Medical Gas Management

A Safe Backbone for the Hospital

Hans-Karsten Reimers
Lbeck, October 2012
SBF IP

Medical Gas Management Systems

Table of Content
1. Gas Management Systems (GMS)
2. History of the standards
3. Requirements
4. Additional Requirements as a Medical Product
5. Safe Product and System Design
6. Solution Drger

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Medical Gas Management Systems

1. The Elements

Distribution
system
Terminal units
Area
control
units
Alarms

Plant alarm

Vacuum plant

Cylinder manifolds
Air plant

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Liquid Oxygen

Medical Gas Management Systems

2. History of Norms

Standards
No Law
Defining the state of the art
In a trial case, reference will be made to the state of the art !

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Medical Gas Management Systems

2. History of Norms

EN 7396-1
Common Requirements and
Safety Standards

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DIN

BS

French

Others

German
Standard

British Standard
HTM 02-01

Air Liquide
System

C11

AFNOR

AGA
Dutch
etc.

GMS Requirements and Solution | Hans-Karsten Reimers 2012-10-30

Medical Gas Management Systems

2. History of Norms

EN 7396-1
Common Requirements and
Safety Standards
BS

French

Others

British Standard
HTM 02-01
C11

Air Liquide
System

AGA
Dutch
etc.

DIN
German
Standard

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Medical Gas Management Systems

2. History of Norms

ISO 7396-1
Common Requirements and
Safety Standards

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Europe

US

EN 7396-1

NFPA 99

GMS Requirements and Solution | Hans-Karsten Reimers 2012-10-30

Japanese

Others

Rest
of the
World.

Medical Gas Management Systems

2. History of Norms
Comparison of Gas Terminal Units

French System

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German System

Medical Gas Management Systems

2. History of Norms

Comparison of Area Control Units

French System

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German System

Medical Gas Management Systems

3. Requirements
A Gas Management System must supply medical gases to the outlets:
The right type of gas

Proper installation and testing/

commisioning
Physical prevention of any interchange of
gases during operation
3 sources of supply for each gas system

Uninterrupted (24/7)

All systems and components redundant

Emergency feeding points

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Medical Gas Management Systems

3. Requirements
To meet the standard of DIN EN ISO 7396 a medical air plant has to consist of at
least 3 supply sources, because it is possible that:

1 source is in maintenance

1 source has a defect (first failure)

1 source has to deliver 100% of hospital consumption

Possible combinations:
a) 3 compressors

b) 2 compressors + one-sided cylinder manifold

c) 1 compressor + double-sided cylinder manifold

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Medical Gas Management Systems

3. Requirements
Net-pressure e.g. 5 bar
Pressure
Reducer

To Terminal Units

AutoChangeover

O2

Emergency Inlet
Point

Liquid Gas
Pressure
Reducer

e.g. 18 bar
Filter
Evaporator
Main Supply
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Titel der Prsentation | Verfasser der Prsentation | 30.10.2012

Cylinder-pressure e.g. 200 bar

Backup

Emergency Supply

Area Control Unit - 5 gases

Area shut-off valve unit acc. to ISO 7396-1

Valve

Feeding Point
NIST
Alarm Sensor
Gauge

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Titel der Prsentation | Verfasser der Prsentation | 30.10.2012

Medical Gas Management Systems

3. Requirements
A Gasmanagement System must supply medical gases to the outlets:
The right type of gas

Proper installation and testing/

commisioning
Physical prevention of any interchange of
gases during operation
3 sources of supply for each gas system

Uninterrupted (24/7)

All systems and components redundant

Emergency feeding points

With the right pressure

Proper Design of the pipe system

No pressure deviation + or -

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Medical Gas Management Systems

3. Requirements Alarms
System cable

Central Monitoring
Clinical emergency signals
Alarm Management System, R. Harm, 26.02.2009

Operation signals

Local displays

Medical Gas Management Systems

3. Requirements
A Gasmanagement System must supply medical gases to the outlets:
The right type of gas

Proper installation and testing/

commisioning
Physical prevention of any interchange of
gases during operation
3 sources of supply for each gas system

Uninterrupted (24/7)

All systems and components redundant

Emergency feeding points

With the right pressure

Proper Design of the pipe system

No pressure deviation + or -

With the right quality

Defined by Pharmacopoea (Air, O2)

Resposibility of Pharmacist

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Medical Gas Management Systems

3. Quality of Medical Air

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Contamination

Limit values acc. to the European Pharmacopoeia

Carbon dioxide

500 ml / m

Carbon monoxide

5 ml / m

Oil

0,1 mg/m at ambient pressure

Sulphur dioxide

1 ml / m

Nitric oxide

2 ml / m

Nitrogen dioxide

2 ml / m

Oxygen

Volume between 20,4 and 21,4 %

Water

67 ml / m, ca. - 29,4C tpd at 5bar

870 ml / m, ca. - 1,8C tpd at 5bar (with authority consent )

GMS Requirements and Solution | Hans-Karsten Reimers 2012-10-30

Medical Gas Management Systems

3. Quality of Medical Air
Conditioning of medical air
1

Pre-filter - 0,01
oil- , water aerosols , solid particles

Activated charcoal filter - 0,03 mg/m

oil vapours

Heatless desiccant dryer

H2O (PDP -40C) , NOX , SO2 , CO2

Hopcalite filter (catalyst)

CO CO2

Dust filter
dust
2

Drger tubes for testing the

quality of medical air.

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Medical Gas Management Systems

3. Quality of Pipeline System

Soldering

Hard soldering with hydrogen:

Working temperature ~700C
Inert gas:
Avoid oxidation
Hard solder acc. to DIN 8513
Silver (Ag)
:4-6%
Phosphor (P)
: 5,7 - 6,3 %
Copper (Co)
: Rest

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Medical Gas Management Systems

3. Quality of Pipeline System

Medical Gas Management Systems

3. Requirements
A Gasmanagement System must supply medical gases to the outlets:
The right type of gas

Proper installation and testing/ commisioning

Physical prevention of any interchange of gases
during operation
3 sources of supply for each gas system
All systems and components redundant

Uninterrupted (24/7)

Emergency feeding points

Proper Design of the pipe system

With the right pressure

No pressure drops due to high demand

Defined by Pharmacopoia (Air and O2)

With the right quality

Resposibility of Pharmacist
Supervision of status and function by an Alarm
Management System

The operation of the system must

be safe and easy for the staff

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Easy control and service

Easy and safe daily work.
Documented Instruction for Use
(complete System and components)

Gas Communication Cockpit GCC1000

AMS

GDS

Interface

Building Management
SMS / e-mail
Laptop/iPad/iPhone...

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GCC 1000 Produkt Eigenschaften, Funktionen, Kundennutzen & USPs

Medical Gas Management Systems

4. Additional Requirements

In some countries, Medical Gas Management Systems are classified as

medical products class II b.
Countries: Germany, Austria, Belgium, Switzerland.
Others are under discussion.
What are the reasons and argumentations?
GMS is an integral part of the supply of gases to the patient (via anaesthesia
machines or ventilators) and follows the classification of these devices.
To fulfill the required safety, the regulatory requirements of the Medical
Device Directive [MDD] have to be followed.

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Medical Gas Management Systems

4. Additional Requirements

How to create a safe system?

The conformity assessment shall proof that the individual Gas Management
System:
-

is designed, produced and tested according to DIN EN ISO 7396-1

has passed a risk management evaluation acc. ISO 14971
has got a documented test procedure

For countries in which GMS is a medical product,

the Declaration of Conformity
acc. to European Directive 93/42/EEC Annex II
shall be created.

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Medical Gas Management Systems

5. Safe Product and System Design
There are 2 elements which have to
be regarded in order to fulfill the
requirements of the ISO 7396-1:

System
Components
Compressors, Manifolds, Valves
For each component a risk analysis
has to be done. Only proven products
shall be used.
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The complete system is individually

designed and build.
In order to be safe, the design,
the installation and testing /
commissioning has to
follow clear rules

Medical Gas Management Systems

5. Safe Product and System Design
Products
-

All used components are high quality

products and are carefully tested for the
proper function and durability.

Filters and dryers ensure the provision of

defined gas quality

The functionality of the components within

the system is tested

All released components are documented

within the released
Drger Medical System Catalogue.

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Medical Gas Management Systems

5. Safe Product and System Design

For the engineering of an individual Medical Gas Management System

controlled processes have to be followed:
- Calculation of maximum gas consumption
(fully loaded hospital, all operation theatres are working)
- Calculation of plant capacity, pipe dimension etc.
- Site drawings (pipeline systems, control boxes, supply units etc.)
- Complete technical test documentation
- Risk Management Report
- Conformity assessment release
- Declaration of conformity
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Medical Gas Management Systems

5. Safe Product and System Design

All systems shall have a conformity assessment.

A conformity assessments of individual Gas Management Systems
can be optained case-by-case from Notified Bodies
or
Companies who have achieved the following certificates:
ISO 13485:2003
CE Certificate

and the
(Full Quality Assurance System, Annex II, section 3
of the Directive 93 / 42 / EEC on Medical Devices)

can conduct the conformity assessment by themselves and issue a CE

certificate for the complete system.
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Medical Gas Management Systems

Thank you for your attention

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Medical Gas Management Systems

6. Solution Drger
How does Drger Medical fulfill the requirements?
-

For the proper installation of the Gas Management System (on site
production) a released Installation Manual has to be followed.

The Drger processes DMS OG/OF9000 ff. ensure that all requirements are
fulfilled.

Quality documentation for the complete product / project shall be carried out
according DMS OF9000 A6.

Customer documentation including Instruction for Use

(complete system, individual devices)
-> correct use of the system and information for the hospital emergency plan!

* Drger Standard Operational Processes for SBF IP products

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Medical Gas Management Systems

6. Solution Drger
Translation of the requirements into
Drger Standard Operational Processes
Product / Standards
Product
Medical Gas
Management System
acc. to ISO 7396-1
Risk Management
acc. to ISO 14971
Production on Site
acc. to ISO 7396-1
Final Test
acc. to ISO 7396-1

Controlled Documents
System Catalog GMS
released Components
Design Guidelines
Documentation
per Project
DMS OF9000 A6

Installation Manual

Final Test Protocol

Instruction for USE

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Business License
EC-Certificate
Drger Medical GmbH

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