Presented by: Matt Phillips RN BScN, Nephrology Quality Leader Paula Mossop RN CNeph(C), Vascular Access Nurse Carolyn Bartol RN BScN CNeph(C), Clinical Nurse Educator Barb Hodgson RN, Interventional Radiology Capital District Health Authority, Halifax Nova Scotia

1. Canadian Patient Safety Institute
Virtual Poster Forum
October 29 & 30, 2014
Why Report?
Matt Phillips RN BScN, Nephrology Quality Leader
Paula Mossop RN CNeph(C), Vascular Access Nurse
Carolyn Bartol RN BScN CNeph(C), Clinical Nurse Educator
Barb Hodgson RN, Interventional Radiology
Capital District Health Authority, Halifax Nova Scotia

2. Opportunity to Improve Patient Safety
• Seven tunneled Central Venous Catheters (CVCs) for
hemodialysis migrated out of patients without the cuff
adhered to the catheter (the cuff remained adhered inside
the patient, but had become separated from CVC)
• A quality review was initiated to attempt to understand
the scope of the problem
• Goal of the quality review was to determine if patient
safety could be compromised by medical equipment (CVC)
malfunction, and if we needed to switch to a different CVC
product ‘Normal’ CVC line
migration with cuff
adhered to catheter

3. Understanding the Issue
• All incidents occurred in patients receiving hemodialysis treatments through a CVC
over an eighteen month period.
• Aim was to understand scope of problem so that an informed decision could be made.
• Collated extensive data including type of CVC, product lot #, radiologist inserting,
length in situ, as well as completed patient safety reports for incidents that had not
been previously reported.
• Saved identified CVCs for internal evaluation by biomedical engineering.
• Health Canada reports filed with the ‘Canadian Medical Devices Sentinel Network’.

4. Responding to the Issue
• Biomedical engineering examined the CVC prior to returning the device to the
company. Findings of the internal investigation were reported to the organization’s
risk management department, the company, Interventional Radiology, and the
Renal Program.
CDHA Bio-Med Analysis
The image depicts a problem with the separation of the cuff from the
Catheter. Examination of the bond surface revealed that there is no apparent
evidence of bonding other than the area is slightly discolored.
Company Response…Gross and microscopic examinations confirm a complete
separation of the cuff/heat sleeve from the catheter…
• Risk Management initiated reporting to the Health Canada ‘Canadian Medical
Devices Sentinel Network’.
• The company provided the date when manufacturing process related to cuff
bonding was improved. The Renal Program and Interventional Radiology
subsequently removed approximately 17 CVCs from stock that had been
manufactured before this date.

5. MEASUREMENT
• Continue to report all medical equipment device issues through our organization’s
internal patient safety reporting system.
• Related to CVC line migration with cuff non-adherence, we can check to see when
the CVC was inserted, and determine if we are continuing to experience a problem
we know about, or are experiencing a new problem
– To do this check, we rely on our vascular access database that contains
relevant information on all interventions
Old ‘database’: paper-based system;
difficult to find any useful data Current database: electronic; easy to find information

6. CONTRIBUTION TO PATIENT SAFETY
• 17 CVCs removed from stock and not used in patients
• Increase in medical equipment malfunction reporting
• Organization developed a process for internal evaluation of medical equipment devices
by biomedical engineering prior to returning to vendor
• Acknowledgment from Health Canada for improving patient safety through reporting
100
90
80
70
60
50
40
30
20
10
0
2011/12 2012/13 2013/14
CDHA Renal Program Trends.
Event Category: Patient Equipment/Medical Device Issues
Patient Equipment/Medical
Device Issues
Figure 1: Patient Equipment/Medical Device Incidents reported by Renal Program

7. Essential Partnerships
• Partnerships and communication between the Renal Program, Interventional
Radiology, Biomedical Engineering, Risk Management, and the company are
essential to navigate medical device issues.
• As part of the organization’s reporting policy, these incidents were disclosed to
patients. Patients have indicated they are satisfied, knowing we take their safety
seriously, and that we follow-up with vendors of products.
• Staff see the benefits of reporting, resulting in an increase in reported incidents.

8. Key Lessons
• Increased reporting indicates a culture of safety.
• Increased reporting leads to increased opportunity for learning and improvement.
• When staff see the outcomes of reporting, they are motivated to report more often.
• Renal Program shares quarterly patient safety incident trends with all staff. These
trends stimulate action plans.
• Facility-based evaluation by a biomedical engineer prior to return to company is
important.