More information leads to better quality care for patients. Congress can help

There’s no such thing as having too much information when it comes to health care. Evidence and knowledge breed good decisions and quality care – something American health care consumers have come to demand.

When I was first diagnosed with colon cancer 14 years ago, the scarcity of easily accessible information about clinical trials, treatment, and living with cancer was enormously frustrating and drove me to create a mechanism for patients to share their experiences safely and ask questions. Today COLONTOWN is an online, deeply engaged, experience-specific community exclusively dedicated to colorectal patients and family members. Colontown has collaborated to provide a clearinghouse for specific and relevant information about colon cancer treatment and resources – empowering patients to pursue better care proactively.

{mosads}For patients and patient advocates, information sharing raises the bar on quality. The same holds true all across our health care system.

For example, complex imaging equipment – like MRI machines and CT scanners – are tightly regulated by the Food & Drug Administration (FDA) from the time of production throughout their lifespan. Because these machines are powerful and have the potential to cause harm if not appropriately repaired or maintained, service activities performed by the medical device’s original equipment manufacturer (OEM) are closely tracked and documented by the FDA.

It’s a practice that makes complete sense: if a device were to malfunction, resulting in a misdiagnosis or somehow hurt a patient or its operator, the FDA would need to look no further than its databases to begin investigating what might have gone wrong.

Information sharing, in this instance, helps the FDA ensure safety and quality care for the millions of Americans who need medical imaging. But there’s room for improvement.

Under current policy, third-party servicers – who are not the device’s original manufacturers – are not required to register with the FDA. Although most are highly trained, perform quality work, and are committed to the safe operation of imaging equipment, the fact that they are not required to register, document their activities, or report adverse events leaves an alarming blind spot for regulators.

If a device malfunctions, the FDA needs to be able to react swiftly to investigate the cause and make sure corrective action takes place. If improper repairs are discovered by OEMs – like tin foil, sheet metal screws, tape, or hand-secured nuts, as has happened – then the FDA needs to quickly step in and stop these servicers. None of this is possible without easily accessible information and hard documentation about the parties who have been involved in maintaining these machines.

Fortunately, members of the House of Representatives are invested in creating a better system. Reps. Ryan Costello (R-Pa.) and Scott Peters (D-Calif.) have introduced H.R. 2118—Medical Device Servicing Safety and Accountability Act – that would require third-party service companies to register with the FDA and report if anything goes wrong.

More information leads to better quality, without question. New policies requiring third-party servicers to register with the FDA is just one more way to raise the bar and guarantee consistency and safety across the board. It’s a smart strategy that doesn’t wait for a device-related injury or death to occur – rather, it fixes the problem before anyone gets hurt.

As one of many Americans whose lifesaving cancer treatments were based, in part, on the results of diagnostic imaging, I’m overwhelmingly thankful this technology exists. But it’s time our policymakers take a commonsense approach to collecting and sharing valuable information about this powerful equipment – and maintain the level of quality patients expect and deserve.

Erika Hanson Brown, is the founder of COLONTOWN. In 2016, Brown also co-founded the PALTOWN Development Foundation to create additional disease-focused communities. Following successful treatment, Brown refocused on the undeveloped niche of disease-specific patient empowerment, founding COLONTOWN on Facebook.