- Medicines and Healthcare products Regulatory Agency
- 13 December 2016
- 13 December 2016
- Alert type:
- Medical device alert
Updated advice from manufacturers on device management for systems known or suspected to be contaminated with Mycobacterium chimaera.
Notify the manufacturer and MHRA:
- of any heater-coolers known or suspected to be contaminated with Mycobacterium chimaera. The devices should be removed from service
- if you observe specific risks associated with the use of the heater-coolers
Notify Public Health England and MHRA of any cases where patients have been infected with Mycobacterium chimaera
Ensure that the people responsible for operating and maintaining heater coolers are aware that specific advice has been issued by LivaNova (Sorin) and Maquet – details below.
LivaNova has issued an updated field safety notice (FSN) for 3T systems. Users must now follow additional guidance on:
- positioning of heater-coolers within the operating theatre
- when to use new or disinfected accessories
Maquet has also issued an FSN. Users must now follow guidance on:
revised instructions for use – cleaning, descaling and disinfecting heater unit HU 35 when to use new or disinfected accessories *a new weekly routine disinfection as well as a high level disinfection and biofilm reduction.
Deadlines for actions
Actions underway: 4 weeks
Actions complete: 5 weeks
LivaNova (Sorin) has issued operational advice for the 3T heater cooler unit. Maquet has updated the HU35 cleaning and disinfecting instructions and will issue updated instructions for the HCU20, HCU30 and HCU40 soon.
Problem / background
MHRA issued a Medical Device Alert (MDA) on 11 June 2015 concerning all manufacturers of heater-coolers and the risk of patient infection with Mycobacterium species; this advice remains current.
This information has highlighted an infection risk to open-heart surgery patients called non-tuberculous Mycobacterium (NTM).
If the disinfection and maintenance procedures are not strictly followed, organisms can multiply in heater-cooler devices and a biofilm can be formed. The biofilm provides an opportunity for bacteria, including Mycobacteria, to colonise the device. Once colonised, there is a possibility that bacteria can become a source of patient contamination due to aerosolisation when the heater-cooler device is used, or contamination can spread during operational management of the device.
Sorin Group Deutschland GmbH (LivaNova)
Director Quality Assurance
Tel: +49 89 323 01 152
Director Regulatory Affairs
Tel: +49 7222 932 1374
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
- Adult intensive care units *Anaesthesia, directors of
- Anaesthetic medical staff *Anaesthetic nursing staff *Anaesthetists
- Cardiology departments
- Cardiology nurses
- Cardiology, directors of
- Cardiothoracicy departments
- Cardiothoracicy surgeons
- Cardiothoracicy surgery directors
- Clinical governance leads
- Clinical perfusionists
- Health and safety managers
- Infection control departments
- Infection prevention and control directors
- Infectious diseases paediatricians
- Intensive care medical staff/paediatrics *Intensive care nursing staff (adult)
- Intensive care nursing staff (paediatric)
- Intensive care units
- Intensive care, directors of
- Operating department practitioners
NHS England area teams
Directors for onward distribution to:
- Risk manager
- Safety officers
NHS England area teams
CAS liaison officers for onward distribution to all relevant staff including:
- General practice managers
Establishments registered with the Care Quality Commission (CQC) (England only):
*Hospitals in the independent sector * Independent treatment centres * Private medical practitioners
Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: firstname.lastname@example.org and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2016/022 or 2014/007/016/081/003 (Livanova) or 2016/011/023/701/012 (Maquet).
Hiten Patel MHRA
Tel: 020 3080 6115
Email: <Hiten.email@example.com >
Enitan Taiwo, MHRA
Tel: 020 3080 7122
Devices Clinical Team
Tel: 020 3080 6000 (Customer Services)
Reporting adverse incidents in England
Alerts in Northern Ireland are distributed via the NI SABS system
Enquiries and adverse incident reports in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre,
Department of Health,
Social Services and Public Safety
Tel: 028 9052 3868
Reporting adverse incidents in Northern Ireland
Please report directly to NIAIC using the forms on our website.
Enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre,
Health Facilities Scotland,
NHS National Services Scotland
Tel: 0131 275 7575
Fax: 0131 314 0722
Reporting adverse incidents in Scotland
NHS Boards and Local Authorities in Scotland – report to Health Facilities Scotland.
Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients – report to Health Facilities Scotland.
Enquiries in Wales should be addressed to:
Healthcare Quality Division,
Tel: 02920 823 624 / 02920 825 510
Reporting adverse incidents in Wales
Published: 13 December 2016
Issued: 13 December 2016
Alert type: Medical device alert