Incident/Untoward Event Investigation is one of the areas of the CCE examination under the topic of “Risk Management & Safety.” For a complete list of CCE Examination topics, see the new 2008 Candidate Handbook for CE certification available at www.accefoundation.org/certification.asp.
Responding to an Incident
There should be written policies and procedures to guide the staff on how to respond to a medical equipment incident and subsequent investigation. In a health care organization, it is usually the facility risk manager who serves as the coordinator of investigations. The risk manager is usually responsible for developing incident protocols, coordinating the organization’s immediate and ongoing response, and working directly with the relevant staff and the facility’s legal counsel. The clinical engineer (CE) or biomedical equipment technician (BMET) usually works closely with the risk manager in gathering initial information and evidence about what happened. The CEs or BMETs are most likely to be called as first responders in an incident. Sometimes they may hear about incidents days later.
It is important to document the facts of the incident. The clinical staff should be asked what they did and what happened, and their response should be documented. To preserve evidence, the equipment (if possible) and accessories involved in the incident should be sequestered. Also, document the settings, model, and serial numbers of the equipment. Pictures should be taken of the incident scene, the equipment, and the accessories involved in the incident.
The Joint Commission standard EC.6.10 EP7 requires incident reporting and monitoring per the Safe Medical Devices Act (SMDA) of 1990.
A thorough and prompt incident investigation should be undertaken as a response to an incident. Incident investigations are conducted for a number of reasons, including to determine the cause of the incident, avoid future incidents, respond to insurance/legal claims, improve patient safety, and address the accreditation requirements of some agencies.
The Joint Commission standard PI.2.30 requires the health care organization to conduct a root cause analysis of incidents that focuses on processes and systems.
See the January 2007 “CCE Prep” article for more details.
Investigation of an incident requires special skills and training. These investigations usually require interviewing members of the clinical staff to determine the cause of the incident and examining the relevant clinical records, as well as thoroughly inspecting/testing the equipment involved, reconstructing the incident, examining the evidence, reviewing databases (eg, the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database) for adverse events involving similar equipment, and analyzing the equipment’s maintenance and repair history.
To avoid a conflict of interest, one recommendation is that hospital CEs and other biomedical engineering staff should not act as a primary investigator when they maintain the medical equipment involved in the incident. In these cases, an independent CE should be hired. An independent CE may work as a consultant or may work as a CE in another organization.
Knowing the Legal Terms
An incident involving a patient injury or death may lead to a lawsuit. It is important for the CE or BMET to be familiar with some of the commonly used legal terminology.
- Deposition: A statement made under oath in response to questioning by an attorney.
- Discovery: A phase in a lawsuit in which each party can request documents and other evidence from other parties.
- Interrogatory: A list of questions drawn up by opposing counsel for obtaining written information from witnesses.
- Lawsuit: A civil action brought before a court in which the party commencing the action (plaintiff) seeks a legal remedy.
- Plaintiff: A person who initiates a lawsuit by filing a complaint.
- Respondent: The party to whom the complaint is filed against.
- Subpoena: A written order directing you to appear at a particular time and place as a witness.
- Testimony: A form of evidence (oral or written) that is obtained from a witness who makes a solemn statement or declaration of facts. It is usually made by oath or affirmation under penalty of perjury.
- 1. A list of questions drawn up by opposing counsel for obtaining written information from witnesses is called __________.
- None of the above
- 2. A written order directing you to appear at a particular time and place as a witness is called __________.
- None of the above
- 3. A statement made under oath in response to questioning by an attorney is called __________.
- None of the above
- 4. You are working as an in-house clinical engineer at a University Hospital. One day, the COO of the hospital calls you and asks you to lead an investigation of a ventilator incident that occurred in the ICU last week. The in-house clinical engineering staff (of which you are a part) maintains this particular ventilator. Choose the best response.
- Advise the COO that there is a potential conflict of interest in you being the lead investigator for this incident because the in-house clinical engineering staff maintains the equipment. You should recommend that the hospital retain an independent clinical engineer to investigate the incident.
- Advise the COO that you are not qualified to perform the investigation and suggest that another clinical engineer working with you be assigned to lead the investigation.
- Investigate the incident yourself and submit a report to the COO.
- Investigate the incident yourself and submit reports to the COO and FDA.
- None of the above
See the answers
Arif Subhan, MS, CCE, is a senior clinical engineer, Masterplan, Chatsworth, Calif, and chair, education committee, ACCE. For more information, contact .
Suggested References for Further Study:
- Anderson JT. The clinical engineer as investigator and expert witness. Dyro JD. Accident investigation. In: Dyro JD, ed. Clinical Engineering Handbook. Elsevier Academic Press; 2004.
- Daus C. Medical device incidents. 24×7. 2007;12(11):22-28.
- Vockley M. Called to testify? Biomed Instrum Technol. 2006;40(6):429-434.