UK Health Security Agency
Other
Action Planned
PHE will update risk estimates for Mycobacterium chimaera infection and publish them by September 2021, cascading the information to healthcare professionals through clinical networks; they will forward the request to update NHS guidance to NHS England. (AI summary)
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Healthcare-Associated Infection & Antimicrobial Resistance Division National Infection Service 61 Colindale Avenue London NW9 5EQ
8 June 2021
Regulation 28 report dated 31 March 2021 to prevent future deaths pursuant to Her Majesty's Coroner inquest into the death of Nicholas Winterton
Patient’s Name: Nicholas Hugh Winterton
Date of death: 29.09.2018
Response from: Public Health England (“PHE”); National Institute for Cardiovascular Outcomes Research; Society for Cardiothoracic Surgery (“SCTS”); and College of Clinical Perfusion Scientists
1) The Coroner has asked for actions to be taken, without which in her opinion, there is a risk that future deaths could occur from Mycobacterium chimaera infection acquired during cardiac surgery. These relate to a perceived inaccuracy in the risk estimate of “1 person in every 5,000” published by PHE in 2017 in its guidance to primary and secondary care providers and on its website. In summary, this inaccuracy is stated as stemming from:
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(i) being based on data from 2017 and not updated data, and (ii) being based on data which reflects only those patients who are reported to PHE as having died of Mycobacterium chimaera infection.
2) In relation to the above, the Coroner has requested (in summary): (i) a review of all data held to date with a recalculation of the incidence of infection and dissemination of the consequential risk assessment through updated guidance and website information, and (ii) consideration as to the optimal investigative basis for formulating this risk assessment. Inaccuracy in calculation of Mycobacterium chimaera infection risk
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.
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:
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with-heater-cooler-units.
5) With regard to the concern in paragraph (1)(i) above, this risk was estimated to support the nationwide patient notification exercise mounted in 2017. The risk estimate is not inaccurate; it refers to an estimated risk of Mycobacterium chimaera (M. chimaera) infection for patients who underwent NHS surgery between 2007 and
2015. Based on cases reported to PHE to date, the risk for patients undergoing surgery during that period remains unchanged at 1 in 5000. Proposed actions to be taken
6) With reference to the proposed updating of risk estimates referred to in paragraph (2)(i) above, PHE has continued to monitor changes in risk, utilising cases reported to PHE coupled with numbers of patients undergoing heart-valve surgery in NHS hospitals derived from Hospital Episode Statistics. This has shown a continued decline in risk with successive years of surgery since 2014. The most recent date of surgery for cases identified to date is February 2017. Therefore there have been over four years of cardiac surgery performed in the United Kingdom without a further case of M. chimaera identified to date.
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.
8) PHE accepts that information on the risks of infection should be more widely disseminated to inform patients’ decision-making, and for clinical awareness. An
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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.
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.
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.
11) With specific reference to the inclusion of the 1 in 5000 risk estimate on PHE’s website, whilst the risk estimate was produced by PHE, we believe this information is in fact found on the NHS website (which is not controlled by PHE):
1 The ECCMID Abstract Book from which the extract is taken can be downloaded from the following website:
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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.
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Exhibit PHE1
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Healthcare-Associated Infection & Antimicrobial Resistance Division National Infection Service 61 Colindale Avenue London NW9 5EQ
8 June 2021
Regulation 28 report dated 31 March 2021 to prevent future deaths pursuant to Her Majesty's Coroner inquest into the death of Nicholas Winterton
Patient’s Name: Nicholas Hugh Winterton
Date of death: 29.09.2018
Response from: Public Health England (“PHE”); National Institute for Cardiovascular Outcomes Research; Society for Cardiothoracic Surgery (“SCTS”); and College of Clinical Perfusion Scientists
1) The Coroner has asked for actions to be taken, without which in her opinion, there is a risk that future deaths could occur from Mycobacterium chimaera infection acquired during cardiac surgery. These relate to a perceived inaccuracy in the risk estimate of “1 person in every 5,000” published by PHE in 2017 in its guidance to primary and secondary care providers and on its website. In summary, this inaccuracy is stated as stemming from:
2
(i) being based on data from 2017 and not updated data, and (ii) being based on data which reflects only those patients who are reported to PHE as having died of Mycobacterium chimaera infection.
2) In relation to the above, the Coroner has requested (in summary): (i) a review of all data held to date with a recalculation of the incidence of infection and dissemination of the consequential risk assessment through updated guidance and website information, and (ii) consideration as to the optimal investigative basis for formulating this risk assessment. Inaccuracy in calculation of Mycobacterium chimaera infection risk
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.
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:
3
with-heater-cooler-units.
5) With regard to the concern in paragraph (1)(i) above, this risk was estimated to support the nationwide patient notification exercise mounted in 2017. The risk estimate is not inaccurate; it refers to an estimated risk of Mycobacterium chimaera (M. chimaera) infection for patients who underwent NHS surgery between 2007 and
2015. Based on cases reported to PHE to date, the risk for patients undergoing surgery during that period remains unchanged at 1 in 5000. Proposed actions to be taken
6) With reference to the proposed updating of risk estimates referred to in paragraph (2)(i) above, PHE has continued to monitor changes in risk, utilising cases reported to PHE coupled with numbers of patients undergoing heart-valve surgery in NHS hospitals derived from Hospital Episode Statistics. This has shown a continued decline in risk with successive years of surgery since 2014. The most recent date of surgery for cases identified to date is February 2017. Therefore there have been over four years of cardiac surgery performed in the United Kingdom without a further case of M. chimaera identified to date.
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.
8) PHE accepts that information on the risks of infection should be more widely disseminated to inform patients’ decision-making, and for clinical awareness. An
4
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.
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.
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.
11) With specific reference to the inclusion of the 1 in 5000 risk estimate on PHE’s website, whilst the risk estimate was produced by PHE, we believe this information is in fact found on the NHS website (which is not controlled by PHE):
1 The ECCMID Abstract Book from which the extract is taken can be downloaded from the following website:
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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.
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Exhibit PHE1
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