Editor’s Note: This is the first of a two-part interview.
“Medical device data collection has increasingly become a part of the fabric of health IT system deployment,” writes John Zaleski, PhD, CPHIMS, in his new book Connected Medical Devices: Integrating Patient Care Data in Healthcare Systems (HIMSS Books, 2015).
What began as a tool for research has become, according to a survey by CapSite, a major purchasing goal of more than half of all U.S. hospitals and health systems. In this interview, Dr. Zaleski, a noted author and inventor, discusses the growth of medical device integration (MDI) solutions; the benefits and challenges it presents to hospitals and health systems; and what vendors, advocates and government agencies are doing to standardize and improve MDI.
HIMSS Books: In your book you describe the beginnings of MDI as “esoteric” and used primarily by those conducting research within a healthcare environment. Today, according to a recent CapSite survey, more than half of U.S. hospitals and health systems are planning to purchase and implement an MDI solution. What were the causes behind this dramatic shift?
John Zaleski: Partially the maturing deployment of electronic health record systems; partially the maturing of the complexity of integration that requires higher-frequency, higher accuracy, higher fidelity data, such as clinical decision support methods within electronic health record systems; partially the motivation of Meaningful Use and needs for improvement in patient safety; partially the Affordable Care Act (ACA). Other specific motivations, such as the recognition that improved patient care management can be achieved through better, more accurate data.
HIMSS Books: MDI is touted as a beneficial to patient care. What evidence backs up this assertion?
Zaleski: Improvements in patient safety through better data. For example, communication of data that can be used for patient care management. The 2012 AAMI/FDA Medical Device Interoperability Summit identified “Seven Clarion Themes.” Foremost, interoperability impacts patient safety. The ECRI Institute identified interoperability within the Top 10 Health Technology Hazards for 2013. Based on a 2012 AAMI survey of health IT professionals in 1,900 U.S. hospitals, interoperability issues placed first and second on the AAMI list of Top 10 Medical Device Challenges. Specifically,
- Medical devices and systems on the IT network (cited by 72 percent of respondents).
- Integrating device data into electronic health records (EHRs) (cited by 65 percent of respondents).
Studies of the benefits of receiving patient care data into electronic health record systems as a mechanism for improving nurse-charting workflow have been reported by individual institutions in terms of time to chart. But, the Westhealth Institute, in a report published in 2013, estimated that through their top-down and bottom-up modeling, an annual saving of $30 billion may be liberated by widespread adoption of functional interoperability for medical devices.
HIMSS Books: You have more than 25 years’ experience with MDI, both as an author and as an inventor and researcher. What do you think are the major milestones and trends of MDI, and where do you see it going in the coming years?
Zaleski: I would have to say that the recognition of the value of MDI, which occurred not too long after EHR systems became widespread, perhaps not quite 10 years ago; then, the motivating federal guidelines surrounding Meaningful Use Stages 1 and 2; the ACA also provided some motivation. But, beyond that, my opinion is that receipt of data into the electronic health record systems motivated new ideas about what to do with those data. This, in my opinion, is leading to “higher-level” use cases other than charting. For example, use of the data to assist in improved patient care management and clinical decision making.
When I started in this field, I was a graduate student and needed to collect data on live patients whom I was studying to develop methods for weaning from post-operative mechanical ventilation. I was running a study on patients recovering from coronary artery bypass grafting surgery and was following “my” patients from surgery through extubation from mechanical ventilation in surgical intensive care and general surgery. When I was conducting this study, it was years before the commercial electronic health record system was widely publicized.
Furthermore, none of the medical devices with which I was working had any automated data collection capability that was exploited within the hospital system I was working. Hence, I had to write my own code and perform data collection on my own, right at the patient bedside. My purpose was in using the data to develop models of patient state; to better predict time-based changes in physiologic and respiratory parameters, and guided by patient demographics, intakes and outputs, and other information.
Yet, what was really lacking was a way to collect this information using an automated, standardized approach. So, I got into the MDI field as it was a necessary utility to meet my ultimate needs: complete data for better clinical decision making.
HIMSS Books: So many healthcare technologies are seemingly easy to explain and, if implemented properly, promise game-changing results in terms of cost-reduction, increased efficiency and improved quality of care. It’s easy to overlook or underestimate the adoption and implementation challenges many of these technologies present. What are the major challenges of MDI implementation from the perspective of a hospital and health system?
Zaleski: Well, MDI can be a complex proposition to implement. Medical Device Integration crosses technical and clinical boundaries, and for the healthcare system that has never undertaken it, can require staff to develop seemingly new, hybrid skills that are totally foreign to some.
For instance, MDI requires drawing data from physical devices at the bedside. The bedside medical devices were traditionally relegated to the realm of the clinician and biomedical or clinical engineering. The Information Technology team was not really “in that space.” With MDI, there is a crossover involving the healthcare information technology team to now become cognizant of data collected from point-of-care devices. This requires education on the part of those not familiar with the clinical space.
Furthermore, clinical staff normally used to interacting with medical devices now are being asked to validate information. Hence, effective and accurate MDI mandates that each actor look outside his or her role to take on some aspects of their team mates to make for a successful integration.
For this reason, it is my belief (based on experience) that highly successful MDI involves a team approach, complete with actors from (minimally) clinical, information technology, clinical engineering, facilities, networking departments. MDI involves aspects of all of these departments (and more). Hence, MDI represents true systems engineering from the perspective of marrying together different sub-systems, developing clear and repeatable interfaces, and establishing workflows that incorporate clinical operations, information messaging, and infrastructure communication.