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The EU GPP criteria for medical devices Karin Lundquist EU GPP Webinar 2014-12-02
The EU GPP criteria for medical
devices
Karin Lundquist
EU GPP Webinar
2014-12-02
Timeline
SEMCo Swedish
Competition Authority
?
2014-07-01 2015-09-01
2012:
project start 2014: health
care EEE
criteria
published
2014-10-03
2011: EU
initiative Phase II:
consumables &
pharmaceuticals?
The process
Stakeholder expertise
Statistics
Internet information
Literature
Scientific journals
Preparatory
meeting
COCIR
SRI
Eucomed
EEE
Medical
engineering
Medical
profession
Procurement
expertise Industry
expertise
NGO:s
Public
authorities
Testing
expertise
WG
Procurement
expertise
Industry
expertise
NGO:s Ministry
expertise
Public consultation
GPP AG
Inter-service
consultation Environmental expertise
within health care
Basis
Preliminary
report
Technical report &
draft criteria
Final report & GPP criteria
Patient safety!
EU GPP criteria – Green Public Procurement
Why does it matter?
– 2 406 billion euros annually
– Impact of purchasers decisions
on sustainability
The EU GPP criteria are:
– translated into all official
languages
– free to use directly in tendering
documents
Why EU GPP criteria for medical devices?
• Top 14 most procured product
category
• High-tech healthcare drives
energy use
• New population and survival
trends
• Large future investments
Accelerating energy use
• Top 5 of most energy using products in Europe
• Third largest electricity user in health care buildings
Energy use in use phase
Large saving potential
• CT
– Energy savings 85 % (cardiac), 45 % (thorax), dose
reduction 15-68 %
– Annual savings $ 3,300 per CT system
– Faster, more detailed images
• Dialysis: water efficiency 30 %, energy saving 50 %,
50 % lower use costs
• Mammography: energy saving 50 %, dose reduction
20 %
Criteria for 20 product groups
Anaesthesia equipment
CT
Dialysis equipment
Diathermy equipment
Disinfectors
ECG equipment
Endoscopy equipment
Incubators for babies
Infusion pumps
Intensive care equipment
Laser instruments for surgery
Medical freezers
Medical lighting
Monitoring equipment
MRI
Patient warming systems
Sterilizers
Ultrasound
Ventilators
X-ray (incl. mammography)
Environmental aspects addressed in
the criteria
• Energy performance criteria
• Low power mode criteria
Energy usage during the use
phase
• Water efficiency criteria Water usage during
the use phase
• Low GWP criteria Use of refrigerants
• Low flow equipment criteria Gas usage
Climate change
Water scarcity
All equipment
Sterilizers, disinfectors,
CT, ECG, MRI, US
Medical Freezers
Anaesthesia equipment
Dialysis, disinfectors
Environmental aspects
• Content of hazardous
chemicals
– Chemicals management systems
– Information on candidate list
substances
Planetary boundaries
Source: Azote Images/Stockholm Resilience Centre, 2009, Planetary boundaries: exploring the safe operating space for humanity, Ecology and Society, 2009
?
Core criteria
Criteria for all types of equipment
Selection criteria 1 Chemicals management system
Technical specification 2 User instructions for green performance management
3 Product longevity and warranty
4 Training for energy efficiency optimisation
5 Installation with energy efficiency optimisation
Contract performance clause 6 Information on content of Candidate List SVHC
Award criteria Energy performance requirements
7 Energy performance for 14 devices
8 Computed Tomography (CT)
9 Haemodialysis equipment
10 Magnetic Resonance Imaging (MRI)
11 Medical sterilizers
12 Flusher and washer disinfectant equipment
13 Automatic low power mode for 6 devices
14 Equipment with a metering device
Water efficiency requirements for different types of equipment
15 Haemodialysis equipment
16 Flusher and washer disinfectant equipment
Comprehensive criteria
Award criteria 17 Refrigerants in medical freezers
18 Gas consumption for anaesthesia equipment – low flow equipment
• Energy criteria:
– Definition of modes and
test conditions
– Pre-determined use
scenarios available
– Can easily be inserted in
an LCC
• Up-coming?
– LCC-tool
Q&A during presentation
Potential of energy savings, are they due to a natural advance in energy efficiency using
more modern technology? Data in Technical Background Report, chapter 13.3, page 82, comes
from the stakeholder questionnaires and other background material. The savings are most often
comparisons between a new model and the preceding one. In some cases, comparisons are
between a new model and a standard model on the market.
In Sweden, energy requirements on medical devices have been used for a long time. However,
requirements used related to energy measurement standards that actually were not applicable, so
apples were compared with pears. Energy requirements were in great need of revision and
carrying out the project on an EU level was crucial to its success.
Have energy savings been calculated on an LCC basis? LCC = Life Cycle Costs, which
includes all costs (purchase, energy, disposable goods, maintenance etc). Potential energy
savings figures relate to actual energy savings in the equipment.
See also COCIR report on Age profile, 2009, COCIR Good Environmental Practice, 2014
Thank you
Read more in the Technical Background Report
Find the criteria here
Karin Lundquist
+46 8 586 21 724
