In an effective healthcare facility, who bears the ultimate responsibility for managing the telemetry infrastructure and associated devices? Should it fall under the clinical IT umbrella, as it's entwined with IT networks? Some hospital leaders assume so. But the fact is, biomed teams take the lead on telemetry services since these are medical devices. This team works to keep these devices safe and well managed. That includes a lifecycle and risk management plan for telemetry infrastructure.
How Telemetry Infrastructure Failures Affect Safety
Telemetry infrastructure and the associated clinical IT networks that connect patient monitoring systems are sometimes overlooked. This may stem from alarm fatigue or overworked technicians; at the same time, issues can also arise as built-in redundancies mask multiple failures. Redundancies are necessary, because they often provide the time needed to fix issues without causing full system outages. However, this means that staff can miss points of malfunction for weeks or even months until a complete outage, patient harm, or death occurs.1
Therefore, unsurprisingly, when ECRI released its Top 10 Patient Safety Concerns in Healthcare for 2022, telemetry monitoring was included. If telemetry systems are not adequately managed and maintained, it puts patient safety at risk. Among several common issues related to telemetry monitoring, ECRI called out poor safety culture, telemetry infrastructure failures, and a lack of emergency outage plans.2
How to Create a Plan for Managing Patient Risk
Addressing these safety concerns boils down to building a lifecycle and risk management strategy for telemetry and clinical network infrastructure.3 Having a strategy in place can prevent unplanned downtime, expenses, and potential safety risks for patients.
In 2010, the International Electrotechnical Commission (IEC) released a standard called IEC 80001-1 and an update to that standard in 2021.4 This standard helps organizations manage risks associated with technology used for the benefit of patients. The standard provides requirements for roles, process, and risk management, as well as how to document these within your organization.
Although every healthcare facility operates differently, there are common starting points for clarifying essential safety and management tasks. In addition to adhering to the 80001-1 standard, here are some initial steps you can take to create your own lifecycle management strategy.
Assess Your Current Position
Per the 80001-1 standard, documentation is key. Determine whether you have a formal, written, and well-communicated strategy that everyone knows and uses. If not, learn where gaps exist. This includes verifying that safety procedures are in place and being followed, redundancies exist in case of infrastructure failure, and plans detail how to respond to and recover from emergency outages.
This step should also include an audit of recent patient safety issues that have occurred to uncover any specific points of failure.5
Verify Device and Infrastructure Lifecycles
Before creating a plan, determine what the manufacturer's lifecycle recommendations are for each telemetry device in use at your facility and any maintenance and service recommendations for the infrastructure that supports them. The manufacturer of each device and infrastructure component should provide this information. As part of a patient safety audit, investigate whether care teams are following maintenance and service recommendations—and, if not, why?
Define Who Is Responsible
Specialized equipment and other telemetry-specific expertise may be needed to properly manage, troubleshoot, and maintain these systems. Establish the job roles that are in charge of each part of the lifecycle management plan. This may be as simple as determining which role places devices into patient rotation and which performs scheduled and corrective maintenance of those devices.6
Your strategy should explicitly state who manages each part of the lifecycle. This plan should also include accountability so that failures in one part of the team don't lead to failures in another.
Determine Staff Capacity
When safety and management plans are lacking, staffing concerns offer potential clues. Appraise your staffing capacity, priority, and expertise first; capacity needs will likely vary from facility to facility, as they are closely tied to the experience and expertise of your staff as well as retention rates. Particularly in cases of understaffing, teams may struggle to assess or create a management strategy on top of their current duties, and it may make sense to call in outside assistance.
If you have concerns about understaffing or the team's inexperience, outside resources can offer support, either through initial help in creating a strategy or by maintaining service and maintenance across infrastructure and devices.
Prioritizing Telemetry Infrastructure
Ultimately, patient outcomes are the main driver of telemetry lifecycle management plans. Technology often underpins patient safety as medical teams rely on telemetry to supply the essential data needed to provide effective care.
When telemetry systems break down, the expense and time to repair or replace them can cut into the facility's budget and add unnecessary stress to care teams. Prioritizing implementation of a fully functional telemetry infrastructure management plan—one that supports your biomed team and its goal for patient care—will ensure that a healthcare organization, and everyone inside, is protected.
With one of the largest installed bases in the country, GE HealthCare has a long history of designing, installing, and managing telemetry systems. In addition, GE HealthCare helps customers understand and manage their own GE HealthCare systems. To this end, our ApexPro telemetry systems use filtering to protect against outside influences and redundancy to prevent downtime. Learn how ApexPro can help manage risk and ensure patient safety inside your organization.
References:
1. Pennsylvania Patient Safety Authority. Telemetry Monitoring in PA — Eliminating Dead Batteries & End-of-Life Alarms. October 26, 2020. https://www.youtube.com/watch?v=N4HYqVY6MF4
2. ECRI's Top 10 Patient Safety Risks for 2022. ECRI. Published March 8, 2022. https://blog.ecri.org/ecris-top-10-patient-safety-risks-for-2022
3. Iadanza E, Gonnelli V, Satta F, Gherardelli M. Evidence-based Medical Equipment Management: A Convenient Implementation. Medical & Biological Eningeering & Computing. 2019;57(10);2215–2230. https://doi.org/10.1007/s11517-019-02021-x
4. International Organization for Standardization. IEC 80001-1:2021. Application of risk management for IT-networks incorporating medical devices — Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software. Published September 2021. https://www.iso.org/standard/72026.html
5. Hut-Mossel L, Ahaus K, Welker G, Gans R. Understanding How and Why Audits Work in Improving the Quality of Hospital Care: A Systematic Realist Review. Published March 31, 2021. https://doi.org/10.1371/journal.pone.0248677
6. Corciovă C, Andriţoi D, and Luca C. A Modern Approach for Maintenance Prioritization of Medical Equipment. Operations Management: Emerging Trend in the Digital Era. Published June 6, 2020. doi: 10.5772/intechopen.92706
