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Surgical Perspectives

Hey, I Just Did a New Operation!

Introducing Innovative Procedures and Devices Within an Academic Health Center

Sagar, Stephen P. MSc*; Law, Peggy W. MSc*; Shaul, Randi Zlotnik JD, LLM, PhD†,‡,§,‖; Héon, Elise MD, FRCSC*,¶,**; Langer, Jacob C. MD, FRCSC*,‖; Wright, James G. MD, FRCSC, MPH*,‖

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doi: 10.1097/SLA.0000000000000748

A foundational goal of academic health science centers is to develop, implement, and evaluate innovative treatments.1 Although essential for the advancement of clinical care, not all innovations are beneficial to the patient.2 Issues related to the introduction of surgical innovations include (1) ensuring that patient consents clearly state when the treatment being offered is an innovative intervention, (2) declaring all conflicts of interest involving personal gain, (3) considering the potential costs of new technology, (4) confirming the surgeon, team, and hospital have the appropriate expertise to deliver the care, and (5) defining the dividing line between innovation and required modification based on individual patient circumstances.2–4

Although most international jurisdictions have regulations governing the approval of new drugs and devices, there is little governance over the introduction of surgical innovations.3–6 Research on novel therapies is monitored by institutional research ethics boards that ensure scientific rigor and adherence to ethical standards. However, the research ethics approval process can be cumbersome and prolonged, which potentially acts as a disincentive for surgeons wanting to try an innovative procedure that is not the subject of a research study. Thus, the main question is how to introduce innovative treatments that may be new to an institution but not necessarily new to the world, where research is not the primary interest, and therefore the innovation is not within the jurisdiction of an institutional research ethics board.

Despite the need articulated by surgeons and ethicists, few centers have developed explicit strategies for the introduction of innovative therapy if they are not the subject of research. In 2003, The Hospital for Sick Children (SickKids) developed a policy with the goal of providing a transparent governing process and improving accountability for surgeons who wished to innovate.7,8 The policy, arising from concerns of the chief surgeon about the monitored introduction of surgical innovations, was developed by a group of surgeons and ethicists (see Supplemental Digital Content Appendix 1, available at http://links.lww.com/SLA/A567). For the purposes of the policy, innovation is defined as a significant change in clinical procedures, techniques, technology, devices, and treatment/therapy that have not yet been introduced at SickKids but have been validated elsewhere. Formal approval is required before introduction for those innovations that (1) have significant cost implications and/or (2) pose sufficient risk that independent review would benefit the patient, clinician, or staff person, and/or hospital, particularly in the event of an adverse outcome.

Under this policy, staff surgeons must submit a 1-page application for an innovative treatment not considered research to the Surgeon-in-Chief. The application addresses such criteria as evidence of effectiveness, rationale for request, declaration of conflicts of interest (such as commercial interest in product), number of patients, resource implications, potential risks and benefits, evidence of necessary skills and training, and plans to collect outcome data. After receiving approval from the Surgeon-in-Chief, staff must comply with 3 requirements: (1) document on the Consent to Treatment form that the innovative treatment was explained to patients6; (2) provide a report of all patients treated and their clinical outcome within 6 months after approval; and (3) present a summary of all cases at a departmental/divisional M&M (morbidity and mortality) round. The primary goal of follow-up is to ensure the innovation is safe.

Between January 2005 and June 2012, a total of 40 innovations were approved. We did not evaluate innovations in 2013 with less than 1 year follow-up. No applications were refused, and 5 were ultimately not implemented because the surgeon was unable to obtain the required instrument from the vendor, the patient received alternative treatment, the innovation lacked Health Canada approval, or the patient received an organ transplant, thereby making the innovative procedure unnecessary. Of the 33 innovations with final reports, 16 (49%) were techniques, 9 (27%) were equipment or devices, and 8 (24%) were medications. Of the 124 patients (or pairs of patients in the case of transplants) with outcome information, 23 patients (19%) receiving 11 innovations experienced adverse events. In total, there were 21 minor events, defined as those that resulted in no long-term consequences, and 2 fatalities. We were unable to determine whether the adverse events were due to the innovation or some other aspect of the treatment or the disease. The fatalities included one case of laparoscopic tissue harvesting for living related donation and one case of an infected cerebral shunt requiring removal. In the latter case, the parents subsequently opted for palliative care over active treatment for their child who had a number of severe congenital abnormalities. Of the 33 performed innovations, 23 (70%) have since been adopted into practice.

Compliance with several elements of the policy was relatively low. All surgeons indicated they had explained the innovative nature of the intervention with explicit discussion of the risks, but only 8 (24%) of 33 innovations had the required documentation on the consent form. Although 67% of the surgeons submitted final reports, only 2 (6%) did so within the specified time frame. Finally, only 9 (27%) innovations were presented at a departmental/divisional M&M rounds.

Interviews were conducted with 12 staff members who were responsible for submitting 23 (70%) of all approved and performed innovations. The majority of the interviewees commended the policy, indicating that it was a valuable alternative when the treatment was not considered research. Comments such as “form is short, comprehensive and easy to fill out” and “application process was simple” were frequently noted. Many actually stated that they had been encouraged to innovate as a result of having the policy in place. The 2 suggestions to improve the process included “increase awareness of the policy to all surgeons” and “more frequent reminders to comply with the policy requirements.” Surgeons were clear that to encourage compliance with the policy, the process should be simple with rapid turnaround. However, staff also recognized the extent to which having a new therapy approved under this policy was in the best interest of their patients, the institution, and themselves.9 Such preapproval supports the reasonableness of performing the innovation. Furthermore, should the outcome of an innovative treatment be unfavorable, the surgeon could refer to the process as indication that the best practices were followed, along with both collegial endorsement and approval from the Surgeon-in-Chief.

The lack of institutional policies regarding innovation is a missed opportunity to protect the rights and welfare of patients, including protection from both unintentional harm and unconsented interventions, and to encourage the use of innovative therapies that optimize health outcomes for individual patients and advance medicine for all patients.2 The fact that almost three quarters of the innovations approved through this process were adopted by the hospital suggests that the introduction of innovation was not impeded by our policy. Although 2% of patients had fatalities, many of the patients had limited options, and for these 2 patients, the innovation was a treatment of “last resort.”

There are several caveats in considering our experience that relate primarily to the implementation of the policy. First, we could not ascertain whether any innovations were introduced outside of the policy. However, in absence of a policy, all innovative treatments would have been performed without any formal accountability framework. Second, we were unable to capture all the data and patient outcomes treated by each approved innovation due to the lack of information provided in the final reports. This highlights the need for more frequent reminders to the responsible staff in the future. Third, we were unable to speak with all SickKids staff members who used this policy. It is possible that the views presented may not be reflective of those who were unavailable for interviews. Finally, the policy was used to introduce different types of innovations such as techniques, devices, and medications, but the numbers preclude differentiating meaningful distinctions among them.

In summary, the policy for introducing innovations at SickKids had the goal of providing cutting-edge care in a timely manner while preserving patient safety and upholding ethical values and legal standards. We have described one type of formal policy that successfully facilitated the transparent and monitored introduction of surgical innovations into a clinical setting.

REFERENCES

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Supplemental Digital Content

© 2015 by Lippincott Williams & Wilkins.