Transcript National Patient Safety Notifications

National Medical Device Safety
19th
November
2014
Network
Better Together
Dagmar Luettel
Patient Safety Lead
NHS England
NAMDET 2014 Annual
‘Comple Conference
ting the
Manchester Conference Centre
Picture’
The National Reporting and Learning
System (NRLS)
www
NHS net
The system collects
Local Risk
Management
Systems
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all types of incidents
from all care settings
from all specialties
from all staff groups
99%
2
Open
Access
E-Forms
1%
Over 10 million incidents have been submitted to date
since inception in 2003
Reported Incident Types
Source: Apr 2013 - Mar 2014 (NRLS Quarterly Data Workbook Oct 2014)
43,342 medical device incidents in 2013
Reported incident type level 2. Source: Incidents reported to the NRLS in 2013 and
categorised by the reporter as incident type ‘medical device’, in percentage.
43,342 medical device incidents in 2013
No Harm
Low
Moderate
Severe
Death
Total
Number of
reports
35,729
6,419
1,113
63
16
43,342
Percentage
82
15
3
<1
<1
100
All severe harm and death
incidents are individually
reviewed on a weekly basis by
the Patient Safety Team.
Reported degree of harm. Source: Incidents reported to the NRLS in 2013 and categorised by
the reporter as incident type ‘medical device’.
43,342 medical device incidents in 2013
Top 10 types of devices. Source: Number of incidents reported to the NRLS in 2013 and
categorised by the reporter as incident type ‘medical device’.
Some examples of incident reports
… staff did not have the training to use the [xx] pump and had 1 patient with
a pump in situ . A further 3 nurses were questioned none of which had been
trained in the use of the device and they were unable to identify named
trainers for their ward . .
Patient vomited, so staff asked for the portable suction machine. When
received, it had no power as it had not been on charge whilst on the crash
trolley…
Nurse checked emergency equipment at bedside and found that suction unit
was not correctly assembled. Tubing connected incorrectly….
I was called to see a CF patient due to trouble with NIV mask overnight. … On
my arrival I reviewed the mask which was a non vented [xx] mask . I noticed no
expiratory port in the ventilator circuit . The ventilator was alarming 'low leak' . I
immediately replaced the mask with a vented [xx] mask. The patient was
drowsy but rousable to voice. Spo2 91% and machine no longer alarmed.
Incidents involving ECG machines and
categorised as ‘user error’
… one of the consultant cardiologists
queried a trace and it was found that the
chest leads had been wired in the wrong
way round after repair. So all patients
done that morning on this machine had
inaccurate results.
Call out to AMU regarding 2 x ECG
recorders reported not printing traces .
Questioned nurse if the paper was
correctly fitted before coming in. Informed
that paper was fitted correctly. Fault Incorrect paper fitted.
The HCA performed an ECG
for a patient but clicked the
wrong button. Instead of auto
button, the HCA clicked on
copy.
On closer inspection.. the machine on
the ward had the left sided and right
sided ECG electrodes plugged into
the wrong parts of the terminal
connector, not in concordance with
the colour coding . No fail safe
mechanism in place - both connectors
fitted both plugs on the machine . .
Example of patient outcome: Blood tests were unnecessarily performed and
patients could have been started on medications unnecessarily.
National Patient Safety Alerting System
Launched in January 2014 to strengthen dissemination of patient
safety alerts to healthcare providers via CAS.
Stage One Alert: Warning
This stage ‘warns’ organisations of emerging risk. It can be
issued very quickly once a new risk has been identified to allow
rapid dissemination of information.
Stage Two Alert: Resource
This alert may be issued some weeks or months after the stage
one alert, and could consist of examples of local good practice,
tools, resources, and access to learning resources.
Stage Three Alert: Directive
Organisations will be required to confirm they have implemented
specific solutions or actions to mitigate the risk.
All Alerts are available at http://www.england.nhs.uk/ourwork/patientsafety/psa/
NHS England and MHRA initiative
Background
MHRA to maximise reporting
of all medical device incidents and
of all medical device incidents and
ensure these reports are of high
ensure thesequality
reports are of high
quality
NHS to develop systems
devoted to continual learning and
improvement of patient care
NHS England and MHRA initiative
Background
Data quality issues in the NRLS
Data miscoded
Type of device reported as ‘other’ (30%)
Delayed reports
Incidents reported more than 4 weeks after the
incident occurred (51%)
Missing information
Name of device (53%)
Name of manufacturer (80%)
Important information for learning not recorded in
free text descriptions
MHRA to maximise reporting
of all medical device incidents and
ensure these reports are of high
quality
…
The role of the MDSO
 active membership of the National Medical Devices Safety Network
 improve reporting of and learning from medical devices incidents
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review all medical devices incident reports to ensure data quality for local and
national learning, where necessary investigate and get additional information
from reporters;
make sure that medical device incidents are sent to the NRLS as soon as
possible and a least every week;
 receive and respond to requests for more information from the Patient
Safety Domain in NHS England and the MHRA
 work as a member of the medical devices safety committee
 act as an additional senior point of contact for manufacturers and
support local actions on Field Safety Notices; and,
 support the dissemination of medical devices safety communications
from NHS England and the MHRA throughout the organisation.
The aim of the Network
 ensure effective dialogue between all partners in
the network;
 ensure effective reporting of medical device
incidents;
 share learning from reporting;
 disseminate relevant research; and
 share information about new risks and best
practices.
Web meeting structure
Introduction – including ‘what’s new’
NRLS medical device incident panel review
Presentation of 4-5 serious incidents reported in the previous month and
comments from the review panel
Detailed briefing – updates, new risks, safer practice
Previous topics included:
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MHRA’ s One-liners and guidance on Field Safety Notices
Implementation of alert: Risk of associating ECG records with wrong patients
New risk: Accidentally switching of power and medical devices, Battery issues
Patient story involving a hoist
Presentation on the role of a medical device safety officer
Presentation by an individual describing their role, governance, challenges and
successes
www.patientsafetyfirst.nhs.uk
• Material from six monthly online meetings available online
(slides, recording, discussion forum and further resources)
• To access, you need to register, log in and go to Forum/
Resources, then look for medical devices – monthly webex
Get involved
The network is intended to
support the work of the MDSOs
1. Join the incident review panel
2. Present information about a new risk
3. Share a safer practice example
4. Talk about your role
5. Join in the discussions and share materials on
www.patientsafetyfirst.nhs.uk
6. Suggest topics for future web meetings
Thank you for listening.
Contact details:
[email protected]
[email protected]
Tel: 07769 687490
Websites:
http://www.patientsafetyfirst.nhs.uk
http://www.england.nhs.uk/ourwork/patientsafety/