CDRH Report Shows Steady Increase in Complaints, but Few Clear Reasons Why

The Center for Devices and Radiological Health's (CDRH) ombudsman has released a report indicating that complaints made against the center and its employees have increased for a fourth straight year.

The data-driven annual report is an accounting of the total number of inquiries, complaints, disputes and other points of contact made to the ombudsman's office during each calendar year. The report is meant to identify any lingering issues that might be affecting the agency, as well as showcase general trends in complaints and inquiries.

The trend line for the past several years can be categorized in a word: up.

In 2012, the report notes that CDRH, the US Food and Drug Administration's (FDA) medical device regulatory center, received 493 inquiries and complaints through its ombudsman. That marks an average of 1.35 contacts for every calendar day of 2012, or 1.9 contacts for every weekday.

Of those 493, 45% (224) were actual complaints, while 44% (217) were inquiries, 8% (21) were disputes and 2% were "other" contacts.

The number of complaints has steadily risen over the last several years. In 2011, there were 202 complaints and 171 in 2010-an increase of 31% in two years, and 10.9% since 2011.

Inquiries, meanwhile, have remained nearly flat since 2010, when they totaled 206.

Explanations Scarce

What's behind the spike? CDRH's report doesn't explain in words, but the data does show some trends. While industry accounts for a large number of contacts, it's actually not the source of the majority of the rise. In 2010 it registered 269 contacts, which rose to 285 in 2012.

Consumers, however, are contacting CDRH in greater and greater numbers, registering 124 complaints and inquiries in 2012-up 33% from 2010, when they registered just 93.

The overwhelming majority of all complaints registered in 2012 were sent to the Office of the Center Director-that is, Jeffery Shuren's office-which saw 330 points of contact, up 164% from the year prior and 440% from 2010.

The other notable trend seen in the data was the drop in complaints and inquiries sent to the Office of Device Evaluation (ODE), which saw a 36.8% decrease in contacts from 2011 to 2012.

The reasons for these complaints remained relatively constant, the ombudsman's data shows, with the exception of its "other" category, which seemed to account for the entirety of the increase from 2011 (47) to 2012 (86).

It was not clear from the data whether this increase was due to a spike in a single issue of interest generating concern, or if a rising number of complaints are just more difficult to categorize using the ombudsman 10 pre-defined categories. A similar increase was seen between 2010 and 2011, from 7 to 47.