Downloaded 11 times
More Related Content
Similar to Improving Patient Care conference-Mark Grumbridge presentation.v2pptx
Improving Patient Care conference-Mark Grumbridge presentation.v2pptx
- 1. Nursing, Technology andthe role of the regulator Presented by Mark Grumbridge, Senior Clinical, Advisor, MHRA
- 2.
- 3. 3 Nursing and Technology ‘Nurseleaders need to be involved in the planning and implementation of new healthcare technology to ensure it is appropriate and practical for frontline workers’ Hamer S, Cipriano P (2013) Involving nurses in developing new technology. Nursing Times; 109: 47, 18-19
- 4. 4 Background In October 2012the Prime Minister announced the establishment of a Nursing Technology Fund to support nurses, midwives and health visitors to make better use of digital technology in all care settings, in order to deliver safer, more effective and more efficient care.
- 5. 5 Nursing Technology Fund 1.Digitally-enabled observations management 2. Mobile access to digital care records across the community 3. Digital capture of clinical data at point-of-care 4. Safer clinical interventions 5. Real-time digital nursing dashboards 6. Smart workforce deployment 7. Remote face-to-face interaction 8. Digital images for nursing care
- 6. 6 Nursing Technology Fund2nd round Second round outcomes 276 applications were received 62 organisations have been awarded funding Value of awards totals almost £35M.
- 7. 7 Carter Report –June 2015 Author – Lord Carter of Coles Review of Operational Productivity in NHS providers Purpose is to review efficiencies in the NHS The NHS does not have a consistent approach to measuring efficiency Everyday consumables – dressings,syringes and so on (around £2bn) Hi-value medical devices – hip joints, cardio devices and so on (around £3bn) Primary knee replacement. £943 - £1,674 78%
- 8. 8 Technology , Nursingand MHRA • Clinical trials – first in man studies, development of existing technologies • Regulatory process • Procurement process • Safe • Effective • Legitimate • User friendly
- 9. 9 Examples of newand emerging technology - Apps
- 10. 10 Examples of newand emerging technology – Software & Telehealth
- 11.
- 12.
- 13. 13 Argus Retinal Implant– Manchester July 2015
- 14. 14 MHRA - Whowe are, what we do and how we impact on technology! • The MHRA is the competent authority (CA) for the UK • On behalf of the Secretary of State for Health, we administer and ensure compliance with medical device legislation in England, Northern Ireland, Scotland and Wales
- 15. 15 Health & CareSystem - 2013
- 16. 16 The MHRA meetsits functions by Investigating allegations received about possible non- compliance with the regulations Operating a proactive inspection programme where manufacturers are randomly selected for inspection by MHRA's own staff. Designating UK notified bodies and audits them. Investigates post-market surveillance reports received from medical device manufacturers Reviewing clinical trial applications for drugs and devices
- 17. 17 What is aMedical Device ? Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of: - diagnosis, prevention, monitoring, treatment or alleviation of disease …..does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means
- 18.
- 19. 19 Medical Devices • Currently,around 500,000 medical devices on the market • Classification dependant on risk • Insulin Pens– pre filled (drug) refillable (device)
- 20. 20 Once a deviceis on the market it is subject to the following; • Post - Market surveillance • Vigilance • Safeguard action
- 21. 21 Causes of adverseevents Inadequate training Incorrect device Incorrect use Instructions not followed Local modification Too complex Not monitored
- 22. 22 Why should Ireport ? • You have a duty of care • You may prevent serious harm to others • You may be the first to identify a significant device problem of national significance
- 23. 23 What should Ireport ? • Device failures prior to use • Device failures in use • Devices causing harm to patients • General safety concerns about a device • Instructions not clear
- 24. 24 How do Ireport ? • Follow local policy for incident reporting • On line reporting direct to MHRA (Yellow Card) • Direct report to manufacturer • Combination of all the above
- 25. 25 Competent Authority, 651 Devolved Administration, 936 Manufacturer,8658 Member of Public, 164 MHRA, 22 NHS Trust, 2873 Others, 752 Private healthcare, 496 Incidents by reporting body 2014 – 14,552 Reports in total Competent Authority Devolved Administration Manufacturer Member of Public MHRA NHS Trust Others Private healthcare 277 NHS Roles Nurses Total
- 26. 26 Nurse reports 20132014 2015 (YTD) NHS 233 277 193 Non NHS 112 95 75 0 50 100 150 200 250 300 2013 2014 NHS Trust Non NHS 18.9% increase from 2013 to 2014 NHS incident reports 2013 2014 2015 (ytd) NHS Trust total 2620 2873 1847 NHS Fatality (death) 47 49 35 NHS Minor Injury 394 398 248 NHS Significant Injury (serious) 580 700 481 NHS human error 269 238 79 All incident reports 2013 2014 2015 (ytd) Total 13637 14552 10644 Fatality (death) 310 255 201 Minor Injury 1144 1094 963 Significant Injury (serious) 4925 5500 4336 Human error 781 742 341 Nurse reports
- 27. 27 Yellow Card The YellowCard Scheme is vital in helping the MHRA monitor the safety of all healthcare products in the UK to ensure they are acceptably safe for patients and users. On 14th July 2015 the Yellow card app was launched for medicines
- 28. 28 MHRA / NHS England PatientSafety Alerts March 2014 MDSO MSO
- 29. 29 What happens tomy report ? • Pre Triage - reported incidents reviewed on a daily basis and provide a preliminary grading • Triage - A daily meeting to review and make a final decision on grading.
- 30. 30 Pre triage conclusions •Trending & Surveillance - Not all incidents need active investigation. • Monitored - Manufacturers will investigate and provide a final report. • Specialist investigation - ALL reports from members of the public.
- 31. 31 Outcome of aninitial single report • Devices located in patients homes • Provided by the drug company • Available on FP10 • High risk if the product was recalled • No immediate alternative available
- 32. 32 Key messages Advances intechnology in healthcare continue to surge We must embrace technology whilst ensuring it is safe and effective ……….however, We must remain vigilant We must ensure staff are trained and competent We must report adverse events relating to medicines and devices We must ensure patients in our care are safe Patient Safety is a ‘Team Sport’
- 33.