National Institute for Cardiovascular Outcomes Research

Health and care · Health-system partnership

Pin Request correction

First report 31 Mar 2021•Latest report 31 Mar 2021

Reports, concerns and published responses

Reports over time

Reports naming this recipient by issue year.

* 2026 is projected from reports observed to 7 Sep 2026.

Reports
1

Naming this recipient

Published responses
100%

Found for named reports

Concerns addressed
3

Across all linked responses

Stated actions
5

Described in responses

Concerns and recipient responses

Statements from National Institute for Cardiovascular Outcomes Research linked to the concerns in each report. Select any concern, action or position to view the source wording.

  1. 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 The principal concerns were that the nationally reported infection risk was based on outdated and incomplete data, and that equipment use was not recorded and cleaning was performed less frequently than recommended by the manufacturer.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. The report was sent to National Institute for Cardiovascular Outcomes Research; that does not assign responsibility.

    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. ”
    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Cardiovascular Outcomes Research; that does not assign responsibility.

    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. ”
    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Cardiovascular Outcomes Research; that does not assign responsibility.

    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. ”
    Open source report
Back to top

Information checked against published PFD reports and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Data last updated 7 September 2026