HIQA’s programme of monitoring of the decontamination and reprocessing of reusable medical devices in public acute hospitals from August to November 2018

Date of publication:

Six inspection reports on infection prevention and control practices in public acute hospitals have been published today by the Health Information and Quality Authority (HIQA). These inspections focused on the decontamination and reprocessing of reusable medical devices.

Following the declaration of a National Public Health Emergency Plan to address Carbapenemase-Producing Enterobacteriales (CPE) – a very resistant type of bacteria that can cause serious infections – by the Minister for Health on 25 October 2017, HIQA sought clarification from hospital management through these inspections that they were implementing the latest national guideline on screening for CPE at the hospital.

Inspections were carried out between August and November 2018 at:

  • Naas General Hospital
  • Connolly Hospital, Blanchardstown
  • St Michael’s Hospital, Dun Laoghaire
  • University Hospital of Limerick, Ennis
  • Roscommon University Hospital
  • Mercy University Hospital, Cork.

HIQA found that five of the six hospitals inspected were in full compliance with the Health Service Executive’s (HSE’s) February 2018 guideline on screening patients for CPE; however, Connolly Hospital was not compliant. Following this inspection, HIQA sought assurances from hospital management that this risk would be managed and assurances were provided.

 

Overall HIQA found that all six hospitals were working to implement the National Standards and HSE best practice guidance in relation to decontamination and reprocessing of reusable medical devices in the areas inspected. High-level opportunities for improvement identified by HIQA across all six hospitals in relation to decontamination and reprocessing of reusable medical devices included:

  • a need to embed a culture of continuous audit, feedback and quality improvement cycles in relation to decontamination and reprocessing procedures
  • a need for the appointment of a hospital group decontamination lead, as per national recommendations.

A summary of additional key findings from each inspection are outlined below.

Naas General Hospital

An unannounced inspection was undertaken on 16 August 2018. Areas of good practice observed by HIQA during this inspection included:

  • clear lines of accountability and responsibility in relation to governance and management arrangements for decontamination and reprocessing of reusable medical devices were in place
  • a risk management system to identify, evaluate, control and monitor hazards and risks associated with the decontamination process was in operation
  • training and education for staff working in decontamination was established
  • quality improvement initiatives had been introduced
  • management was in the process of addressing deficiencies in relation to decontamination facilities in the Endoscopy Unit; consideration was also given to centralising decontamination activity across the hospital.

Opportunities for improvement included:

  • progression to automated validated systems for decontamination of all semi-critical ultrasound probes was required
  • hospital management need to address challenges faced by equipment that goes beyond expected lifecycles
  • timely review of policies and procedures is required.

Connolly Hospital, Blanchardstown

An unannounced inspection was undertaken on 23 August 2018. Areas of good practice observed by HIQA included:

  • following a risk assessment and previous concerns raised by HIQA around surgical instrument decontamination practices in theatres, the hospital had taken the decision to outsource decontamination to an external company as a risk mitigation measure
  • clear lines of accountability and responsibility in relation to governance and management arrangements for decontamination and reprocessing of reusable medical devices
  • a risk management system to identify, evaluate, control and monitor hazards and risks associated with the decontamination process
  • monitoring, testing and evaluation systems, and outcome measures had been implemented
  • validated automated systems for decontamination of all critical and semi-critical reusable medical devices were available at the hospital in line with best practice guidance.

Opportunities for improvement included:

  • the hospital must continue to work towards a centralised model of endoscope decontamination
  • infrastructure in the interventional radiology department should support the implementation of best infection prevention and control practices for semi-critical ultrasound probes
  • frequency of hygiene audits requires review.

St Michael’s Hospital, Dun Laoghaire

An unannounced inspection was undertaken on 11 September 2018.

It was identified during the course of the inspection that the hospital had not implemented a track and trace system in relation to nasopharyngeal endoscopes in the Outpatient Department. HIQA sought assurances from hospital management in relation to managing this risk and such assurances were provided.

Areas of good practice observed by HIQA included:

  • clear lines of accountability and responsibility in relation to governance and management arrangements for decontamination and reprocessing of reusable medical devices; the hospital had appointed a dedicated decontamination lead
  • a risk management system was in place to identify, evaluate, monitor hazards and risks associated with the decontamination process
  • training and education for staff working in decontamination was well established.

Opportunities for improvement included:

  • progression to automated validated systems for decontamination of all semi-critical reusable medical devices was required
  • hospital management need to address challenges faced by equipment that goes beyond expected lifecycles
  • a need to address deficiencies in relation to decontamination facilities across the hospital.

University Hospital of Limerick, Ennis

An unannounced inspection was undertaken on 27 September 2018. HIQA identified a lack of clarity in relation to reporting relationships at the hospital. In line with national guidance, the hospital should ensure that a designated person with responsibility for reusable invasive medical device reprocessing within Ennis Hospital is in place. 

Management needs to ensure adherence to national guidelines with a system of feedback to the quality and risk committee (or appropriate committee) on the action taken by wards and departments.

National guidelines recommend that decontamination services should be provided within central locations such as Endoscopy Decontamination Units and Central Decontamination Unit to remove the need for decontamination to take place in or near patient areas. The hospital had also identified and escalated these risks in line with the HSE risk management system.

It is recommended that the hospital reviews decontamination technologies in order to facilitate the recommended national standards of disinfection for nasopharyngeal endoscope decontamination.

Roscommon University Hospital

An unannounced inspection was undertaken on 12 October 2018. Areas of good practice observed by HIQA included:

  • hospital management had almost completed the process of addressing deficiencies in relation to the satellite decontamination facility in the Operating Theatre Department by outsourcing decontamination service provision to an external service provider in the interim of proposed on-site capital development plans
  • clear lines of accountability and responsibility and management arrangements in relation to decontamination and reprocessing of reusable medical devices
  • a risk management system was in place to identify, evaluate, monitor hazards and risks associated with the decontamination process
  • training and education for staff working in decontamination was established
  • up-to-date policies, procedures and guidelines were available to support staff
  • validated automated systems for decontamination of all critical and semi-critical reusable medical devices were available
  • frequency of hygiene audits conducted was appropriate to the risk associated with the functional area.

 

Opportunities for improvement included:

  • a suitable dedicated nonclinical space for decontamination of semicritical ultrasound probes in the X-ray Department is identified
  • ventilation systems in the Operating Theatre are in line with best practice guidance
  • delays in uploading incidents to the National Incident Management System be addressed.

Mercy University Hospital, Cork

An unannounced inspection was undertaken on 2 November 2018. Areas of good practice observed by HIQA included:

  • following a risk assessment and previous concerns raised by HIQA around surgical instrument decontamination facilities and infrastructure in the Operating Theatre Department, the hospital had taken the decision to outsource decontamination to an external company as a risk mitigation measure
  • there were clear lines of accountability, responsibility and management arrangements in relation to decontamination and reprocessing of reusable medical devices
  • a risk management system was in place
  • good reporting of decontamination-related incidents
  • training and education for staff working in decontamination was well established.

Opportunities for improvement included:

  • a suitable dedicated nonclinical space for decontamination and storage of semicritical ultrasound probes in the Radiology Department is identified
  • validated automated systems for decontamination of all semi-critical reusable medical devices are progressed
  • policies, procedures, standard operating procedures and guidelines are reviewed promptly to ensure that staff have access to the most up-to-date documents to support practice
  • frequency of hygiene audits needs to be appropriate to the risk associated with the functional area  
  • ongoing validation of processes based on outcome measurements and microbiological testing on surgical instruments or endoscopes kept overnight and transported for decontamination the following day takes place.

Notes to Editors

  • HIQA’s approach to monitoring against the National Standards for the prevention and control of healthcare-associated infections in acute healthcare services was revised in 2017.
  • As part of this monitoring programme there was a particular focus on the decontamination and reprocessing of critical and semi-critical reusable medical devices in 2018, as these are the areas of highest risk of microorganism transmission should decontamination and reprocessing practices fail.
  • HIQA focused in the first instance on decontamination facilities outside of designated controlled decontamination units to ensure that structures, systems, processes and outcomes were aligned to national guidelines. It is intended that these inspection monitoring programmes will continue in 2019 in parallel with phase 2 of the monitoring programme which began in May 2017.
  • A National Public Health Emergency Plan was declared on 25 October 2017 by the Minister for Health in response to the increase and spread of Carbapenemase-Producing Enterobacteriales (CPE) in Ireland. As a result a National Public Health Emergency Team was convened.
  • Carbapenemase-Producing Enterobacteriales (CPE) is the newest in a long line of 'superbugs' (bacteria that are hard to kill with antibiotics). Of all the superbugs, CPE is among the most difficult to kill with antibiotics. It is carried in the bowel and can cause blood stream infection in people who are vulnerable, such as the elderly and those with low immunity. More than half of all patients who develop blood stream infections with CPE die as a result of their infection.