Healthcare Incident Investigation

Our members have told me, 'When a near miss, close call, or adverse event occurs during the delivery of healthcare, some form of technology is often involved,' says Bruce Hansel, Ph.D., CCE, Chief Scientist with ECRI's Healthcare Incident Investigation Group. 'ECRI investigators can help you uncover the cause of healthcare incidents and take the necessary steps to prevent recurrence.'

Incidents happen. But they need not be repeated. At ECRI, our technical and clinical experts work with you to determine what went wrong and why, so we can help you build strategies, procedures, and safeguards aimed at preventing future incidents. Incident response and preparedness are essential for healthcare organizations looking toward the future and aiming to reduce the number of accidents and hazards that they encounter.

After an accident occurs, staff members' actions must center around restoring safety and maintaining normal operations, and yet, the important investigation work must be handled promptly, thoroughly, and in best practice, independently.

ECRI's Healthcare Incident Investigation and Technology Consulting (HII-Tech) team has the knowledge and expertise to conduct unbiased, scientific clinical incident investigations to uncover and document facts and set your facility on a successful path forward. With the proper healthcare incident management support, you can give your patients the level of care they deserve.

Why ECRI

With the trusted ECRI name and more than 50 years of partnering with healthcare facilities across the continuum of care from large health systems, aging services facilities and ambulatory care centers to promote safety, ECRI can be counted on to help you determine causes and prevent recurrences.

• Incident investigations and incident management for patient safety
• Sentinel event investigations and analyses
• Root-cause analyses and risk-reduction strategies
• Technical consultations, gross and microscopic inspections, accident reconstruction, and biomedical testing
• Expert witness consultation and testimony
• Proactive consultations to prevent known hazards
• Evaluating compliance (to prevent the termination of Medicare and Medicaid)

Taking action before incidents occur with proactive assessments

It is critical to understand why healthcare incidents occur so that actions can be taken to prevent these issues in the future. However, ECRI doesn't stop there. Beyond investigating and analyzing the root causes of healthcare incidents, we offer proactive safety consultations designed to prevent known hazards. These include:

• Surgical Fire Prevention: ECRI estimates around 90-100 surgical fires occur each year in the United States. These fires can have devastating consequences for patients, staff, and the facility. Turn to ECRI ’s experts to learn how to prevent and extinguish surgical fires.
• Infusion Pump Management – Infusion Pump investigations are the most frequently requested device-related investigations. Our subject matter experts perform on-site or virtual assessments designed to address how you manage infusion pumps, learn of known hazards, and establish a strategy for responding appropriately to reported incidents of infusion pump adverse events.
• Infection Prevention and Control: The COVID-19 pandemic exposed critical issues in the healthcare system that revealed most healthcare facilities are not prepared for outbreaks. With the support of infection prevention and infection control consultants, we work with you to address emergency preparedness, evaluate and investigate weaknesses in your systems and processes that need to be addressed so you can deal with such an emergency, and develop a plan and proper response actions so that your patients and your hospital personnel are protected.
• Device Evaluations: Having the right equipment to treat your patients and understanding how to use it safely is not only essential for providing the best care but also for reducing incidents that occur in your facilities. ECRI works with you to help you better understand the different types of devices your hospital may wish to employ for certain healthcare purposes, how they compare to other similar devices made available to healthcare facilities, and whether or not they're a good fit for your facilities' needs.
• Physiologic Monitoring Assessment – Monitoring of physiologic parameters is essential for certain patient populations but it must be utilized appropriately to prevent alarm fatigue and other potentially dangerous scenarios. Our subject matter experts can come on-site to assess your use of monitoring technology and specifically the proper management of alarms to make sure that you are following best practices and are employing the latest technology to avoid risks.

ECRI also offers extensive risk analysis and management services to support those in the healthcare industry looking to proactively identify and manage risk so that they can reduce the likelihood of healthcare incidents and adverse events, including Health System Risk Management, Aging Services Risk Management, Ambulatory Care Risk Management, and Risk Assessments.

Overall, ECRI offers comprehensive services and solutions designed to prevent accidents before they happen, better understand the accidents that do occur regardless, and make the necessary changes required to improve current practices so that these accidents don't happen again.

Respond appropriately and effectively manage healthcare incidents with education

Healthcare staff need to be properly educated and informed about facility protocols and processes so that they can provide the best possible care to patients and protect themselves every step of the way. ECRI offers traditional in-person education as well as interactive e-Learning courses that provide a wealth of resources designed to help your personnel thrive in their roles. This includes comprehensive causal analysis training, such as our Healthcare Incident Management and Investigation (HIMI) Course. Our HIMI course trains risk managers, providers, and biomedical engineers on how to broadly manage and investigate any type of healthcare incident, starting from its inception to potential litigation that may stem from the incident.

Of course, we offer more than just this. In fact, ECRI has an extensive eLearning catalog with courses that can help modern healthcare professionals improve their risk assessment and response knowledge.

Support to meet your biomedical engineering, capital purchasing, and operational challenges

In addition to supporting incident response, we can also support you with Data Standardization, Department Benchmarking, Service History Review, Contract & Needs Review, Equipment Standardization, Strategic Planning, Predictive Replacement Planning (PRP), Medical Device SME Assistance, Technology Analysis, PPE Testing and more.

Get assistance today

Are you ready to receive the consulting support and solutions that your facilities demand? If so, schedule time with an ECRI expert to learn more.

Meet our experts

Barbara G. Malanga, BSEE

Director, Healthcare Incident Investigation & Technology Consulting (HII-Tech)
Ms. Malanga is the Director of ECRI’s Healthcare Incident Investigation and Technology Consulting services. She has been with ECRI for 17 years and has performed comparative evaluations and investigations related to defibrillators, pacemakers, electrocardiographs, and fires. She has developed educational materials designed to train risk management personnel as well as biomedical engineers on best practices in incident management and investigation. Download Barbara Malanga’s CV

Bruce C. Hansel, PhD, CCE, CPHRM

Principal and Chief Scientist
During the last four decades, Dr. Hansel has performed nearly 1,000 medical incident investigations involving many types of medical technologies and procedures. He has provided technical expert opinion and testimony regarding anesthesia, ventilation, infusion, surgical instruments, monitors, catheters, implants, surgical burns, gas embolism, and more. Download Bruce Hansel’s CV

Marc Schlessinger, RRT, MBA, FACHE

Sr. Consultant and Investigator, HII-Tech Consulting
Marc Schlessinger is an experienced healthcare administrator, enhanced by a strong clinical skill set, having been responsible for ancillary service operations in hospitals for over 30 years. As a Senior Consultant Marc provides consulting services and assistance to hospitals and other healthcare institutions in matters concerning technology, strategic planning, operations, and reimbursement. He has been a practicing Registered Respiratory Therapist since 1978. Download Marc Schlessinger’s CV

Jeremy F. Suggs, ScD

Senior Investigator, HII-Tech Consulting & Senior Engineering Manager, Medical Device Evaluation
Dr. Suggs earned his doctorate in Mechanical Engineering with a focus in orthopedic biomechanics, specifically looking at the biomechanics of ACL injury and reconstruction and in- vivo knee kinematics after total knee replacement. Dr. Suggs worked in consulting and product development. His consultant activities included providing technical assistance in patent infringement and product liability litigation, review of complaint databases, and analysis of potential injury mechanisms in personal injury litigation. His product development work was primarily in spine implants. Download Jeremy Suggs’ CV

Are you ready to receive the consulting support and solutions that your facilities demand? If so, you can contact us to learn more by emailing clientservices@ecri.org or by calling us at 610.825.6000 ext. 5891.