Dear Ms Saunders, Reference: Mr David Anthony SKETCHLEY write with reference to your Regulation 28 letter following the inquest into the death of Mr Sketchley: You requested that we take action to prevent similar events of this kind occurring The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and is responsible for the regulation of medical devices and medicinal products. The aim of the MHRA Devices Division is to take all reasonable steps to protect the public's health and safeguard the interests of patients and users by ensuring that medical devices and equipment meet appropriate standards of safety, quality and performance and that comply with relevant Directives of the European Union _ One major area of the MHRA's responsibilities is the investigation of adverse incidents. An adverse incident is an event involving a medical device, which produces, or has the potential to produce, unwanted effects involving the safety of patients , users and other persons. These effects may arise from shortcomings in the device, its operating instructions, user practice or conditions of use Incident summary Mr Sketchley sustained fatal injuries when he fell between the gap in the front of a commode chair he was using at the Ashley House Nursing Home in Cirencester: The commode chair was intended for bariatric use (manufactured by Performance Health) and Mr Sketchley's became trapped in the gap at the front of the seat when he dislodged the commode pan as he tried to stand_ From your communication, it would appear that there was no supervision in place at the time of the incident and that the risk assessment conducted for Mr Sketchley's use of this chair was inadequate_ Although the type of commode provided for Mr Sketchley may have been inappropriate and contributed to his death, there should have been a risk assessment conducted by the healthcare professionals with the responsibility for his care before its use_ This is requirement for all TJlje they leg key

Medicines & Healthcare products MHRA Requualing Medlcines Jnd Medical Dovicer Regulatory Agency Occupational Therapy equipment and is always emphasised in the Instructions for Use issued by the manufacturers of such equipment and generai guidance published by organisations such as the CQC. The MHRA is unable to comment on the level of supervision, or lack of it, that was in place for Mr Sketchley at the time of incident that led to his death_ Classification of commodes as Medical Devices Under the heading 'Coroner's Concerns" in the Reg 28 report you have highlighted the fact that the MHRA (formerly the Medical Devices Agency) has downgraded the commode into a category which does not require investigation of incidents associated with the product This is in fact incorrect; commodes are not regulated as medical devices in the UK, as they are regarded as aids to personal hygiene and do not perform the function of medical device in accordance with the definitions contained in the Medical Device Directives Therefore, manufacturers of commodes are not obliged to report adverse incidents involving their products to the MHRA, as the Competent Authority for medical devices, under the vigilance process. in that respect; the evidence heard at the inquest into Mr Sketchley's death from Performance Health was correct: However, the MHRA is prepared to receive reports of adverse incidents involving commodes (or similar products) from manufacturers, healthcare professionals, members of the public etc; Where we consider there is safety issue that needs addressing we would pass the report to the appropriate Trading Standards Organisation to take any necessary action, as these products are outside our remit to take direct action against the manufacturer as are not CE marked as medical devices. Conclusion Commodes and associated equipment not regulated as Medical Devices in the UK and it is, therefore, outside the remit of the MHRA to take action with the manufacturer in this case If a product of this type is regarded as unsafe in its design or construction the matter should be referred to the Trading Standards Organisation. MHRA will continue to pass any reports of adverse incidents for commodes to the appropriate TSO and to endorse the general advice issued to healthcare professional using OT equipment and aids to daily that it is essential to carry out a detailed risk assessment for each individual patient as to the suitability of the product before it is brought into use. Yours sincerely, Dr lan Hudson Chief Executive Officer Medicines and Healthcare products Regulatory Agency 151 Buckingham Palace Road, London, SWIW 9SZ 3 0 APR the they are living 2018

CareQuality Commission HSCA Further Information Citygate Gallowgate Newcastle upon Tyne NE1 4PA Telephone: 03000 616161 For attention of: Fax: 03000 616171 Ms Caroline Saunders HM Assistant Coroner for Gloucestershire Gloucestershire Coroner's Court Corinium Avenue Barnwood Gloucester GL4 3DJ 19 April 2018 Care Quality Commission Our Reference: ENQ1-4973662699 Dear HM Assistant Coroner Prevention of future death report following inquest into the death of Mr David Anthony Sketchley: D.O.B (11/03/1933) We write to acknowledge receipt and provide a response to the prevention of future death report dated gth March 2018 issued jointly to CQC and BUPA following the death of Mr David Anthony Sketchley: In the report you ask whether; in the light of the evidence provided, CQC and BUPA intend to commission a new investigation We can assure you that CQC is gathering information into circumstances that contributed to Mr Sketchley's death in accordance with our regulatory powers. As you may be aware since Aprii 2015 CQC has been given new powers to prosecute registered providers (operators of care homes and nursing homes) and registered managers for failures to provide safe care and treatment. The offence is found within Regulations 22 and 12 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. The CQC does not have the power to prosecute individual care workers or nurses. Our prosecution powers are limited to failures at registered provider or registered manager level. In order to successfully prosecute this offence CQC must establish to the criminal standard (beyond reasonable doubt) that; the

The registered provider or manager failed to provide safe care and treatment to the service user (service user is the language used in the legislation); and That the failure resulted in avoidable harm to the service user; or Resulted in significant risk of exposure to avoidable harm. Once the CQC has established these elements of the offence the burden then shifts the registered provider or manager to establish on the balance of probabilities to took all reasonable and exercised all due diligence to that ensure safe care and treatment was provided. In order to prosecute any offence the Code for Crown Prosecutors must be satisfied, The Code has two stages; the evidential test and the public interest test In order to satisfy the evidential test the CQC must be satisfied there is sufficient evidence to amount to a realistic prospect of conviction. If the evidential test is satisfied the interest test must also be met; is it in the public interest to public the case to Court? The public interest test cannot be considered unless the evidential test is satisfied . You are aware that the CQC is gathering evidence into this matter with a view to whether there has been a failure by BUPA andlor the Registered Manager to deciding the Health and Social Care Act 2008 comply with (Regulated Activities) Regulations 2014 (the Regulations') We will update you when decisions have been made With regard to BUPA's investigation, we have no regulatory remit to judge the effectiveness of the provider's investigation or require that quality and carry out an additional investigation into this concern: The BUPA investigation outcome came after our responsive inspection on 31 2017 of Ashley House Care Centre, Cirencester which we gained assurances that action was benge kee Cenreverrenceseer siuilag incidents_ similar CQC will also contact BUPA to request copy of their response to the prevention future death report once the 56 response time has passed. We will also be of regular ypdates rom BUPA %o monitor andsensure progressed befg ilfade to compirete the action(s) intend to take. information regardig sheseectongadit te comilord at the next inspection to ensure have been effectively explored in the work practices at Ashley House Care Centre, implemented and embedded Cirencester to prevent future harm. Please send any correspondence to: By email: CQCInquestsandCoroners_@cgG orguk 2 they steps bring they July days they Any they

By post: Care Quality Commission Citygate Gallowgate Newcastle upon NE1 4PA Please include the reference number ENQ1-4973662699.