‘We Need a New Risk Management Paradigm’


Posted June 5, 2015

It’s time for the healthcare technology management (HTM) field and healthcare delivery organizations to develop a better appreciation for and use of risk management, according to a presenter at the 31st Annual Conference on Clinical Engineering Productivity and Cost Effectiveness, also known as the “Manny Meeting.” Held Friday in Denver, the meeting is tied to AAMI's Annual Conference & Expo, which concludes Monday.

“We need a new risk management paradigm in order to effectively identify, analyze, and control risks related to the growing and increasingly complex array of healthcare technology making its way into those organizations,” said Stephen L. Grimes, chief technology officer at ABM Healthcare Support Services in Boston, MA. Grimes laid out an approach similar to those used by aviation and other high-reliability industries.

The risk management paradigm needs to be both relatively simple and demonstrably effective, Grimes stressed.

“If you keep it simple, it’s more likely to get used. If it’s complicated, it discourages implementation,” he said. “Any paradigm or tool that fails to yield actionable and beneficial results is unnecessary and a waste of resources.”

Grimes offered advice on how to apply a risk matrix to medical devices. First, he said, begin with a medical device, such as a defibrillator or ophthalmoscope, and assign risk by the device category. Once that is done, conduct an assessment of the differences in risk between manufacturers, models, locations, and devices.

“Clinicians most often are in the best position to make the best judgment in terms of severity of levels or potential consequences of failure,” he said. “Clinical engineers or HTM professionals are best at assessing probability.”

Grimes detailed the new paradigm in “Evolution of a Risk-Based Approach to Effective Healthcare Technology Management,” which appeared in the spring 2015 edition of AAMI's Horizons supplement. The development of a risk-based approach to the management of healthcare technology should help the HTM field meet requirements from the federal Centers for Medicare & Medicaid Services and hospital accreditation organizations such as The Joint Commission and DNV GL.

Example from the Field

Frank Painter, a consultant and professor of clinical engineering at the University of Connecticut, and Matt Baretich of Baretich Engineering, Inc., in Colorado, spoke about their work assessing risk in the Kaiser Permanente Clinical Technology Program. They also documented their experience in the spring Horizons.

“The goal of the project was to evaluate technology management issues throughout the entire clinical technology life cycle,” Painter said. The project included an online survey, 40 phone interviews, document reviews, and four site visits, including 35 face-to-face interviews.

“It’s important to be thorough,” Baretich said. “There’s a lot of information to be gained by digging in.”

The types of risks that were assessed related to patient and staff safety, regulations and compliance, finances, the reputation of the organization, and operations and liability.  Once those risks were sorted, the team created a list of items needing additional attention, and they were listed in five partially overlapping groups: scope of clinical technology services, computerized maintenance management system (CMMS), regional variation, life cycle management, and the role of the national clinical technology team.

The risk categories and initiatives are under further review within KP and will be addressed in coordination with other work, according to the presenters.