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Int J Surg. 2016 Apr;28:141-8. doi: 10.1016/j.ijsu.2016.01.082. Epub 2016 Feb 11.

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

Author information

1
Department of Surgery, Maimonides Medical Center, 4802 10th Ave, Brooklyn, NY, 11219, USA.
2
IDEAL Collaboration, University of Oxford, Nuffield Department of Surgical Sciences, John Radcliffe Hospital, Headley Way, Oxford, OX3 9LA, UK.
3
New York Presbyterian Hospital, Weill Cornell Medical College, 402 East 67th Street, LA 223, New York, NY, 10067, USA.
4
IDEAL Collaboration, University of Oxford, Nuffield Department of Surgical Sciences, John Radcliffe Hospital, Headley Way, Oxford, OX3 9LA, UK. Electronic address: peter.mcculloch@nds.ox.ac.uk.

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.

KEYWORDS:

Delphi survey; IDEAL Framework; IDEAL Recommendations; Medical device; Medical device safety

PMID:
26876957
DOI:
10.1016/j.ijsu.2016.01.082
[Indexed for MEDLINE]
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