Final preparation for major surgery falls upon both patients and doctors alike. It generally starts two weeks ahead of surgery for New England Baptist Hospital (NEBH) (Boston, Massachusetts, USA) patients, with a half day of pre-surgery tests and a list of day-by-day pre-surgery instructions for the once- or twice-in-a-lifetime joint replacement surgery they will have.
Dr. Geoffrey Van Flandern, head of the Joint Fellowship at NEBH, starts his final preparation a week ahead of each patient's procedure. He knows, based on his thirty plus years of experience working as both a practitioner and academic leading new doctors through the fellowship program, that no patient is the same and every case must be studied to achieve the best outcome. Driven by the quest to do the perfect joint replacement, his desire is to provide excellent patient care, whether it's his personal phone call to each patient the night before their surgery or his dedication to keeping up with technology.
Orthopedic Arthroplasty and Standards
One of the most popular elective surgeries, joint replacement of the hip or knee, is an innovation that's been around for decades. In fact, the inventor of the Mako robot, a CT scan technology aimed at enabling precise implant placement, cites his grandmother's successful surgery as the reason he created the robotic tool.1 Today, the reasons behind the surgery's popularity haven't changed from years ago. People are living longer lives with a desire for greater mobility, while athletes of all levels view sports medicine as a promise to be back on the field to compete. The regulatory body in the USA for joint replacement, the Federal Drug Administration (FDA), has approved a variety of prosthetics and an equally large number of technologies to aid the surgeon, to the point where this major procedure is a common outpatient event that is accessible to many more patients than in the past.
The Innovation Challenge
Yet, as Van Flandern knows, technical innovation is an enabler, not a standalone answer. The same technologies that have allowed a move to surgery centers and same-day patient discharge have complicated consistent adherence to established safeguards. The process for treatment at a surgical center often differs from the rigor of hospital pre-screening, and although the FDA assesses procedures and device safety, the FDA can't tell a surgeon what will work best for each patient. Not only does the uniqueness of each case create a challenge, some device and technology issues take years to uncover. It's not easy for surgeons to identify what is always the most helpful new prosthetic material or medical software, yet the final safety net at the point of surgery is the hospital system and the doctors performing the operation.
Ultimately, one finds that the burden of technology can only be mitigated by trust.
The challenge of technology and the changing safety net means that surgeons must be conductors of an orchestra of options. As a practitioner, Van Flandern's process of case review, participation in orthopedic boards where change is evaluated and put into practice, and general research is key to what he considers thoughtful use of technology built on a foundation of experience. In essence, he is the final risk manager of each case and the auditor of the point-of-surgery process.
Experience Leads to Good Outcomes
As an academic, Van Flandern believes in a holistic approach to teaching technology to doctors in NEBH's Joint Fellowship. Several factors guide his strategy:
- Not all fellows will have the opportunity to specialize in a specific type of orthopedics. It is crucial to teach and provide a clinical experience for the typical surgeon who does less than 100 replacements a year.
- The hospital environment NEBH fellows ultimately work in may not have all the latest technology, so manual processes and shared fellowship experiences with mentors are important.
- Business continuity/disaster recovery for a surgeon is all about efficiency. Teaching must include experiential information about outlying cases that don't meet standard expectations. A surgeon must move carefully but quickly given health considerations for the patient under anesthesia.
- New doctors can be easily overwhelmed by the available technologies, from artificial intelligence (AI)-assisted electronic patient records to operating room robotics. Fellowship means balancing exposure to innovation while taking advantage of the mentorships that surgeons such as Van Flandern can provide.
Human and Machines: It Is Complicated
Of all industries, medicine is a centerpiece for the hope fostered by technical innovation. One imagines a day when there exists a "bionic human" who, after suffering an injury or growing older, can feel good about choosing technology to have better quality of life. Yet, no one wants to be the "million-dollar human" saddled with an exorbitant medical bill or even worse, excluded from access to medical technology because of the price tag. Technology is expensive and improving the predictability of safe outcomes is time-consuming and costly. Pressure to perform the perfect surgery is just as high as the pressure to make a good personal decision and have an outcome that restores the good life, whatever that means to each individual. Managing technology's fast pace means considering the following from an ISACA professional's perspective:
- Medicine is a field that is highly reliant on the processes that take place before the surgical procedure. From systems development to manufacturing standards and execution, scrutiny and careful inspection are key.
- Due diligence for clinical trials is a must for continued innovation and positive future outcomes. Constructive questioning and the use of AI to enable compliance are important constructs of human evaluation and collaboration.
- Risk management and first line of defense practitioners are the gatekeepers of safe materials and devices, starting with product development up to managing conformance on the manufacturing floor.
- Regulatory management, in all fields, but especially in medicine, is more than establishing standards. It's critical to review and refresh standards with an eye on feasibility and practical execution. As an example, if surgery centers don't fit the regulatory framework, a new framework that is conducive to conformance must be developed.
Trust Alleviates the Burden of Complexity
Technology is stressful. There is so much information available, creating all kinds of lofty expectations. Patient research, like professional medical research, is important for a collaborative patient-doctor relationship, but the challenge of information accuracy must be recognized in this age of inaccurate and/or outdated social media and search engine data. Ultimately, one finds that the burden of technology can only be mitigated by trust. The surgeon cannot parse through manufacturing audit reports for the prosthetic devices they use, although their practice benefits from familiarity regarding prosthetic performance and patient outcomes using the devices. Patients must also evaluate their decision for surgery and choice of surgeon based on overview knowledge, placing trust that the surgeon is the expert in command of the details and caretaker of the best outcome. Accurate expectations and proper post-surgery patient follow-through rely on a trusting relationship. As Van Flandern notes, trust recognizes that the medical team is careful, insightful, and patient-driven, performing a lifetime of work to make sure they can do the best for each patient.
Editor’s Note
The author would like to thank Dr. Geoffrey Van Flandern for his time and insights.
Endnotes
1 Stryker, "Mako: Robotics Driving Innovation Across Specialities," 6 July 2023, stryker.com/us/en/about/news/2023/features/mako--robotics-driving-innovation-across-specialties.html
CINDY BAXTER | CISA, ITIL FOUNDATION
Is executive assistant to the Massport Community Advisory Committee (MCAC). Baxter is pleased that technology has allowed her to reinvent her career and continue learning through all of it. She had the privilege of learning technology and managing Fortune 100 client relationships at AT&T. Baxter then applied her expertise as an IT operations director at Johnson & Johnson before moving to compliance and risk management roles at AIG and State Street Corporation. After a brief period of running her own consulting business, Baxter joined MCAC, which advocates on behalf of communities impacted by the US State of Massachusetts Port Authority aviation and port operations. She applies her expertise to website redesign, drafting vendor requests for proposals (RFPs), updating bylaws, and providing regulatory support to the MCAC board. In her spare time, Baxter serves as compliance and operations officer for the ISACA® New England Chapter (Maine, Massachusetts, New Hampshire, and Vermont, USA) and volunteers on the Nantucket Lightship.