Patient Safety and Medical Devices
Challenges for Manufacturers, Operators and Legislative Authorities
Fachhochschule Münster University of Applied Sciences
Lübeck Summer Academy on Medical Technology 2016
Patient Safety and Medical Devices Challenges for Manufacturers, Operators and Legislative Authorities Uvo M. Hölscher German Coalition for Patient Safety APS Fachhochschule Münster AG „Medical Device Associated Risks“ Zentrum für Medizintechnik und Ergonomie www.aktionsbuendnis-patientensicherheit.de
[email protected] www.mt-e.info
Fachhochschule Münster University of Applied Sciences
Risks associated with the use of medical devices Causes of Adverse Events (AEs): 1. Technical defect: mono-causal (solely attributed to the device) 2. Use Error: poly-causal (eg training deficit) 3. User Error: mono-causally (solely attributed to the user)
ECCLESIA (insurance broker): 80% of claims after Use Error
1
2
3
Use Error
Uvo M. Hölscher Aktionsbündnis Patientensicherheit AG Medizinprodukt-assoziierte Risiken
Fachhochschule Münster Zentrum für Medizintechnik und Ergonomie
www.aktionsbuendnis-patientensicherheit.de
[email protected] www.mt-e.info
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Patient Safety and Medical Devices
Challenges for Manufacturers, Operators and Legislative Authorities
Fachhochschule Münster University of Applied Sciences
Risks associated with the use of medical devices Most Use Errors are poly-causal:
Active failure
Latent (error prone) conditions James Reason: Swiss cheese model
Fachhochschule Münster University of Applied Sciences
Risk management (ISO 31000) Framework • Risk management policy • Task assignment • Communication • Resource provisioning ...
• Consultation • Monitoring and review of the framework
• Continuous improvement of the framework
focus today Risk identification
Risk treatment
Risk assessment PDCA
Risk analysis
Risk evaluation
Uvo M. Hölscher Aktionsbündnis Patientensicherheit AG Medizinprodukt-assoziierte Risiken
Fachhochschule Münster Zentrum für Medizintechnik und Ergonomie
www.aktionsbuendnis-patientensicherheit.de
[email protected] www.mt-e.info
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Patient Safety and Medical Devices
Challenges for Manufacturers, Operators and Legislative Authorities
Fachhochschule Münster University of Applied Sciences
Chain?
http://sersys.net/Alarmanlagen_Kundendienst/kette.jpg
Fachhochschule Münster University of Applied Sciences
Gears!
http://www.cars2fast4u.de/g/getriebe.htm
Uvo M. Hölscher Aktionsbündnis Patientensicherheit AG Medizinprodukt-assoziierte Risiken
Fachhochschule Münster Zentrum für Medizintechnik und Ergonomie
www.aktionsbuendnis-patientensicherheit.de
[email protected] www.mt-e.info
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Patient Safety and Medical Devices
Challenges for Manufacturers, Operators and Legislative Authorities
Fachhochschule Münster University of Applied Sciences
Gears
Manufacturer Risk management
Health payer
Liability insurance
Context: Laws, regulations, resolutions, standards ...
Health care provider Risk management
Assessment, monitoring, certification
Fachhochschule Münster University of Applied Sciences
• Instructions for use • Training
Gears
Risk information
Manufacturer
Health care provider
AE - Information Reporting • BfArM • CIRS
Uvo M. Hölscher Aktionsbündnis Patientensicherheit AG Medizinprodukt-assoziierte Risiken
Fachhochschule Münster Zentrum für Medizintechnik und Ergonomie
www.aktionsbuendnis-patientensicherheit.de
[email protected] www.mt-e.info
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Patient Safety and Medical Devices
Challenges for Manufacturers, Operators and Legislative Authorities
Fachhochschule Münster University of Applied Sciences
Safety for patients and users
Key points of this presentation: KP 1: Path for risk information impaired KP 2: Insufficiencies in vigilance system KP 3: Insufficient risk management of health care providers KP 4: Shortcomings in context
Fachhochschule Münster University of Applied Sciences
KP 1: Path for risk information impaired Users must be informed about (residual) risks: • From manufacturer by Labels Instructions for use Training
Observed • Manufacturer has no concept for training • Health care facilities “tinker” own training concept • Incomplete training, insufficient information on residual risks • ...
Uvo M. Hölscher Aktionsbündnis Patientensicherheit AG Medizinprodukt-assoziierte Risiken
Fachhochschule Münster Zentrum für Medizintechnik und Ergonomie
www.aktionsbuendnis-patientensicherheit.de
[email protected] www.mt-e.info
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Patient Safety and Medical Devices
Challenges for Manufacturers, Operators and Legislative Authorities
Fachhochschule Münster University of Applied Sciences
Instructions: Compliance, effectiveness Anonymous survey at the Bavarian Conference on Surgery 2014 – 21 surgeons and nurses
Use of high frequency surgery
Users
8
4
0 0,5 – 1a1 11 –- 2a 1/2 bis 2 Jahr Jahre
2 2 –- 5a 5 Jahre
55 –- 10a 10
10 >15aals 10 –- 15a 15 Mehr
Jahre
Jahre 15 Jahre
Experience Kisker, Hoelscher, Heidecke; 2014
Fachhochschule Münster University of Applied Sciences
Instructions: Compliance, effectiveness Anonymous survey at the Bavarian Conference on Surgery 2014 – 21 surgeons and nurses
Duration of training for HF Surgery
Users
10
5
0 0
10 - 15 15 - 30 min
30 - 60
Uvo M. Hölscher Aktionsbündnis Patientensicherheit AG Medizinprodukt-assoziierte Risiken
Fachhochschule Münster Zentrum für Medizintechnik und Ergonomie
www.aktionsbuendnis-patientensicherheit.de
[email protected] www.mt-e.info
Kisker, Hoelscher, Heidecke; 2014
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Patient Safety and Medical Devices
Challenges for Manufacturers, Operators and Legislative Authorities
Fachhochschule Münster University of Applied Sciences
Instructions: Compliance, effectiveness Anonymous survey at the Bavarian Conference on Surgery 2014 – 21 surgeons and nurses
Minimal knowledge on residual risks
% right
100
50
0 1
2
3
4
5
6
7
8
9
10
Knowledge item
Kisker, Hoelscher, Heidecke; 2014
Fachhochschule Münster University of Applied Sciences
Challenge 1: Assure risk information Timeliness and completeness of risk information: • • • • • • •
Distributeeducational training concept, audit training Manufacturer: distribute concept, audit training Demand trainingdemand, concept,training audit training Operator: training concept audit Compliance with training requirement User: training compliance Lawmakers: MPBetreibV State authorities: training compliance audit Audit training compliance Certifier manufac.: Audit implementation of ISO 14971, ISO 62366-1 Certifier care prov.:Audit: quality management, training compliance in Audit: implementing ISO14971, ISO62366-1
Manufacturer: How does risk management audit the trainings?
Operator: How do quality and risk management audit the framework and validate the trainings?
Uvo M. Hölscher Aktionsbündnis Patientensicherheit AG Medizinprodukt-assoziierte Risiken
Fachhochschule Münster Zentrum für Medizintechnik und Ergonomie
www.aktionsbuendnis-patientensicherheit.de
[email protected] www.mt-e.info
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Patient Safety and Medical Devices
Challenges for Manufacturers, Operators and Legislative Authorities
Fachhochschule Münster University of Applied Sciences
KP 2: Insufficiencies in vigilance system Observed • Other manufacturers are prevented from learning • Reporting users gain no benefit may be punished, feels threatened report seldom (about 5%?)
• Vigilance system differentiates only technical and User Error (present)
Techn. defect …
User Error
Use Error
Consequence: Big risk and little gain for reporting user & operator
Fachhochschule Münster University of Applied Sciences
Anxiety and behavioral economics mitigate effectiveness Participation in the legal medical device vigilance system – Results of an anonymous survey in hospitals – On average over 20 years of professional experience
Tested knowledge
correct
There is a statutory reporting system
86%
Addressee of the message is an authority
50%
Authority is named BfArM
33%
Have you ever even reported
29%
Have got feedback of BfArM
17%
Geissler, Korb, Lauer, Hoelscher; 2011
Uvo M. Hölscher Aktionsbündnis Patientensicherheit AG Medizinprodukt-assoziierte Risiken
Fachhochschule Münster Zentrum für Medizintechnik und Ergonomie
www.aktionsbuendnis-patientensicherheit.de
[email protected] www.mt-e.info
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Patient Safety and Medical Devices
Challenges for Manufacturers, Operators and Legislative Authorities
Fachhochschule Münster University of Applied Sciences
Effectiveness of vigilance system mitigated The upcoming MPSV probably will recognise usability deficits of the device, if they can cause an incident, similar as a malfunction. Thus incidents caused by usability deficits shall be reported in future.
For this procedure the user (physician, nurse) has to be able to analyse and rate the design of a medical device ergonomically.
Incidents related to deficits in the training (concept) continue to be unreported.
Fachhochschule Münster University of Applied Sciences
Challenge 2: Improve vigilance system
• Provide benefits Evaluate more / all safety factors Systematise insights and make it accessible easily1 Make reviews accessible
• Critically consider risk control by manufacturers and operators MPBetreibV currently under revision
1 findings
should be accessible to all who wish to improve patient safety (European Parliament legislative resolution of 2 April 2014)
Uvo M. Hölscher Aktionsbündnis Patientensicherheit AG Medizinprodukt-assoziierte Risiken
Fachhochschule Münster Zentrum für Medizintechnik und Ergonomie
www.aktionsbuendnis-patientensicherheit.de
[email protected] www.mt-e.info
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Patient Safety and Medical Devices
Challenges for Manufacturers, Operators and Legislative Authorities
Fachhochschule Münster University of Applied Sciences
KP 3: Insufficient risk management of health care provider Observed • Incomplete training • Essential deficits in knowledge of risks • Reporting compliance (MPSV) very low • Merging of risk information is incomplete • No requirement to audit the framework • Purchased medical devices foster use error
Fachhochschule Münster University of Applied Sciences
KP 3: Insufficient risk management of health care provider Observed • Social Code Book V (SGB V): Quality management is mandatory Essential elements only described in ISO 15224
• Federal Joint Committee (G-BA, self-government) The monitoring of the framework and its continuous improvement are missing in the directive on “Quality across Health Care Institutions and Settings"
Uvo M. Hölscher Aktionsbündnis Patientensicherheit AG Medizinprodukt-assoziierte Risiken
Fachhochschule Münster Zentrum für Medizintechnik und Ergonomie
www.aktionsbuendnis-patientensicherheit.de
[email protected] www.mt-e.info
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Patient Safety and Medical Devices
Challenges for Manufacturers, Operators and Legislative Authorities
Fachhochschule Münster University of Applied Sciences
Challenge 3: (clin.) Risk management • Establish safety culture Establish non-punitive vigilance system Exemplary role of management
• Implement complete risk management Risk policy Resources Auditing and improvement of the frame
• Procurement Embed risk management Always procure training concept together with device Plan training effort
• Training Treat compliance deficits Audits
Fachhochschule Münster University of Applied Sciences
KP 4: Shortcomings in context • Non-punitive only for anonymous CIRS reports, not for reports to BfArM!! • •
Germany contrary to EU Recommendation 2009 Denmark has implemented non-punitive system in 2003
• Present focus for vigilance system does not cover Use Risks • Requirement for training (MPBetreibV annex 1 products) Not very effective Reference to instructions for use is in conflict with European Medical Device Law
• No central database of risks (present) • No detailed requirements regarding quality and risk management in health care provider • In comparison very little funding for research on patient safety
Uvo M. Hölscher Aktionsbündnis Patientensicherheit AG Medizinprodukt-assoziierte Risiken
Fachhochschule Münster Zentrum für Medizintechnik und Ergonomie
www.aktionsbuendnis-patientensicherheit.de
[email protected] www.mt-e.info
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Patient Safety and Medical Devices
Challenges for Manufacturers, Operators and Legislative Authorities
Fachhochschule Münster University of Applied Sciences
Challenge 4: improve conditions • MPSV: Non-punitive system
• Order to BfArM:
Application risks Transparency Benefit for reporters Learning support
• SGB V, G-BA: detailed requirements for risk management
Fachhochschule Münster University of Applied Sciences
Our view on Medical Device associated problems
https://de.wikipedia.org/wiki/Eisberg
https://upload.wikimedia.org/wikipedia/commons/a/ac/Iceberg.jpg
approximately 85% under water
Uvo M. Hölscher Aktionsbündnis Patientensicherheit AG Medizinprodukt-assoziierte Risiken
Fachhochschule Münster Zentrum für Medizintechnik und Ergonomie
www.aktionsbuendnis-patientensicherheit.de
[email protected] www.mt-e.info
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Patient Safety and Medical Devices
Challenges for Manufacturers, Operators and Legislative Authorities
Fachhochschule Münster University of Applied Sciences
Conclusion 1 1. Establish complete risk management at health care providers 2. Couple risk management of manufacturers and operators effectively 3. Improve legal framework 4. All parties must cooperate 5. The German coalition for patient safety is supporting
Fachhochschule Münster University of Applied Sciences
Conclusion 2 Active failures are like mosquitoes. They can be swatted one by one, but they still keep coming. The best remedies are to create more effective defences and to drain the swamps in which they breed. The swamps, in this case, are the ever present latent conditions. James Reason, BMJ 2000; 320; 768-770
Uvo M. Hölscher Aktionsbündnis Patientensicherheit AG Medizinprodukt-assoziierte Risiken
Fachhochschule Münster Zentrum für Medizintechnik und Ergonomie
www.aktionsbuendnis-patientensicherheit.de
[email protected] www.mt-e.info
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