First reported 17 Dec 2013•Latest report 7 Jul 2021
Definition
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.
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
5
Distinct published reports
Individual concerns
5
A report can raise multiple concerns
Date range
2013–2021
First to latest report issue date
Stated actions
8
Described in published responses
Reports over time
Reports over time
Reports about this concern issued each year.
* 2026 is projected from reports observed to 7 Sep 2026.
Most frequent recipients
Most frequent recipients
Reports about this concern sent to each recipient.
Department of Health and Social Care3
Medicines and Healthcare products Regulatory Agency2
Care Quality Commission1
Faculty of Intensive Care Medicine1
NHS England1
Royal College of Anaesthetists1
Ministerial department3
Medicines and medical devices regulator2
Executive non-departmental public body1
Health and social care service regulator1
Health professional body1
Concerns and responses across reports
Only concerns grouped under this recurring concern are included. Select any concern, action or position to view the source wording.
East London
Concerns raised1
Lack of standardised classification and colour coding of breathing system filters and HMEs
This report raised 1 other concern. They are not shown here because they do not form part of this recurring concern.
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 respondent says it has done, is doing, or plans to do in response to the concern raised.6
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.
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.
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.
Action
Write to filter manufacturers, ABHI and UK Approved Bodies requesting review of device labelling against regulatory requirements and inquest findings.
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.
Action
Contact HSIB and pass on the recommendation to investigate possible confusion over filter types.
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.
Action
Refer standardised breathing-filter labelling and colour-coding to the MHRA for consideration.
Stated by Faculty of Intensive Care Medicine and Royal College of AnaesthetistsStatus unclearThe respondent did not make the status of this action clear when they made their response on 9 July 2021.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.6
Position
A universal filter colour standard would be difficult and protracted because filter types lack agreed classification and manufacturers could deviate.
Stated by Medicines and Healthcare products Regulatory AgencyUnable to actThe respondent said that a constraint prevented them from taking the relevant action.
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.
Position
Existing evidence suggests colour coding may have little or no impact on distinguishing medical devices.
Stated by Medicines and Healthcare products Regulatory AgencyDisputes the concernThe respondent disagreed with part of the concern or the basis for it.
Position
HSIB is responsible for further investigating possible confusion over filter types, with professional bodies involved as appropriate.
Stated by Medicines and Healthcare products Regulatory AgencyRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
Position
Implementing standardised breathing circuit filter labelling is outside the respondent’s power.
Stated by Faculty of Intensive Care Medicine and Royal College of AnaesthetistsOutside remitThe respondent said that this matter was outside its role or authority.
Position
The Medicines and Healthcare products Regulatory Agency was referred the issue for consideration of standardised breathing circuit filter labelling.
Stated by Faculty of Intensive Care Medicine and Royal College of AnaesthetistsRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
Suffolk
Concerns raised1
Insufficiently distinctive packaging and visual identification of intravenous fluids for arterial line transducer sets
This report raised 1 other concern. They are not shown here because they do not form part of this recurring concern.
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 respondent says it has done, is doing, or plans to do in response to the concern raised.1
Action
Consider improvements with the marketing authorisation holder to make statutory information easier for clinical staff to assimilate and reduce selection errors.
Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 23 November 2020.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.2
Position
Colour cannot be used in IV-fluid labelling because container manufacturing prevents it; other local risk controls are required.
Stated by Department of Health and Social CareUnable to actThe respondent said that a constraint prevented them from taking the relevant action.
Position
Because Viaflo containers cannot use colour differentiation, local clinical areas must implement other measures to identify intravenous fluids correctly.
Stated by Medicines and Healthcare products Regulatory AgencyRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
Portsmouth and South East Hampshire
Concerns raised1
Failure to provide clearly differentiated packaging for stent sizes
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 respondent says it has done, is doing, or plans to do in response to the concern raised.1
Action
Update the prosthesis-verification standard to reflect developments in implant selection and verification, including potential future scanning of prostheses and implants.
Stated by NHS EnglandStated in progressThe respondent said that this action was in progress when they made their response on 28 July 2019.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.1
Position
Packaging changes for different-sized stents are assigned to the Medicines and Healthcare products Regulatory Agency as the appropriate responsible body.
Stated by NHS EnglandRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
Manchester South
Concerns raised1
Lack of reliable visual differentiation between PEJ and PEG tubes
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.2
Position
Further colour coding may not reliably prevent tube confusion and could introduce additional hazards, including misconnections and risks for colour-blind users.
Stated by Department of Health and Social CareDisputes the concernThe respondent disagreed with part of the concern or the basis for it.
Position
Manufacturers cannot be compelled to change device designs unless changes form part of internationally required standards.
Stated by Department of Health and Social CareUnable to actThe respondent said that a constraint prevented them from taking the relevant action.
South Yorkshire (West)
Concerns raised1
Failure to ensure that detachable syringe caps are visibly different in colour from the equipment
This report raised 3 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.2
Position
Responsibility for medicines and devices, including syringes, rests with the MHRA, which is gathering information on the case.
Stated by Department of Health and Social CareRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
Position
Existing manufacturer safety measures, NHS surgical never-event work and revised guidance are considered sufficient to address the concerns and prevent future deaths.
Stated by Department of Health and Social CareExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.
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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.
