MEDICAL GASES & RELATED FACILITIES

By

Ismail Yusof

Contents
Introduction References Medical Gas Medical gas Pipeline Systems Properties of Gases and cylinders Medical Compressed Air Medical Vacuum Anaesthetic Gas Scavenging System Conclusion

This is purely an introduction to the subject of Medical Gases an AWARENESS SEMINAR The intention being to give everyone a feel of the subject and a common language pointers will be included to enable those interested to review such installations as to their compliance and hopefully encourage some to delve deeper into the subject and make reference

MEDICAL GAS PIPELINE SYSTEMS (MGPS)

Internationally all medical gases are deemed to be drugs Such gases and all things relating to them are subject therefore to very stringent regulations : Technically (Design & construction) Materials used Pharmacological consideration Maintenance and operation Testing & commissioning Modification

In most parts of the world Medical Gas systems at all times

From design through to commissioning to operation and maintenance and periodic testing and validation of gases

Both a competent Engineer and competent Pharmacist are required to sign off and certify any system for use

TERMINOLOGY
Medical Oxygen Medical Air Nitrous Oxide Nitric Oxide Entonox Medical Vacuum O
2

A4 + A7 NO
2

N0 - A newly used gas N O/O

2 2

- VAC

Anaesthetic Gas Scavenging System AGSS Synthetic Air

SOURCE OF REFERENCE Hospital Technical Memoranda (HTMs)

HTM 2022 published 1994 supercedes HTM22 (Circa 1970s)

Plus C11 National Health Service Model Engineering Specification

HTM2022

Published in 5 Sections/Volumes Management Policy Design Considerations Validation and Verification Operational Management Good Practice Guide

RECOMMENDED SOURCES OF REFERENCE FOR MEDICAL GAS PIPELINE SYSTEMS HTM2022

C11 Model Engineering Specifications

BS 5682 Terminal Units and Hoses

BS 6384 WAGS/AGSS (EN 737/2)

HEALTH ENGINEERING INFORMATION

HEI 163 (Cylinder Handling) British Compressed Gas Association Codes of Practice No. 1 7 (Pathology Laboratories) Health Service Engineering (HSE Manual Handling)

PRESSURE

The Pascal Pascal French guy 1623 1662 derived the unit = one Newton per square metre Newton English guy 1642 1727 So a Frenchman decided that the unit of pressure should equal one Englishman per square metre

PRESSURE

The kilo Pascal kPa

1 bar = 100 kPa 14.51 psi

Standard Atmosphere = 760 mmHg = 14.7 psi

GAS GENERAL PROPERTIES

Gas Property Oxygen O2 Nitrous Oxide N20 Entonox 50/50 N2O + O2 1.61 Medical Air Carbon Dioxide CO2 1.98

Density at STP Kg/m3 Boiling point At 1.013 bar gauge Colour of Gas Colour of Cylinders

1.43

1.98

1.3

-183.1

-88.6

-60

-190

-78

None

None

None

None

None

White tops Black body

French blue

Blue and white1/4 tops blue body

Black & white tops grey body

Grey

GAS GENERAL PROPERTIES

Gas Property Oxygen O2 Nitrous Oxide N20 Entonox 50/50 N2O + O2 Faint Slightly sweet No Vigorously Medical Air Carbon Dioxide CO2 None None

Odour Taste

None None

Faint Slightly Sweet No Vigorously

None None

Flammable
Supports Combustion (Oxidiser)

No Very Vigorously

No Yes

No No

GAS GENERAL PROPERTIES

Gas Property State in Cylinder Medical Uses Precaution Oxygen O2 Gas 137 bar Life support and therapy Nitrous Oxide N20 Liquid 40 bar Analgesic And weak anaesthetic Entonox 50/50 N2O + O2 Gas above 7 at 137 bar Analgesic Medical Air Carbon Dioxide CO2 Liquid 50 bar Respiratory stimulant Danger of Asphyxiation to be well ventilated Cylinders

Gas 137 bar

Respiratory, Tools, vents

Oils and greases to be avoided

Method of Supply

Pipelines & cylinders

 Nitric Oxide

Relaxed blood vessel Blue baby syndrome

hypoxic respiratory failure (HRF)

HANDLING OF MEDICAL GAS CYLINDERS

Medical gas cylinders are robust but should be:Handled with care Personnel changing cylinders should have received adequate training Naked flames are prohibited Cylinders should never be used as rollers Cylinders should never be lifted by their valves or caps Cylinders, their valves and caps must be kept free from oil & grease

TYPES / SIZES OF CYLINDERS

E&F

Used on anaesthetic trolleys, baby incubators, resuscitators, portable emergency supplies and ambulances Used on Medical equipment in ward areas

Used on Medical gas manifolds

SOME POINTS WORTH NOTING WITH CYLINDERS

A compressed gas cylinder can explode if damaged or overheated If a cylinder is damaged at its neck (its weakest point) it can take off like a rocket destroying anything in its path Discharge of high pressure gas can blast particles into eyes and at a very high pressure can pass through the skin causing death Some gases can cause explosions if allowed to come into contact with oils or grease Some cylinder are filled with liquid which if discharged are so cold they could cause severe frost bite or even death by freezing or hypothermia

HTM2022
Requires that manifold rooms should be well ventilated It should be noted With just a 4% increase in the level of oxygen in an environment

Combustion rate is doubled

At 100% oxygen level even steel will burn !!

OXYGEN

Has a nasty habit of hanging around in the fibres of clothing

So if you have been exposed to a high level of oxygen go and walk around in the fresh air for at least TEN MINUTES before running the risk of coming into contact with a point of combustion smoking etc.

Medical Gas Pipeline Systems

All fittings / fixtures/ pipe work etc. throughout all MGPS have to be manufactured especially de-arsenic degreased etc. All materials are provided in sealed plastic wrapping direct from manufacturers/agent. Seals - valves etc. cannot be replaced with standard engineering material (i.e. from the hardware store). Flux less solder Purge gas Mechanical joints Ultrasound

TYPES OF GAS FOUND IN HOSPITALS

There are 2 classifications of gas to be found in the healthcare environment MEDICAL GAS Is gas prescribed for a patient by a Doctor, allowable contaminants are controlled by national and international standards PATHOLOGY GAS Is any gas used in a pathology department, this conforms to different standards. The are used to supply analytical equipment as a carrier or fuel gases

PROPERTIES OF GASES
PERMANENT GASES Are gases which remain in the gaseous condition in cylinders at normal temperatures. We can judge how much gas remains because the pressure directly relates to the contents. i.e. When at pressure the cylinder may assumed to be full LIQUEFIABLE GASES These gases are provided in liquid form in the cylinder, at normal temperature. The pressure of the gas remains constant as the liquid vaporises to provide the supply of gas. We would not know the contents until suddenly the cylinder would be empty. Only by weighing the cylinder could we tell the contents

SOME MORE ABOUT OTHER GASES

Argon has uses in Pathology Departments but also it is used for high quality welding where it acts as a shield against oxygen to produce a high quality weld Oxygen free Nitrogen is used as a purge and shield gas particularly when fabricating MGPS Ethylene Oxide Used in certain sterilizers (Autoclaves) it is an extremely dangerous gas Hydrogen tempting to use to fill up balloons could lose your head!! IT IS VERY EXPLOSIVE WHEN MIXED IN AIR

CRYOGENIC GASES

Cryogenics is the science of the cold very very cold below 4000 C Various gases may be cooled to below this temperature and stored as a liquid in a giant thermos flask in the hospital world we see them as VIE Units which store bulk oxygen A Vacuum Insulated Evaporator

CRYOGENIC GASES
Such a device may also be found containing liquid Nitrogen in the Laboratory usually they are 25 litre flasks Cryogenic gases are very dangerous because as the liquid vaporises to a gas the gas comes away at a very cold temperature (typically -2000 C) There is a very great danger of frostbite if the liquid or the just vaporised gas comes into contact with the skin Also the possibility exists of suffocation in the case of spilled liquid Nitrogen

CRYOGENIC PRECAUTIONS WITH OTHER GASES

It should also be remembered that Carbon Dioxide and Nitrous Oxide are in their liquid form in cylinders provided to hospitals Whilst these are not classed as Cryogenic gases when vaporising to provide a substantial supply demand the manifold pipe work immediately receiving the flow of gas can drop in temperature to 3000 C If touched by human skin it will freeze the skin to the pipe work

NOTE

Entonox (50%Oxygen + 50% Nitrous Oxide) If a cylinder of Entonox is allowed to cool to 6 0C the gases separate - which of course is dangerous. If this were to occur cylinders should be placed horizontally in an environment at a temperature of between 10 and 340 for 24 hours

DECANTING DONT do it
It is very very dangerous

Something about nothing !! Medical vacuum it is included with other medical gases when defining standards it is defined as a medical gas Pathology Departments are not allowed to utilise medical Vacuum pipe systems

NOTE
You may find a Green Cylinder This will probably from America and will have contained Oxygen

You may find an orange cylinder this could contain CYCLOPROPANE.

This is a highly explosive gas never discharge an orange cylinder

NOTE
The J size cylinder (the ones fitted to a manifold) are cumbersome and heavy They weigh on average 69Kg or 150 pounds They must always be secured they must never be left free standing LIABILITY Proper training must be given to personnel who are to handle cylinders Proper PPE must be made available and used Medical gas cylinders must be located and stored in a secure well ventilated store

NOTE
Medical gas cylinders must be located and stored in a secure well ventilated store, they should be restrained from falling over. Such storage area must be exclusively for cylinders, it is not permitted to store cylinders in a room containing Medical Air compressors or Vacuum Plant They should be stored in a segregated manner This is a requirement of HTM 2022 it is therefore a requirement of the MoH therefore a requirement of the Concession Agreement A cylinders shelf life is 3 years - the stock must be rotated

MEDICAL GAS MANIFOLD ROOMS

Manifold rooms should not be used for storage of cylinders One set of replenishment cylinders may be held in the room (remember all cylinders have to be chained) The room should be clean and free from grease/oil etc Proper fire extinguishers must in place Proper signage should be in place together with a cylinder chart The manifold room should be kept locked at all times except when delivery is made doors to open out

PATHOLOGY GAS SYSTEMS

Various gases including air and vacuum are used by laboratories for driving and for use by analytical equipment Normally management of these gases is undertaken by the laboratory These gases should not be mixed with Medical gases and Medical gases should never be taken to a laboratory Many of these gases are highly flammable and or toxic

MEDICAL COMPRESSED AIR

There are 2 types of Medical Air provision to be found in a hospital not all hospitals Medical Air this air provided for administering to patients, it is distributed and utilised at a pressure of 400 kPa ( 58 psi, 4 bar) Surgical Air the air is provided to drive surgical tools, it is distributed and utilised at a pressure of 700 kPa ( 100 psi, 7 bar)

MEDICAL AIR QUALITY - BOTH TYPES

Dry particulate matter Oil mist and vapour Water Carbon monoxide Carbon dioxide 0.5 0.01 Ditto mg/m*

115.0 Ditto 5.5 Ditto = 5 ppm

500.0 Ditto = 500 ppm

*HTM2022 Statement is Air should be free from visible particles in 75 litres The first 3 qualities are achieved by the production process and filtration systems, the last 2 depend greatly upon the location, the immediate environment and air intakes (later)

QUALITY TESTING
As mentioned at the start of this session, In most countries commissioning and testing retesting is a combined role undertaken jointly with an Authorised Pharmacist. This is not the case here Yet ? Again HTM2022 requires that such testing be done with input from a Pharmacist so in years to come this may happen

QUALITY TESTING
Routine testing of medical air (across the 5 conditions)

Should be undertaken quarterly and records kept

This is required by regulation HTM2022

It is therefore a requirement of the Concession Agreement

MEDICAL AIR PROCESS

The passage of environmental air through a system to produce Medical Air (Refer to hand out) A nine stage process Notes Coalescing = sticking stuff together!! Oh the English!! Note that final filtration cannot remove viruses only bacteria So in the case that sterile air is required there has to be a tenth stage

MEDICAL AIR PROCESS

MEDICAL AIR PROCESS

MEDICAL AIR PROCESS

BACK UP

It is recommended that any Medical Gas compressing station should have a back up Manifold (cylinders) system capable of providing a 4 6 hour supply to the hospital in case of plant failure

Medical Air Manufacturing plant

Air intake This is critical, regulations state that the compressors should have their air intake taken from a point 5m from the ground. The point here is that the quality of the air to be processed should be as good as you can get Even with the best filtration systems etc if you start with polluted air you have to end up with polluted air

Medical Air Manufacturing plant

For example If the Medical air compressors are in the same location as the Medical Vacuum Plant AND the Medical Vacuum Plant is discharging into the plant room AND the air compressors are drawing their supply locally (within the room). The system will be recycling at least viruses and who knows what else (remember normal final filtration only removes bacteria)

Medical Air Manufacturing plant

We mentioned earlier The need to test medical air for

Carbon Dioxide

Carbon Monoxide

?????

Medical Air Manufacturing plant

If the compressors intake air is taken from and environment that is thick with traffic fumes or the like (in or close to a boiler house or incinerator) ???? If the plant room is dirty and thick with oil and grease and water

?????

Medical Air Manufacturing plant

AN OVERVIEW OF WHAT TO LOOK FOR There should be twin identical air compressors with aftercoolers (air gets hot when being compressed) These are normally air cooled refrigerant type and may require a ducted air supply Reciprocating compressors should be two stage Water sealed compressors should not be used Air intake should be provided with a filter take note of previous points regarding quality of intake air

Medical Air Manufacturing plant

An Air Receiver ( it is recommended and preferable to have 2) The air receiver should be sized at being able to hold a quantity of water equal to 50% of compressor output in l/m free air delivery at normal working pressure Current regulations require that the receiver should have: A test certificate A PRV test certificate Automatic drains Pressure gauge Fusible plug (now) and a manual bypass

Medical Air Manufacturing plant

Although not mandatory it is highly recommended that the system should have two receivers Receivers are subject to Statutory testing NOTE The effluent being drained from the receiver is sure to contain oil it therefore should not be discharged into the normal drainage system

Medical Air Manufacturing plant

Next We look for the separator / pre-filter and then that coalescing filter thing Next comes The desiccant dryers (silica gel) The dust filters The activated carbon filters Followed by Pressure reducing valves and lastly The bacteriological filter All filters PRVs etc. should be duplex i.e 2 of everything

Medical Air Manufacturing plant

GENERAL NOTES Compressors and associated plant should be located in a secure room providing good ventilation and easy access to components There should be adequate air intake for the compressors and to cool all items of plant The Medical Gas system should be connected to the hospital essential electrical supply

Medical Air Manufacturing plant

The system must be able to auto start after reinstatement of the power supply

The system should have its own monitoring and control / alarm / plant condition system it may be monitored by a Building Management system but must not be controlled by it we cover this later

Medical Air Manufacturing plant

Medical Air Manufacturing plant

ONE LAST POINT We mentioned earlier that medical air is manufactured for Medical use (400kPa) and for Surgical use (700kPa). Prior to 1994 it was allowed (HTM2022) to run a system to provide Medical air at 700kPa with a pressure reducing station being utilised to provide Medical air at 400 kPa Strictly speaking this is no longer allowed post 1994 two separate systems should be used Here in Malaysia we are allowed to manufacture Medical air from one system at 700kPa providing Medical Air via a pressure reducing station This a fairly reasonable deviation to regulations and is cost effective

MEDICAL VACUUM

Medical vacuum is required to provide immediate reliable suction, particularly to Theatres With reference to HTM2022 A minimum of two identical pumps are necessary The type of pump is left to the discretion of the plant manufacturer but cannot be of the water sealed type

MEDICAL VACUUM
Vacuum is required to be provided at the Terminal Point at a level of 300 mmHg with a flow rate of 40 l/min To compensate for pressure drops, the compressors usually produce a vacuum of between 500 - 600 mmHg but can be found operating to 650 mmHg There should be a vacuum of 450mmHg at the test point in the vacuum plant room

TEMPERATURE AND PRESSURE MEASUREMENTS

Pressure Bar/Atm/kPa/psi/ Vacuum mmHg/inHg/Torr Temperature oC/oF/K/R Standard temperature and pressure (STP) for vacuum systems Degrees Celsius (oC) and millimetres Mercury (mmHg) Absolute Temperature Kelvin = oC + 273 0 to 1 Atmosphere = 760 Torr (Torricelli Italian 1608 - 1647) The Torricellian vacuum took over from Galileo 0 to 1 Atmosphere = 20.9213 in Hg = 33.8985 ft H 2O Absolute vacuum = 760 Torr/mmHg

Absolute scale

Gauge scale

5.0135 bar / 29.2 psi / 201.2 kPa

4 bar / 100kPa / 14.5 psi

14.7 psi / 1.0135 bar /0 mmHg

0 mm Hg / 0 psi / 0 kPa / 0 bar Atmospheric pressure (Standard)

Cut in 500 mmHg Cut in 650 mmHg 760 mm Hg / 0 psi / 0 bar

Negative range

Absolute zero of pressure 760 mm Hg / -14.7 psi / -101.35 kPa / -1.0135 bar

Absolute scale

Celsius scale

373.16 K

100 0 C

273.16 K

00C

273.16 Degrees 0 K - 273.16 0 C

Negative temperature range

Absolute zero Temperature

MEDICAL VACUUM SYSTEM

The regulations require that the pumps are to be sized so that 1 pump running on its own will provide 100% service So if you see a system where both pumps are having to run to cope with demand ??

MEDICAL VACUUM SYSTEM

Although it is acceptable to have only one receiver it is recommended to have duplex sets In the case of a single receiver a bypass arrangement must be provided to facilitate maintenance to the receiver whilst the supply is being provided Receivers must be fitted with a double valve drain arrangement for drainage this is to allow for any particulate to be cleared easily These receivers (UK) are now not subject to Statutory Test

MEDICAL VACUUM SYSTEM

Bacteriology filter sets must be fitted as a duplex facility they must never be operated in parallel or changed to a schedule Note maintenance to these is very stringent, filters must be changed in accordance to manufacturers recommendations They present distinct hazards to maintenance personnel Such filters must be changed according to manufacturers guidelines a pressure differential must never exceed 25 mmHg across the filters

MEDICAL VACUUM SYSTEM

Cut in of the compressors should be set at 500 mmHg

Cut out may be set as high as 650 mmHg but actual setting will depend on pump characteristics and system design.

MEDICAL VACUUM SYSTEM

Normally vacuum is distributed using the same grade of copper pipe used for other medical gases However approval has recently been given to use PVC But typically although we can now use PVC the only other approved factor is that the pipework has to be tested to a pressure of 750 mmHg approx 14.5 lbf/in2 TYPICAL !! No mention is made on what grade of PVC, what jointing methods are to used etc.

MEDICAL VACUUM SYSTEM

One great danger with Medical Vacuum systems is line contamination Sometimes through carelessness or oversight a vacuum receiving jar located at a Terminal Unit may be left to overflow Its contents are then drawn into the pipework and effectively contaminate the entire system Action must be taken quickly not just because of the risk of spreading infection if the fluids are allowed to dry out the pipework will start to block up

MEDICAL VACUUM SYSTEM

MEDICAL VACUUM SYSTEM

MEDICAL VACUUM SYSTEM

MEDICAL VACUUM SYSTEM

MEDICAL VACUUM SYSTEM

ANAESTHETIC GAS SCAVENGING SYSTEM

Anaesthetic Gases are considered to be substances hazardous to health, except when they are administered to patients in the course of medical treatment. For all practical purposes it is only necessary to consider the effects of nitrous oxide pollution. Control of the risk of pollution is achieved by a combination of good housekeeping, that is, minimising leaks, room ventilation and the removal of waste anaesthetic gasses at source by a scavenging system generally used in operating theatres. Nitrous oxide is used in other areas i.e. ITU, acute wards, dentistry, midwifery, physiotherapy. In this case good ventilation should be provided (see HTM 2025)

ANAESTHETIC GAS SCAVENGING SYSTEM

ANAESTHETIC GAS SCAVENGING SYSTEM

The performance criteria should be achieved regardless of the number of terminal units on each system; where more than one terminal unit is provided on the system, the performance criteria should be achieved with all, or one, of the terminal units operative. Careful consideration should be given to sighting the discharge outlet from the disposal system. It should be preferably be sited at roof level, well away from ventilation inlets, opening windows and other apertures, to prevent pollution from re entering the building.

ANAESTHETIC GAS SCAVENGING SYSTEM

ANAESTHETIC GAS SCAVENGING SYSTEM

AGSS Prevention of Pollution

Prolonged exposure Anaesthetic Gases can cause: Lowered Fertility Increased risk of spontaneous abortion Increased risk of birth defect. Therefore HSS Staff should ensure that the AGSS system is fully functional and should be tested annually The pumps have a tendency to collect fluff and lint from dressings drapes and theatre clothes this can result in fires within the pump or fan, consequently the pump or fan should be cleaned at least once a year!!

MEDICAL GASES Conclusion

As mentioned earlier in this Seminar Cylinders are not allowed to be located in plant rooms containing medical gas or air systems therefore manifolds cannot be placed in such rooms It is unfortunately allowed to have both Medical Compressed Air and Vacuum systems located in the same room Special attention must be made with respect to the Vacuum pumps exhaust and the drainage from the components of the vacuum system

Pipelines Colour Codes BS 1710

VAC

O2

Tests INSTALLATION Pressure (1.5 X pressure) Material Brazing (fluxless,dry nitrogen) Identification ( colour codes, labelling) Sleeving and support

Testing and Commissioning

Leak test Vacuum leak test Area Valve Service Units Cross-connection (anti confusion) Functional test on terminal units Terminal unit Flowrate (flow and pressure drop Total Flowrate Purging Gas identity (purity) Pressure safety valves Warning systems (hi-lo alarm)

Validation Tests Oxygen

Oxygen < 99 % N2O o = %

N20
N2O < 98% O2 = 0%

Air
O2 = 21% + 1% N2O = 0%

Entanox
O2 = 50% + 2% N2O= 50% + 2%

Vacuum
?????

CEN/TC215/WG3 Published British/European Standards

BSEN737-1 - Terminal units for compressed medical gases and vacuum. BSEN737-2 - Anaesthetic gas scavenging systems. BSEN737-3 - Medical Gas Pipeline Systems BSEN737-4 - Terminal units for anaesthetic gas scavenging systems. BSEN738-1 - Pressure regulators and pressure regulators with flow metering devices. BSEN738-2 - Manifold and line pressure regulators. BSEN738-3 - Pressure regulators integrated with cylinder valves BSEN738-4 - Low pressure regulators intended for incorporation into medical equipment BSEN739 - Low pressure hose assemblies for use with medical gases. BSEN793 - Particular requirements for safety of medical supply units.

BSEN13221 - High pressure flexible connections for use with medical gases. BSEN12218 - Rail systems for supporting medical equipment.

MEDICAL GASES
THIS IS THE LAST SLIDE HONEST We all know that the hospital has to purchase gases and fuels However we should also all be aware that the Concession Agreement places the responsibility of notifying the hospital of the need to order, also to certify receipt, onto the Concession To protect the Concession from liability in this activity all Notification of the Need to Order and Certification of Receipt activities MUST be conducted in writing In the case where the hospital fails to place an order or does so late, what proof would you have that notification was given and in good time

Thank You