Adverse incidents include death, injury, or other harm to patients, staff, and visitors. They also include financial losses due to damage to equipment, systems, and facilities. Our focus is on investigation of incidents in which medical devices, building systems, information technology, or other technology-related aspects of healthcare delivery may have been contributing factors. Our ultimate objective is to decrease risk for the organization by the reducing the likelihood that such events will recur.
Incident investigations are most effective when they are comprehensive in scope and multidisciplinary in participation. Baretich Engineering provides an independent perspective on the role that technology may have played in an adverse incident. We are prepared to work with engineering and technical personnel, quality and risk managers, clinicians, attorneys, and manufacturers.
We can lead or participate in RCA and FMEA processes. We can provide equipment testing services. We can also provide assistance to device user facilities in complying with FDA Medical Device Reporting regulations and Joint Commission standards related to the Safe Medical Devices Act (Standard EC.02.04.01 EP5).