Ronald Clark
PFD Report
Partially Responded
Ref: 2019-0151
Coroner's Concerns (AI summary)
Stents supplied in identical packaging with only small labels pose a risk of using incorrect sizes during medical procedures.
View full coroner's concerns
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. was also told that stents in this sort of packaging are in general use in most, if not all, NHS hospitals 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 used, as was the case with Mr Clark
Responses
Action Planned
The National Patient Safety Team is reviewing the National Safety Standards for Invasive Procedures (NatSIPPs) and the NatSIPP on prosthesis verification is being updated to reflect developments in implant selection and verification processes, including the potential for future scanning for all prothesis/implants. (AI summary)
The National Patient Safety Team is reviewing the National Safety Standards for Invasive Procedures (NatSIPPs) and the NatSIPP on prosthesis verification is being updated to reflect developments in implant selection and verification processes, including the potential for future scanning for all prothesis/implants. (AI summary)
View full response
Dear Mr Horsley Regulation 28 Report – Mr Ronald CLARK Thank you for the Regulation 28 report dated 8 April 2019, that was received on 23 April 2019. Although your report was directed at NHS Improvement, NHS England and NHS Improvement have been operating as a single organisation since 1 April
2019. This response is provided in my capacity as the National Director of Patient Safety, NHS Improvement. 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. The related action that I have been able to take, to reduce the potential for such incidents from happening again, is detailed below. The National Patient Safety Team, being part of NHS Improvement, is in the process of reviewing the National Safety Standards for Invasive Procedures (NatSIPPs). These are a set of high-level, national standards for all invasive procedures that have been produced to support local providers in developing and maintaining their own more detailed standardised local procedures and in order to reduce the likelihood of Never Events occurring. 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 prothesis/implants. Wellington House 133-155 Waterloo Road London SE1 8UG
6th June 2019
NHS England and NHS Improvement I hope you will be able to share my reply with Mr Clark’s family. I was very sorry to hear that this error occurred, and I hope it will give the family some comfort that we are taking steps to prevent this type of error in future. I trust that you will find this information of assistance and should you require any further detail, please do not hesitate to contact me.
2019. This response is provided in my capacity as the National Director of Patient Safety, NHS Improvement. 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. The related action that I have been able to take, to reduce the potential for such incidents from happening again, is detailed below. The National Patient Safety Team, being part of NHS Improvement, is in the process of reviewing the National Safety Standards for Invasive Procedures (NatSIPPs). These are a set of high-level, national standards for all invasive procedures that have been produced to support local providers in developing and maintaining their own more detailed standardised local procedures and in order to reduce the likelihood of Never Events occurring. 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 prothesis/implants. Wellington House 133-155 Waterloo Road London SE1 8UG
6th June 2019
NHS England and NHS Improvement I hope you will be able to share my reply with Mr Clark’s family. I was very sorry to hear that this error occurred, and I hope it will give the family some comfort that we are taking steps to prevent this type of error in future. I trust that you will find this information of assistance and should you require any further detail, please do not hesitate to contact me.
Sent To
- Medicines and Healthcare products Regulatory Agency
- NHS Improvement
Response Status
Linked responses
1 of 2
56-Day Deadline
22 Sep 2019
About PFD responses
Organisations named in PFD reports must respond within 56 days explaining what actions they are taking.
Source: Courts and Tribunals Judiciary
Report Sections
Investigation and Inquest
On 21 May 2018 commenced an investigation into the death of Ronald CLARK age 64_ investigation concluded at the end of the inquest on 15 February 2019. The conclusion of the inquest was cause of death: 1a. Multi-organ Failure, 1b. Necrotising Pancreatitis, Chronic Obstructive Pulmonary Disease. Ronald CLARK died due to an Accident,
Circumstances of the Death
On the Nineteenth January 2018 Ronald CLARK underwent the insertion of a stent in his common hepatic duct . The incorrect sized stent was inadvertently inserted and this, on the balance of probabilities, significantly contributed to his death at Queen Alexandra Hospital, Portsmouth on Second of April 2018.
Action Should Be Taken
In my opinion action should be taken to prevent future deaths and believe your organisation the power to take such action, The being have
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Data sourced from Courts and Tribunals Judiciary under the Open Government Licence.