The steps taken immediately after a medical device-related incident can make or break an investigation. Thus, it’s critical that staff know how to respond when an incident occurs. Over its 50-year history, ECRI has conducted thousands of investigations to uncover and document facts, determine causes, and prevent recurrence of medical device-related incidents. ECRI’s guidance for establishing an effective response plan derives from the lessons learned investigating cases like the one outlined below.
With no hint of imminent trouble, surgical staff began wrapping up a cardiac cryoablation procedure. They deflated the balloon at the tip of the cryoablation catheter, withdrew it back into its sheath, and began removing the catheter from the patient’s heart. That’s when the patient’s blood pressure dropped precipitously.
Within seconds, a successful procedure became a fatal incident. Fluoroscopy revealed an extremely large volume of gas in the left ventricle and the aorta. Perhaps the balloon had become damaged: a ruptured balloon could allow nitrous oxide coolant gas to be pumped into the heart. Staff tried resuscitating the patient, but to no avail. The massive gas embolism proved fatal.
Tragically, this patient could not be saved. But some clear thinking by the clinicians who were present, and later by the facility’s clinical engineering and risk management teams, helped investigators identify the cause – it wasn’t the balloon – and implement measures to prevent a recurrence.
When an Incident Occurs
“Knowing how to respond when an incident occurs is critical,” advises Chris Schabowsky, Ph.D., CCE, director of Accident & Forensic Investigation (AFI) Services for ECRI. “It can be the difference between preventing future incidents and remaining vulnerable to repeat occurrences.” A thorough incident response will incorporate the following steps.
Attend to the Injured
The first step is to attend to the injured, which could be the patient, clinicians, other hospital staff or visitors.
2. Preserve the Equipment and the Environment
Staff should be educated and periodically reminded about the importance of preserving anything that may have caused or contributed to the incident. This applies to any devices, items or information that could facilitate an incident investigation. The acrostic S.A.V.E.D. may help staff remember what to preserve:
S = Settings. Document the equipment settings at the time of the incident and whether any error codes were displayed.
A = Accessories. When possible, leave accessories and components assembled as they were at the time of the incident.
V = Valuable Data. Save paper printouts that may have been generated during the procedure, and print or download data that is stored by the equipment as soon as possible. Be aware that stored data may be lost when the equipment is powered down or overwritten if the equipment remains in use.
E = Equipment. Preserve equipment in its state at the time of the incident until the equipment can be examined and tested by qualified personnel.
D = Disposables. Save disposables, including the packaging if possible. (The product’s serial number or lot number may be an important detail.) This may require carefully retrieving items from the trash or a sharps container.
With respect to the environment, investigators may want to consider aspects such as temperature, lighting, electrical power, medical gas supply or unusual odors where the incident occurred. In some cases, environmental factors can play a pivotal role.
3. Report the Incident
Report incidents in a timely manner to the investigation coordinator, risk manager or other appropriate person within your facility.
4. Sequester Equipment
Devices or equipment suspected to have caused or contributed to an incident should be set aside in a secure area. Sequestration serves two key purposes: it prevents devices that may be defective from being used on other patients, and it secures devices and data until such a time that they can be examined and tested by qualified individuals. It also helps prevent spoliation-of-evidence claims, if there is subsequent legal action.
5. Gather Evidence
Gather and preserve other evidence. This may include collecting data stored on the devices that were in use; taking photographs of the location, equipment settings and identifiers, and any injuries that were sustained; reviewing documentation from pertinent medical records (which might shed light on the circumstances that led up to the incident); obtaining exemplars of the devices or disposables involved (i.e., samples identical to those that were used during the incident); and compiling relevant instructions for use or policies and procedures related to the equipment involved.
Completing the Puzzle
After learning about an incident and initiating a response, the health care organization needs to methodically work through the investigation process. “Investigating an incident is like completing a puzzle,” explains Bruce C. Hansel, Ph.D., CCE, chief scientist for ECRI’s AFI Services. “Each piece of evidence is a piece of the puzzle. The investigator’s job is to fit the pieces together to form the big picture.”
Health care organizations may wish to tackle this process on their own, or they may determine that it’s best to engage an independent third party to manage and perform the investigation. Either way, they can reference ECRI’s Incident Management and Investigation (IMI) plan to help navigate the process. (Details about an e-learning training course that introduces this plan and shows you how to apply it are provided below.)
To identify the cause of the cryoablation incident described above, the hospital worked with ECRI and the device manufacturer to examine the equipment involved and to assess the evidence collected. Testing showed that the cryoablation balloon was undamaged and had functioned normally – thus, the hospital’s initial assumptions were incorrect. Investigators would need to look elsewhere for the cause.
Fortunately, the clinical team preserved all of the accessories and supplies that had been in use. This allowed ECRI investigators to examine everything that was used during the incident (see the figure). A careful examination of each component allowed the investigators to identify which IV line contained air and trace it to its source.
The likely source of the gas embolism in this case was determined to be air that had not previously been purged from a heparin-saline bag; the delivery of air to the patient was facilitated by the use of an inflatable pressure infuser to deliver the contents of the bag through the sheath flush line. (These infusers lack an air-in-line alarm, which would have been available if an infusion pump instead had been used; and the presence of air in the bag can be difficult to see once the bag is placed in the pressure infuser.) With the cause identified, ECRI was able to provide recommendations to avoid similar incidents.
For Barb Malanga, investigator and program manager for ECRI’s AFI Services, this case emphasizes the importance of verifying staff readiness: “It’s not enough to have a plan – your staff need to be trained to use it.”
To Learn More . . .
Technology managers and other health care professionals can learn about ECRI’s seven-step IMI methodology through a new e-Learning course. For details, see:
https://www.ecri.org/healthcare-incident-
management-investigation-course. To learn more about the six-module course or to inquire about ECRI’s AFI Services, you can contact ECRI by telephone at 610-825-6000, ext. 5891, or by email at clientservices@ecri.org.
