CIED Product Line Training Initiative: FDA Regulatory Staff

In this article, Bob Mattioli from PrepMD talks with Mitchell Shein, Chief, Implantable Electrophysiological Devices Branch, Division of Cardiovascular Devices at FDA, about the FDA’s use of PrepMD’s training to support regulatory staff. In January 2013, PrepMD concluded a cardiovascular implantable electronic device (CIED) product line training initiative on behalf of the Center for Devices and Radiological Health (CDRH), specific to training 20 FDA regulatory staff on the functionalities and clinical applications of CIEDs from all device manufacturers. The training included two months of preparatory online training using the iPrepMD platform and curriculum, as well as one week of on-site training at the FDA campus.

Mattioli: Given that FDA staff receive extensive training on medical devices, why did FDA choose to augment current FDA training resources? 

Shein: Most of the formal training that FDA staff receive is focused on the regulations and processes associated with pre-market evaluation of these devices. In fact, all new reviewers complete the Center’s Reviewer Certification Program (RCP). Device-specific training is handled through one-on-one mentoring of new staff by more experienced staff or our medical officers. However, we felt that a more formal, structured training on the devices, as well as the underlying cardiovascular conditions that the devices treat, would benefit the group. Our goal was to provide a consistent foundation of the key concepts in a format that would be easy to recall as staff gain experience with the devices during their interactions with manufacturers and review of submissions.

What training needs did FDA identify that suggested a benefit from product-specific training? 

In the last few years, FDA has hired a large number of pre-market reviewers, in order to keep up with the increasing number of submissions requiring FDA review. These staff sometimes have biomedical engineering backgrounds but not specific experience working with the devices that they regulate. Training is available through a variety of forums, but this typically requires travel to another location. The cost of the training and associated travel is significant and limits the number of staff that are able to receive formal training. We thought that it would be beneficial to bring the training to us, on our FDA campus, in order to provide training to a much larger group.

Can you describe the process for adapting the PrepMD’s standard program to meet FDA’s needs? 

The PrepMD cardiac pacing and defibrillation training required only minor tweaking to tailor to the issues encountered by reviewers in their daily responsibilities. It required someone with background in both the clinical and regulatory environments to modify/adjust the agenda to the proper level and topics for the reviewers who were going to be taking the course. PrepMD scheduled a number of discussions with our group to discuss our specific needs. FDA staff must be familiar with the devices but aren’t responsible for supporting follow-up and implant procedures. As a result, we focused more on the underlying operation of the device, rather than the interaction with the clinicians and patients. Once we identified our goals, we selected presentations from their existing curriculum. Our greatest challenge was limiting the timeframe of the training to a single week, in contrast to the more extensive training that PrepMD can provide over a number of months.

What was FDA’s goal as it considered using PrepMD as an independent training resource? 

Manufacturers of these devices typically have well-developed training programs, both for clinical staff supporting implants and follow-ups as well as engineering staff that design, test, and manufacture the devices. However, it is important for FDA staff to not be influenced by the manufacturers. We wanted to select a group with a well-known track record of developing training, specifically focused on these devices. Most importantly, we wanted to offer staff some introductory pre-training, so that staff with very limited experience could be brought up to speed and to understand basic concepts, in preparation for the face-to-face training. PrepMD provided an online prep course iPrepMD, their online delivery platform, and our staff reviewed and discussed these materials as a group, with a mix of new and experienced staff. The availability of this web-based training was one of the main deciding factors behind our selection of PrepMD.

How did you determine which FDA staff would receive the most benefit from the training program? 

In the months leading up to selecting this training, some staff had been meeting on a weekly basis to review and discuss device-related questions in a group forum. Most of the individuals from these weekly meetings, who were hungry to learn more about the devices and their clinical use, were able to attend. In addition to the staff responsible for pre-market reviews of these devices, we identified a number of staff in other offices that would also benefit from a better understanding of these devices. These individuals are responsible for evaluating post-market performance or evaluating compliance with the applicable regulations.

Can you describe the components of the PrepMD training itself as well as the length of time involved in training FDA staff? 

The PrepMD course began with a pre-training evaluation in the form of an online assessment test that PrepMD designed and delivered using iPrepMD in order to evaluate the staff’s overall background knowledge. Then, participants were provided access to self-directed online tutorials on a variety of topics to ensure that everyone taking the class was starting from a similar baseline of knowledge. In the months leading up to the training, the participants met as a group to develop a schedule to cover the topics in the time remaining before the face-to-face training. They also met to discuss questions as a group, supporting each other as a team. The main training class was a full week of day-long sessions covering different topics each day. Following the training, the participants completed a post-training evaluation, which allowed participants to identify what they learned. 

Can you share with us your sense of the value of PrepMD’s online training component, iPrepMD, and its contribution to the overall learning of the participants? 

Those taking the class found it extremely valuable, particularly those who were new to this clinical discipline. The knowledge gained was directly applicable to their work, and the benefits of this training were immediately evident in the content of the reviews they performed after the training was completed.

How effective was the program in meeting your goals? 

We found the training program to be very effective. PrepMD conducted a post-training survey of participants, and everyone had positive things to say about the training. Some FDA staff rated the training as “the best since they joined FDA.” Staff also felt that the interactive presentation style was very engaging and helped them to stay focused throughout the week.

What would you do differently to increase the positive impact among FDA staff who attended the PrepMD program? 

I would have further tailored the syllabus to include case studies closer related to the medical/regulatory issues reviewers frequently encounter. In particular, I would use examples to illustrate how the medical concepts impact the regulatory decisions we need to make. 

If the program was considered successful, would FDA consider using PrepMD as a training resource in the future?  

We would absolutely consider them as a vendor for additional training. This training focused on implantable devices such as pacemakers and defibrillators, but there is definitely an opportunity to cover other devices, such as EP catheters and ablation procedures, in more depth.