Recurring concern

Unreliable Mycobacterium Chimaera infection-risk information and notification

First to latest report 31 Mar 2021 — 29 Jun 2023

Reports that mention this concern
2
Times this concern has been raised
5
Stated actions linked to this concern
5

What this concern includes

Includes failures in national or coordinated arrangements for assessing, updating, disseminating and applying Mycobacterium Chimaera infection-risk information after relevant cardiac surgery, including risk estimates, clinical guidance, web information, notification thresholds and communication to patients and clinicians.

What is not included
  • Excludes generic infection-control, cardiothoracic-surgery, consent or postoperative follow-up deficiencies unless they specifically concern Mycobacterium Chimaera infection-risk information or notification.
  • Excludes diagnosis or treatment failures after accurate and current Mycobacterium Chimaera risk information has been reliably provided.
  • Excludes unrelated mycobacterial infections, heater-cooler equipment controls and general public-health guidance without a Mycobacterium Chimaera risk-information or notification connection.

Reports and published responses 2 reports

See individual reports that have raised this concern, and the actions taken in response

  1. Avon

    AI-generated summary

    Mr. Clinton Peter Fear · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Mr Clinton Peter Fear underwent cardiac valve replacement surgery in November 2012, contracted Mycobacterium Chimaera infection from a Liva Nova heater cooler unit, suffered a disabling illness and died from the infection in July 2022. The report raises concerns that guidance limiting patient notification to surgeries from January 2013 was inconsistent with evidence of infections occurring earlier, potentially contributing to delayed diagnosis and harm.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Inconsistency between guidance and evidence on the surgery date from which patients should be notified of Mycobacterium Chimaera infection risk

    Wider context from the report

    “1. There is an inconsistency between – Previous Public Health England and current NHS guidance only to notify patients undergoing surgery from January 2013 of the risk of Mycobacterium Chimaera infection And Evidence of patients contracting Mycobacterium Chimaera infection from surgery substantially earlier than January 2013 (at least as far back as 2008); ”

    Source location

    Mr. Clinton Peter Fear · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to notify patients undergoing surgery before January 2013 of Mycobacterium Chimaera infection risk

    Wider context from the report

    “2. There appears to be no current basis for maintaining a start date of surgery in January 2013 for patient risk notification when there is evidence of infection substantially earlier than this date; 3. Patients who have contracted Mycobacterium Chimaera infection from surgery before January 2013 may be suffering a delay in diagnosis and consequent harm as a result of a lack of notification due to the existing guidelines. ”

    Source location

    Mr. Clinton Peter Fear · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

  2. City of London

    AI-generated summary

    Nicholas Hugh Winterton · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Nicholas Hugh Winterton developed Mycobacterium chimaera infection after aortic valve replacement surgery involving a heater-cooler unit in May 2016. The infection led to endocarditis, sepsis and multi-organ failure, and he died on 29 September 2018. The principal concerns were that the nationally reported infection risk was based on outdated and incomplete data, and that equipment use was not recorded and cleaning was performed less frequently than recommended by the manufacturer.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to ensure nationally consistent formulation of Mycobacterium Chimaera risk levels

    Wider context from the report

    “1. It is apparent that it is important that the nationally recognised level of the risk of developing Mycobacterium Chimaera from exposure to a heater cooler unit is accurate, in that it accurately reflects the most current statistical data, and is based on the best gathering of statistical data as to the true incidence of such infection as can practically be achieved. This is because the nationally recognised level of risk is the proper basis upon which – (i) The informed consent of a patient for a relevant surgery is obtained, and (ii) Post-operatively, the patient and the clinician(s) caring for him (including his General Practitioner) will base their “threshold for suspicion” for Mycobacterium Chimaera if the patient develops an infection which cannot quickly be identified and treated. 2. Public Health England, together with the National Institute for Cardiovascular Outcomes Research, the Society for Cardiothoracic Surgery, and the College of Clinical Perfusion Scientists, are the national bodies which are able to co-ordinate collation of relevant statistical evidence and then formulate and disseminate accurate information about the level of risk. It is inappropriate for individual hospitals, cardiac centres, or Trusts to formulate risk level on the basis of their own data as this would result, nationally, in the dissemination of inconsistent information. 3. Public Health England’s “Clinical guidance for secondary care” and “Information for general practice” are based on January 2017 data. Further, on its website, under the heading “Who could be at risk of Mycobacterium chimaera infection”, Public Health England currently states, “People most at risk are those who’ve had heart valve surgery since January 2013. About 1 person in every 5,000 who has this type of surgery will develop the infection.” This assessment is also based on data collated to January 2017. 4. The evidence at the inquest showed that the figure of “1 person in every 5,000” is inaccurate, in that : (i) It is based on data from 2017 and not updated data, and (ii) It is based on data which reflects only those patients who are reported to Public Health England as having died of Mycobacterium Chimaera infection, whereas the true incidence of the infection is very likely to be higher; the likelihood is that there is a potentially significant number of deaths from undiagnosed Mycobacterium Chimaera, given the patient cohort’s usual level of co-morbidities and clinicians’ low threshold of suspicion for this infection. 5. A more accurate assessment of the risk, and more accurate guidance, would therefore result from – (i) An immediate review by Public Health England of all data held to date with a re-calculation of the incidence of Mycobacterium Chimaera infection and consequential risk being reflected in updated guidance and web-site information, and (ii) Consideration being given by all the bodies to whom this Report is sent of whether there is a better investigative basis which could be used for obtaining relevant data and statistics as to the true incidence of Mycobacterium Chimaera infection, whether by means of a research study or otherwise. ”

    Source location

    Nicholas Hugh Winterton · Prevention of Future Deaths report
    Page 3 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to keep national Mycobacterium Chimaera risk guidance and web information updated

    Wider context from the report

    “1. It is apparent that it is important that the nationally recognised level of the risk of developing Mycobacterium Chimaera from exposure to a heater cooler unit is accurate, in that it accurately reflects the most current statistical data, and is based on the best gathering of statistical data as to the true incidence of such infection as can practically be achieved. This is because the nationally recognised level of risk is the proper basis upon which – (i) The informed consent of a patient for a relevant surgery is obtained, and (ii) Post-operatively, the patient and the clinician(s) caring for him (including his General Practitioner) will base their “threshold for suspicion” for Mycobacterium Chimaera if the patient develops an infection which cannot quickly be identified and treated. 2. Public Health England, together with the National Institute for Cardiovascular Outcomes Research, the Society for Cardiothoracic Surgery, and the College of Clinical Perfusion Scientists, are the national bodies which are able to co-ordinate collation of relevant statistical evidence and then formulate and disseminate accurate information about the level of risk. It is inappropriate for individual hospitals, cardiac centres, or Trusts to formulate risk level on the basis of their own data as this would result, nationally, in the dissemination of inconsistent information. 3. Public Health England’s “Clinical guidance for secondary care” and “Information for general practice” are based on January 2017 data. Further, on its website, under the heading “Who could be at risk of Mycobacterium chimaera infection”, Public Health England currently states, “People most at risk are those who’ve had heart valve surgery since January 2013. About 1 person in every 5,000 who has this type of surgery will develop the infection.” This assessment is also based on data collated to January 2017. 4. The evidence at the inquest showed that the figure of “1 person in every 5,000” is inaccurate, in that : (i) It is based on data from 2017 and not updated data, and (ii) It is based on data which reflects only those patients who are reported to Public Health England as having died of Mycobacterium Chimaera infection, whereas the true incidence of the infection is very likely to be higher; the likelihood is that there is a potentially significant number of deaths from undiagnosed Mycobacterium Chimaera, given the patient cohort’s usual level of co-morbidities and clinicians’ low threshold of suspicion for this infection. 5. A more accurate assessment of the risk, and more accurate guidance, would therefore result from – (i) An immediate review by Public Health England of all data held to date with a re-calculation of the incidence of Mycobacterium Chimaera infection and consequential risk being reflected in updated guidance and web-site information, and (ii) Consideration being given by all the bodies to whom this Report is sent of whether there is a better investigative basis which could be used for obtaining relevant data and statistics as to the true incidence of Mycobacterium Chimaera infection, whether by means of a research study or otherwise. ”

    Source location

    Nicholas Hugh Winterton · Prevention of Future Deaths report
    Page 3 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to capture the true incidence of Mycobacterium Chimaera infection

    Wider context from the report

    “1. It is apparent that it is important that the nationally recognised level of the risk of developing Mycobacterium Chimaera from exposure to a heater cooler unit is accurate, in that it accurately reflects the most current statistical data, and is based on the best gathering of statistical data as to the true incidence of such infection as can practically be achieved. This is because the nationally recognised level of risk is the proper basis upon which – (i) The informed consent of a patient for a relevant surgery is obtained, and (ii) Post-operatively, the patient and the clinician(s) caring for him (including his General Practitioner) will base their “threshold for suspicion” for Mycobacterium Chimaera if the patient develops an infection which cannot quickly be identified and treated. 2. Public Health England, together with the National Institute for Cardiovascular Outcomes Research, the Society for Cardiothoracic Surgery, and the College of Clinical Perfusion Scientists, are the national bodies which are able to co-ordinate collation of relevant statistical evidence and then formulate and disseminate accurate information about the level of risk. It is inappropriate for individual hospitals, cardiac centres, or Trusts to formulate risk level on the basis of their own data as this would result, nationally, in the dissemination of inconsistent information. 3. Public Health England’s “Clinical guidance for secondary care” and “Information for general practice” are based on January 2017 data. Further, on its website, under the heading “Who could be at risk of Mycobacterium chimaera infection”, Public Health England currently states, “People most at risk are those who’ve had heart valve surgery since January 2013. About 1 person in every 5,000 who has this type of surgery will develop the infection.” This assessment is also based on data collated to January 2017. 4. The evidence at the inquest showed that the figure of “1 person in every 5,000” is inaccurate, in that : (i) It is based on data from 2017 and not updated data, and (ii) It is based on data which reflects only those patients who are reported to Public Health England as having died of Mycobacterium Chimaera infection, whereas the true incidence of the infection is very likely to be higher; the likelihood is that there is a potentially significant number of deaths from undiagnosed Mycobacterium Chimaera, given the patient cohort’s usual level of co-morbidities and clinicians’ low threshold of suspicion for this infection. 5. A more accurate assessment of the risk, and more accurate guidance, would therefore result from – (i) An immediate review by Public Health England of all data held to date with a re-calculation of the incidence of Mycobacterium Chimaera infection and consequential risk being reflected in updated guidance and web-site information, and (ii) Consideration being given by all the bodies to whom this Report is sent of whether there is a better investigative basis which could be used for obtaining relevant data and statistics as to the true incidence of Mycobacterium Chimaera infection, whether by means of a research study or otherwise. ”

    Source location

    Nicholas Hugh Winterton · Prevention of Future Deaths report
    Page 4 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Complete and submit an updated M. chimaera infection risk assessment for publication.

    Verbatim wording from the response

    “updated risk assessment was undertaken by PHE in November 2019 and submitted to an international medical conference with a view to publication of an article in a medical journal. An extract from the conference abstract book is attached at Exhibit PHE1¹. The advent of the COVID-19 pandemic resulted in the cancellation of the conference and delayed completion of the publication.”

    Source location

    2021-0204-Response-from-Public-Health-England-Redacted
    Page 4 · response
    Published 28 June 2021

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Further update the risk estimates and publish them by September 2021.

    Verbatim wording from the response

    “9) PHE will further update the risk estimates and ensure that these are published by September 2021. The respondent bodies will thereafter cascade these updated risk estimates to healthcare professionals involved in informing and consenting patients or investigating and diagnosing these infections, namely consultant microbiologists and cardiothoracic surgeons. This will be achieved through our respective clinical networks.”

    Source location

    2021-0204-Response-from-Public-Health-England-Redacted
    Page 4 · response
    Published 28 June 2021

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Cascade updated risk estimates through clinical networks to professionals informing or consenting patients and investigating or diagnosing infections.

    Verbatim wording from the response

    “9) PHE will further update the risk estimates and ensure that these are published by September 2021. The respondent bodies will thereafter cascade these updated risk estimates to healthcare professionals involved in informing and consenting patients or investigating and diagnosing these infections, namely consultant microbiologists and cardiothoracic surgeons. This will be achieved through our respective clinical networks.”

    Source location

    2021-0204-Response-from-Public-Health-England-Redacted
    Page 4 · response
    Published 28 June 2021

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Forward requests to NHS England to agree responsibility and a timetable for updating healthcare guidance and NHS website information.

    Verbatim wording from the response

    “12) Given the transfer of responsibility for management for the incident, we will forward this request for the further updating of guidance and to the need to update the NHS website to NHS England to agree responsibilities and a timetable for updating.”

    Source location

    2021-0204-Response-from-Public-Health-England-Redacted
    Page 5 · response
    Published 28 June 2021

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Maintain surveillance capturing all potential M. chimaera cases and publish information on newly diagnosed cases and associated deaths.

    Verbatim wording from the response

    “4) In responding to the potential threat posed by transmission of M. chimaera from contaminated heater cooler units (“HCUs”) used in open-heart surgery, PHE established a surveillance system to capture data on all cases (not just cases resulting in death) potentially arising as a result of open-heart surgery performed in the UK. PHE continues to collate and publish information on newly diagnosed cases and associated deaths. This can be found on:”

    Source location

    2021-0204-Response-from-Public-Health-England-Redacted
    Page 2 · response
    Published 28 June 2021

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    The risk estimate was not inaccurate because it measured infection risk using data on all reported cases, not only deaths.

    Verbatim wording from the response

    “3) With regard to the concern in paragraph (1)(ii) above, we would like to clarify to the Coroner that these risk calculations were not based solely on risk of death but in fact based on risk of infection associated with this type of surgery, namely heart-valve surgery performed on bypass. As such, data collection was not restricted to patients reported to PHE as having died of Mycobacterium chimaera (M. chimaera) infection.”

    Source location

    2021-0204-Response-from-Public-Health-England-Redacted
    Page 2 · response
    Published 28 June 2021

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    NHS England is responsible for updating guidance and the NHS website, so the requests will be forwarded to it.

    Verbatim wording from the response

    “10) In relation to the updating of the guidance for healthcare providers, we would like to make the Coroner aware that NHS England assumed responsibility for management of the M. chimaera incident in October 2016. PHE and SCTS worked with NHS England to support the patient notification exercise launched in February 2017, including the development of guidance for healthcare providers.”

    Source location

    2021-0204-Response-from-Public-Health-England-Redacted
    Page 4 · response
    Published 28 June 2021

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Existing surveillance provides a reasonable basis for ongoing risk monitoring, so a revised or alternative investigative method is unnecessary.

    Verbatim wording from the response

    “7) With reference to paragraph (2)(ii) above and given that the current methodology includes surveillance data not just restricted to deaths, the respondent bodies believe the established mechanism provides a reasonable means for ongoing monitoring of risk and that a revised or alternative investigative basis is not required.”

    Source location

    2021-0204-Response-from-Public-Health-England-Redacted
    Page 3 · response
    Published 28 June 2021

    Open published response

Actions and positions describe what organisations say in published responses. Implementation is not independently verified.

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Data last updated 7 September 2026