Adapting the IDEAL Framework and Recommendations for medical device evaluation: A modified Delphi survey. (April 2016)

• Record Type: Journal Article
• Authors: Pennell, Christopher P.; Hirst, Allison; Sedrakyan, Art; McCulloch, Peter G.
• Is Part Of: International journal of surgery. Volume 28(2016)
• Page Start: 141
• Page End: 148
• Publication Date: 2016-04
• Subjects: IDEAL Framework -- IDEAL Recommendations -- Medical device -- Medical device safety -- Delphi survey; Surgery -- Periodicals; Surgical Procedures, Operative -- Periodicals; 617.005
• DOI: 10.1016/j.ijsu.2016.01.082
• Languages: English
• ISSNs: 1743-9191

Abstract

Abstract: 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. Methods: We conducted a Delphi expert consensus exercise to determine how IDEAL might be modified to accommodate the needs of device regulation. 34 experts were invited to participate in 3 rounds of questioning, with feedback of the results of each round to participants before the next. Results: 27 of 34 experts responded in at least one survey round. Experts agreed that, after appropriate modifications, IDEAL could form an evidence template for a TPLC-based regulatory system. Necessary modifications include a new Stage 0 should guide reporting of pre-clinical studies, expansion of registries to all stages, and omission of IDEAL stages 2 and 3 for "successor" devices under certain conditions. Discussion: A standard approach to TPLC evaluation of medical devices does not currently exist. The IDEAL Framework, if modified appropriately, could fill such a void and improve the safety of new medical devices. Highlights: Medical devices have unique features that make evaluation different than for surgical procedures. The IDEAL Framework standardizes the evaluation of innovative surgical procedures. With some modification, the IDEAL Framework could be used for medical devices.