PFD report

Mr Kishorkumar Patel and Mr Kofi Aning · Prevention of Future Deaths report

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Issued 7 Jul 2021•East London

Report record

Published report and response evidence

This page connects the concerns raised in this report with statements found in recipients’ published responses. A link shows a clear evidence connection; it does not assign responsibility.

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Concerns
2

Raised in this report

Recipients
2

Named on the report

Responses found
4

Of 2 recipients

Stated actions
10

Described in responses

Source document

Full report text

This is the full text from the original published report.

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Concerns and recipient responses

Select any concern, action or position to view the source wording.

Report evidence summary

Concerns raised2

  1. Insufficient ICU staff knowledge of breathing system filter and HME selection
  2. Lack of standardised classification and colour coding of breathing system filters and HMEs
    Part of recurring concern: Failure to ensure safety-critical medical equipment is reliably visually identifiable
Responses linked to these concerns

Each statement is shown once, even when linked to more than one concern.

Actions described in response An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.7

  1. Action

    Work with manufacturers, regulators and health-service stakeholders to explore the patient-safety effects of potential filter-use measures.

    Stated by Medicines and Healthcare products Regulatory AgencyStated in progressThe respondent said that this action was in progress when they made their response on 9 July 2021.
  2. Action

    Work with stakeholders to improve reporting of filter-related incidents and build knowledge of risks from multiple filter types and labelling.

    Stated by Medicines and Healthcare products Regulatory AgencyStated in progressThe respondent said that this action was in progress when they made their response on 9 July 2021.
  3. Action

    Review emerging evidence concerning possible risks associated with the devices.

    Stated by Medicines and Healthcare products Regulatory AgencyStated in progressThe respondent said that this action was in progress when they made their response on 9 July 2021.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.7

  1. Position

    There is insufficient evidence that standardised filter colours would reduce patient harm.

    Stated by Medicines and Healthcare products Regulatory AgencyDisputes the concernThe respondent disagreed with part of the concern or the basis for it.

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Insufficient ICU staff knowledge of breathing system filter and HME selection

Wider context from the report

“An independent expert has advised: In my opinion, the non-standardised colour coding used by manufacturers of these filters, the number of different types of filters with different names, the variable optimal position of the filters, and whether a wet or a dry breathing system is being used, results in an extremely confusing situation. One of the leading manufacturers of these filters (Intersurgical) produces HME's that are blue, which is the same colour as the non-HME filters supplied to NHS by another company. A photograph of the non-HME blue filter is inconsistent with the photograph of the green HME and yellow non HME's shown on page 6 of the guidance for use of anaesthetic machines for the ventilation of adult critical care patients. In my experience, few doctors and nurses working in ICU are knowledgeable about all these different filters and which ones should be used for any given breathing system. In my opinion, the confusion over breathing system filters and HMEs is widespread among ICU staff (doctors and nurses) and the classification and colour coding of these filters/HMEs is worthy of review, simplification, and standardisation. The concerns raised by the independent expert are not confined to the Nightingale, emergency provision hospitals, but relate equally to all intensive care settings, particularly when the intensive care provision has to be extended to other areas of the hospital. As there are still pressures within the ITU settings and in light of the imminent, planned reduction in COVID-19 safeguards, I consider that action should be taken to address this concern at the earliest possible stage. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

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Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Lack of standardised classification and colour coding of breathing system filters and HMEs

Wider context from the report

“An independent expert has advised: In my opinion, the non-standardised colour coding used by manufacturers of these filters, the number of different types of filters with different names, the variable optimal position of the filters, and whether a wet or a dry breathing system is being used, results in an extremely confusing situation. One of the leading manufacturers of these filters (Intersurgical) produces HME's that are blue, which is the same colour as the non-HME filters supplied to NHS by another company. A photograph of the non-HME blue filter is inconsistent with the photograph of the green HME and yellow non HME's shown on page 6 of the guidance for use of anaesthetic machines for the ventilation of adult critical care patients. In my experience, few doctors and nurses working in ICU are knowledgeable about all these different filters and which ones should be used for any given breathing system. In my opinion, the confusion over breathing system filters and HMEs is widespread among ICU staff (doctors and nurses) and the classification and colour coding of these filters/HMEs is worthy of review, simplification, and standardisation. The concerns raised by the independent expert are not confined to the Nightingale, emergency provision hospitals, but relate equally to all intensive care settings, particularly when the intensive care provision has to be extended to other areas of the hospital. As there are still pressures within the ITU settings and in light of the imminent, planned reduction in COVID-19 safeguards, I consider that action should be taken to address this concern at the earliest possible stage. ”

Is this part of a recurring concern?

Yes — Failure to ensure safety-critical medical equipment is reliably visually identifiable.

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

Work with manufacturers, regulators and health-service stakeholders to explore the patient-safety effects of potential filter-use measures.

Verbatim wording from the response

“We acknowledge there is a concern that confusion over the type of filter used in ventilation could potentially lead to patient harm. However, at the current time there is insufficient evidence to show that a standardised colour scheme would reduce the risk of patient harm. The MHRA will work with manufacturers, other regulators, NHS England and Improvement and other stake holders to fully explore the effects that enacting the kind of actions detailed above would have on patient safety. We will also work with these groups to improve reporting of this type of incident and build our knowledge base surrounding the risks with the use of multiple filter types and any issues surrounding their labelling. Any emerging evidence relating to possible risks associated with these devices will be carefully reviewed and, if appropriate, regulatory action will be taken if any serious risks were confirmed”

Source location

2021-0233-Response-from-MHRA_Published
Page 3 · response
Published 9 July 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

Work with stakeholders to improve reporting of filter-related incidents and build knowledge of risks from multiple filter types and labelling.

Verbatim wording from the response

“We acknowledge there is a concern that confusion over the type of filter used in ventilation could potentially lead to patient harm. However, at the current time there is insufficient evidence to show that a standardised colour scheme would reduce the risk of patient harm. The MHRA will work with manufacturers, other regulators, NHS England and Improvement and other stake holders to fully explore the effects that enacting the kind of actions detailed above would have on patient safety. We will also work with these groups to improve reporting of this type of incident and build our knowledge base surrounding the risks with the use of multiple filter types and any issues surrounding their labelling. Any emerging evidence relating to possible risks associated with these devices will be carefully reviewed and, if appropriate, regulatory action will be taken if any serious risks were confirmed”

Source location

2021-0233-Response-from-MHRA_Published
Page 3 · response
Published 9 July 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

Review emerging evidence concerning possible risks associated with the devices.

Verbatim wording from the response

“We acknowledge there is a concern that confusion over the type of filter used in ventilation could potentially lead to patient harm. However, at the current time there is insufficient evidence to show that a standardised colour scheme would reduce the risk of patient harm. The MHRA will work with manufacturers, other regulators, NHS England and Improvement and other stake holders to fully explore the effects that enacting the kind of actions detailed above would have on patient safety. We will also work with these groups to improve reporting of this type of incident and build our knowledge base surrounding the risks with the use of multiple filter types and any issues surrounding their labelling. Any emerging evidence relating to possible risks associated with these devices will be carefully reviewed and, if appropriate, regulatory action will be taken if any serious risks were confirmed”

Source location

2021-0233-Response-from-MHRA_Published
Page 3 · response
Published 9 July 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

Contact HSIB and pass on the recommendation to investigate possible confusion over filter types.

Verbatim wording from the response

“We will contact HSIB and pass on your recommendation that an investigation into the possible confusion over filter types is carried out. In this communication we will suggest that they involve both the Royal College of Anaesthetists and The Faculty of Intensive Care Medicine in their investigation. We will also support the HSIB in any investigation that they undertake into this matter.”

Source location

2021-0233-Further-response-from-MHRA_Published
Page 2 · response
Published 9 July 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

Write to filter manufacturers, ABHI and UK Approved Bodies requesting review of device labelling against regulatory requirements and inquest findings.

Verbatim wording from the response

“MHRA will write to known manufacturers of filters registered with MHRA and the Association of British HealthTech Industries (ABHI) and UK Approved Bodies, to ask them to conduct a review of the labelling of filter devices against the regulatory requirements, taking into consideration the findings of the inquest, and making improvements where identified.”

Source location

2021-0233-Further-response-from-MHRA_Published
Page 1 · response
Published 9 July 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

Refer standardised breathing-filter labelling and colour-coding to the MHRA for consideration.

Verbatim wording from the response

“We confirm our support for standardisation of labelling/colour coding of breathing circuit filters and heat and moisture exchange filters (HMEF) between manufacturers. We highlight that it is not within our power to implement beyond referring the issue to the Medicines and Healthcare products Regulatory Agency to consider whilst recognising the challenges in implementing such a change.”

Source location

2021-0233-Response-from-Royal-College-of-Anaesthetists-and-The-Faculty-of-Intensive-Care-Medicine.pdf
Page 1 · response
Published 9 July 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

Highlight key breathing-filter safety lessons to members through the Patient Safety Update and FICM Safety Bulletin.

Verbatim wording from the response

“We can confirm that the key lessons will be highlighted to our respective membership through the Safe Anaesthesia Liaison Group’s Patient Safety Update and FICM Safety Bulletin. These will include:”

Source location

2021-0233-Response-from-Royal-College-of-Anaesthetists-and-The-Faculty-of-Intensive-Care-Medicine.pdf
Page 1 · response
Published 9 July 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

There is insufficient evidence that standardised filter colours would reduce patient harm.

Verbatim wording from the response

“We acknowledge there is a concern that confusion over the type of filter used in ventilation could potentially lead to patient harm. However, at the current time there is insufficient evidence to show that a standardised colour scheme would reduce the risk of patient harm. The MHRA will work with manufacturers, other regulators, NHS England and Improvement and other stake holders to fully explore the effects that enacting the kind of actions detailed above would have on patient safety. We will also work with these groups to improve reporting of this type of incident and build our knowledge base surrounding the risks with the use of multiple filter types and any issues surrounding their labelling. Any emerging evidence relating to possible risks associated with these devices will be carefully reviewed and, if appropriate, regulatory action will be taken if any serious risks were confirmed”

Source location

2021-0233-Response-from-MHRA_Published
Page 3 · response
Published 9 July 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

A universal filter colour standard would be difficult and protracted because filter types lack agreed classification and manufacturers could deviate.

Verbatim wording from the response

“With regards to the introduction of a standard on filter colours. At the current time there is no agreed classification of all the filter types, which means that manufacturers can design and make any filter “type” to suit the design of their devices and perceived clinical need. There are not necessarily filters that fulfil the exact same function and specification between manufacturers. This diversity would make agreeing a standard and universal colour coding extremely difficult.”

Source location

2021-0233-Response-from-MHRA_Published
Page 3 · response
Published 9 July 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

HSIB is responsible for further investigating possible confusion over filter types, with professional bodies involved as appropriate.

Verbatim wording from the response

“It is worth noting that existing evidence suggests colour coding to distinguish devices can have little or no impact. This issue should be explored further by HSIB.”

Source location

2021-0233-Further-response-from-MHRA_Published
Page 1 · response
Published 9 July 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 evidence suggests colour coding may have little or no impact on distinguishing medical devices.

Verbatim wording from the response

“It is worth noting that existing evidence suggests colour coding to distinguish devices can have little or no impact. This issue should be explored further by HSIB.”

Source location

2021-0233-Further-response-from-MHRA_Published
Page 1 · response
Published 9 July 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

Providing or enforcing medical device training is outside the respondent’s remit.

Verbatim wording from the response

“The MHRA fully encourages users to be trained on the use of any medical device before using it, as detailed in our published guidance Managing Medical Devices, however it is not within MHRA’s remit to provide training or to enforce it. There are a number of national organisations that carry out medical device training, for example Health Education England and The National Association of Medical Device Educators and Trainers (NAMDET). Training resources may also be available via the Royal Colleges’ and other professional organisations/societies.”

Source location

2021-0233-Further-response-from-MHRA_Published
Page 1 · response
Published 9 July 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

Implementing standardised breathing circuit filter labelling is outside the respondent’s power.

Verbatim wording from the response

“We confirm our support for standardisation of labelling/colour coding of breathing circuit filters and heat and moisture exchange filters (HMEF) between manufacturers. We highlight that it is not within our power to implement beyond referring the issue to the Medicines and Healthcare products Regulatory Agency to consider whilst recognising the challenges in implementing such a change.”

Source location

2021-0233-Response-from-Royal-College-of-Anaesthetists-and-The-Faculty-of-Intensive-Care-Medicine.pdf
Page 1 · response
Published 9 July 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 Medicines and Healthcare products Regulatory Agency was referred the issue for consideration of standardised breathing circuit filter labelling.

Verbatim wording from the response

“We confirm our support for standardisation of labelling/colour coding of breathing circuit filters and heat and moisture exchange filters (HMEF) between manufacturers. We highlight that it is not within our power to implement beyond referring the issue to the Medicines and Healthcare products Regulatory Agency to consider whilst recognising the challenges in implementing such a change.”

Source location

2021-0233-Response-from-Royal-College-of-Anaesthetists-and-The-Faculty-of-Intensive-Care-Medicine.pdf
Page 1 · response
Published 9 July 2021

Open published response

Other statements in published responses

These actions and other statements could not be clearly connected to one concern in this report.

Recipient-stated actions An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.3

  1. 1

    Engage the medical device safety officers network to raise awareness of filter incidents and encourage reporting to the MHRA.

    Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 9 July 2021.
  2. 2

    Continue monitoring filter-related safety signals through incident data, published reports, media sources and stakeholder engagement.

    Stated by Medicines and Healthcare products Regulatory AgencyStated in progressThe respondent said that this action was in progress when they made their response on 9 July 2021.
  3. 3

    Suggest formal analysis of national incident-reporting data to assess the frequency of incorrect breathing-filter use.

    Stated by Faculty of Intensive Care Medicine and Royal College of AnaesthetistsStated completedThe respondent said that this action was complete when they made their response on 9 July 2021.

Recipient positions A position is what a recipient says about a concern when they do not describe a specific action.1

  1. 1

    The MHRA lacks resources and specialist equipment to independently test or inspect medical devices.

    Stated by Medicines and Healthcare products Regulatory AgencyUnable to actThe respondent said that a constraint prevented them from taking the relevant action.

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

Engage the medical device safety officers network to raise awareness of filter incidents and encourage reporting to the MHRA.

Verbatim wording from the response

“This lack of reported incidents could indicate that this type of issue does not occur as frequently as believed. It is also possible that for the reasons discussed in our previous letter this type of incident may be under reported. To attempt to address this and encourage reporting the MHRA will engage with the medical device safety officers (MDSO) network at the next scheduled meeting in February 2022, to raise awareness of possible incidents involving filters and encourage reporting of such incidents to the MHRA.”

Source location

2021-0233-Further-response-from-MHRA_Published
Page 1 · response
Published 9 July 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

Continue monitoring filter-related safety signals through incident data, published reports, media sources and stakeholder engagement.

Verbatim wording from the response

“Thank you for your letter dated 19/10/21 highlighting further concerns about the use of incorrect filters. We acknowledge the concerns raised by the consultant anaesthetists in your findings and will continue to monitor the situation through our regular safety signal and surveillance activities. This includes reviewing multiple data sources, including our own database of reported incidents, reports in journals and other media, as well as routine stakeholder engagement. Where necessary we will issue safety messages to health care organisations, patients, and the public.”

Source location

2021-0233-Further-response-from-MHRA_Published
Page 1 · response
Published 9 July 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

Suggest formal analysis of national incident-reporting data to assess the frequency of incorrect breathing-filter use.

Verbatim wording from the response

“We would again highlight the unprecedented circumstances arising from the need to develop a remote surge ICU during the early stages of the COVID pandemic which are likely to have had a significant contribution to the errors that occurred. The type of filter (with an integral port for capnography) that was mistaken for an HMEF is designed for use with anaesthetic machines and there would be no reason for such a filter to be used in ICU. We are not aware of previous incidents being highlighted from our regular review of national incident reporting in critical care. However, we have been in communication with NHS improvement to suggest that a formal analysis of the national reporting and learning system database (NRLS) should be undertaken to assess the frequency of incidents arising from incorrect use of breathing circuit filters.”

Source location

2021-0233-Response-from-Royal-College-of-Anaesthetists-and-The-Faculty-of-Intensive-Care-Medicine.pdf
Page 1 · response
Published 9 July 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 MHRA lacks resources and specialist equipment to independently test or inspect medical devices.

Verbatim wording from the response

“2. Witness the above testing/inspection of device(s) by the manufacturer or its representatives in the UK only. Please note, we do not have the resources or specialist equipment to undertake our own testing/inspection of medical devices. Normally the manufacturer will undertake testing at their premises, which may be located overseas.”

Source location

2021-0233-Response-from-MHRA_Published
Page 1 · response
Published 9 July 2021

Open published response
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Data last updated 7 September 2026