A new electroanatomical cardiac mapping system becomes available that has significant advantages over current systems in the EP laboratory and is cost neutral. A novel intracardiac echocardiography (ICE) system is released after FDA approval and is available at the same price as other systems on the market. How difficult will it be to get these new technologies into the hospital in 2019, so that patients can potentially benefit?
The ability to bring new technologies into EP laboratories is increasingly difficult. There are several obstacles. One major obstacle is that many of the technologies in the EP lab have both a disposable and a capital component. For example, an EP mapping system requires both disposable multielectrode catheters and specialized computer equipment. Acquiring something like this requires hospital approval by both a supply chain team and a capital committee. Hospitals cannot legally receive capital from a company at no cost because it could be perceived as an inducement to use their products. However, one mechanism by which new technology can be legally acquired without a significant capital expense is to obtain the capital through “catheter deals” or other methods by which the capital costs are covered by a predetermined number of supply purchases, either upfront as a bulk purchase or over time. Unfortunately, this approach is often discouraged at hospitals, where it is assumed that the end result will be higher supply costs to offset the capital costs, or when hospitals are concerned about placement of hospital capital that cannot be depreciated.
We need new ideas to address this challenge of accessing new technology in the EP laboratory. One idea is to change the model by completely eliminating the need for the capital. For example, a powered transseptal needle currently requires a generator to deliver the RF energy using a connection cable. Requiring approval of both items by two separate parts of the hospital (the supply chain and the capital committee), adds to the complexity and delay as well as lowers the chances of ever having the system available for patients. If one developed a powered transseptal needle that has an energy source and electrical components built into the hub of the needle that could be used to deliver a couple of seconds of radiofrequency current, the need for the generator would be eliminated. Although this may slightly increase the supply costs, it would greatly simplify the technology and eliminate the need for capital acquisition.
Another idea is to consider the regulatory and hospital equipment status of device programmers. For unclear reasons — likely historic — pacemaker and defibrillator programmers, which are ever present throughout most hospitals, are not purchased by the hospital. They are also often exempt from inspection and certification by the hospital biomedical engineering team. So it is interesting to consider that if a device manufacturer were to develop a new implantable cardiac monitor, for example, the programmer that would be used at the time of implantation and follow-up would be provided by the company free of charge and stored in the hospital. How is this any different than a mapping system connected to a mapping catheter? Why are programmers in a category of their own? According to the FDA, pacemaker and defibrillator programmers are defined as “pacemaker/ICD/CRT non-implanted components [that] provide programming, interrogation, printing, remote monitoring, and communication between the pulse generator and health care provider.”1 It is considered device class III with premarket review by the FDA’s Cardiovascular Devices committee. It seems that electroanatomic cardiac mapping systems that also receive information from pacing and sensing catheters placed temporarily in the heart could also be placed in the same FDA category. Classifying mapping systems as non-implanted temporary pacemaker components might allow hospitals to consider mapping systems in the same category as programmers and avoid the capital purchase.
New creative ideas are needed to simplify the process of acquiring new technology in modern EP laboratories to avoid the need for approval of both the disposable components by the hospital supply chain and the hardware by the hospital capital committee.
Disclosure: Dr. Knight reports that he is a consultant, speaker, investigator, and offers fellowship support for Abbott, Baylis Medical, Biosense Webster, Inc., BIOTRONIK, Boston Scientific, Medtronic, and SentreHEART.
- Product Classification. U.S. FDA. Published August 19, 2019. Available at https://bit.ly/2Z0bHhs. Accessed August 20, 2019.