Prevention of Future Deaths reports · 2015
Regulation 28 report to prevent future deaths, reference 2015-0079, written 4 Mar 2015. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 4 Mar 2015 |
|---|---|
| Reference | 2015-0079 |
| Deceased | David Bladen |
| Coroner | Nicola Mundy |
| Coroner area | South Yorkshire (East) |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 1 |
Text recovered by OCR from a scanned PDF. OCR is imperfect: check anything you rely on against the source PDF. Reproduced verbatim, including the scan's own layout.
Nicola Jane Mundy Senior Coroner for South Yorkshire (East District) REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: National Institute For Health And Care Excellence Level 1a City Tower Piccadilly Plaza Manchester M1 4BT CORONER am Nicola Jane Mundy, Senior Coroner for South Yorkshire (East District) CORONER’S LEGAL POWERS | make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and regulations 28 and 29 of the Coroners (Investigations) Regulations 2013. http://www. legislation.gov.uk/ukpga/2009/25/schedule/5/paragraph/7 http://Awww.legislation.gov.uk/uksi/2013/1629/part/7/made INVESTIGATION and INQUEST On 04/09/2014 | commenced an investigation into the death of David Andrew Bladen, 58 . The investigation concluded at the end of the inquest on 13 January 2015. The conclusion of the inquest was Narrative conclusion. The cause of death was : 1a. Pulmonary embolism 1b. Deep vein thrombosis ic. Ruptured right quadriceps (Operated in July 2014) CIRCUMSTANCES OF THE DEATH Mr Bladen ruptured his quadriceps tendon after falling down some stairs on 14th July 2014. He underwent surgery to reconstruct the right quadriceps tendon. He was provided with mechanical thromboprophylaxis during surgery and post operatively received two doses of medication thromboprophylaxis before being discharged two days post surgery. He was prescribed no extended prophylactic treatment on discharge and further assessments led to no further treatment being provided for thromboembolism. Mr Bladen died on 2nd September 2014 from a massive pulmonary embolism. During the course of evidence | not only heard from doctors who had been involved in Mr : and the issue of thromboprophylaxis but also from a specialist in this area It became clear during the evidence | heard that although NICE provides guidance in relation to the need for extended prophylaxis in certain cases e.g. where a patient has been given as cast, there is no clear guidance for patients in a brace. (As was the case with Mr Bladen) and there are many arguments to say that such patients are at as much risk as developing thromboembolism as those with casts. Medics who gave evidence at the inquest were in agreement that the NICE guidelines does not provide advice as to what is the best thromboprophylaxis management for these categories of patients. CORONER'S CONCERNS During the course of the inquest the evidence revealed matters giving rise to concern. In my opinion there is a risk that future deaths will occur unless action is taken. In the circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows. — (1) Absence of guidance for optimum thromboprophylaxis management in patients who are not in casts but still have restriction of mobility eg. due to a brace. eee PE ee Coroner's Court and Office, Doncaster Crown Court, College Road, Doncaster, DN1 3HS Tel 01302 320844 | Fax 01302 364833 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and | believe you National Institute For Health And Care Excellence have the power to take such action. YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by 28 April 2015. I, the coroner, may extend the period. Your response must contain details of action taken or proposed to be taken, setting out the timetable for action. Otherwise you must explain why no action is proposed. COPIES and PUBLICATION | have sent a copy of my report to the Chief Coroner and to the following Interested Persons ld | am also under a duty to send the Chief Coroner a copy of your response. The Chief Coroner may publish either or both in a complete or redacted or summary form. He may send a copy of this report to any person who he believes may find it useful or of interest. You may make representations to me, the coroner, at the time of your response, about the release or the publicftian of your response by the Chief Coroner. Dated 04 March 4 Signature — Senior Coroner for orkshire (East District) Coroner's Court and Office, Doncaster Crown Court, College Road, Doncaster, DN1 3HS Tel 01302 320844 | Fax 01302 364833
1 response published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.
RECEIVED | N IC National Institute for 30 APR 2013 10 Spring Gardens Health and Care Excellence | _____--.------- London SW1A 2BU United Kingdom 27 April 2014 +44 (0)300 323 0140 Ms N J Mundy Senior Coroner South Yorkshire (East District) Coroners Court and Office Crown Court College Road Doncaster DN1 3HS Your ref: Our ref: Dear Ms Mundy, Thank you for sending me a copy of your Regulation 28 report into the death of David Andrew Bladden dated 4 March 2015, for information and comment. | was very sorry to learn of his death. | note your concern regarding the lack of national guidance on the prophylaxis for patients who have had lower limb surgery and have been placed in a brace and your recommendation that there should be national guidance on this topic. In our clinical guideline (CG92) on venous thromboembolism (VTE), which makes recommendations on reducing risk, we recommend that surgical patients undergoing lower limb surgery should be regarded as being at increased risk of VTE if they undergo a surgical procedure with a total anaesthetic and the surgical time exceeds 60 minutes. We also recommend that mechanical VTE prophylaxis should be continued unti! the patient no longer has significantly reduced mobility, which would be a matter of clinical judgement. Of course, our advice cannot cover every Clinical situation and does not override the knowledge and skills of health and care professionals or any decisions that they make for specific patients. As you are aware we make a specific recommendation on pharmacological VTE prophylaxis to patients with lower limb casts, however there was no evidence to indicate that a specific recommendation on prophylaxis for patients in a brace was warranted. www.nice.org.uk | nice@nice.org.uk It is worth noting thatthe wording used in the recommendations in our clinical guidelines denotes the strength of the recommendation. On this occasion we have said that clinicians should ‘consider’ offering pharmacological VTE prophylaxis to patients with lower limb casts after evaluation of the risks. The use of the term ‘consider’ means that we are confident that the intervention will be beneficial; however it also reflects some uncertainty in this area. Following consideration of the evidence, the orthopaedic subgroup of the Guideline Development Group (GDG) were unsure whether a pulmonary embolism would have occurred with or without VTE prophylaxis in this circumstance. Due to the uncertainty in the evidence base, the GDG agreed a research recommendation to increase our knowledge of this aspect of post-operative care. As part of our routine surveillance process, this guideline is to be updated and a new scope will be prepared as part of the process. We have not yet scheduled this project into our work programme, however | will make arrangements for a copy of your report to be forwarded to guideline developers at the appropriate time so that they are aware of the circumstances around this case and your concerns about the lack of specific guidance for patients in a brace. Please let me know if you or Mr Bladen’s family would prefer that this information should not be shared. | hope this information is helpful to you. Yours sincerely, Sir Andrew Dillon Chief Executive
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