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 introduced earlier in the process resulting in a lower RPN.
This has also altered the ranking of the risks associated with the process.
There are a number of low level residual risks.
The current top risk is the potential for leads not being compatible with a MR compatible device.
This is an area that the device industry is evolving and the Multidisciplinary team has been in consultation with a number of Device Manufacturers:
1. Incorrect information regarding cardiac device received from the referrer (RPN =180)
Action – Provide on-going education sessions with local hospital staff,
educate referrers nationally by sharing this document with the Healthcare Products Regulatory Agency (HPRA) and professional bodies (faculty of radiology,Ireland) at upcoming scientific meetings.
Continue increasing awareness of risks to this patient cohort when sending letters to referrers outlining adverse effects of MRI scanning and asking they inform patients of the associated risks.
- Devices and leads are now interrogated on-site prior to scanning using wireless technology & cross referenced with Heart Rhythm Ireland website and patient charts to identify the device and the leads compatibility.
- MRI questionnaire has been expanded to include body diagram and types of risk,
visually prompting patients to identify sources of metal in their body or previous sites of surgery,
as outlined by ACR guidelines for MR safety (1).
Residual RPN ,
post implementation of changes: RPN=40
2. Incorrect data on device compatibility obtained from Heart Rhythm Ireland (RPN =120)
Action - Devices are now interrogated on-site prior to scanning & cross referenced with Heart Rhythm Ireland website and patient charts to identify the device and the leads compatibility for MRI scanning.
Residual RPN ,
post implementation of changes: RPN=20
3. Radiographer identifies that one part of the device is MRI compatible but the leads are not (RPN = 120)
Action - Devices are now interrogated on-site prior to scanning.
Any non-MRI compatible element of the device or leads will result in a refusal to scan the patient without further risk benefit analysis and a letter explaining the rational sent to the referrer.
Residual RPN ,
post implementation of changes: RPN=60
4. Patient completes scan but fails to return to cardiology to have device reset (RPN = 120)
Action – Patient is monitored throughout the scan by a senior cardiac physiologist.
The device is immediately reset following the scan by the cardiac physiologist in the MRI department,
rather than in Cardiology department.
This will be documented for auditing purposes.
Residual RPN ,
post implementation of changes: RPN=10
A revised flowchart outlining the new actions (figure 6) was created and has been be incorporated into new policies for pacemakers and ICDs.
Effect of FMEA and changes on Risk Priority Number:
Risk Priority Number December 2016
|
Risk Priority Number September 2017
|
1426
|
658
|
The alteration in number reflects the improved safety profile of the process.