RESEARCH OBJECTIVES Develop an approach to reducing interoperability failures in medical devices, specifically, the software upgrade process of medical devices. • Identify stakeholders affected by upgrade process risks which become failures. • Identify a Qualitative Model of the process which identifies failures at each PPTONE level. • Identify data sources to provide Quantitative values for the probability and severity of these failures, and for performance indicators and benchmarking. • Identify risk mitigations, performance indicators and benchmark sources for each failure. • Suggest an approach to Health IT system integration which will supply data for decision making for benchmarking and analyzing risk mitigations. PROBLEM STATEMENT Interoperability failures between medical devices and Health IT systems affect both patient safety and intended purpose. •Change management introduces the risk of interoperability errors. Change Management Failures With Medical Device Upgrades Johnson, D.M., M.S., Vaughn-Cooke, M., Ph.D. Hybrid-System Integration and Simulation Laboratory, Department of Mechanical Engineering, Reliability Engineering Program METHODS AND MODEL BACKGROUND Scheduled and unscheduled upgrades of software to medical devices cause interoperability risks. The six systems of healthcare are at risk: Patient, Population, Team, Organization, Network and Environment (PPTONE). With the suggested custom Health IT systems and internal benchmark sources, good decision making data will be available to the stakeholders. •More data related to process, training and adherence is needed. •The model provides a method to quantify change management effectiveness. DISCUSSION •Collection and aggregation of retrospective data from the identified sources. •The application of this methodology to a prospective risk analysis tool (i.e. FMEA). •The application of the methods to a specific type of failure in the healthcare domain. FUTURE WORK

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RESEARCH OBJECTIVES

Develop an approach to reducing interoperability failures in medical devices, specifically, the software upgrade process of medical devices.

• Identify stakeholders affected by upgrade process risks which become failures.

• Identify a Qualitative Model of the process which identifies failures at each PPTONE level.

• Identify data sources to provide Quantitative values for the probability and severity of these failures, and for performance indicators and benchmarking.

• Identify risk mitigations, performance indicators and benchmark sources for each failure.

• Suggest an approach to Health IT system integration which will supply data for decision making for benchmarking and analyzing risk mitigations.

PROBLEM STATEMENT Interoperability failures between medical devices and Health IT systems affect both patient safety and intended purpose.

•Change management introduces the risk of interoperability errors.

Change Management Failures With Medical Device Upgrades

Johnson, D.M., M.S., Vaughn-Cooke, M., Ph.D.

Hybrid-System Integration and Simulation Laboratory, Department of Mechanical Engineering, Reliability Engineering Program

METHODS AND MODEL

BACKGROUND Scheduled and unscheduled upgrades of software to medical devices cause interoperability risks. The six systems of healthcare are at risk: Patient, Population, Team, Organization, Network and Environment (PPTONE).

With the suggested custom Health IT systems and internal benchmark sources, good decision making data will be available to the stakeholders.

•More data related to process, training and adherence is needed. •The model provides a method to quantify change management effectiveness.

DISCUSSION

•Collection and aggregation of retrospective data from the identified sources. •The application of this methodology to a prospective risk analysis tool (i.e. FMEA). •The application of the methods to a specific type of failure in the healthcare domain.

FUTURE WORK