Health Systems Risk Management Series: Medical Device Safety
Since World War II, medical devices have become increasingly important in the practice of medicine for diagnosis, monitoring and treatment. Advances in technology and new materials have resulted in the development of sophisticated and complex products such as cardiac pacemakers, artificial heart valves and replacement joints. At the same time, faulty design, poor workmanship or improper use have resulted in new threats to patient safety.
As a result, the Food and Drug Adminstration (FDA) passed the Safe Medical Devices Act (SMDA) of 1990 and the Medical Device Amendments of 1992 (MDA) to regulate the reporting of device-related deaths and serious injuries by user facilities. In addition to prescribing significant penalties for failure to report in a timely manner, these regulations attempted to define terms and timelines for reporting.
According to Dr. Underdahl, the definition of a medical device in the SMDA is “quite broad. Anything that has to do with patient care—a band-aid or a wheelchair—could be considered a medical device.” So, health system risk managers must use discretion when tracking and reporting medical device safety issues.
Nearly a decade after regulations for reporting went into effect, the FDA felt hospitals were underreporting medical device incidents and initiated a pilot program to help hospitals file the necessary paperwork to meet the reporting deadlines. In fact, in partnership with MedSun, they offered health systems up to $15,000 for ideas to improve medical device incident reporting.
Underdahl took the opportunity to not only cash in on the “tag and sequester” program at the health system she worked at, but as a way to improve upon it. The tag and sequester program involved medical personnel who either had issues with a medical device or witnessed a malfuntion to take the device out of service, tag it and remove it from service. However, as Underdahl discovered when she did an informal needs assessment, many of the medical personnel didn’t know the system, where to find the tags and where to put the equipment or who to contact once it had been tagged. In addition, the tag was a two-inch by two-inch piece of paper which didn’t have enough room to adequately document the information necessary to report the incident.
Says Dr. Underdahl, “Although the tag and sequester program was a solid system, there was not a consistent process or place to gather equipment, as well as a forum to gather specific, meaningful information for clinical engineering to fix the equipment or risk management to report an issue.”
So she went to work collaborating with a colleague to develop the STAR program, which stands for Stop, Tag, and Report. The STAR program included: a new, larger tag with room to describe the malfunction; an updated policy and procedure outlining exactly how, when and what information is needed to document medical device safety issues; and an online method to report malfunctions.
When it came time for implementation, Underdahl encountered great resistance, especially to the new tag. “We have a better policy and procedure, yet sadly, nearly a year later we have yet to even meet on the new tag.” Despite the challenges within her own organization, Underdahl takes great pride in knowing her efforts have helped other medical centers, and especially, patients. In fact, one medical center in Michigan adopted Underdahl’s ideas and successfully implemented them.
“It proves that you can’t give up because you don’t win them all.”