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Ann Surg. 2019 Mar 26. doi: 10.1097/SLA.0000000000003290. [Epub ahead of print]

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

Author information

1
Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
2
Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
3
Department of Neurosurgery, The University of Texas MD Anderson Cancer Center, Houston, TX.
4
Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.
5
Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.
6
Department of Thoracic and Cardiovascular Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.

Abstract

MINI: Future advancement of the field of surgery is dependent on its ability to safely implement innovative devices and procedures. This study describes a structured institutional approach to the introduction of surgical innovations that improved efficiency and patient safety, and is transferrable to other centers.

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.

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