Subject(s)
Microvascular Decompression Surgery , Trigeminal Neuralgia , Humans , Microvascular Decompression Surgery/methods , Trigeminal Neuralgia/diagnostic imaging , Trigeminal Neuralgia/surgery , Vertebral Artery/diagnostic imaging , Vertebral Artery/surgery , Basilar Artery/surgery , Cerebellum/blood supplyABSTRACT
The public health community faces increasing demands for improving vaccine safety while simultaneously increasing the number of vaccines available to prevent infectious diseases. The passage of the US Food and Drug Administration (FDA) Amendment Act of 2007 formalized the concept of life-cycle management of the risks and benefits of vaccines, from early clinical development through many years of use in large numbers of people. Harnessing scientific and technologic advances is necessary to improve vaccine-safety evaluation. The Office of Biostatistics and Epidemiology in the Center for Biologics Evaluation and Research is working to improve the FDA's ability to monitor vaccine safety by improving statistical, epidemiologic, and risk-assessment methods, gaining access to new sources of data, and exploring the use of genomics data. In this article we describe the current approaches, new resources, and future directions that the FDA is taking to improve the evaluation of vaccine safety.
Subject(s)
Drug Approval/legislation & jurisprudence , Drug Stability , United States Food and Drug Administration , Vaccination/statistics & numerical data , Vaccines/pharmacology , Communicable Disease Control/standards , Drug Design , Drug Evaluation , Drug Evaluation, Preclinical , Drug-Related Side Effects and Adverse Reactions , Humans , Product Surveillance, Postmarketing , Randomized Controlled Trials as Topic , Risk Assessment , Safety Management , United States , Vaccination/adverse effects , Vaccines/adverse effectsABSTRACT
STUDY DESIGN: Retrospective, multicenter study of robotically-guided spinal implant insertions. Clinical acceptance of the implants was assessed by intraoperative radiograph, and when available, postoperative computed tomography (CT) scans were used to determine placement accuracy. OBJECTIVE: To verify the clinical acceptance and accuracy of robotically-guided spinal implants and compare to those of unguided free-hand procedures. SUMMARY OF BACKGROUND DATA: SpineAssist surgical robot has been used to guide implants and guide-wires to predefined locations in the spine. SpineAssist which, to the best of the authors' knowledge, is currently the sole robot providing surgical assistance in positioning tools in the spine, guided over 840 cases in 14 hospitals, between June 2005 and June 2009. METHODS: Clinical acceptance of 3271 pedicle screws and guide-wires inserted in 635 reported cases was assessed by intraoperative fluoroscopy, where placement accuracy of 646 pedicle screws inserted in 139 patients was measured using postoperative CT scans. RESULTS: Screw placements were found to be clinically acceptable in 98% of the cases when intraoperatively assessed by fluoroscopic images. Measurements derived from postoperative CT scans demonstrated that 98.3% of the screws fell within the safe zone, where 89.3% were completely within the pedicle and 9% breached the pedicle by up to 2 mm. The remaining 1.4% of the screws breached between 2 and 4 mm, while only 2 screws (0.3%) deviated by more than 4 mm from the pedicle wall. Neurologic deficits were observed in 4 cases yet, following revisions, no permanent nerve damage was encountered, in contrast to the 0.6% to 5% of neurologic damage reported in the literature. CONCLUSION: SpineAssist offers enhanced performance in spinal surgery when compared to free-hand surgeries, by increasing placement accuracy and reducing neurologic risks. In addition, 49% of the cases reported herein used a percutaneous approach, highlighting the contribution of SpineAssist in procedures without anatomic landmarks.
