Nursing, Technology and the role of the regulator

1. Nursing, Technology and the
role of the regulator
Presented by
Mark Grumbridge, Senior Clinical, Advisor, MHRA

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Then and now……

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Nursing and Technology
‘Nurse 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

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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.

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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

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Nursing Technology Fund 2nd round
Second round outcomes
276 applications were received
62 organisations have been awarded funding
Value of awards totals almost £35M.

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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%

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Technology , Nursing and MHRA
• Clinical trials – first in man studies,
development of existing technologies
• Regulatory process
• Procurement process
• Safe
• Effective
• Legitimate
• User friendly

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Examples of new and emerging
technology - Apps

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Examples of new and emerging
technology – Software & Telehealth

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Mersey Burns App

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Heart Valve technology

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Argus Retinal Implant – Manchester
July 2015

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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

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Health & Care System - 2013

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The MHRA meets its 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

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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 Devices
• Currently, around
500,000 medical
devices on the market
• Classification
dependant on risk
• Insulin Pens– pre
filled (drug) refillable
(device)

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Once a device is on the market it is
subject to the following;
• Post - Market
surveillance
• Vigilance
• Safeguard action

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Causes of adverse events
Inadequate training
Incorrect device
Incorrect use
Instructions not
followed
Local modification
Too complex
Not monitored

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Why should I report ?
• 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

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What should I report ?
• Device failures prior to use
• Device failures in use
• Devices causing harm to patients
• General safety concerns about a device
• Instructions not clear

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How do I report ?
• Follow local policy
for incident
reporting
• On line reporting
direct to MHRA
(Yellow Card)
• Direct report to
manufacturer
• Combination of all
the above

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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

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Nurse reports 2013 2014
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

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Yellow Card
The 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

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MHRA / NHS
England
Patient Safety
Alerts
March 2014
MDSO
MSO

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What happens to my 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.

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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.

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Outcome of an initial 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

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Key messages
Advances in technology 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. Any Questions