Facilitation of Surgical Innovation

Is It Possible to Speed the Introduction of New Technology While Simultaneously Improving Patient Safety?

Rebecca K. Marcus, MD; Heather A. Lillemoe, MD; Abigail S. Caudle, MD, MS, CMQ; Jeffrey S. Weinberg, MD, FAANS; Paul W. Gidley, MD; John M. Skibber, MD; Charles F. Levenback, MD; Stephen G. Swisher, MD; Thomas A. Aloia, MD

Disclosures

Annals of Surgery. 2019;270(6):937-941. 

In This Article

Abstract and Introduction

Abstract

Objective: To review efficiency metrics and patient safety data before and after implementation of a structured review process for surgical innovations.

Summary Background Data: Surgical innovation ranges from minor incremental improvement to radical experimentation. Although innovation paradigms have been described, these are not widely adopted or enforced in the surgical community.

Methods: A Continuous Quality Improvement Team (CQIT) of surgical quality officers and perioperative nurses was organized to perform structured reviews of proposed new surgical devices and procedures at a large quaternary cancer care center. The CQIT process was placed to precede an established Value Analysis Team business evaluation. Pre- and post-CQIT implementation metrics of approval process efficiency and patient safety data were compared. Seven novel procedures were also vetted by the CQIT.

Results: Forty-six product requests were evaluated after CQIT implementation. Compared with 34 products evaluated prior to CQIT establishment, the total mean evaluation time decreased from 124 to 51 days (P = 0.007). For new devices requiring intraoperative trial, the time between product proposal and trial decreased from a mean of 260 to 99 days (P = 0.014). The rate of device-related complications in the pre-CQIT group was 10% compared with 0% post-CQIT. Two devices, which administratively bypassed CQIT review, had both minor and major complications, including a mortality. Five novel procedures approved by CQIT with simulation were performed without complications.

Conclusions: Using novel algorithms, the addition of a dedicated team of surgical quality officers to the surgical innovation evaluation process improved both the efficiency and the safety associated with introducing new devices and procedures into practice.

Introduction

The history of surgery has been a study in continuous evolution of practice through innovation. Within this arc, the field of surgery has recently experienced an explosion in technique, approach, and device innovation. Although it is clear that, on balance, millions of patients have benefited from the introduction of new surgical approaches and technologies, it is equally true that the vast majority of innovation implementations in surgery have been and continue to be associated with some initial increased level of patient harm.[1,2] Furthermore, the harm level associated with the vulnerable period of innovation implementation typically exceeds the traditional approach that the new device or technique promises to replace.[2] The increase in harm when moving from the traditional approach to the new method is a recognized component of the learning curve. The cause of these complications may be previously undiagnosed faults in the new technology, problems with its usability, lack of prior training of the surgeon, operating team inexperience, or a combination of factors.

In previous eras, the complication spike associated with the introduction of new innovations was largely hidden from patients, the public, and the media. Professionally, surgeons made a paternalistic bargain that the future benefit would justify any short-term increase in risk. Over time, two specific forces have coalesced to change this paradigm. First, rigorous application of health services and outcomes research methodologies have exposed that many purported innovations do not result in future outcomes improvement.[1] Second, transparent reporting of postoperative outcomes, while still rudimentary, has exposed information regarding the harm associated with the introduction of new surgical technologies and procedures to the public.[3,4] The media, in particular, has sensationalized harm events, particularly when they involve surgical technology.[5,6]

Further complicating this issue is the field's realization that surgical innovations span a wide spectrum, from minor incremental modifications that are best classified as quality improvement to wholesale changes that clearly qualify as human experimentation. The line between incremental quality improvement and human experimentation is much more gray than black and white, and a delicate balance must be struck between advancement and human protection.

Over the past decade, the field of surgical innovation has been formally recognized. In 2009, McCulloch et al's seminal paper in Lancet introduced the IDEAL framework: the current standard by which development and evaluation of surgical innovation should proceed.[7] Since that time, refinements of the IDEAL collaboration and the introduction of similarly structured frameworks for specific populations have been proposed.[8–11] Despite this progress, qualitative analyses of surgeons' perspectives on innovation demonstrate that while surgeons recognize innovation as critical to the advancement of the field, there is no uniformity in regards to its definition or the regulatory processes required for introducing new technology.[12–14] Further, the existing guidelines are not widely adopted or enforced in the surgical community.[13,15] To address these knowledge and process gaps, this study was performed to assess the safety and efficacy outcomes of an institutional structured review process specifically focused on the introduction of surgical innovations.

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