Incident Investigation

Medical Device Incident Investigation

Incidents involving health technology are unfortunately fairly common in healthcare. Some used to blame them on clinical users who were poorly trained or overwhelmed, calling those incidents “user errors,” but the reality is much more complex. Recognizing this fact, the US-FDA has advocated the term “use error” (see link below) to call attention to other contributing factors. While device-related incidents cannot be fully eliminated, they can be reduced if their root causes are determined through thorough investigation and both corrective and preventive actions promptly and comprehensively taken.

Link to FDA's webpage on Human Factors

BSI has consultants who have investigated thousands of incidents when they were responsible for the oversight of up to a million pieces of medical equipment deployed in the entire United States. They also participated in numerous litigations, from both the plaintiff and the defense side. Using such experience, we can offer the following services:

Perform forensic investigation of the incident and determine its root cause(s)
Make recommendation on the proper procedure to conduct the investigation with the possible participation of the manufacturer(s), clinical staff, legal representative(s), independent investigators, etc. to avoid possible future allegations of mishandling and loss of evidence
Advise on the proper storage and disposition of the material and documents involved to ensure strong defense against accusations of evidence spoliation and tampering
Suggest appropriate corrective and preventive actions to decrease risks of similar incidents in the future, thus avoiding risks of punitive damages
Help defend medical malpractice claims involving medical devices and other health technology

BSI's incident investigation approach considers not only the medical device in question but also the environment, facility, other devices present, clinical users, and the patient, as shown on the figure on the left. As James Reason postulated, a hazard can only result in a patient incident if the gaps in each of the multi-leyer protection system are lined up.

Potential Beneficiaries

Risk management leaders in hospitals, health systems, service organizations
Risk and regulatory leaders in design and manufacturing companies
Attorneys in plaintiff and defense firms dealing with medical device incidents
CE/BME/HTM leaders in hospitals, health systems, service companies,
Test/measurement equipment producers

Page updated

Google Sites

Report abuse