SASA Practice guideline 2022 ; ANAESTHESIA EQUIPMENT AND ANAESTHETISING FACILITIES

Question 1

District hospital (Level 1)

Answer 1

This category is divided into small (50–150 beds), medium (150–
300 beds) and large (more than 300 beds). District hospitals
provide a 24-hour service staffed by general practitioners and
clinical nurse practitioners, on an inpatient, ambulatory and
emergency basis. A district hospital receives outreach and sup-
port from general specialists based at regional hospitals.

Question 2

Regional hospital (Level 2)

Answer 2

It has between 200–800 beds and provides 24-hour service in
internal medicine, paediatrics, obstetrics and gynaecology, and
general surgery, with additional services in at least one of the
following: orthopaedic surgery, psychiatry, anaesthesia, and
diagnostic radiology. Services include trauma and emergency
services, and the facility must provide short-term ventilation in a
critical care unit. A regional facility receives referrals from several
district hospitals in its geographic area and should receive
outreach and support from tertiary hospitals.

Question 3

Tertiary hospital (Level 3)

Answer 3

It has 400–800 beds, provides the services of a regional hospital,
and has subspecialties of internal medicine, paediatrics, obstet-
rics and gynaecology, and general surgery. The critical care unit
will provide intensive care under the supervision of a specialist
or specialist intensivist. Tertiary hospitals receive referrals from
regional hospitals and may provide training for healthcare
professionals.

Question 4

Central hospital (Level 4)

Answer 4

It has a maximum of 1 200 beds and provides tertiary services. In
addition, it provides central referral and national referral services, must conduct research, must provide training for healthcare
professionals, and must be the main teaching platform for a
medical school.

Question 5

Specialised hospital

Answer 5

It has a maximum of 600 beds and provides specialised services
like psychiatry, infectious diseases, tuberculosis or rehabilitation
services.

Question 6

Private facilities

Answer 6

The Health Act (2012) only provides for “for-profit” and “not-for-
profit” categories of private hospitals. For the purposes of these
guidelines, the committee regards most private healthcare
facilities with inpatient beds to meet the criteria of at least
a regional hospital. Therefore, the facility needs to meet the
applicable standards.

Question 7

Stand-alone, day-care facilities

Answer 7

Stand-alone, day-care facilities providing sedation and anaes-
thesia in a theatre must be equipped to the level expected of a
regional hospital.

Question 8

Facilities for office-based sedation

Answer 8

Facilities that provide office-based sedation only must be
equipped according to the standards required in the SASA
“Guidelines for the safe use of procedural sedation and analgesia
for diagnostic and therapeutic procedures in adults: 2021.”

Answer 9

• Essential items are equivalent to a mandatory standard of care.
• Recommended/desirable items should be available where
resources allow and if appropriate for the surgical/anaesthesia
services delivered.

Question 10

Anaesthesia equipment

Answer 10

• Regional (Level 2) hospital requirements will include most of
the recommended equipment.
• Tertiary (Level 3) and central/specialised hospital requirements
must include all items listed as “Recommended”.

Question 11

Anaesthesia mixture components: Essential items Gas sources exclusively from cylinders must have:

Answer 11

• Pin-index yokes with pressure-reducing valves for both
oxygen, air and nitrous oxide. These should be marked with
the name or the chemical symbol of the gas and colour-coded
in accordance with international standards.
• Pressure indicators for all cylinders must be available.
• One nitrous oxide cylinder and one full spare per machine, or
one medical air cylinder and one full medical air cylinder spare
per machine.
• Two oxygen cylinders and two full spares per machine.
• A suitable spanner or key must be available to open and close
gas cylinders, even if the cylinders have finger-control knobs.
The spanner should be attached to the anaesthesia machine.

Question 12

Anaesthesia mixture components:Gas sources from pipelines with backup cylinders must have:

Answer 12

• SASA recommends that all new facilities be provided with
piped medical air and oxygen and nitrous oxide.
• Non-interchangeable wall points and connectors for nitrous
oxide, oxygen and any other gases, conforming to national
standards.
• Colour-coded pipeline hoses capable of withstanding
pressures of up to 1 000 kPa affixed to anaesthesia machines
by non-interchangeable fittings. Colour-coding according to
international standards: oxygen (white), nitrous oxide (blue)
and medical air (black).
• Pressure indicators for each line, either outside the operating
theatre, or in the gas pipeline before the anaesthesia machine.
(South African National Standards [SANS] 7396-1:2009 Medical
gas pipeline system).
• Non-return valves fitted at the machine connection point of
the pipeline.
• One backup cylinder with pin-index yoke for oxygen attached
to the anaesthesia machine.
• One spare oxygen cylinder, in addition to the spare on the
machine’s yoke.
• A suitable spanner or key must be available to open and close
gas cylinders, even if the cylinders have finger-control knobs.
This should be attached to the anaesthesia machine.
• Medical air pipelines should be fitted with a water trap
between the wall supply and the anaesthesia machine.
An oxygen-failure device with an audible alarm, preferably
continuous, must be fitted to the anaesthesia machine.

Question 13

Appropriate flow controllers for all available gases:

Answer 13

• The flow meter for oxygen must be accurate to 100 ml/minute
or less for flows up to 1 l/minute and accurate to 500 ml/
minute for higher oxygen flows.
• Where there is a sequence of gas control knobs, oxygen must
be positioned on the right, as seen from a position facing the
machine.
• Oxygen must always be the final gas delivered to the common
gas pathway.
• Machines with electronic flow controllers must have a manual
device for oxygen delivery, independent of electrical supply

Question 14

Volatile anesthetic delivery system

Answer 14

○ One volatile delivery system that can deliver accurate, controllable partial pressures of volatile anaesthesia agents at varying fresh gas flows, and under the full range of normal clinical conditions. The graduations of the control should not exceed 0.5 minimum alveolar concentration (MAC) and should provide at least three times the MAC of the selected agent.

Question 15

Pressure relief valve

Answer 15

The breathing system pressure relief valve should be set to 6
kPa/60 cm H2O.

Question 16

Oxygen flush

Answer 16

An oxygen flush system, delivering at least 35 l/minute of oxygen
to the machine outflow and controlled by a prominent, recessed,
non-lockable button.

Question 17

Outflow point connection

Answer 17

Outflow point connector of 22 mm International Organization
for Standardization (ISO) standard male taper

Question 18

Mounting frame

Answer 18

The mounting frame for a mobile anaesthesia machine must be
sufficiently stable to prevent it from being accidentally tipped
over. All ancillary monitoring equipment should be mounted
on a suitable horizontal surface, or securely attached to the
machine.

Question 19

Oxygen analyzer

Answer 19

Oxygen analyser with an audible low-concentration warning
device which should be adjustable, but with a minimum of 18%.

Question 20

Hypoxic guard

Answer 20

Where a potentially hypoxic gas mixture could be delivered, a
hypoxic guard must be fitted to ensure a minimum oxygen
concentration of 25%.

Question 21

Fail safe devices to avoid hypoxic mixture

Answer 21

High-pressure gas supply master/slave switches, whereby low
oxygen pipeline or cylinder pressure cuts off hypoxic gas sources
(fail-safe device).

Question 22

Gas delivery system at low flow

Answer 22

Gas delivery systems capable of delivering accurately propor-
tioned fresh gas mixtures at flow rates down to 250 ml/minute.
It should be noted that low flow anaesthesia using a fresh gas
flow less than the patient’s minute ventilation, mandates the use
of real-time capnography and anaesthetic agent analysis (AA).
SASA recommends anaesthetic AA at all sites.

Question 23

Breathing circuit : essential items

Answer 23

• A suitable breathing system for adult patients fitted at all
junctions with ISO-standard tapered fittings.
• Paediatric anaesthetic breathing systems must be available in
institutions where children might be anaesthetised.
• One set of face masks per machine in a suitable range of sizes
that are appropriate for the patient population.
• Ready availability of sufficient stock of single-use, Guedel-
type oral airways, available in every size, for all patients to be
anaesthetised on any given day in each operating theatre.
• Complete set of supraglottic/laryngeal mask airways per
theatre complex, as appropriate for the caseload (e.g., full
range of adult sizes (3–5) for adults or paediatric sizes (1–21/2)
for children.
• An appropriate range of different endotracheal tube sizes with
standard connectors which are immediately available.
• Breathing circuit pressure gauge.
• A self-inflating resuscitation bag (Ambu® or similar), with
reservoir bag and adaptors/oxygen cylinder for administering
supplementary oxygen.
• A ventilator suitable for the cases anaesthetised at that
location.

Question 24

Recommended items: Anaesthesia workstation

Answer 24

• Anaesthesia workstation with central processing unit con-
trolling electronic flow meters, electronic vaporisers and
integrated multi-mode anaesthesia ventilator, e.g., rising
bellow or piston-driven, with integrated patient monitoring
and a circle breathing circuit with a carbon dioxide absorber.
• Venturi® injector for airway inflation within the theatre
complex.

Question 25

Ancillary equipment per theatre

Answer 25

Laryngoscopes (preferably with fibre-optic light carrier and
light-emitting diode light source)
Two functional handles with
• Full range of adult blade sizes, preferably Macintosh pattern.
• Appropriate range of paediatric laryngoscope blades when
providing paediatric anaesthesia.
Video-assisted laryngoscope (considered essential in all large
level 1, level 2 and level 3 hospitals and high turnover obstetric
units).

Question 26

Ancillary equipment per theatre

Answer 26

Laryngoscopes (preferably with fibre-optic light carrier and
light-emitting diode light source)
Two functional handles with
• Full range of adult blade sizes, preferably Macintosh pattern.
• Appropriate range of paediatric laryngoscope blades when
providing paediatric anaesthesia.
Magill adult and paediatric endotracheal tube-introducing
forceps.
Nonmetallic or plastic-coated, malleable endotracheal tube-
introducing stylettes.
Inflating device (syringe and a cuff pressure manometer) for
endotracheal tube cuffs.
Two kidney dishes as receivers for clean and dirty oral and
endotracheal instruments.
Designated difficult airway management trolleys with appro-
priate equipment should be in every theatre complex.
Anaesthesiologist’s chair on wheels with backrest.
A wall clock with a sweep second hand or digital equivalent
should be present in each theatre.
Suction unit for exclusive use by the anaesthesiologist, generat-
ing a minimum negative pressure of 50 kPa at a minimum airflow
of 25 l/minute into a reservoir bottle of at least one-litre capacity.
Adequate length of suction tubing and an appropriate range of
cannulas/catheters for oral and endotracheal suction.
Anaesthesia and surgical suction bottles should be graduated
for volume.

Question 27

Suction capabilities

Answer 27

Suction unit for exclusive use by the anaesthesiologist, generat-
ing a minimum negative pressure of 50 kPa at a minimum airflow
of 25 l/minute into a reservoir bottle of at least one-litre capacity.
Adequate length of suction tubing and an appropriate range of
cannulas/catheters for oral and endotracheal suction.

Answer 28

A wall clock with a sweep second hand or digital equivalent
should be present in each theatre.

Question 29

Defib

Answer 29

A monitor-defibrillator with adult and infant electrodes per
theatre suite must be available. The ability to provide external
cardiac pacing is desirable in all age groups, including neonates
and paediatric patient

Question 30

OT TABLE

Answer 30

Operating table with Trendelenburg-position controls at the
head of the table.
• Two lateral padded straight arm supports.
• Appropriate padding and equipment for the positioning of
patients to prevent injury.

Answer 31

Drug trolley for exclusive use by the anaesthesiologist.

Answer 32

Topical anaesthesia spray.

Question 33

IV FLUID

Answer 33

Two intravenous (IV) infusion poles.
An appropriate selection of IV fluids and IV cannulas must be
available.
In-line warmer for blood and IV fluids.
Pressure infuser for both 500 ml (blood) and 1 000 ml IV bags.
Infusion devices: volumetric pumps and/or syringe drivers.

Answer 34

A pair of strong scissors.
A method of securing the anaesthesia breathing system to the
operating table.

Question 35

Warming device

Answer 35

Warming blankets/convection warmers for use in the theatre.
Availability of warming blankets/convection warmers is an
absolute requirement for neonates and infants.
Where infants and small children are to be anaesthetised, a full
range of the necessary paediatric equipment (as outlined above)
must be available.

Question 36

Back up electrical supply

Answer 36

Electrical generator backup for hospital and/or theatre complex.
Uninterruptible power supply (UPS) or battery backup for life-
support equipment.

Question 37

Guidelines for power outrage

Answer 37

In the event of a power outage (failure of main Eskom power
supply), the following guidelines should be followed:
1. If the theatre complex only has one electrical backup system
(generator/UPS), current elective cases should be completed
as soon as possible, and all other cases postponed until
the main power is restored. Urgent emergency cases may
continue (See Appendix F[iii]).
2. If a theatre complex has a second backup power supply, e.g.,
a second generator or UPS unit, elective cases can continue
if it is verified that the second backup supply has adequate
capability for the duration of the power outage.
3. Equipment battery backup is not deemed to be a second
backup power supply as the duration of the battery supply
is not dependable enough to continue with an elective list.

Question 38

Recommended items

Answer 38

A telephone in each theatre for communication.
Individual illumination of the anaesthesiologist’s area, including
an emergency backup, battery-powered illumination source.
Blood salvage system.
High-flow blood/fluid warmer.
Syringe drivers programmed to administer target-controlled IV
anaesthesia.
Intermittent pneumatic calf compressors and related consum-
ables.
Low amperage peripheral nerve stimulator to assist with region-
al anaesthesia techniques per theatre suite.
Equipment for patient-controlled analgesia (PCA).
Transportable ventilator and monitor.
Video-assisted or normal light source fibre-optic bronchoscope.
A rigid bronchoscope (this need not be for exclusive use by the
anaesthesiologist) with attachments for ventilating apnoeic
patients (available in the theatre suite).
All electrical equipment should be able to operate from batteries,
particularly when a reliable emergency electrical supply is not
available.

Question 39

Monitors

Answer 39

Essential items
A stethoscope.
A multi-parameter vital signs monitor, incorporating and
displaying:
• An electrocardiogram (ECG) channel with 3- and/or 5-lead ECG
monitoring. The unit must incorporate a diathermy filter.
• Heart rate: Derived from ECG, pulse oximetry or non-invasive
blood pressure (NIBP) readings.
• An automated electronic NIBP module displaying systolic,
mean, and diastolic blood pressure (BP), with an appropriate
range of cuffs.
• Pulse oximetry, displaying oxygen saturation and a plethys-
mograph.
• Anaesthetic agent analyser and capnography, displaying end-
tidal anaesthetic agent concentrations and CO2 in mmHg, kPa
or a percentage, and a capnograph.
• Patient temperature for oropharyngeal, oesophageal, rectal,
bladder or tympanic use, reading 22–42 °C minimum range.
• Alarms: adjustable alarm limits for all parameters.
Oxygen monitor (inspired and expired), with a low-limit alarm
(may be incorporated in the multi-parameter vital signs monitor
or the anaesthesia machine).
Whenever an automatic ventilator is used, a breathing circuit
pressure monitor with high- and low-limit alarms must be
incorporated.
A peripheral nerve stimulator to monitor neuromuscular
function when muscle relaxants are used, with double burst
stimulation, train-of-four and post-tetanic count facilities.
A point-of-care (POC) device to estimate blood glucose.
A POC device to measure haemoglobin and/or haematocrit.
A thermometer that permanently displays the operating theatre
temperature.

Answer 40

Invasive pressure module for intra-arterial/IV pressure monitor-
ing incorporated in the multi-parameter vital signs monitor or
anaesthesia machine.
Portable ultrasound device for guided nerve blocks and vascular
access.
Blood gas analyser.
Transportable vital signs monitor.
Scale for weighing swabs.
Processed electroencephalogram (EEG) depth of anaesthesia
monitor.
Non-invasive cardiac output monitor.
Coagulation monitoring device. (Essential in a theatre where
heparin is used, e.g., cardiac surgery, vascular surgery).
Transoesophageal echocardiography equipment.
Near-infrared spectroscopy (NIRS) cerebral oximetry monitor.
See Table I for essential equipment list (anaesthesia)

Answer 41

Each bed space should be provided with:
1. An oxygen flow meter with attachment for oxygen tubing for
mask or nasal prongs.
2. A hook, or pole, for suspension of IV fluids
3. Suction equipment, including a receiver, tubing, a rigid
handpiece and a range of suction catheters, including
Yankauer.
4. An automated NIBP monitor with appropriately sized cuffs.
5. A stethoscope.
6. A pulse oximeter.
7. Means of measuring body temperature.
Within the RR, there must be:
1. A range of devices for the administration of oxygen to
spontaneously breathing patients.
2. A self-inflating manual resuscitator, e.g., Ambu® bag or
similar, able to deliver 100% oxygen and allow manual
ventilation. A minimum of two per recovery room complex
is required.
3. Equipment and drugs for airway management and endo-
tracheal intubation.
4. Emergency drugs.
5. A range of IV equipment and fluids.
6. Drugs and equipment for acute pain management.
7. A range of syringes and needles.
8. An ECG monitor.
9. Patient-warming devices.
There should be immediate access to:
1. A monitoring defibrillator, preferably with pacing capability.
2. A blood warmer.
3. A thermostatically controlled warming cupboard for IV
solutions.
4. A refrigerator for drugs and blood.
5. A procedure light.
6. A range of appropriate anaesthesia and emergency drugs.
7. A surgical tray for procedures, including tracheostomy and
chest drains.
8. POC access to diagnostic services, e.g., blood glucose, blood
gases and radiology.
9. A peripheral nerve stimulator.
10. Other equipment as appropriate to the patient’s condition,
e.g., wire cutters.
11. A ventilator.

Question 42

Recovery trolley and bed

Answer 42

The recovery trolley or bed must:• Have a firm base and mattress.
• Tilt from either end, both head up and head down, to at least
15 degrees.
• Be easy to manoeuvre.
• Have functional and accessible brakes.
• Have provision for the patient to be able to sit up.
• Have straps or side rails capable of being dropped below the
base or easily removed.
• Include provision for a pole from which IV solutions may be
suspended.
• Include provision for monitoring, mounting portable oxygen
cylinders, underwater seal drains and suction apparatus for
use during transport

Question 43

Routines for checking, cleaning, servicing
and storage of equipment

Answer 43

To promote maximum safety in relation to service procedures,
the following points are important prerequisites:
• Individual anaesthetic machines should be clearly identified,
either by the maker’s serial number, or preferably by a hospital
marking. This identification must extend to all the readily
removable components, such as canisters and vaporisers, so
that the performance and checking of these can be followed
without confusion.
• A record of service procedures performed on each machine,
signed by the person responsible for the service, must
be provided to the appropriate hospital personnel, e.g.,
department of anaesthesia, anaesthetic technical staff or
theatre nursing staff, depending on local circumstances.
• In newly built operating theatres, where operating suites
have undergone major structural alterations, before the com-
missioning of the area, all new and existing gas lines are
pressure-tested, followed by gas flow and purity testing. This
must be carried out by a third party licensed to install, and test
medical gas lines.
• When any medical gas installation is tested, the persons that
should be present are the mechanical engineer from public
works/hospital group, the mechanical engineer from health
infrastructure, the hospital/facility engineer; the medical en-
gineer; the medical gas engineer and the third party doing
the testing.
• The installation of new or altered gases requires certification
once the installation is completed and deemed operational.
• Adequate time must be available for service personnel to
perform regular and emergency servicing without compro-
mising safety.
• Storage facilities should be available for nitrous oxide and
oxygen within the operating theatre suite. This storage area
should fulfil the criteria described in the appropriate South
African Bureau of Standards (SABS) Code of Practice.

Answer 44

• Essential items are equivalent to a mandatory standard of
care.
• Recommended/desirable items should be available
where resources allow and if appropriate for the surgical/
anaesthesia services delivered.
• Regional (Level 2) hospital requirements will include most
of the recommended equipment.
• Tertiary (Level 3) and central/specialised hospital require-
ments must include all items listed as “Recommended”.
• SASA recommends that all new facilities be provided with
piped medical air and oxygen and nitrous oxide.
• SASA recommends a medical air supply for all new
operating theatres, including theatres for minor proce-
dures/occasional use.
• SASA recommends AA at all sites.
• Video-assisted laryngoscope is considered essential in all
large level 1, level 2 and level 3 hospitals and high turnover
obstetric units.
• The ability to provide external cardiac pacing is desirable in
all age groups, including neonates and paediatric patients.
• Warming blankets/convection warmers are an absolute
requirement for neonates and infants.

Question 45

Low flow anaesthesia guidelines: Definition

Answer 45

Low flow anaesthesia is anaesthetic gas delivery using a fresh
gas flow less than the patient’s minute volume.

Question 46

Classification of fresh gas flow rates

Answer 46

High-flow: greater than 4 litres per minute
Moderate flow: 2–4 litres per minute
Low-flow: less than 2 litres per minute
Basal flow: 250–500 ml per minute
250 ml/min is the minimal basal oxygen requirement for metabolic processes at rest in a normothermic patient and must
therefore be administered as 100% O2

Question 47

Low flow anaesthesia guidelines: Equipment Anaesthesia delivery system

Answer 47

• Anaesthesia machine capable of delivering accurate, fresh gas
flow of less than 1 L per minute
• Flow meters capable of increments of less than 100 ml
• Leak of fewer than 100 ml on machine and circuit check done
immediately before the case
• Carbon dioxide absorber
• Circle system with unidirectional flow valves

Question 48

Monitoring

Answer 48

• Standard routine monitors as required for any anaesthetic
(ECG, pulse oximeter, BP and other monitoring according to
the case)
• Inspired oxygen monitor
• Capnography
• Agent analyser
• Ventilatory pressure and tidal volume

Question 49

CO2 absorber

Answer 49

• Canister containing between 450 ml and 3 L of carbon dioxide
absorbent that undergoes a colour change when exhausted
(Soda lime or Baralyme undergo a colour change when
exhausted).
• When the absorber is exhausted, a rise in the inspired CO2
(FiCO2) is seen on the capnograph.
• Absorber must be changed once FiCO2 is greater than 4 mmHg
(0.5 kPa)

Question 50

Volatile delivery

Answer 50

• Vaporiser out of circuit
• Desflurane, isoflurane and sevoflurane are the agents of choice
• Older, soluble, highly metabolised agents like halothane and
enflurane cannot be delivered at high enough concentrations
to be easily delivered with flows less than 1 L
• Poorly metabolised gases like desflurane may accumulate
during lengthy procedures at very low flows
• The use of nitrous oxide is not recommended when using low
flows as it increases the risk of hypoxia

Question 51

Gas delivery

Answer 51

• Gas delivery using a standard anaesthetic machine
• Flow meters must be able to deliver flows from 250 ml to 10 L
per minute
• Flow meters must be graduated to measure accurately at flows
less than 1 L, preferably in 50 ml to 100 ml increments

Question 52

Closed circuit

Answer 52

• Often called a circle system as gas flow is in a single direction
from machine to patient and back from patient to machine • Circuit to be able to deliver constant gas flow at low resistance
with minimal leak
• Circuit to be checked before use for leaks during spontaneous
and assisted ventilation
• Do not proceed if leak is greater than 100 ml/min at 30 cmH2O

Question 53

Unidirectional valves

Answer 53

• Circuit requires two unidirectional valves that move freely with
low resistance to flows down to less than 250 ml
• Valves must delineate the circuit’s inspiratory and expiratory
limb, allowing flow to occur through the circuit in one direc-
tion only without mixing inspiratory and expiratory gases

Question 54

Oxygen delivery

Answer 54

• Inspiratory and expiratory oxygen concentration needs to be
monitored constantly
• Hypoxia can occur due to inadequate fresh gas flow, delivery
of a low FiO2, changes in patients’ metabolic rate, and dilution
by accumulating gases such as N2O, CO2, CO, and methane

Question 55

Set up of the circuit

Answer 55

• Fresh gas must be delivered into the reservoir bag or ventilator
bellows and not directly into the circuit
• Gas is delivered to the patient and returned via the CO2
absorber in a circular pattern using a “closed system”. The same
gas is continuously recycled with small amounts released
from the ventilator or breathing valve to allow for additional
fresh gas to be introduced, with one-way valves producing
unidirectional flow around the circuit.

Question 56

How to do low flow

Answer 56

What to give
1. Oxygen: A minimum of 250 ml of oxygen is needed to
meet the basic metabolic requirements of a normothermic,
awake patient at rest. The delivery of at least this amount of
oxygen per minute is required in an anaesthetised patient.
This replacement will be constant, provided the metabolic
rate remains constant. At flows of less than 1 L per minute,
a FiO2 of at least 50% is recommended. If the monitored FiO2
decreases, the minimum amount of oxygen delivered will
need to be increased.
2. All circuits have a small leak that will usually be detected by
the preoperative machine check (most machines will allow
a leak of fewer than 40 ml per minute to pass this test). In
addition to the gas loss from sampling lines and uncuffed
tubes, this leak needs to be added to the minimal amount of
gas delivered. Most people are comfortable with a minimum
of 300–500 ml per minute fresh gas flow.
3. Volatiles are delivered from a vaporiser out of circuit. This
gas replaces metabolised and absorbed volatile agent and
gas vented to the atmosphere. A variable replacement is
needed as it depends on the solubility and amount of agent
metabolised
4. N2O, when used as an adjuvant anaesthetic agent, must
always be added to at least 250 ml of oxygen. Saturation
occurs quickly, and metabolism is minimal, so N2O will start
to accumulate over time. It is not recommended to use
nitrous oxide with low flow.
5. Air is often added to flows above 250 ml of oxygen to avoid
complications from using 100% oxygen, provided the FiO2 is
maintained

Question 57

Principles of altering gas concentrations

Answer 57

1. The entire circuit comprises about 6 L—the tubing makes up
   about 1.5 L, the ventilator or rebreathing bag about 2 L, the
   carbon dioxide absorber 2 L, and the patient’s tidal volume
   0.5 L.
2. The aim is to obtain a constant concentration of volatile
   agent throughout this 6 L at the MAC value we require.
3. This 6 L needs to be changed five times to reach a steady gas
   state, so a total of 30 L of circuit gas needs to be changed.
4. If we introduce the volatile agent at 1 L per minute, it will
   take 6 minutes to change all the gas in the circuit once, and 6
   x 5 = 30 minutes to reach steady state. At 250 ml, it takes 120
   minutes to reach steady state.
5. One can also speed this up by setting a greater volatile
   concentration than is desired until the agent is at the
   required concentration on the agent analyser.

Question 58

Starting a case

Answer 58

Use the above principles at the beginning of a case. The circuit
contains no volatile agent. The aim is to saturate it with a certain
MAC of volatile agent in a patient who will awaken quickly from
the initial dose of the induction agent.
• Following an initial IV and opiate induction.
• Fresh gas flow of 2 L/minute and desflurane at 12% or
sevoflurane at 4% until the end-tidal agent concentration
reaches the desired concentration (6% desflurane or 2%
sevoflurane).
• Lower fresh gas flow to 250–500 ml and monitor oxygen and
volatile concentration. Adjusting the vaporiser as needed.

Question 59

Changing gas concentration

Answer 59

• Using the above principles shows that changing the con-
centration of volatile to a higher or lower MAC while at low
flow can take quite a long time.
• Rapid changes in concentration can be achieved by increasing
the fresh gas flow to 2 litres.

Question 60

Maintenance of anaesthesia

Answer 60

• Due to the metabolism and absorption of volatile agents, the
concentration of volatile agent in the entire system will slowly
decrease over time. While the circuit receives low fresh gas
flow, the absorbed and metabolised agent is not completely
replaced; the result is a further decrease in alveolar volatile
concentration. This may result in the patient becoming aware.
• Therefore, a higher vaporiser setting than the desired end-
tidal agent concentration is needed.
• Minimally metabolised agents like desflurane, isoflurane and
sevoflurane require a vaporiser setting of 10–20% higher
than required to accommodate for this but may also start to
accumulate over time.
• An agent analyser eliminates this guesswork.
• Nitrous oxide in a closed circuit will start to accumulate over
time as it is minimally metabolised, resulting in hypoxia.

Question 61

Switching off

Answer 61

1. The same principles apply to wakening the patient at the end
   of the procedure. If the volatile agent is switched off and low
   fresh gas flow maintained, the patient can take between 10
   and 20 minutes to wake up while the volatile concentration
   slowly decreases.
2. A fresh gas flow of 6 L will rapidly flush the circuit of residual
   volatile agent.

Question 62

Paediatrics

Answer 62

In paediatric anaesthesia, the same principles apply but use
smaller bore tubing, size-appropriate filters and cuffed tubes.

Question 63

Troubleshooting

Answer 63

1. Hypoxia – due to low delivered FiO2, dilution from other
   gases, increased metabolic rate.
2. Tachycardia – due to rapid changes in gas concentration with
   desflurane (the rule is fresh gas flow x volatile concentration
   should be less than 24, i.e., 2 L x 12% = 24).
3. Overdose – due to prolonged high fresh gas flow and high
   vaporiser setting.
4. Awareness – due to circuit leak or low vaporiser setting.
5. Hypercapnoea – carbon dioxide absorber exhaustion.
6. Prolonged awakening – fresh gas flow still low during
   emergence.
7. Low circuit volume – due to leaks in the circuit and can lead
   to inadequate ventilation as bellows and reservoir bag are
   not refilled, hypoxia and awareness.

Question 64

3.4 Medication

Question 65

Off-label drug use definition

Answer 65

Off-label prescription and/or use refers to the prescription or use
of a medicine or medical device outside of its approved label,
i.e., outside of the indication for which the manufacturer has
submitted studies to the satisfaction of regulators and which
has therefore not been proven at all or to the level at which it
would satisfy regulators to register the product for that particular
indication or use.

Question 66

Off-label drug use: duty to patients

Answer 66

The Consumer Protection Act (CPA) requires patients to be
informed of the nature of the specific goods or services they
are to receive, and the conditions under which they are to be
provided. Furthermore, this information is to be provided in
plain language, which means that the patient should understand
what an off-label prescription and use means.

Question 67

Ampoule labelling standard

Answer 67

SASA deems the standard SANS 44/2014: Labelling of small-
volume (50 ml or less) parenteral drug containers, as essential
and to be adopted.

Question 68

Substitution of medicines and devices

Answer 68

The Medicines and Related Substances Act only permits generic
substitution within the criteria set by the section 22F:
1. Pharmacists must inform patients with a prescription for
dispensing of the benefits of the substitution.
2. When substitution has taken place, the pharmacist must
take reasonable steps to inform the prescriber of such
substitution.
3. Pharmacists may dispense the generic instead of the
prescribed medicine, unless expressly forbidden by the
patient.
4. The prescriber has written in their own hand on the
prescription the words “no substitution” next to the item
prescribed.
5. The retail price of the generic is higher than that of the
prescribed medicine.
6. The product has been declared not substitutable by
the South African Health Products Regulatory Authority
(SAHPRA).
7. Although there was, in the past, a list of non-substitutable
products issued by SAHPRA, the current list only contains
rules relating to biologics. SASA, however, strongly rec-
ommends that practitioners who deem that the generally
accepted circumstances under which substitution should
not take place, are present in a particular case, should ensure
that a non-substitutable order is issued to clearly indicate the
opinion of the practitioner.

Question 69

Drug substitution duty to patients

Answer 69

The CPA also prohibits the substitution of any goods without the
consent of the consumer (patient).
Therefore, the WMA, the Medicines Act, and the CPA, read with
the NHA, make it clear that:
1. Information must be provided on drug choices and the
patient’s condition to enable the practitioner to select
medicines carefully.
2. Once the patient consents to the medicine selected, that
medicine should not and cannot be changed without the
patient’s consent.
3. In the case of therapeutic substitution, practitioners should
re-evaluate the patient and the options and issue a new
prescription.

Question 70

ADR

Answer 70

The WMA recommends that practitioners document ADRs and
report it to appropriate drug regulatory authorities.
The WMA recommends that medical practitioners and pharma-
cists cooperate within the definitions set by their respective
roles, making it clear that the practitioners assess and prescribe
based on an assessment of the patient’s pharmacological needs.
It furthermore states that pharmacists have the role of “reviewing
prescription orders to identify interactions, allergic reactions,
contraindications and therapeutic duplications.” They should,
however, discuss “concerns with the prescribing physician, but
the pharmacist should not change the prescription without
consulting the prescriber”.
SASA recommends that, in the practical theatre setting, the
practitioner be able to issue an advanced instruction to the
hospital pharmacist that generic substitution would not be
indicated for a particular patient or patient group, and that a
specific medicine should therefore be available in theatre.

Question 71

What is pharmacovigilance?

Answer 71

Pharmacovigilance is defined as the science and activities con-
cerned with the detection, assessment, understanding and
prevention of adverse reactions to medicines (i.e., ADRs). This
activity aims to improve the safe and rational use of medicines,
thereby improving patient care and public health.

Question 72

What is an adverse drug reaction?

Answer 72

SAHPRA defines an ADR as a response to a medicine that is
noxious and unintended, including lack of efficacy, and which
occurs at any dosage and can also result from overdose, misuse,
or abuse of medicine.

Question 73

Who should report adverse drug reactions?

Answer 73

All healthcare workers, including doctors, dentists, pharmacists,
nurses, and other health professionals, are encouraged to report
all suspected adverse reactions to medicines (including vaccines, X-ray contrast media, traditional and herbal remedies), especially
when the reaction is not in the package insert, potentially serious
or clinically significant.

Question 74

What happens to a report?

Answer 74

All ADR reports are entered into a national ADR database. Each
report is evaluated to assess the causal relationship between the
event and the medicine. A well-completed ADR/product quality
form submitted could result in any of the following:
• additional investigations into the use of the medicine in South
Africa;
• educational initiatives to improve the safe use of the medicine;
• appropriate package insert changes to include the potential
for the reaction, and
• changes in the scheduling or manufacture of the medicine to
make it safer.
ADR reporting aims to reduce the risks associated with using
medicines and ultimately improve patient care.

Question 75

Will reporting have any negative consequences on
the health worker or the patient?

Answer 75

An ADR report does not constitute an admission of liability or
that the health professional contributed to the event in any
way. The outcome of a report, together with any important or
relevant information relating to the reaction, will be sent back to
the reporter as appropriate. The details of a report are stored in
a confidential database. The names of the reporter or any other
health professionals named on a report and that of the patient
will be removed before any details about a specific ADR are used
or communicated to others. The information is only meant to
improve the understanding of the medicines used in the country.

Question 76

Is the event possibly an adverse drug reaction?

Answer 76

The following factors should be considered when an ADR is
suspected:
• What exactly is the nature of the reaction? (Describe the
reaction as clearly as possible and, where possible, provide an
accurate diagnosis.)
• Did the reaction occur within a reasonable time relationship
to starting treatment with the suspected medicine? (Some
reactions occur immediately after administration of a medicine
while others take time to develop.)
• Is the reaction known to occur with the medicine as stated
in the package insert or other reference? (If the reaction is not
documented in the package insert, it does not mean the reaction
cannot occur with that medicine.)
• Did the patient recover when the suspected medicine was
stopped? (Some reactions can cause permanent damage, but
most reactions are reversible if the medication is stopped.)
• Did the patient take the medicine again after the reaction
abated (i.e., rechallenge)?
• If so, did the same reaction occur again? (In most situations, it
is not possible or ethical to rechallenge the patient with the same
medicine. If such information is available or if such a rechallenge
is necessary, recurrence of the event is a strong indicator that the
medicine may be responsible.)
• Can this reaction be explained by other causes, e.g., underlying
disease/s; other medicine/s; toxins or foods? (It is essential that
the patient is thoroughly investigated to decide the actual cause
of any new medical problem. A medicine-related cause should
be considered when other causes do not explain the patient’s
condition.)

Question 77

What types of reactions should be reported?

Answer 77

The following ADRs should be reported:
• all ADRs to newly marketed drugs or new drugs added to the
EML,
• all serious reactions and interactions,
• ADRs that are not clearly stated in the package insert, and/or
• all adverse reactions or poisonings to traditional or herbal
remedies.
Report even if you are not certain that the medicine caused the
event

Question 78

What product quality problems should be
reported?

Answer 78

The following product quality problems should be reported:
• suspected contamination,
• questionable stability,
• defective components,
• poor packaging or labelling, and/or
• therapeutic failures

Question 79

How can adverse drug reactions be prevented
from occurring?

Answer 79

Some ADRs are unavoidable and cannot be prevented. However,
most ADRs can be prevented by following the basic principles of
rational use of medicines.

Question 80

How are adverse drug reactions reported?

Answer 80

1. Reporting of suspected ADRs can be done via the eReporting
   link on the SAHPRA website (https://www.sahpra.org.za).
   Alternatively, an ADR/product quality report form should
   be completed and emailed to adr@sahpra.org.za. The form
   can be obtained from the SAHPRA website. Report forms
   may also be accessed via the following website: http://www.
   mccza.com.
2. The National Adverse Drug Event Monitoring Centre
   C/o Division of Pharmacology, University of Cape Town,
   Observatory, 7925
   (021) 447 1618; Fax: (021) 448 6181

Question 81

Ampoule sharing

Answer 81

From the clinical governance
point of view, there is little doubt that ampoule sharing is
certainly not in our patients’ best interests. The inability to
maintain sterility once an ampoule is opened, the risk for cross infection with subsequent sepsis, the possibility of mistakes in
labelling or administration, and the risk of theft from an open
ampoule negate the small cost benefit of sharing a single large
ampoule between patients.

Answer 82

• SASA deems the standard SANS 44/2014: Labelling of
small-volume (50 ml or less) parenteral drug containers, as
essential and to be adopted.
• The WMA recommends that practitioners document ADRs
and report it to appropriate drug regulatory authorities.
• The WMA recommends that medical practitioners and
pharmacists cooperate within the definitions set by their
respective roles, making it clear that the practitioners
assess and prescribe based on an assessment of the
patient’s pharmacological needs. It furthermore states
that pharmacists have the role of “reviewing prescription
orders to identify interactions, allergic reactions, contrain-
dications and therapeutic duplications.” They should,
however, discuss “concerns with the prescribing physician,
but the pharmacist should not change the prescription
without consulting the prescriber”.
• SASA recommends that, in the practical theatre setting, the
practitioner be able to issue an advanced instruction to the
hospital pharmacist that generic substitution would not be
indicated for a particular patient or patient group, and that
a specific medicine should therefore be available in theatre.