April 2008

PORTABLE OXYGEN
GENERATOR SYSTEM
- GASTEC ® System

 
HEALTH TECHNOLOGY ASSESSMENT UNIT 
MEDICAL DEVELOPMENT DIVISION 
i 
MINISTRY OF HEALTH MALAYSIA 
 
007/08 
DISCLAIMER

Technology review is a brief report, prepared on an urgent basis, which draw on restricted
reviews from analysis of pertinent literature, on expert opinion and / or regulatory status where
appropriate. They are not subjected to an external review process. While effort has been made to
do so, this document may not fully reflect all scientific research available. Additionally, other
relevant scientific findings may have been reported since completion of the review.

Please contact: htamalaysia@moh.gov.my, if you would like further information.

Health Technology Assessment Unit,

Medical Development Division
Ministry of Health Malaysia
Level 4, Block E1, Precinct 1
Government Office Complex
62590 Putrajaya

Tel: 603 88831246

Fax: 603 8883 1230
This report is also available at the following website: http://www.moh.gov.my

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Prepared by:
Dr Sheamini Sivasampu
Principal Assistant Director
Health Technology Assessment Unit
Ministry of Health Malaysia
April 2008

Reviewed by:
Datin Dr Rugayah Bakri
Deputy Director
Health Technology Assessment Unit
Ministry of Health Malaysia
April 2008

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EXERCUTIVE SUMMARY

Portable oxygen generator system is a form of onsite oxygen generating system. The oxygen
produced by this system has been used for medical purposes, ozone generation, waste treatment,
and other industrial oxygen applications. There are two basic types of this technology employed
to separate oxygen from the ambient air; the adsorption type or the cryogenic system.

The Food Drug Administration (FDA) in the US has classified portable oxygen generator system
as a medical device under regulatory class II. The portable oxygen generator system is intended
to be used only by trained personnel in disaster relief and emergency preparedness situations, or
military settings where bottled oxygen is not readily available in the USA.

The GASTEC ® system in this technology review uses the Pressure Swing Adsorption (PSA)
design that is a based on the adsorption system. From this review the GASTEC® System has not
been registered by FDA, Therapeutic Goods Administration or Medical Device Directorate.

An extensive literature search was performed. However there was no scientific evidence on the
safety or effectiveness of the portable oxygen generator system. Hence, since the oxygen therapy
is an established technology we propose this medical device for technical evaluation by the
Engineering Division, Ministry of Health.

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 MEDICAL DEVELOPMENT DIVISION
MINISTRY OF HEALTH MALAYSIA

TITLE: PORTABLE OXYGEN GENERATOR SYSTEM - GASTEC ® System

BACKGROUND

The Director General of Health has requested the Health Technology Assessment Unit to carry
out a technology review on the portable oxygen generator system.

1. INTRODUCTION

Portable oxygen generator system (POGS) is a form of onsite oxygen generating system. The
oxygen produced by this system has been used for medical purposes, ozone generation, waste
treatment, and other industrial oxygen applications. This system is claimed to be more reliable,
economical (save 20 to 30% of cost of cylinder gas), environmentally friendly and safe
compared to the existing system where oxygen is being supplied using cylinder oxygen or bulk
liquid oxygen in the hospitals. (http://www.loteproesg.com/Eng)

There are two basic types of this technology employed to separate oxygen from air. The
adsorption type consists of the Pressure Swing Adsorption (PSA) System or the Vacuum Swing
Adsorption (VSA) System that are used commonly in small to medium facilities. The other type
is the cryogenic system that is used in larger facilities. (http://www.loteproesg.com/Eng)

2. TECHNICAL FEATURES

PRESSURE SWING ADSORPTION (PSA) system

The GASTEC ® system that we have been asked to review, uses the Pressure Swing Adsorption
(PSA) design. In this PSA system the ambient air is compressed and flows to the vessel that
contains the zeolite molecular sieve. The molecular sieve selectively removes carbon dioxide and
most of the nitrogen producing up to 90% to 95% purity oxygen with -73 °C dew point from the
adsorber vessel. Once the adsorbent is loaded with impurities the adsorber bed is depressurized
to atmospheric pressure where the impurities are removed from the adsorbent in preparation for
the adsorption cycle.
(http://www.gastec.com.my/downloads/Oxygen/GasTec%20Ind%20O2%20Supply%20System).

This device consist of 3 major components namely the feed air compressor, dryer and oxygen
generator.
(http://www.gastec.com.my/downloads/Oxygen/GasTec%20Ind%20O2%20Supply%20System.p
df)

Below is the schematic diagram provided by GASTEC® on how oxygen is extracted from the
ambient air and processed.
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3. REGISTRATION AS A MEDICAL DEVICE
The Therapeutic Goods Administration (TGA) in Australia has classified oxygen generators
under the category of medicine whereas the Food Drug Administration (FDA) in USA and
Medical Device Directorate (MDD) in Europe have classified it as a medical device.
The US Pharmacopeia (USP) has set standards for medical oxygen purity at 93%. The FDA
classifies this medical device as a portable oxygen generator (POGS) regulatory class II. There
are some manufactures of POGS that have received 510(k) registration by FDA. However this
device is intended to be used only by trained personnel in disaster relief and emergency
preparedness situations, or military settings where bottled oxygen is not readily available.

GASTEC® System is not registered by FDA, TGA or MDD.

4. SEARCH METHODOLOGY

Literature search was conducted using the following electronic databases: HTA sites like
INAHTA, ANZHSN, EUROScan, ARSNEPS; EBM reviews; Cochrane Database of Systematic
Reviews; Medline (1966- 17th April , 2008), Current Contents, Cochrane Controlled Trials
Registry and general databases like Google and Yahoo. The manufactures website was also
searched for further information

These databases were initially searched using the below search terms: ‘oxygen generator’;
‘onsite oxygen generator; ‘portable oxygen generating system’; ‘oxygen gas generator’;
GASTEC; ‘pressure swing adsorption’ OR “vacuum swing adsorption”. There was no limitation
in the search.

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5. RESULTS AND DISCUSSION

(i)SAFETY

There are no studies with regards to the safety of this device.

(ii)EFFECTIVENESS

There is only anecdotal evidence from various web pages with regards to the effectiveness of this
technology.

CONCLUSION

There is no scientific evidence on the safety or effectiveness of the portable oxygen generator
system. The POGS is intended to be used only by trained personnel in disaster relief and
emergency preparedness situations, or military settings where bottled oxygen is not readily
available in the USA.

RECOMMENDATION

Although there is no scientific evidence of safety and effectiveness of this technology, oxygen
therapy is an established technology. We propose for a technical evaluation by the Engineering
Division, Ministry of Health.

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REFERENCES

1. Oxygen Generation systems. Available at

http://www.loteproesg.com/Eng_11_AirSeperation_1_3.htm. Accessed on the 17th April
2008

2. Oxygen gas generators. Available at http://www.mvsltd.com/oxygen-gas.html. Accessed

on the 17th April 2008

3. GasTec On-Site Medical Oxygen Supply Systemsfor Hospitals & Clinics. Available at
http://www.gastec.com.my/downloads/Oxygen/GasTec%20Ind%20O2%20Supply%20Sy
stem.pdf. Accessed on the 17th April 2008

4. Canogen Portable Oxygen Generator. Available at

http://www.fda.gov/cdrh/pdf3/K033863.pdf. Accessed on the 17th April 2008

5. Manufacturers I Designers of Oxygen & Nitrogen Generating Equipment 5. 510(k)

Summary MAY 9 'O-' POGS 33 Portable Oxygen Generation System. Available at
http://www.fda.gov/cdrh/pdf6/K063454.pdf. Accessed on the 17th April 2008

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