Failure modes and effects analysis (FMEA) 1 is a step-by-step approach,
commonly used as a tool in industry,
for identifying all possible failures in a design,
a manufacturing or assembly process,
or a product or service.
“Failure modes” means the ways,
or modes,
in which something might fail.
Failures are any errors or defects,
especially ones that affect the patient,
and can be potential or actual.
“Effects analysis” refers to studying the consequences of those failures.
Failures are prioritized according to how serious their consequences are,
how frequently they occur and how easily they can be detected.
The purpose of the FMEA is to take actions to eliminate or reduce failures,
starting with the highest-priority ones.
FMEA is used during design to prevent failures.
Later it’s used for control,
before and during ongoing operation of the process.
Ideally,
FMEA begins during the earliest conceptual stages of design and continues throughout the life of the product or service.
If incorrectly reprogrammed or incompatible pacemakers or ICDs are scanned using MRI,
the possible complications can be extremely serious and in some cases,
fatal.
Potential complications include failure of the device to pace appropriately,
induction of ventricular fibrillation,
heating of the tissue adjacent to the pacing or ICD system,
heating of lead tips adjacent to heart tissue,
early battery depletion and complete device failure requiring replacement2.
Additionally,
patients may have inactive (abandoned) hardware from previous implants that whilst is therapeutically inactive with regard to pacing functionality,
can pose a risk if exposed to MRI electromagnetic radiation.
Serious harm and multiple deaths have been reportedm a number of years ago, as a result of poor characterisation of cardiac and other in Vivo devices and inactive (abandoned) cardiac leads prior to MRI scanning 3,4.
More recent studies have suggested that with an appropriate scanning protocol in place including patient selection.
device interrogation and follow up and that certain devices previously thought to be MR contraindicated may be safely scanned5.
Identifying if the implanted device and leads are MRI compatible is paramount to ensure patient safety and allow MRI scanning to take place to faciliate clinical diagnoses.
In Ireland a national database of implanted cardiac devices,G-pace (previously Heartrhthym Ireland, http://www.heartrhythmireland.com, has been set up by a private concern based on manual data entry.
This is commonly used in identification of implanted cardiac devices.
Following international reports of harmful incidents concerning patients with cardiac implants caused by MRI scans and discussions held with the Healthcare Products Regulatory Agency (HPRA) which regulates medical devices in Ireland ,
the radiation safety committee of our hospital ,
which also covers MRI safety,
agreed to proactively undertake a Failure Modes Effects Analysis to fully identify the high risk areas in the current process that a patient may be inadvertently harmed and to reduce those risks where possible.
The aim of this poster is to describe an FMEA that was carried out specifically to address local safety and clinical concerns surrounding scanning these patients,
to facilitate scanning in this cohort of patients and to minimise risk associated with these scans.
Furthermore,
in harmony with the risks identified by the FMEA,
a workflow was created to simplify the new process put in place to ensure patient safety.