Presentation title

Nursing, Technology and the role of the regulatorPresented byMark Grumbridge, Senior Clinical, Advisor, MHRA

#Then and now

#Nursing and TechnologyNurse leaders 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

#Background

In October 2012 the 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.

#Nursing Technology Fund1. Digitally-enabled observations management2. Mobile access to digital care records across the community3. Digital capture of clinical data at point-of-care4. Safer clinical interventions5. Real-time digital nursing dashboards6. Smart workforce deployment7. Remote face-to-face interaction8. Digital images for nursing care

#Nursing Technology Fund 2nd roundSecond round outcomes

276 applications were received

62 organisations have been awarded funding

Value of awards totals almost 35M.

#Carter Report June 2015Author Lord Carter of ColesReview of Operational Productivity in NHS providersPurpose is to review efficiencies in the NHSThe NHS does not have a consistent approach to measuring efficiencyEveryday 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%

#Technology , Nursing and MHRAClinical trials first in man studies, development of existing technologiesRegulatory processProcurement processSafeEffectiveLegitimateUser friendly

#Examples of new and emerging technology - Apps

#Examples of new and emerging technology Software & Telehealth

#Mersey Burns App

#Heart Valve technology

#Argus Retinal Implant Manchester July 2015

#MHRA - Who we 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

#Health & Care System - 2013

#The MHRA meets its functions byInvestigating allegations received about possible non-compliance with the regulationsOperating 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 manufacturersReviewing clinical trial applications for drugs and devices

#What is a Medical 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

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#Medical DevicesCurrently, around 500,000 medical devices on the marketClassification dependant on riskInsulin Pens pre filled (drug) refillable (device)

#Once a device is on the market it is subject to the following;

Post - Market surveillance

Vigilance

Safeguard action

#Causes of adverse eventsInadequate trainingIncorrect deviceIncorrect useInstructions not followedLocal modificationToo complexNot monitored

#Why should I report ?You have a duty of careYou may prevent serious harm to othersYou may be the first to identify a significant device problem of national significance

#What should I report ?Device failures prior to useDevice failures in use Devices causing harm to patientsGeneral safety concerns about a deviceInstructions not clear

#How do I report ?Follow local policy for incident reportingOn line reporting direct to MHRA (Yellow Card)Direct report to manufacturerCombination of all the above

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#Nurse reports201320142015(YTD)NHS233277193Non NHS1129575

18.9% increase from 2013 to 2014NHS incident reports201320142015 (ytd)NHS Trust total262028731847NHS Fatality (death)474935NHS Minor Injury394398248NHS Significant Injury (serious)580700481NHS human error26923879All incident reports201320142015 (ytd)Total136371455210644Fatality (death)310255201Minor Injury11441094963Significant Injury (serious)492555004336Human error781742341

Nurse reports

#Yellow CardThe Yellow Card 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

#MHRA / NHS England Patient Safety AlertsMarch 2014

MDSO

MSO

#What happens to my report ?Pre Triage - reported incidents reviewed on a daily basis and provide a preliminary gradingTriage - A daily meeting to review and make a final decision on grading.

#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.

#Outcome of an initial single reportDevices located in patients homesProvided by the drug companyAvailable on FP10High risk if the product was recalledNo immediate alternative available

#Key messagesAdvances in technology in healthcare continue to surgeWe must embrace technology whilst ensuring it is safe and effective .however,We must remain vigilantWe must ensure staff are trained and competentWe must report adverse events relating to medicines and devicesWe must ensure patients in our care are safePatient Safety is a Team Sport

#Any Questions

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