PFD report

Savannah-Rose Michelle Owen · Prevention of Future Deaths report

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Issued 22 Nov 2018•Manchester South

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.

View original report
Concerns
4

Raised in this report

Recipients
2

Named on the report

Responses found
2

Of 2 recipients

Stated actions
1

Described in responses

Source document

Full report text

This is the full text from the original published report.

Open published report

Concerns and recipient responses

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

Report evidence summary

Concerns raised4

  1. Lack of specific safety regulation for multi-purpose nursing pillows
  2. Misleading warning leaflet imagery about leaving babies unattended on multi-purpose nursing pillows
    Part of recurring concern: Inadequate product safety warnings about serious hazards
  3. Failure to keep safety warnings attached to multi-purpose nursing pillows through resale or recycling
    Part of recurring concern: Inadequate product safety warnings about serious hazards
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.1

  1. Action

    Refer concerns about the nursing pillow to the Office for Product Safety and Standards’ Product Safety Enforcement Team.

    Stated by Department for Business, Energy & Industrial StrategyStated completedThe respondent said that this action was complete when they made their response on 10 May 2019.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.4

  1. Position

    Nursing pillows are already regulated under the General Product Safety Regulations 2005, requiring safety in normal or reasonably foreseeable use.

    Stated by Department for Business, Energy & Industrial StrategyExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.

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 specific safety regulation for multi-purpose nursing pillows

Wider context from the report

“1. Unlike many items associated with babies/young children such as high chairs/cots there was no specific safety regulation for such items. Instead manufacturers had to interpret the all-embracing safety policy. This risked inconsistent safety warnings/labelling; ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

Open source report

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

Misleading warning leaflet imagery about leaving babies unattended on multi-purpose nursing pillows

Wider context from the report

“3. On the warning/information leaflet were 5 pictures of a baby positioned on the pillow. In only 2 images was the baby with an adult. On the other 3 the baby was alone. The inquest was told that this could be misleading as to the importance of never leaving a baby unattended on the pillow; and ”

Is this part of a recurring concern?

Yes — Inadequate product safety warnings about serious hazards.

Open source report

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

Failure to keep safety warnings attached to multi-purpose nursing pillows through resale or recycling

Wider context from the report

“4. The warning label was not attached to the item therefore; once the package had been opened, there was a high risk that the warning label would be lost. On resale/recycling of baby items this meant that second hand users/purchasers were unlikely to see the warning. ”

Is this part of a recurring concern?

Yes — Inadequate product safety warnings about serious hazards.

Open source report

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 assurance that health visitors and midwives flag the risks of babies being propped on multi-use pillows for naps

Wider context from the report

“2. It was unclear if Health Visitors/ Midwives in the community seeing multi-use pillows being used were flagging up the risks of allowing babies to be propped on them for naps and that their use in such a way was wholly inconsistent with safe sleeping advice; ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

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

Refer concerns about the nursing pillow to the Office for Product Safety and Standards’ Product Safety Enforcement Team.

Verbatim wording from the response

“I have passed your concerns regarding the nursing pillow on to OPSS’s Product Safety Enforcement Team but in order to investigate further they have asked that any details you have of the specific product involved, including information about the distributor be shared with them. If you have any further information that would assist their assessment, I would be grateful if you could pass it directly to Graham Russell, Chief Executive, OPSS, Victoria Square House, Birmingham B2 4AJ. This would allow OPSS to work with Local Authority Trading Standards to determine whether further action is needed, based on all the evidence available.”

Source location

2018-0367-Response-by-Department-for-Business-Energy-Industrial-Strategy
Page 2 · response
Published 10 May 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

Nursing pillows are already regulated under the General Product Safety Regulations 2005, requiring safety in normal or reasonably foreseeable use.

Verbatim wording from the response

“You raise the concern that there are no specific safety regulations for nursing pillows. The safety of nursing pillows, along with many other products, is regulated by the General Product Safety Regulations 2005 (GPSR). Under the GPSR, products are required to be safe in normal or reasonably foreseeable use when placed on the market.”

Source location

2018-0367-Response-by-Department-for-Business-Energy-Industrial-Strategy
Page 1 · response
Published 10 May 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

OPSS and local authority Trading Standards are responsible for determining and taking any further enforcement action on the nursing pillow.

Verbatim wording from the response

“Both the Office for Product Safety (OPSS) and Local authority Trading Standards have powers to act where unsafe products are identified including, requiring changes to safety information and instructions for use and, where appropriate, issuing a recall of the product.”

Source location

2018-0367-Response-by-Department-for-Business-Energy-Industrial-Strategy
Page 2 · response
Published 10 May 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

Responsibility for nursing-pillow safety regulation rests with the Department for Business, Energy and Industrial Strategy.

Verbatim wording from the response

“Firstly, I should clarify that nursing pillows are not classified as medical devices and are therefore outside the remit of the Medicines and Healthcare Products Regulatory Agency (MHRA). Safety regulation in this case is a matter for the Department for Business, Energy and Industrial Strategy and I note you have issued your report to the Secretary of State.”

Source location

2018-0367-Response-by-Department-of-Health-Social-Care
Page 1 · response
Published 10 May 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

Nursing pillows are not medical devices, so their safety regulation falls outside the MHRA’s remit.

Verbatim wording from the response

“Firstly, I should clarify that nursing pillows are not classified as medical devices and are therefore outside the remit of the Medicines and Healthcare Products Regulatory Agency (MHRA). Safety regulation in this case is a matter for the Department for Business, Energy and Industrial Strategy and I note you have issued your report to the Secretary of State.”

Source location

2018-0367-Response-by-Department-of-Health-Social-Care
Page 1 · response
Published 10 May 2019

Open published response
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Information checked against the published report and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Official responses located
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Data last updated 7 September 2026