Adapting the IDEAL Framework and Recommendations for medical device evaluation: A modified Delphi survey.

Introduction: Current regulatory systems for medical device marketing approval lack adequate requirements for evidence of safety and efficacy. The Total Product Life Cycle (TPLC) concept, with clinical use and marketing expanding as evidence develops, has won support, but lacks a template to define evidence requirements at different stages. The IDEAL Framework & Recommendations, originally developed for new surgical procedures, might provide such a template, but may require modification.

The Safer Delivery of Surgical Services Program (S3): Explaining Its Differential Effectiveness and Exploring Implications for Improving Quality in Complex Systems.

Objective: To analyze the challenges encountered during surgical quality improvement interventions, and explain the relative success of different intervention strategies.

Summary Background Data: Understanding why and how interventions work is vital for developing improvement science. The S3 Program of studies tested whether combining interventions addressing culture and system was more likely to result in improvement than either approach alone.

Quality and safety on an acute surgical ward: an exploratory cohort study of process and outcome.

Objective: To evaluate patient safety in an emergency surgical unit using process and outcome measures in parallel.

Background: Patient harm from errors in care is common in modern surgical practice. Measurement of the problem is essential to any solution, but current methods of evaluating patient harm are either impractical or inadequate.