How Regulation Can Improve Surgery

Font Size:

Scholar argues that agencies should collect evidence on surgical procedures to help implement best practices.

Font Size:

Thousands of American lives are in surgeons’ hands every day. But, according to a recent article by a Harvard professor, these patients have good reason to worry about mistakes in the operating room and their chances at recovery.

Surgeons currently work under a decentralized regulatory structure that undermines evidence-based surgical care, writes Jonathan Darrow, a professor at Harvard Medical School. Because of this structure, surgeons operate on patients using procedures that do not have a solid grounding in research, which can compromise patient safety. Darrow argues that federal agencies should fill the gap in surgical literature by collecting evidence on surgical procedures, analyzing the data, and determining which of these procedures maximize patient welfare.

Admittedly, at the state level, medical boards have broad powers over the practice of medicine, and they can enforce disciplinary measures against surgeons who do not satisfy professional standards. The Virginia Department of Health Professions, for example, can permanently disqualify a surgeon from practicing medicine for professional failings, and it may even pursue investigations against offending surgeons.

Beyond state medical boards, nongovernmental organizations, like the American Board of Surgery, exercise regulatory power over surgical examinations and licensing, admits Darrow. States prohibit specialized surgeons from operating on patients if these organizations have no record of requisite certification.

Moreover, several private initiatives, like The Joint Commission and The Leapfrog Group, monitor the quality of surgical care delivered by thousands of hospitals across the county, and these initiatives encourage hospitals to spend resources in ways that optimize patient health.

In contrast to these state and nongovernmental regulations, the federal government only oversees the use of drugs and medical devices used during surgery, notes Darrow. The U.S. Food and Drug Administration (FDA) examines the safety of surgical drugs—which include anesthetics and antibiotics—and sanctions their use in the operation room.

According to Darrow, surgery scholars provide several reasons that support the current decentralized regulatory structure. These surgery scholars claim that the highly variable needs of patients require tailored surgical procedures, and any source of direct regulatory oversight would hamper the flexibility required for optimal medical care.

Darrow also points to a recent statute that severely limits the ability of patent holders to generate profits from their surgical innovations. If potential innovators already lack the financial incentives to create new surgical procedures, a tedious and expensive regulatory oversight process would further discourage them from marketing their inventions, explains Darrow.

Although Darrow recognizes the validity of these justifications, he argues that federal agencies should play an important regulatory role in collecting evidence on surgical procedures and addressing current gaps in surgery literature.

Darrow asserts that evidence on surgical correction of Haglund’s deformity—a bony protrusion on the back of the foot—provides support for his perspective. Although research on surgical procedures for correcting the deformity dates back almost 80 years, studies are of very low quality and little use to practitioners, mainly because systematic data collection and analysis are difficult to perform without a centralized regulatory body, according to Darrow. Because of this research gap, surgeons across the country employ surgical procedures that lack robust scientific grounding and thus pose potential safety concerns for patients.

To solve this problem, Darrow proposes four solutions.

First, the Agency for Healthcare Research and Quality (AHRQ)—which is located within the U.S. Department of Health and Human Services—could identify medical conditions typically treated by surgery and the specific surgical procedures used for treatment. Darrow suggests that, if the AHRQ finds insufficient evidence on surgical best practices, it could fund and spearhead studies to fill gaps in data.

Second, surgeons or hospitals could report so-called adverse event data—that is, negative patient experiences associated with a medical product or procedure—to FDA. Indeed, FDA already has in place similar reporting systems for problematic pharmaceutical products and medical devices. According to Darrow, monitoring adverse events would both increase data on current procedures and inform optimal surgical decision-making.

Third, federal agencies, like the AHRQ or FDA, could implement regulations that would increase the usefulness of research evidence. In exchange for federal research funding, regulations would require researchers to use standardized terminology in their studies to increase consistency and “cross-study comparability,” adds Darrow.

Fourth, regulators could create a database that would collect data from the thousands of surgical procedures performed every day. Darrow argues that leveraging big data in the field of surgery would promote safety and efficacy, all in the hopes of optimizing the ability of regulators to avoid surgical mistakes and increase patient welfare.

Darrow’s paper appears in the Cornell Journal of Law and Public Policy.