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Facilitation of Surgical Innovation

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

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

doi: 10.1097/SLA.0000000000003290
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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.

*Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX

Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX

Department of Neurosurgery, The University of Texas MD Anderson Cancer Center, Houston, TX

§Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX

Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX

||Department of Thoracic and Cardiovascular Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.

Reprints: Thomas A. Aloia, MD, Department of Surgical Oncology, University of Texas MD Anderson Cancer Center, 1400 Pressler Street, Unit #1484, Houston, TX 77030. E-mail: taaloia@mdanderson.org.

Author contributions: RKM, HAL, and TAA contributed to the conception and design, and participated in drafting the article. All authors were involved in acquisition, analysis, and interpretation of data or revising it critically for important intellectual content. All authors approved the final version to be published.

Drs. R.K.M. and H.A.L. are supported by National Institutes of Health grant T32CA009599 and the MD Anderson Cancer Center support grant (P30 CA016672).

Drs. R.K.M. and H.A.L. contributed equally to this work.

The authors report no conflicts of interest.

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