Archive for the ‘Compliance’ Category

Using the FDA’s data on citations to guide compliance efforts

“It’s a full thickness tear of your right rotator cuff.”

Not words I ever wanted to hear, let alone leading up to a holiday. But this diagnosis gave me the opportunity to consider the safety and efficacy of the medical devices and drugs involved in its treatment on a personal level, from the standpoint of the end user.

My pre-Christmas surgery comprised arthroscopic repair to shave the bone and enable greater range of motion for the rotator cuff, a fixation device and suturing to repair the torn tendon, and drugs to anesthetize, manage pain, and ward off infection. It was followed by six weeks with my right arm in a sling, and 12 weeks of physical therapy.  

For those of us working in the Life Sciences industry, it’s common to view our own medical conditions, or those of family members, through the lens of our work. And that’s exactly what I found myself doing during those months of treatment, recovery, and rehabilitation. “What company made this fixation device?” I found myself wondering. “Do they have any citations from the FDA?” “What about the company that made the pain medication I’m using?” Read more »