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Patient Safety and Medical DevicesChallenges for Manufacturers, Operators and Legislative Authorities

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Uvo M. HölscherAktionsbündnis Patientensicherheit Fachhochschule MünsterAG Medizinprodukt-assoziierte Risiken Zentrum für Medizintechnik und Ergonomie

hoelscher@fh-muenster.dewww.aktionsbuendnis-patientensicherheit.de www.mt-e.info

FachhochschuleMünster University of

Applied Sciences


Applied Sciences

Patient Safety and Medical Devices

Challenges for Manufacturers, Operators and Legislative Authorities

Lübeck Summer Academy on Medical Technology 2016

Uvo M. HölscherGerman Coalition for Patient Safety APS Fachhochschule MünsterAG „Medical Device Associated Risks“ Zentrum für Medizintechnik und

[email protected]

www.aktionsbuendnis-patientensicherheit.de www.mt-e.info


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

Use Error

1 2 3


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Risks associated with the use of medical devices

Most Use Errors are poly-causal:

James Reason:Swiss cheese model

L a t e n t ( e r r o r p r o n e )

c o n d i t i o n s

Active failure


Applied Sciences

Risk management (ISO 31000)Framework• Risk management policy• Task assignment• Communication• Resource provisioning ...

• Consultation• Monitoring and

review of the framework

• Continuousimprovement of the framework

focus todayRisk

identification

Risk analysis

Riskevaluation

Risktreatment

Riskassessment

PDCA


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Applied Sciences

Chain?

http://sersys.net/Alarmanlagen_Kundendienst/kette.jpg


Applied Sciences

Gears!

http://www.cars2fast4u.de/g/getriebe.htm


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Gears

Health care providerRisk management

ManufacturerRisk management

Context: Laws, regulations, resolutions, standards ...

Assessment, monitoring, certification

Liab

ility

insu

ranc

eH

ealth payer


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Manufacturer Health care provider

Gears

Risk information

AE - Information

• Instructions for use• Training

Reporting • BfArM• CIRS


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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


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

• ...


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Applied Sciences

Anonymous survey at the Bavarian Conference on Surgery 2014– 21 surgeons and nurses

Kisker, Hoelscher, Heidecke; 2014

Instructions: Compliance, effectiveness

0

4

8

1/2 bis 1Jahr

1 - 2Jahre

2 - 5Jahre

5 - 10Jahre

10 - 15Jahre

Mehr als15 Jahre

Use

rs

Experience

Use of high frequency surgery

0,5 – 1a 1 – 2a 2 – 5a 5 – 10a 10 – 15a >15a


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0

5

10

0 10 - 15 15 - 30 30 - 60

Use

rs

min

Duration of training for HF Surgery



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0

50

100

1 2 3 4 5 6 7 8 9 10

% r

ight

Knowledge item

Minimal knowledge on residual risks


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Timeliness and completeness of risk information:

• Manufacturer: distribute educational concept, audit training

• Operator: training concept demand, training audit

• User: training compliance

• Lawmakers:

• State authorities: training compliance audit

• Certifier manufac.:

• Certifier care prov.:

in Audit: implementing ISO14971, ISO62366-1

Challenge 1: Assure risk information

Distribute training concept, audit training

Demand training concept, audit training

Compliance with training requirement

MPBetreibV

Audit training compliance

Audit implementation of ISO 14971, ISO 62366-1

Audit: quality management, training compliance

Manufacturer:How does risk management audit the trainings?

Operator:How do quality and risk management audit the framework andvalidate the trainings?


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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)

Consequence: Big risk and little gain for reporting user & operator

UserErrorUse Error

Techn.defect

…


Applied Sciences

Participation in the legal medical device vigilance system– Results of an anonymous survey in hospitals

– On average over 20 years of professional experience

Geissler, Korb, Lauer, Hoelscher; 2011

Tested knowledge correctThere 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%

Anxiety and behavioral economics mitigate effectiveness


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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 analyseand rate the design of a medical device ergonomically.

Incidents related to deficits in the training (concept) continue to be unreported.

Effectiveness of vigilance system mitigated


Applied Sciences

• 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)

Challenge 2: Improve vigilance system


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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


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"


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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


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


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• MPSV: Non-punitive system

• Order to BfArM: Application risks

Transparency

Benefit for reporters

Learning support

• SGB V, G-BA: detailed requirements for risk management

Challenge 4: improve conditions


Applied Sciences

Our view on Medical Device associated problems

approximately 85% under water

https://de.wikipedia.org/wiki/Eisberg

https://upload.wikimedia.org/wikipedia/commons/a/ac/Iceberg.jpg


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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


Applied Sciences

Conclusion 2Active 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

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