What prompted the need to create these recommendations?

The Heart Rhythm Society is the international leader for cardiac arrhythmia professionals and patients. As part of our mission to improve the care of patients by promoting optimal healthcare policies and standards, we believed it was necessary to develop a set of recommendations and guidelines to address concerns that have been raised about the safety, effectiveness and post-market surveillance of cardiac devices. Change to the current system is needed to ensure continued access to life-saving treatments and to enhance public knowledge, confidence and trust in these therapies.

These draft recommendations involve the participation of the FDA, Congress, CMS, physicians, industry, etc. Once the public comment period ends on May 30th, what will be the next step? How will those public considerations be used, and what process will be used to make sure all parties involved are in agreement?

What is the size of your EP lab facility and number of staff members? What is the mix of credentials at your lab?

We have two EP suites that consist of: 1 bi-plane Philips system 1 single-plane Philips FP system Both suites were constructed to meet OR standards allowing utilization for implant procedures as well as electrophysiology procedures. Pre/post procedure holding areas are divided into a 10-bed outpatient unit, a 13-bed inpatient/outpatient unit, and a two-bed pediatric area. These areas prep and recover patients from cardiovascular procedures as well as EP procedures. The EP staff consists of 10 FTEs that work 10 hours a day for four days/week. At least eight are scheduled daily. Credentials include RCIS, RCP, RTR, and RN. Seniority runs from a few months to 10 years, with the average length of service at approximately two years.

When was the EP lab started at your institution?

Electrophysiological procedures were first performed in 1975.