SB 1372, An Act Concerning Medical Device Representatives

TESTIMONY OF THE CONNECTICUT HOSPITAL ASSOCIATION
SUBMITTED TO THE PUBLIC HEALTH COMMITTEE

Monday, March 10, 2025

The Connecticut Hospital Association (CHA) appreciates this opportunity to submit testimony concerning SB 1372, An Act Concerning Medical Device Representatives. CHA opposes the bill.

Connecticut hospitals and health systems care for patients, strengthen the state’s economy, and support vulnerable communities across the state. Every day, they work to improve healthcare access, affordability, and health equity. Even as they face ongoing challenges, hospitals provide world-class care to everyone who walks through their doors, regardless of their ability to pay. Hospitals also support an exemplary workforce as the largest collective employer in the state, contribute significantly to the state’s economy, and invest in their communities addressing social drivers of health.

SB 1372 seeks to require hospitals to “credential” “medical device representatives” who may provide technical or simply educational assistance for medical devices. The obligation would extend to all preparation, conduct, or completion of surgical procedures using medical devices.

As drafted, SB 1372 confuses the roles played by various entities and individuals in the healthcare continuum. Medical device representatives do not provide care or treat patients. They are a necessary part of the care continuum and provide vital information on how devices are, for example, positioned, set, calibrated, initiated, or disabled. They are usually employees or agents of the device manufacturer. The device manufacturer has both an interest and a responsibility to ensure its devices, almost always FDA-approved devices, are not only safe but also used correctly in the field, consistent with FDA approvals and other official instruction.

For example, a person with atrial fibrillation may need a pacemaker or internal defibrillator implanted, or perhaps the battery needs to be changed on an existing device. The manufacturer — the entity with significantly superior knowledge about the device, technical expertise and system access, and a continuing obligation to ensure the device is safely used —will make a representative available to ensure the device settings are calibrated, aligned, and functional and to answer any questions the surgeon or electrophysiologist performing the procedure may have. There are similar examples for orthopedic implants and appliances, breathing apparatus, other cardiac devices, and a host of other devices. Inserting the hospital into the mix as the credentialing entity for the manufacturer’s employee or agent is inappropriate and misguided.

The bill would, for example, bar a medical device representative from providing educational literature or a PowerPoint presentation to practitioners who need to learn the manufacturer’s instructions for implanting a new device in preparation for a surgery unless and until that representative had been “credentialed” by the hospital. It is unnecessary and unwise to make the hospital the oversight body for medical device manufacturer representatives when the hospital is not the appropriate entity to exert this type of unwarranted control.

SB 1372 does nothing to improve patient safety, adds healthcare costs, and creates inefficiencies. We are not aware of any mishaps, adverse outcomes, events, or patient safety issues in Connecticut that would support this type of legislation.

Thank you for your consideration of our position. For additional information, contact CHA Government Relations at (203) 294-7301.