1. Benefits of IEC 80001-1 and introduction into new EN 14971:2012
Dr. Jürgen Stettin
CEO Prosystem AG / Prosystem USA LLC

2. Software Recalls in the US (03/06/2012)
Prof. Dr. Jürgen Stettin

3. Is this a medical device?

4. Who is responsible for the components?
Telecommunications
-provider
Manufacturer ?
Telecommunications
-provider
Manufacturer
Hospital
Manufacturer

5. Examples for the benefits of an IEC 80001 compliant network
Change Management
Event Management
Managing Responsibilities
Increased Performance
Verification & Validation Evidence
Process-oriented Management

6. Change Management – Planing bevor doing
Changes are well planned and will not effect the Key Porperties of the network
E.g. Network switch need an upgrade prior to the change 
Patient Monitor
Digital X-ray
Without
Change Management
With
Change Management
PACS - Server

7. Event Management - Proactive response to Events× ×
Workstation
Workstation
Hospital
IT-Network × × ×
HIS- Server
PACS - Server
Diagnostic Workstation

8. Clearly defined responsibilities
Responsible organisation
IT engineering
Medical engineering
Purchase & contract
management
Service & maintenance
Manufacturer

9. Networks with improved performance
Radiology - Network
Ambulance Network
Digital X-ray
Workstation

10. Verified & Validated Medical IT-Networks
before
after
Test Specification
Digital X-ray ü
PACS - Server
Test Report
Diagnostic Workstation

11. Process-oriented Management of Networks
Network Properties
Change Management
Risk Management
Configuration Management
Continous Monitoring
Contract Management
Event management

12. New Standard: IEC 82304 IEC 82304-1 Healthcare Software Systems
IEC Medical electrical equip.
IEC Medical electrical equip
IEC Medical electrical equip
IEC Medical electrical equip
IEC Medical device software life cycle processes
ISO Active implantables
Prof. Dr. Jürgen Stettin

13. Changes in EN 14971:2012
Prof. Dr. Jürgen Stettin

14. The European Commission has released a list of Harmonized Standards on 08/30/2012. In this list are EN 14971:2012 und EN 13485:2012
The European approach that the assumption is that you fulfill the „Essential Requirements“ is limited in the amendments ZA, ZB und ZC EN und EN
There is no transition period. The changes are in effect from 09/01/2012
Prof. Dr. Jürgen Stettin

15. Risk reduction "as far as possible" versus "as low as reasonably practicable"
a) ISO contains the concept of reducing risks "as low as
reasonably practicable" (ALARP concept). The ALARP concept contains an element of economic consideration.
b) However, the Directive 93/42/EEC and various particular Essential Requirements require risks to be reduced "as far as possible" without there being room for economic considerations.
c) Accordingly, manufacturers and Notified Bodies may not apply the ALARP concept with regard to economic considerations.
Prof. Dr. Jürgen Stettin

16. The Riskgraph non-acceptable risk
Probability of occurence high
Probability of occurence low
Severity low
Severity high
non-acceptable risk
ALARP (As Low As Reasonable Practicable)
acceptable risk

17. The Riskgraph non-acceptable risk
Probability of occurence high
Probability of occurence low
Severity low
Severity high
non-acceptable risk
ALARP (As Low As Reasonable Practicable)
acceptable risk

18. Discretionary power of manufacturers as to the acceptability of risks
ISO seems to imply that manufacturers have the freedom to decide upon the threshold for risk acceptability and that only non-acceptable risks have to be integrated into the overall risk-benefit analysis.
b) However, Medical Device Directive requires that all risks have to be reduced as far as possible.
c) Accordingly, the manufacturer may not apply any criteria of risk acceptability prior to applying MDD
Prof. Dr. Jürgen Stettin

19. The Riskgraph non-acceptable risk
Probability of occurence high
Probability of occurence low
Severity low
Severity high
non-acceptable risk
ALARP (As Low As Reasonable Practicable)
acceptable risk

20. Treatment of negligible risks:
According to ISO 14971, the manufacturer may discard negligible risks
However, Directive 93/42/EEC requires that all risks, regardless of their dimension, need to be reduced as much as possible and need to be balanced, together with all other risks, against the benefit of the device.
Accordingly, the manufacturer must take all risks into account when assessing Directive 93/42/EEC.
Prof. Dr. Jürgen Stettin

21. The Riskgraph non-acceptable risk
Probability of occurence high
Probability of occurence low
Severity low
Severity high
non-acceptable risk
ALARP (As Low As Reasonable Practicable)
acceptable risk

22. Deviation as to the first risk control option
ISO obliges the manufacturer to "use one or more of the following risk control options in the priority order listed: (a) inherent safety by design …" without determining what is meant by this term.
However, Directive 93/42/EEC requires to "eliminate or reduce risks as far as possible (inherently safe design and construction)".
Accordingly, as the Directive is more precise than the standard, manufacturers must apply the former and cannot rely purely on the application of the standard.
Prof. Dr. Jürgen Stettin

23. Information of the users influencing the residual risk
The residual risk is in ISO defined as the risk remaining after application of the risk control measures.
However, Directive 93/42/EEC says that users shall be informed about the residual risks. This indicates that, according to Directive 93/42/EEC and contrary to the concept of the standard, the information given to the users does not reduce the (residual) risk any further.
Accordingly, manufacturers shall not attribute any additional risk reduction to the information given to the users.
Prof. Dr. Jürgen Stettin

24. Thank you for your attention
Questions?