and Reduce Duplicative Efforts.

Cellular and Gene Therapy product (CGT product) manufacturers are required by regulations to qualify sites performing cell collection and processing as part of their manufacturing processes. The use of audits to qualify a site is part of the traditional supplier quality models for drug products. Due to the rapid growth of the CGT industry in recent years, healthcare institutions and manufacturers are finding it difficult to manage the increasing workload and resources needed to support audits when they are applied to the provision of Cellular Starting Material (CSM) collection from patients/subjects for the purpose of manufacturing.

Influence of Hospital Transfer Status on Surgical Outcomes for Traumatic Thoracolumbar Spine Fractures: Insights from a Multicenter Investigation.

Objective: Surgical intervention for unstable thoracolumbar spine fractures is common, but delayed management and complications can impact outcomes. This study compares perioperative outcomes between patients directly admitted and those transferred from another facility for thoracolumbar spine surgery, aiming to identify predictors of complications and mortality.

Methods: A multicenter retrospective cohort study used the American College of Surgeons National Surgical Quality Improvement Program database from 2011 to 2021 identified 61,626 patients undergoing fusion surgeries for thoracolumbar spine fractures, excluding spinal cord injury or pathological fractures.

The effects of supplemental instruction derived from peer leaders on student outcomes in undergraduate human anatomy.

Supplemental instruction (SI) confers student success, as represented by grades, knowledge retention, and student engagement. However, studies often report professional, not undergraduate, program findings. To measure these effects, students studying human anatomy at a university in Ontario, Canada, attended structured (peer-assisted) or unstructured (nonpeer-assisted) SI sessions and completed a pre-/post-survey.

Transabdominal motor evoked potential neuromonitoring of lumbosacral spine surgery.

Background Context: Transcranial Motor Evoked Potentials (TcMEPs) can improve intraoperative detection of femoral plexus and nerve root injury during lumbosacral spine surgery. However, even under ideal conditions, TcMEPs are not completely free of false-positive alerts due to the immobilizing effect of general anesthetics, especially in the proximal musculature. The application of transcutaneous stimulation to activate ventral nerve roots directly at the level of the conus medularis (bypassing the brain and spinal cord) has emerged as a method to potentially monitor the motor component of the femoral plexus and lumbosacral nerves free from the blunting effects of general anesthesia.

An Integrated 3-Dimentional Navigation System Increases the Accuracy, Efficiency, and Safety of Percutaneous Thoracolumbar Pedicle Screw Placement in Minimally Invasive Approaches: A Randomized Cadaveric Study.

Study Design: Cadaveric study.

Objectives: The purpose of this study was to compare a novel, integrated 3D navigational system (NAV) and conventional fluoroscopy in the accuracy, efficiency, and radiation exposure of thoracolumbar percutaneous pedicle screw (PPS) placement.

Methods: Twelve skeletally mature cadaveric specimens were obtained for twelve individual surgeons.