Surveillance of Wound Infections in Implant Devices (pacemakers, loop systems and internal cardiac defibrillators)

The prevalence of device infection is broadly known from high-quality studies and national data collection. Increasingly, service commissioners and external monitoring bodies such as Care Quality Commission (CQC) are looking beyond benchmarks and are seeking assurance from providers that their work demonstrates a proactive approach to reducing patient harm and improving the patient experience.


Despite the relatively short primary admission period for implant devices, some centres are responding to the challenge via local multidisciplinary surveillance. Local surveillance can provide timely trends in device infection as well as potentially supporting root cause analysis and duty of candour requirements. Surveillance work is perhaps under-recognised in invasive cardiology group, though in many cardiothoracic specialist centres surgical site infection surveillance is well established for cardiac surgery.

Below, the RBHT surveillance team outline how they set up a surveillance approach, working with clinician adjudication and Cardiac Physiologists. NB: the sites use PaceNet for data reporting (see and follows national guidance (see PDF: HRS document on perioperative management of CIEDs














Collaborative Working 


As with other specialist cardiothoracic centres, our Trust has seen an increase in the number of patients requiring implantable cardiac devices [1].  Similarly, interventions are increasingly performed on at-risk patients predisposed to complications [2].  Infection is of particular concern for this patient group because they are physiologically dependent upon the device and infective endocarditis (a possible consequence) carries a significant risk of mortality.


In 2010, the cardiothoracic teams collected information on complications including wound infection and infective endocarditis, but no monthly, dedicated and validated wound infection rate was produced. No national wound surveillance scheme for this patient group exists consequently there is no existing benchmark, although data from studies are available.


Here, we outline some of the key actions taken in establishing the surveillance service and some early results are presented.













Our primary methodology was to focus on three main areas:

1.   Developing a multidisciplinary team surveillance scheme for implant devices

2.   Improving data capture using existing information systems

3.   Monitoring care bundle compliance 


Developing a Multidisciplinary Team (MDT) Surveillance Scheme

  • Wound concerns are identified in Pacing Clinics / on the wards by cardiac physiologists, the Device Nurse Specialist or the surveillance nurses. 

  • All wounds are discussed at the MDT meetings and clinician confirmation was required.

  • Incidences of wound infection are superimposed onto the monthly procedure totals (provided by the cardiac physiologist team and the clinical audit team).

Improving Data Capture Using Existing Information Systems


  • Microbiology now reports pus cells (host response) + cultured organism, which then can be evaluated alongside the clinical impression. This allows for a more accurate assessment of clinical significance.

  • Monthly reports of patients re-admitted within thirty days of implantation are now produced.

  • The integrated care pathways were amended to monitor compliance with NICE guidance.

Monitoring Compliance With Care Bundle


The care bundle is used for snapshot audits of patients undergoing implantation.

Any patients identified with device wound infection needing extraction also have the care bundle scores incorporated into the Trust’s Root Cause Analysis (RCA) process




This approach produces a monthly wound infection rate and allows for crude data analysis.Preliminary data shows implant wound infection rate at one hospital is 1.5% while at the other hospital it is 1.0% for the period, July 2010-June 2011.  These data were collected from a sample which included >1700 patients. This difference in infection rates between the two hospitals may be a reflection of more accurate and complete data collection at one site because standardised data has been collected for a longer period of time.




Challenges to data collection


The data produced can be difficult to manage as some patients who present with wound infections may have been implanted at other centres.  Additionally, wound infections may arise in the years following intervention from our own Trust.  As a result, data may be time-consuming to capture and to interpret.  Moreover, a denominator is not available for these other wound infections, resulting in two disparate data sets:

  1)  a twelve-month rolling wound infection rate of Trust implanted patients

  2)  admissions to the Trust for wound management (patients from another hospital and from our Trust interventions prior to 2010)

 As these data mature, we expect the distinction between the two sets of data to become clearer.

 Alternative surveillance methodologies were considered, however, given that the length of stay is so short for this patient group, prospective surveillance is unsuitable [3].  Patient questionnaires were also considered an impractical approach as there are a number of complications, including haematoma and erosion, in addition to the normal physiological response of tissues to device implantation, which may reduce the accuracy of reporting.


Responses to challenges


There are national device survey groups which recommend follow up of all patients following device implantation.  Our approach has been to access this existing resource and enhance the identification, communication and reporting of wound infections. Surveillance nurses ensure all infections were confirmed/refuted by the registrar or consultant at the MDT Cardiology meetings.  This results in a consistent, impartial approach to identifying and recording infections.


As a result, a strong working relationship between the interventional cardiology and the Infection Prevention and Control teams has been forged and we believe this can only enhance patient outcomes.




  • MDT working ensures data accuracy and provides a more robust dataset.

  • Capitalising on the use of existing systems and processes ensures workload is not unduly increased and data are not duplicated.

  • Consistent, impartial and accurate surveillance schemes can drive improvement and reduce wound infection rates.

  • Further development of existing cardiology databases will allow easier and faster data collection.


Article on Defibrillation. It was written by one of Pacific Medical Training staff writers, Sarah Gehrke, MSN, RN, and it talks about the history of defibrillation, its different types, and when not to use it. Please see article,



1.  Cunningham, D., Charles, R., Cunningham, M. et al. (2010) Heart Rhythm Devices: UK National Clinic Audit 2009.  Final Version.

2.  Greenspon, A.J., Patel, J.D., Lau, E. et al. (2011) 16-year trends in the infection burden for pacemakers and implantable cardioverter-defibrillators in the United States. J Am Coll Cardiol. 58 (10): 1001-6.

3.  Health Protection Agency (HPA) (2010) Protocol for the surveillance of surgical site infection.  HPA: London.