Despite the extraordinary efforts of legislators, grassroots organizations, and individual healthcare organizations nationwide to prevent accidents related to medical devices, procedures, and processes, serious and fatal events continue to occur.
A recent survey undertaken by ECRI Institute revealed that 75% of approximately 450 respondents do not involve third-party investigation assistance, even in the most complex and confounding events. In those cases, incident investigation was carried out by hospital personnel, and in some cases, by personnel actually involved in the incident.
Hospitals should ensure that an internal accident investigation be performed and have a mandate to do so; however, there are some circumstances in which it may be unwise to rely solely on an internal investigation. In most cases, more than one of these circumstances may be involved.
Events involving serious injury or death are likely to result in legal claims by the injured party or the estate of the deceased. The defense of such claims involves investigation and potentially court testimony that must ultimately withstand the court’s requirements.
In addition to education and training, the professional needs expertise in the matter at hand and must be capable of applying that expertise, scientifically, to the issues in the case.
Tip 1: Eliminate investigation bias
The qualifications of the health technology management (HTM) or facilities investigative staff persons to provide expert opinion and testimony is likely to be problematic. Foremost, the investigation is always vulnerable to the suggestion of bias, if not actual bias. The claimant will argue that the same person using the same test methods with the same test equipment can repeatedly miss a problem. Using internal staff to perform incident investigation exposes them to subpoena, deposition, and trial that in most cases is not part of their job description, experience, or expertise.
Tip 2: Seek impartial, specialized engineering expertise
Healthcare-related incidents frequently involve technology, such as a medical device, procedure, or process that includes equipment of some type. For this reason, an essential component of the investigation is to have engineering expertise brought to bear. Medical devices and instrumentation typically involve biomedical/clinical engineering personnel, whereas process equipment, such as that used in central sterile processing, involves facilities engineering personnel. In either instance, with internal investigations, the same persons responsible for the maintenance of the devices or equipment can become tasked with testing the incident devices or equipment as part of the investigation. In a very real sense, they are investigating themselves.
In general, facilities, HTM, biomedical engineers, and associated technicians are not experienced, trained investigators. Their main responsibility is to maintain devices and equipment so that they continue to work properly, meet the manufacturer’s performance specification, and are safe.
Incident reconstruction, devising simulations, or developing test methodologies to scientifically explore possible mechanisms of injury is neither in their wheelhouse nor comfort zone. Therefore, their focus can become testing, rather than investigating. The testing usually involves the same persons, methods, and test equipment that is used for the periodic inspection and maintenance tests.
Tip 3: Remove the drain on internal resources
Internal investigations can consume significant staff time and resources, which can potentially affect work flow and ability to complete routine tasks needed to maintain patient safety. The time needed to perform investigation testing always exceeds that needed for routine maintenance testing in that investigation testing requires test protocol development and is more documentation intensive.
Frequently, proper investigation requires equipment that is not available in the hospital. Incidents involving mechanically broken devices, such as catheters and guidewires, require, at minimum, the use of a visual light stereo microscope with photographic capability. Hospitals generally do not have these microscopes. Occasionally, scanning electron microscopy is needed to perform a defensible failure analysis.
Tip 4: Benefit from independent expertise
Internal investigations can often benefit from outside perspectives, such as when a cluster of incidents involve a particular device or process. Oftentimes, the healthcare facility has to change to a different manufacturer’s product line entirely in order to maintain services and prevent clinical migration. However, rather than going to such an extreme, retraining may be a better and less expensive solution. An outside perspective can often calm the situation and avert the crisis.
The complexity of advanced medical care is daunting. We often find that internal investigations target the wrong device and/or reach the wrong conclusion regarding the cause of the injury. For example, intraoperative skin injuries are often charted in the patients’ records as a “Bovie burns” from an electrosurgical injury. However, in many cases, the skin injury was actually due to pressure, contact with a hot object, or chemical irritation. An experienced, knowledgeable investigator knows the various mechanisms of iatrogenic skin injury and how those injuries present and progress.
When a patient has been injured or died from their injury while under a healthcare system’s care, the institution needs to have the unvarnished truth upon which to base decisions related to patient safety, device/equipment decisions, staff credentialing and training, negotiations with the patient/family, while maintaining the integrity of the institution. Assistance from an independent investigator is well worth the cost because it helps to:
For nearly 50 years, ECRI Institute’s Accident and Forensic Investigation team has been conducting independent accident investigations in healthcare settings. In fact, our team of PhD-level biomedical engineers has conducted thousands of independent investigations primarily on behalf of healthcare organizations, but also for general counsel offices, insurance providers, and defense attorneys.
For more information about ECRI Institute’s capabilities or you are seeking assistance with an incident, please contact us at firstname.lastname@example.org or visit https://www.ecri.org/solutions/accident-forensic-investigation-services/
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