Compliance In Focus

The FDA released a follow-up statement to their “Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health” release that was unveiled in April 2018. The focus was expanding on post-market surveillance for medical devices. In this plan, the main objectives were to promote and improve public safety and detect safety risks earlier while keeping all those involved, including physicians, informed.

When the FDA reviews a new drug application (NDA), they typically review multiple data sets, summaries, and other reports provided by the Sponsor. However, the amount of information that is usually released by the FDA at the time of approval was limited at best as well as sporadic. Under the FDA’s Clinical Data Summary Pilot Program, transparency of the approval process and access to more study-related documents are the goals, according to FDA commissioner Scott Gottlieb, M.D. who released a statement on 16 January 2018 about the new pilot program.

What happens if you have a site that requests to use an unapproved device that could be life-saving for a patient without an Investigational Device Exemption (IDE)? The device has been through the phases of clinical trials and the Sponsor is working on submitting the premarket approval (PMA). The site in question was part of that clinical trial but now the study and enrollment goal has been met and the both the site and study are closed.

Patient A+0x3, ST with PVCs and PACs. Lungs clear bilaterally with POX 98% on RA and SOB on exertion, PPP, NPO after midnight. PERRLA. Normal BSx4 quadrants. Abd dressing C/D/I C scant amt of serosang drainage. MAE, SBA, and OOB as tolerated. BP WNL. NS infusing @75 ml/hr through RTL PICC, F/P.

I was reading an article on the FDA’s website over concerns related to devices causing serious adverse events, the determination that the benefits outweigh the risks was the conclusion.  This raises some interesting questions with regards to patient safety.  The article specifically talks about devices that are used primarily as a bridge to transplant (BTT) or destination therapy in relation to severe heart failure.  Having been trained on the particular devices in question and taking care of the patient population whom received the devices, these patients have very few if any options.  Determining whether or not a device is safe is one thing but distinguishing if a device that has been shown to cause serious adverse events is acceptable in a certain patient population is another.

Selecting clinical sites for research purposes may be a difficult and seemingly overwhelming task  for a sponsor.  Familiarity with a site might help with selection, but multiple contributing factors can influence whether or not a site is ultimately chosen.  Choosing the wrong sites could have a detrimental effect on the study including: