The FDA needs disruption to calm the latest endoscopy scare


Mar 2, 2015

Last month, news broke that nearly 200 patients at Reagan UCLA Medical Center had been exposed to a deadly bacterium because of improperly cleaned re-usable endoscopes. The media hailstorm surrounding the outbreak is only the latest in a larger debate on the FDA’s role in patient safety and the medical device industry. While many are calling for stricter regulations, disruptive innovation theory suggests that to help patients, we should also explore safer, lower-cost technologies.

The endoscopes in question—used in colorectal exams—preemptively scan for colon cancer, and have unquestionably enabled physicians to save many lives. Still, these methods are not risk free—and not just thanks to the risk of a “superbug” infection. Many colonoscopies are performed under general anesthesia, which carries its own associated risk.

Faced with events like UCLA’s endoscope crisis, the knee-jerk reaction of regulators, consumer advocates, and hospitals is to double-down on security protocols. This means tighter regulations on who can perform the procedures and how colorectal endoscopes should be disinfected. Others will likely call for providers to invest in additional systems and checks designed to prevent similar mistakes from happening again. While many of these are essential short-term measures to protect patient safety, they come with trade-offs, including higher cost burden, increased risk of non-compliance, and decreased access to care, because the expertise is in the hands of even fewer practitioners. We’ll risk spending even more money—for fewer patients.

Disruptive innovation theory suggests that it is possible to simultaneously achieve two seemingly incongruous objectives. We can lower costs and increase safety. The key is the development of enabling technologies, or processes that allow providers to perform the functions of an endoscope with less complex training, less risk, and in a lower-cost environment.

Given Imaging may have part of the answer. The Israeli medical technology company (recently acquired by Covidien) has pioneered what they call “capsule endoscopy” technology and recently developed the PillCam COLON capsule. The PillCam resembles any other pill or medication – but it’s actually a microcamera with advanced imaging capabilities. Given Imaging claims the pill is highly effective at detecting pre-cancerous polyp clusters and does so at very little risk, entirely without sedation or irradiation.

This is tremendous news for patients. If the risks for PillCam are as minimal as reported, and the device works as effectively as early trials suggest, then this has the potential to improve cost, efficacy, and access all in one swing. The procedure could feasibly be performed in a cheaper ambulatory setting for otherwise healthy consumers. And giving patients a low-risk screening tool means they will be less likely to forgo screening.

Yet this excitement comes with a major caveat. Currently, the capsule must be used in conjunction with standard colonoscopy. Essentially, the FDA has only approved the PillCam COLON as a back-up plan in the roughly 750,000 annual cases when initial colonoscopy is ineffective. Permanently restricting the use of PillCam or similar technologies to a co-technology with endoscopy greatly reduces its potential impact for change—both in mitigating patient harm and reducing costs. None of the risks of the original technique will be mitigated, and the technology will benefit only a small segment of the population for whom colonoscopies are ineffectual.

PillCam has tremendous potential if it can become a self-standing diagnostics option. While the FDA likely has criteria for this in place, the agency should be anxious to facilitate independence for a new technology that will almost certainly lower risks for patients in the long-term.

In 1906, Upton Sinclair’s The Jungle exposed the unsanitary practices of the meatpacking industry, horrified its readers, and spurred the creation of the FDA to protect consumer safety. Similar failings, like the contaminated endoscopes at UCLA, drive an important debate about safety: clearly, there is a need for thoughtful oversight from the FDA. Yet while the agency has a duty to minimize risk related to medical technology, it should be careful not to smother new technologies, which allow for new market disruption, and open up access to patients who truly need it.

Michael Devonas