Aims and objectives
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...
Methods and materials
A multi-disciplinary team was set up consisting of radiographers,
cardiac physiologists,
cardiologists,
radiologist,
research clinician,
and members of the hospital quality team.
Each step in the current process was mapped (Figure 3) and possible failure modes and effects identified.
Each failure mode was attributed a Risk Priority Number (RPN) which is quantified by incorporating the mode’s likelihood of occurrence(O),
likelihood of detection(D) and the severity of impact(S).
We calculated each failure mode’s RPN by multiplying the 3 numbers(S,
O & D) together to achieve a...
Results
Actions taken for High Risk Failure Modes and Effect on Risk Profile.
This FMEA led to changes in our policy for scanning patients with pacemakers and ICDs.
The FMEA team prioritised the top 2 highest ranking failure modes,
based on RPN values that required action. A number of changes have been implemented post the FMEA.
The one with the biggest effect on the RPN number is the presence of the Physiologist and the interrogation of the device.
This has altered primarily the detectability of errors...
Conclusion
Discussion
The outcome of the FMEA has improved understanding of the high risk areas in our scanning process and led to actions being taken to enhance MRI safety for this patient cohort.
Residual risk exists in terms of patients or staff being uneducated about the risks of MRI scanning on patients who have ICDs or pacemakers.
Since undertaking this FMEA,
staff education sessions have begun and the FMEA has been presented at the radiation safety meeting.
As part of CPD session to radiographers ,
lectures...
Personal information
Departments of Quality,Radiology & Cardiology,
Mater Private Hospital & Mater Misericordiae University Hospital,Eccles St.
Dublin 7.
Presenting Author:
Assoc.
Prof Paddy Gilligan
Chief Physicist & Registered Radiation Protection Advisor
UCD Associate Clinical Professor
UCD School of Medicine
Diagnostic Imaging Department,
Mater Private Hospital
Eccles St,
Dublin 7,
Ireland
T: 01 885 8199
F: 01 885 8198
E:
[email protected] www.materprivate.ie
References
1.
iSixSigma.
FEMA: Preventing a Failure Before Any Harm Is Done.
Smith DL.
https://www.isixsigma.com/tools-templates/fmea/fmea-preventing-failure-any-harm-done
2. Expert Panel on MR Safety.,
Kanal E,
Barkovich AJ,
Bell C,
Borgstede JP,
Bradley WG Jr,
Froelich JW,
Gimbel JR,
Gosbee JW,
Kuhni-Kaminski E,
Larson PA,
Lester JW Jr,
Nyenhuis J,
Schaefer DJ,
Sebek EA,
Weinreb J,
Wilkoff BL,
Woods TO,
Lucey L,
Hernandez D.
ACR guidance document on MR safe practices: 2013.
J Magn Reson Imaging.
2013 Mar;37(3):501-30.
3.http://www.mrisafety.com
4. Irnich W,
Irnich B,
Bartsch C,
Stertmann WA,
Gufler...
