From the May 2018 issue of HealthCare Business News magazine
By Rich Sable
New regulations shape how HTM is conducted.
As we prepare for AAMI 2018, healthcare technology management (HTM) reflects on the top issues and concerns of our community. While these concerns continue to be, as they always have been, those of meeting regulatory compliance and providing patient safety, they require a new perspective. HTM evolved because of the patient safety issues associated with widespread use of new medical devices.
Today, medical devices are safer due to engineering advances such as optical isolation and insulated cases. With devices becoming ever more sophisticated we now face new issues from operator errors, software failures, repair difficulty and cybersecurity. So while regulatory compliance and patient safety are still the top issues, they present a far more complex challenge than in the past.
The regulations and resultant new requirements
With respect to regulatory compliance, the rules became stricter during the last several years, as concerns were raised by medical device manufacturers. Because of these changes, preventative maintenance (PM) requirements centered around manufacturers’ recommended procedures, and these procedures placed increased demands on both human and capital resources of the clinical engineering departments. Unfortunately, these increases of departmental resources came at a time when hospital budgets have been reduced due to external pressures on the health care industry.
In the past, many HTM departments utilized risk-based PM to alleviate the burden of this workload. Further, most clinical engineers used this opportunity to perform tasks on equipment that they regarded as needing more attention, while saving time on the devices they determined not to present a risk to patient safety.
In fact, many devices with a low risk score did not have a manufacturer-based PM procedure to begin with, or only required an operational check which the device’s user performed prior to patient use. Using sophisticated algorithms, the CMMS (computerized maintenance management system) performed the device stratification for risk-based PM, and the reasoning for PM exclusion was easy to demonstrate to regulatory inspectors or the environment of care committee.
Due to recent changes, screening devices based on risk alone is no longer permitted. Further, all patient care devices need to be inspected 100 percent of the time regardless of the device’s risk score, causing a pain point for many HTM departments. Most departments were unable to expand their human resources and the need for an expansion would need to be demonstrated to administration.
