Recurring concern

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

First to latest report 17 Dec 2013 — 7 Jul 2021

Reports that mention this concern
5
Times this concern has been raised
5
Stated actions linked to this concern
8

What this concern includes

Includes failures of dedicated visual-identification controls for safety-critical medical equipment or components, including inadequate colour contrast, inconsistent colour coding, ambiguous appearance or other design and standardisation deficiencies that could cause confusion during clinical use.

What is not included
  • Excludes non-medical equipment and general product labelling concerns without a direct clinical-safety connection.
  • Excludes generic training, documentation or communication deficiencies unless the reported unsafe condition is specifically unreliable visual identification of medical equipment.
  • Excludes equipment failures unrelated to identification, such as mechanical malfunction, unavailability or inadequate maintenance.
  • Excludes visual-identification concerns involving items whose confusion does not create a supported patient-safety risk.

Reports and published responses 5 reports

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

  1. East London

    AI-generated summary

    Mr Kishorkumar Patel and Mr Kofi Aning · 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 Kishorkumar Patel and Mr Kofi Aning were treated at the Nightingale Hospital in London in April 2021, where the wrong filter was found to have been used in the breathing systems of their intensive care ventilators. The principal concern was widespread confusion among intensive care staff about filter types, names, colour coding, positioning and use in wet or dry breathing systems, with the expert recommending review, simplification and standardisation; causation of the deaths had not been determined.

    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

    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. ”

    Source location

    Mr Kishorkumar Patel and Mr Kofi Aning · Prevention of Future Deaths report
    Page 2 · 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

    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

    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

    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

    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 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

    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

    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

    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

    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

  2. Suffolk

    AI-generated summary

    Susan Warby · 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

    Susan Warby was admitted to hospital with a perforated bowel and underwent emergency surgery. An incorrect intravenous fluid attached to an arterial line, combined with incorrect blood-sampling technique, produced erroneous results that led to unnecessary insulin treatment, hypoglycaemia and a brain injury; her death followed multi-organ failure, septicaemia and disseminated aspergillus pneumonia. The principal concerns were the lack of distinctive labelling for fluids used with arterial lines and inadequate blood-sampling technique and training.

    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

    Insufficiently distinctive packaging and visual identification of intravenous fluids for arterial line transducer sets

    Wider context from the report

    “1. During the evidence it was clear that packaging and visual identification aids available for intravenous fluids to be used in arterial line transducer sets were not sufficiently distinctive. It was heard that following Mrs Warby's death that as far as possible the West Suffolk Hospital has asked its suppliers to change the labelling on the intravenous fluids it purchases. These were exhibited in court and even with the changes the manufacture was prepared to make, the packaging cannot be considered at all distinctive for fluids to be used in an arterial line. In direct contrast, we saw that the tubing used on an arterial line transducer set has a solid red line running its length. This is to clearly indicate to staff that it is an arterial line therefore must not be used for the administration of drugs or medicinal fluids. I am therefore concerned that the packaging of the 0.9% Sodium Chloride intravenous fluid to be used with an arterial line is not also so clearly distinguished. It was heard in evidence that there is currently no 0.9% Sodium Chloride intravenous fluid available which is specifically and clearly labelled for arterial line use only. It is important to note that the issue identified in this inquest regarding the use of incorrect intravenous fluid in an arterial line is not a new one. In 2008 the UK National Patient Safety Agency issued a Rapid Response report highlighting problems with infusions and sampling from arterial lines. In that 2008 report the UK National Patient Safety Agency had already identified 84 incidents where the wrong infusion was attached to an arterial line with two of those cases proving fatal. It is understood that the 0.9% Sodium Chloride intravenous fluid has a number of medicinal uses other than just as a flushing fluid in an arterial line. However, the number of cases identified where the incorrect fluid is being used in arterial lines, clearly demonstrates the confusion and errors which occur when using generally labelled intravenous fluids with an arterial line transusion set. ”

    Source location

    Susan Warby · Prevention of Future Deaths report
    Page 2 · 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

    Consider improvements with the marketing authorisation holder to make statutory information easier for clinical staff to assimilate and reduce selection errors.

    Verbatim wording from the response

    “Nonetheless, we will consider further with the marketing authorisation holder whether improvements could be made to assist clinical staff to more easily assimilate the statutory information to reduce the likelihood of errors of this nature in future.”

    Source location

    2020-0188-Response-from-MHRA-Redacted.pdf
    Page 1 · response
    Published 23 November 2020

    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

    Colour cannot be used in IV-fluid labelling because container manufacturing prevents it; other local risk controls are required.

    Verbatim wording from the response

    “You will also know that the MHRA has explained that the way in which the containers of the IV fluids described in your report are manufactured (bags composed of polyolefin/polyamide co-extruded plastic), means that judicious use of colour cannot be used within the labelling to aid differentiation and reduce the likelihood of error at the point of selection. The MHRA states that other risk minimisation measures should be employed locally within clinical areas to assist correct identification. However, the MHRA has undertaken to consider further with the marketing authorisation holder whether improvements can be made to the labelling to help ensure the medicine is used appropriately and reduce the likelihood of such errors in future.”

    Source location

    2020-0188-Response-from-Dept.-of-Health-and-Social-Care-Redacted.pdf
    Page 2 · response
    Published 23 November 2020

    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

    Because Viaflo containers cannot use colour differentiation, local clinical areas must implement other measures to identify intravenous fluids correctly.

    Verbatim wording from the response

    “Intravenous fluids as described in your report are supplied in bags known as ‘Viaflo’ which are composed of polyolefin/polyamide co-extruded plastic. The way that these containers are manufactured means that ‘judicious use of colour’ (as recommended in our best practice guidance) cannot be used within the labelling, to aid differentiation and reduce the likelihood of error at the point of selection. As a result, other risk minimisation measures must be employed locally within clinical areas to assist in the correct identification of intravenous fluids one from another.”

    Source location

    2020-0188-Response-from-MHRA-Redacted.pdf
    Page 1 · response
    Published 23 November 2020

    Open published response

  3. Portsmouth and South East Hampshire

    AI-generated summary

    Ronald CLARK · 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

    Ronald CLARK underwent insertion of a stent in his common hepatic duct, but an incorrectly sized stent was inserted and significantly contributed to his death at Queen Alexandra Hospital on 2 April 2018. The report raised concern that identical packaging for different stent sizes made them difficult to identify and could lead to use of the wrong-sized stent.

    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 provide clearly differentiated packaging for stent sizes

    Wider context from the report

    “1. I was told in evidence that the stents used at the hospital are all supplied in identical packaging with only a small label identifying the size of the stents inside. I was also told that stents in this sort of packaging are in general use in most, if not all, NHS hospitals. 2. I believe action should be taken by the purchasing agencies of the NHS to ensure that stent manufacturers should supply different sizes of stents in different coloured packaging to make it easier for them to be identified during medical procedures and to obviate the risk of the wrong-sized stent being used, as was the case with Mr Clark. ”

    Source location

    Ronald CLARK · Prevention of Future Deaths report
    Page 1 · 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

    Update the prosthesis-verification standard to reflect developments in implant selection and verification, including potential future scanning of prostheses and implants.

    Verbatim wording from the response

    “The NatSIPP on prosthesis verification is being updated to reflect developments in implant selection and verification processes and will include the potential for future scanning for all prostheses/implants.”

    Source location

    2019-0151-Response-by-NHS-England
    Page 1 · response
    Published 28 July 2019

    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

    Packaging changes for different-sized stents are assigned to the Medicines and Healthcare products Regulatory Agency as the appropriate responsible body.

    Verbatim wording from the response

    “I am grateful to you for sharing your findings from the inquest with us and highlighting that actions could prevent future deaths. The main action that you highlight relates to changes to manufacturer’s packaging so that different-sized stents are in different-coloured packaging. I note that the Regulation 28 report has also been sent to the Medicines and Healthcare products Regulatory Agency and, as changes to packaging falls within their remit, they are the more appropriate body to respond on this specific action.”

    Source location

    2019-0151-Response-by-NHS-England
    Page 1 · response
    Published 28 July 2019

    Open published response

  4. Manchester South

    AI-generated summary

    Brian Marks · 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

    Brian Marks had motor neurone disease and, in the last stages of life in hospital, was being fed and given medication via a PEJ tube after aspirating and contracting pneumonia. A nurse mistook the PEJ tube for a PEG tube, and the report identified that the similar appearance of the tubes could lead to confusion and that they should be differentiated using colour coding.

    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

    Lack of reliable visual differentiation between PEJ and PEG tubes

    Wider context from the report

    “The appearance of the PEJ tube and the PEG tube are very similar and could be easily confused the one with the other. In discussion with the witnesses, including the lead dietician, it was agreed that a simple colour coding system could be implemented so that even when in situ, the tubes would be immediately able to be differentiated. ”

    Source location

    Brian Marks · Prevention of Future Deaths report
    Page 1 · concerns

    Open source report

    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

    Further colour coding may not reliably prevent tube confusion and could introduce additional hazards, including misconnections and risks for colour-blind users.

    Verbatim wording from the response

    “Both organisations agree that feeding tubes look very similar and can therefore be confused with one another, potentially putting the patient at risk. However, the solution might not be as straightforward as it first appears.”

    Source location

    2015-0025-Response-by-Department-of-Health
    Page 1 · response
    Published 29 January 2015

    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

    Manufacturers cannot be compelled to change device designs unless changes form part of internationally required standards.

    Verbatim wording from the response

    “Your suggestion of introducing a colour coding scheme has already been considered. Some experts in the field believe a suitable scheme could be helpful, although influencing manufacturers to change design to ensure easier visual distinction of their product is not always straightforward. Manufacturers cannot be compelled to make such changes where these are not part of internationally required design standards.”

    Source location

    2015-0025-Response-by-Department-of-Health
    Page 2 · response
    Published 29 January 2015

    Open published response

  5. South Yorkshire (West)

    AI-generated summary

    William Alfred Andrews · 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

    William Alfred Andrews, a 77-year-old man, underwent cardiac surgery and subsequently suffered repeated circulatory arrests after a bulb syringe cap entered and remained in his left ventricle. The cap was later removed during a second operation, but his condition deteriorated and he died. Concerns included the cap's lack of visibility, inadequate awareness of its presence, and the absence of a standard procedure to check and count syringe caps at the end of surgery.

    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 that detachable syringe caps are visibly different in colour from the equipment

    Wider context from the report

    “(1) If a simple precaution was taken in ensuring that the tip of a bulb syringe or similar was a different colour to the rest of the equipment then it is difficult to see how a surgeon could use a syringe with the tip still in place by error. As the attached photograph shows there is no significant difference between the syringe with the tip on or off. (2) There is a further concern in respect of other information which is contained with the Trust’s SUI report as follows: It is perhaps of some relevance that in 2001-2 a number of instances of items of anaesthetic airway equipment being blocked with extraneous pieces of plastic and causing harm to patients were the subject of a national police investigation (Operation Cordian). The police findings were examined by an Expert Group, which published a series of recommendations in 2004. Their conclusion was that there was no criminal intent but that the incidents had happened as a matter of chance. Strategies to reduce the chances of these events recurring were recommended. Recommendation 1 states “The MHRA should recommend to manufacturers and the relevant Standards Committees that ….. detachable caps (eg. On intravenous cannulae and giving sets) be manufactured in brightly coloured material, preferably red, to aid visibility”. No action appears to have been taken in consequence of this. (3) The SUI report goes on to indicate that none of the team undertaking the operation were aware that the bulb syringe came supplied with a cap. The previous brand used by the Trust was not supplied with a syringe cap. The current bulb syringes in use obviously do have a cap but this is normally removed by the scrub practitioner before the syringe is supplied to the operating surgeon. Thus there has been little opportunity for surgeons to appreciate that syringes now have caps. This underlines the importance of ensuring that such devices are manufactured with a brightly coloured cap, if one is to be used at all. (4) There appears to be no standard procedure for checking for syringe caps (where used) at the end of the operation, such as there is with swabs. The evidence available to me suggests that items such as syringe caps are just discarded by the scrub practitioner without being retained for counting. Of course, the fact that some syringes are apparently manufactured with a cap and others without complicates the situation but is not actually a bar to counting the number of caps present at the outset of the operation. ”

    Source location

    William Alfred Andrews · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    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

    Responsibility for medicines and devices, including syringes, rests with the MHRA, which is gathering information on the case.

    Verbatim wording from the response

    “I am aware that you have contacted the Medicines and Healthcare Regulatory Authority (MHRA), which is the body with responsibility for medicines and devices (including syringes), and that officials there are gathering information on this case, with a view to providing evidence to the inquest when it reconvenes.”

    Source location

    2013-0368-Response-by-Department-of-Health
    Page 1 · response
    Published 17 December 2013

    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 manufacturer safety measures, NHS surgical never-event work and revised guidance are considered sufficient to address the concerns and prevent future deaths.

    Verbatim wording from the response

    “I am pleased to note that the MHRA has made significant progress in discussions with Rocielle - the manufacturers of the syringes and have written to let you know that the manufacturers;”

    Source location

    2013-0368-Response-by-Department-of-Health
    Page 1 · response
    Published 17 December 2013

    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