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Guidelines to the Practice of Anesthesia.
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Preamble.
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Basic Principles
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Organization of Hospital Anesthetic Services
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The responsibilities of the Chief of Anesthesia are:
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Privileges
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Residents
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Ancillary Help.
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Anesthetic Equipment & Anesthetising Location.
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The Preanesthetic Period.
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The Anesthetic Period.
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Records
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Patient Monitoring.
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The Postanesthetic Period.
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Recovery Facility.
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Discharge of Patients after Day Surgery.
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Guidelines for Obstetrical Regional Analgesia.
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Initiation of Obstetrical Regional Analgesia.
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Maintenance of Regional Labour Analgesia.
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Oral Intake During Labour
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Guidelines for the Practice of Anesthesia Outside a Hospital
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Patient Selection.
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Preoperative Considerations
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Conduct of Anesthesia.
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Appendix I: Published Standards for Equipment
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For Information.
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Appendix II: Physical Status Classification.
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Appendix III: Preanesthetic Checklist
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A. Gas Pipelines
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B. Anesthetic Machine.
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C. Breathing Circuit
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D. Vacuum System..
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E. Scavenging System..
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F. Routine Equipment
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G. Drugs
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H. Location of Special Equipment in Each Anesthetising Location.
PAGEREF _Toc33834115 \h 26
Anesthesia is a dynamic speciality of medicine in which
many changes have taken place in recent years. Continuous progress is
being made to improve standards of anesthetic care for patients having
surgical and obstetrical procedures in Canada. To reflect the progress
made in the delivery of anesthetic services, this document is reviewed
annually and revised periodically.
The following recommendations are aimed at providing basic guidelines to
anesthetic practice. They are intended to provide a framework for a
reasonable and acceptable standard of patient care and should be so
interpreted, allowing for some degree of flexibility to occur in different
circumstances. Each section of these guidelines is subject to revision as
warranted by the evolution of technology and practice.
In this document, the term anesthesiologist is
used to designate all licensed medical practitioners with privileges to
administer anesthetics. An anesthetic is any procedure that is
deliberately performed to render a patient temporarily insensitive to pain
or the external environment, so that a diagnostic or therapeutic procedure
can be performed.
The practice of anesthesia is a specialized field of
medicine. As such, certified specialists should practise it. The Canadian
Anesthesiologists’ Society acknowledges that
remote communities often lack the population base to support a specialist
anesthetic practice. In these communities, appropriately trained family
physicians may be required to provide anesthesia services. All
anesthesiologists are encouraged to continue their education in all
aspects of the practice of anesthesia and resuscitation.
These guidelines are intended to apply to all
anesthesiologists in Canada.
The Department of Anesthesia should be properly
organized, directed and integrated with other departments in the hospital.
The Department of Anesthesia should include all
hospital staff members who provide anesthetic services to patients for
surgical, obstetrical, diagnostic and therapeutic purposes.
The Department should be staffed appropriately, bearing
in mind the scope and nature of the services provided, and should strive
to ensure that these services are available as required by the health care
facility.
The Chief of the Department should be a physician who
has obtained certification or appropriate training in anesthesia. This
individual should be appointed in the same manner as other chiefs of
clinical departments and should be a member of the Medical Advisory body
for the hospital.
- To maintain an awareness of the current Canadian
Anesthesiologists’ Society Guidelines to the Practice of Anesthesia, the
requirements of the Canadian Council on Health Facility Accreditation,
and the Provincial Licensing Authority’s requirements as they relate to
anesthesia.
- To ensure that written policies with respect to
the practice of anesthesia are established and enforced.
- To evaluate the qualifications and abilities of
the physicians providing anesthetic care and also of other health
professionals providing ancillary care. This includes (but is not
restricted to) the recommendations of clinical privileges for physicians
with anesthetic responsibilities, and annual review of these privileges.
- To monitor systematically the quality of
anesthetic care provided throughout the health care facility. This
should include chart reviews, internal audits, or more detailed reviews
when indicated.
- To ensure that records are kept for all anesthetic
procedures. These records should allow for evaluation of all anesthetic
care in the hospital.
- To carry out such other duties as the governing
body of the hospital may delegate to ensure safe anesthetic care.
All physicians applying for privileges in anaesthesia
should demonstrate satisfactory completion of postgraduate training in a
Department of Anesthesia which has a residency program approved by the
Royal College of Physicians and Surgeons of Canada.
Physicians with anesthetic privileges should possess
the knowledge and technical skills necessary for the practice of
anesthesia.
These include the ability:
- To provide preanesthetic evaluation of the patient
and determine appropriate anesthetic management;
- To render the patient insensible to pain for the
performance of surgical operations and obstetrical procedures;
- To monitor and support the vital organ systems in
the perioperative period;
- To provide immediate postanaesthetic management of
the patient;
- To provide resuscitation and intensive care when
indicated;
- To provide relief of acute and chronic pain.
Residents in anesthesia are registered medical
practitioners and may, as part of their training, administer anesthetics
without direct supervision.The decision to allow a resident to administer
an anesthetic without direct supervision should take into account the
nature of the case and the abilities of the resident. The supervising
attending anesthesiologist must remain readily available to assist the
resident, and should not simultaneously do his or her own slate while
supervising a resident.
The health care facility must ensure that ancillary
personnel are available where appropriate. Anesthesia technicians or other
qualified allied health professionals may, with the approval of the
governing body of the hospital, render certain ancillary assistance in
providing anesthetic, resuscitative, and intensive care services. These
personnel must be properly trained, and must have received accreditation
by the appropriate authority where applicable. The tasks which they may
perform must be clearly defined. An anesthetist must only delegate, or
assign to such personnel, tasks for which they have approval or
accreditation.
An anesthetic
must be given in an appropriate facility. All necessary equipment, drugs
and or other supplies must be readily available. Emergency equipment for
resuscitation and life support must also be available.
The health care facility is responsible for the design
and maintenance of the anesthetising location and for the purchase,
maintenance and inspection of anesthetic and ancillary equipment. The
Canadian Standards Association (CSA) has provided publications pertaining
to anesthetic facilities and to the selection, installation and
maintenance of most anesthetic and ancillary equipment
(Appendix I). When purchasing new equipment or designing new
installations, these standards, as well as specific recommendations
arising from provincial legislation, shall be obtained and followed. The
advice of the Department of Anesthesia should be sought.
The health care facility must ensure that:
- The operating room conforms to the electrical code
and meets the standards for safety in anesthetising locations and excess
anesthetic gas scavenging systems.
- There is compliance with all regulations to
minimize the hazards from fire, explosion and electrocution, and that
all electrical equipment in the operating room conforms to the standards
described in the Canadian Standards Association's current publications.
- Medical gas pipeline systems, including low
pressure connecting assemblies, pressure regulators and terminal units,
meet standards for identification, construction and installation. The
piping systems must be certified by a Canadian Standards Association
approved testing agency. Oxygen concentrators may be an acceptable
substitute for bulk oxygen provided installation and maintenance conform
to all applicable CSA standards
(Appendix I).
When such concentrators
are installed, users must be aware that:
hospital medical oxygen
supply may vary between an FIO2 of .93 and .99
oxygen analysers must be
calibrated against O2 U.S.P. (FIO2.99) and room air or equivalent
(FIO2.21);
use of low-flow (less than
one litre total fresh gas flow) anesthetic techniques may result in the
accumulation of inert gas (argon) and the dilution of nitrous oxide and
oxygen in the circuit.
- There is compliance with all safety regulations
respecting the preparation, storage, identification and use of medical
gases, anesthetic drugs and related materials.
- The anesthetic machine conforms to standard Z168.3
or is an electronic, fluidic, or pneumatic controlled machine. The
machine must be equipped with an oxygen analyser, vaporisers fitted with
keyed filling devices, a ventilator with a low pressure alarm, a
dedicated exhaust gas scavenging system and a high vacuum tracheal
suction system.
- A resuscitator, a defibrillator with synchronised
electrocardiograph, and drugs and equipment to manage emergencies
(including malignant hyperthermia, difficult airways, and failed
endotracheal intubation) must be immediately available. Facilities that
care for children should have specialised paediatric equipment. Wherever
obstetrical anesthesia is performed, a separate area for newborn
assessment and resuscitation including designated oxygen, suction
apparatus, electrical outlets and source of radiant heat, and equipment
for neonatal airway management and resuscitation shall be provided.
- Anesthesia providers must ensure that potentially
infectious materials or agents are not transferred from one patient to
another. Special attention in this regard should be given to syringes,
infusion pump administration sets, and multidose drug vials.
The health care facility must ensure that all
anesthetic and ancillary equipment undergo regular inspection and
maintenance by qualified personnel. Records indicating both conformity to
regulations and inspection and maintenance must be retained by the
hospital administration and the Department of Anesthesia.
Before the introduction of new anesthesia equipment,
members of an anesthetic department should receive training sessions on
this equipment under the guidance of the Chief of the Department. These
training sessions should be repeated as necessary for new or established
department members.
Recommendations for reducing occupational exposure
to waste anesthetic gases:
- The dilution ventilation of 20 changes/hour
recommended by CSA standard Z317.2 should be provided in all operating
rooms.
- Recirculation of exhaust air shall not be
permitted during the hours when operations may be in progress, and is
not recommended at any other time.
- Wherever an anesthetic delivery system is used, a
scavenger shall be provided to capture anesthetic gases that might be
released from the anesthetic circuit or ventilator.
- A maintenance program shall be established in each
health care facility to detect and repair leakage from the anesthetic
delivery system, and to maintain the effectiveness of the scavenging
unit.
- The health care facility shall be responsible for
conducting regular monitoring of exposure to waste anesthetic gases. The
monitoring protocol should include individuals and the air flow patterns
of the rooms being assessed. When N2O is used in the operating room, N2O
monitoring is a suitable representation for the assessment of adequacy
of scavenging.
Basic preanesthetic requirements should be established
in a written policy statement of the Department of Anesthesia. These
should include documentation of a current history and physical
examination, and a review of appropriate laboratory determinations. The
patients medical record should document a pre-anesthetic evaluation by a
physician who has knowledge of the proposed anesthetic procedure.
Ideally, preanesthetic evaluation should be conducted
by the anesthesiologist who is scheduled to provide services for the
patient, but in practice this is not always possible. At the time of the
preoperative visit, the anesthetist should take such history and carry out
such physical examinations as are necessary for the planning of
anesthesia. This history should include enquiry as to drug therapy,
unusual reactions or responses to drugs and previous anesthetics,
including problems and complications. Information about the anesthetic
that the patient considers relevant should be discussed. An American
Society of Anesthesiologists physical status classification
(Appendix II) should be recorded for each patient. Details of the
preoperative assessment should be documented on the patients chart.
Laboratory investigations indicated by the history and
physical examination should be carried out. These should take into
consideration the physical condition of the patient and the proposed
operation.
The surgeon and attending physician have a
responsibility to inform the anesthesiologist of any problems known to
them that may affect the safe administration of an anesthetic. Pertinent
medical consultations should be requested and obtained when indicated.
Any difference of opinion between the operating surgeon
and the anesthesiologist with regard to the care of the patient should be
resolved before the time of the operation.
Fasting policies should vary to take into account age
and preexisting medical conditions, and should apply to all forms of
anesthesia, including monitored anesthesia care. Emergent or urgent
procedures should be undertaken after considering the risk of delaying
surgery versus the risk of aspiration of gastric contents. The type and
amount of food ingested should be considered in determining the duration
of fasting. Prior to elective procedures, the minimum duration of fasting
should be:
Eight hours after a meal
that includes meat, fried or fatty foods;
Six hours after a light meal
(such as toast and a clear fluid), or after ingestion of infant formula or
nonhuman milk;
Four hours after ingestion
of breast milk, and
Two hours after clear
fluids.
Premedication, when indicated, should be ordered by the
anesthesiologist. Orders should be specific as to dose, time and route of
administration.
There may be additional regulations governing the
conduct of anesthesia that are dictated by provincial legislation or
hospital by-laws.
Before beginning an anesthetic the anesthesiologist
must ensure that:
- An explanation of the planned anesthetic procedure
has been given;
- An adequate review of the patient's condition has
been performed;
- All equipment items that are expected to be
required are available and in working order;
- A reserve source of oxygen under pressure is
available;
- All drugs and agents that are expected to be
required are correctly identified;
- Until a specific connection system is devised for
neuraxial use, both sides of all Luer connections should be labelled.
- The manufacturers' recommendations concerning the
use, handling and disposal of anesthetic equipment and supplies have
been considered.
The anesthesiologist's primary responsibility is to the
patient receiving care. The anesthesiologist must remain with the patient
at all times throughout the conduct of all general, major regional, and
monitored intravenous anesthetics. The anesthesiologist should leave only
when the patient has been transferred to the care of the postanesthesia
recovery room (PAR) or ICU personnel. Under exceptional circumstances, for
example to provide life-saving emergency care to another patient, an
anesthesiologist may elect to delegate routine care of the patient to a
competent person whose only responsibility is to monitor that patient
during the anesthesiologist's absence. In this situation the
anesthesiologist must inform the surgeon.
Simultaneous administration of general, spinal,
epidural, or other major regional anesthesia by one anesthesiologist for
concurrent diagnostic or therapeutic procedures on more than one patient
is unacceptable. However, in an obstetrical unit it is acceptable to
supervise more than one patient receiving regional analgesia for labour.
Due care must be taken to ensure that each patient is adequately observed
by a suitably trained person following an established protocol. When an
anesthesiologist is providing anesthetic care for an obstetrical delivery,
a second individual, appropriately trained, should be available to provide
neonatal resuscitation.
Simultaneous administration of an anesthetic and
performance of a diagnostic or therapeutic procedure by a single physician
is unacceptable, except for procedures done with only infiltration of
local anesthetic.
All monitored physiological variables should be charted
at intervals appropriate to the clinical circumstances. Heart rate and
blood pressure should be recorded at least every five minutes. Oxygen
saturation should be continuously monitored and recorded at frequent
intervals. Every patient receiving inhalational, major regional, or
monitored intravenous anesthesia should have oxygen saturation and, if the
trachea is intubated, end tidal carbon dioxide concentration monitored
continuously. Reasons for deviation from these charting guidelines should
be documented in the anesthetic record. Monitors, equipment and
techniques, as well as time, dose and route of all drugs and fluids should
be recorded. Intraoperative care should be recorded.
The anesthesia record should include the recording of
the patient's level of consciousness, heart rate, blood pressure, oxygen
concentration, and respiratory rate as first determined in the
postanesthesia recovery (PAR) Room.
The only indispensable monitor is the presence, at all
times, of an appropriately trained and experienced physician. Mechanical
and electronic monitors are, at best, aids to vigilance. Such devices
assist the anesthesiologist to ensure the integrity of the vital organs,
and in particular, the adequacy of tissue perfusion and oxygenation.
The health care facility is responsible for the
provision and maintenance of monitoring equipment that meets current
published equipment standards.
The Chief of Anesthesia is responsible for advising the
health care facility on the procurement of monitoring equipment, and for
establishing policies for monitoring to help ensure patient safety.
The anesthesiologist is responsible for monitoring the
patient receiving care and must ensure that appropriate monitoring
equipment is available and working correctly. A preanesthetic checklist
(Appendix III or equivalent) shall be completed prior to initiation of
anesthesia.
Monitoring guidelines for standard patient care apply
to all patients receiving general anesthesia, regional anesthesia or
intravenous sedation.
Monitoring equipment is classified either as:
Required: These
monitors must be in continuous use throughout the administration of all
anesthetics.
Exclusively available for
each patient: These monitors must be available at each anesthetic work
station, so that they can be applied without any delay.
Immediately available:
These monitors must be available such that they can be applied without
undue delay.
The following are required:
Pulse oximeter;
Apparatus to measure blood
pressure, either directly or noninvasively;
Electrocardiography;
Capnography, when
endotracheal tubes or laryngeal masks are inserted.
The following shall be exclusively available for each
patient:
Apparatus to measure
temperature;
Peripheral nerve stimulator,
when neuromuscular blocking drugs are used;
Stethoscope - either
precordial, oesophageal or paratracheal;
Appropriate lighting to
visualize an exposed portion of the patient.
The following shall be immediately available:
Spirometer for measurement
of tidal volume.
It is recognised that brief interruptions of continuous
monitoring may be unavoidable. Furthermore, there are certain
circumstances where a monitor may fail and therefore continuous vigilance
by the anesthesiologist is essential. The use of agent-specific anesthetic
gas monitors is encouraged.
Alarms for oximetry and capnography should not be
indefinitely disabled during the conduct of an anesthetic except during
unusual circumstances.
In any hospital providing anesthetic services, a
postanesthesia recovery (PAR) room must be available. Administrative
policies in accordance with hospital by-laws shall be enforced to
co-ordinate medical and nursing care responsibilities.
The Department of Anesthesia should have overall
medical administrative responsibility of the PAR room. There should be a
policy manual for the PAR room, which has been approved by medical,
nursing and administrative authorities.
The anesthesiologist should accompany the patient to
the PAR room, communicate necessary information, and write appropriate
orders. If clinically indicated, supplemental oxygen and appropriate
monitoring devices should be applied during transport. Care should not be
delegated to the PAR room nurse until the anesthesiologist is assured that
the patient may be safely observed and cared for by the nursing staff. The
anesthesiologist or designated alternate is responsible for providing
anesthetic-related care in the PAR room. Discharge from the PAR room is
the responsibility of the anesthesiologist. This responsibility may be
delegated in accordance with hospital policy.
Supplemental oxygen and suction must be available for
every patient in the PAR room. Emergency equipment for resuscitation and
life support must be available in the PAR room. The monitoring used in the
PAR room should be appropriate to the patient's condition and a full range
of monitoring devices should be available. The use of pulse oximetry in
the initial phase of recovery is required (as of July 1, 1995).
An accurate record of the immediate recovery period
shall be maintained. This must include a record of vital signs together
with other aspects of treatment and observation. It shall form a part of
the permanent medical record. Any complications that bear any relation to
the anesthetic should be recorded, either on the recovery record or on the
progress notes on the patient's chart.
The patient must be discharged from the facility
under the care of a responsible adult only when fully conscious and
ambulatory. The patient should be advised not to drive an automobile or to
operate hazardous machinery for at least 24 hours. The patient should also
be advised about the additive effects of alcoholic beverages and sedative
drugs.
Anesthesia services to parturients include obstetric
analgesia for labour and uncomplicated deliveries, obstetric anesthesia
for complicated or operative deliveries. All guidelines regarding
provision of anesthesia for other diagnostic or therapeutic procedures
also apply to provision of obstetric anesthesia. These Guidelines for
Obstetrical Regional Analgesia pertain to epidural and spinal analgesia
during labour. The term “regional analgesia”
includes epidural, spinal, and combined spinal-epidural analgesia.
These guidelines will be reviewed by the Section of
Obstetric Anesthesia every three years and updated as indicated. Each
hospital may wish to develop additional guidelines or policies for
specific situations where obstetrical regional analgesia is provided.
- Prior to introducing obstetrical regional
analgesia, individual hospitals should have appropriate monitoring
protocols in place. These protocols should outline the types of
monitoring required and the frequency of monitoring. In addition, they
should clearly state how to manage common problems and emergencies, and
who to contact if assistance is required.
- Obstetric regional analgesia should only be
provided by physicians with training, hospital privileges and license to
provide these services. This includes trainees with appropriate
supervision.
- Regional analgesia should only be initiated and
maintained in locations in which appropriate resuscitation equipment and
drugs are immediately available.
- Informed consent should be obtained and documented
in the medical record.
- Intravenous access must be established prior to
initiating regional analgesia. The intravenous access should be
maintained as long as regional analgesia is utilized.
- The anesthesiologist should be immediately
available until analgesia is established and the patient’s vital signs
are stable.
- Continuous infusions of low dose (diluted)
epidural local anesthetics with or without other adjuncts are associated
with a very low incidence of significant complications. Consequently, it
is not necessary for an anesthesiologist to remain physically present or
immediately available during maintenance of continuous epidural infusion
analgesia provided that:
there are appropriate
protocols for management of patients receiving epidural analgesia;
the anesthesiologist can be
contacted for the purpose of advice and direction.
- The safety of patient-controlled epidural
analgesia (PCEA) using low-dose (diluted) local anesthetics with or
without other adjuncts is comparable to low-dose continuous infusion
epidural analgesia. Consequently, it is not necessary for an
anesthesiologist to remain physically present or immediately available
during maintenance of PCEA provided that:
there are appropriate
protocols for management of patients receiving PCEA;
the anesthesiologist can be
contacted for the purpose of advice and direction.
- Bolus dose of local anesthetics through the
epidural catheter, or through a catheter or needle presumed to be in the
epidural space, can cause immediate, life threatening complications. For
this reason, when a bolus dose of local anesthetic is injected through
the epidural catheter (except PCEA), an anesthesiologist must be
available to intervene appropriately should any complications occur. The
intent of the phrase available to intervene appropriately is that
individual Departments of Anesthesiology should establish their own
policies regarding the availability of an anesthesiologist to manage any
complications of regional analgesia. Each Department should consider the
possible risk of bolus injection of local anesthetics and the methods of
dealing with emergency situations in developing these policies.
Gastric emptying of solids is delayed during labour.
Opioid analgesics may further delay gastric emptying. Therefore,
parturients should not eat solid foods once they are in established
labour. In contrast to solid food, clear liquids are relatively rapidly
emptied from the stomach and absorbed in the proximal small bowel,
including during labour. Therefore, individual hospitals should develop
protocols regarding the intake of clear liquids for women in established
labour.
The basic principles, training requirements,
techniques, equipment and drugs used for the practice of anesthesia are
noted in other sections of the guidelines. The following are guidelines
for certain aspects particular to anesthetic practice outside a hospital.
Patients should be classified as to physical status
in a manner similar to that in use by the American Society of
Anesthesiologists. Usually, only patients in the ASA Classifications I and
II should be considered for an anesthetic outside a hospital. Patients in
Classification III may be accepted under certain circumstances.
The patient must have had a recent and recorded
history, physical examination and appropriate laboratory investigations.
This may be carried out by another physician or anesthesiologist. The
duration of fasting before anesthesia should conform to the previously
stated guidelines. The patient should be given an information sheet with
pre and postanesthetic instructions.
The anesthetic and recovery facilities shall conform
to hospital standards published by the Canadian Standards Association as
defined in other sections. The standards of care and monitoring shall be
the same in all anesthetising locations.
* new edition
Z5361 Tracheal Tubes
Z7228 Tracheal Tube Connectors
Z168.3 Anaesthetic Machines for Medical Use
Z5360 Anaesthetic Vaporizers - Agent Specific Filling
Systems
Z168.5.1 Anaesthesia Ventilators
Z168.5.2 Critical Care Ventilators
Z168.5.3 Neonatal Ventilators
Z168.5.6 Expired Air Pulmonary Resuscitators
Z8382 Resuscitators Intended for Use with Humans
Z168.8 Anaesthetic Gas Scavenging Systems
Z168.9 Breathing Systems for Use in Anaesthesia
Z168.11 Vacuum Devices Used for Suction and Drainage
Z168.13 Gas Specific Connections: Ancillary Devices for
Medical Air
Z305.1 Non-flammable Medical Gas Piping Systems
Z305.2 Low-pressure Connecting Assemblies for Medical
Gas Systems
Z305.3 Pressure Regulators, Gauges, and Flow Metering
Devices for Medical Gases
Z305.5 Medical Gas Terminal Units
Z305.6 Medical Oxygen Concentrator Central Supply
System For Use with Non-flammable Medical Gas Piping Systems
*Z317.5 Illumination Systems in Health Care Facilities
Z318.6 Commissioning of Medical Gas Systems in Health
Care Facilities
Z264.3 Standard for User-Applied Drug Labels in
Anaesthesia and Critical Care
Z364.3 Blood-Gas Oxygenators
Z8836 Suction Catheters for Use in the Respiratory
Tract
*7767-98 Oxygen Monitors for Monitoring the Patient
breathing Mixtures - Safety Requirements
9703.1 Anaesthesia and Respiratory Care Alarm Signals
Part 1: Visual Alarm Signals
9703.2 Anaesthesia and Respiratory Care Alarm Signals
Part 2: Auditory Alarm Signals
Z9918 Capnometers for Use with Humans - Requirements
Z9919 Pulse Oximeters for Medical Use - Requirements
Z10651.2 Lung Ventilators for Medical Use - Part 2:
Particular Requirements for Home Care Ventilator
Z10651.3 Lung Ventilators for Medical Use - Part 3:
Particular Requirements for Emergency and Transport Ventilators
Z11196 Anaesthetic Gas Monitors
Z32 Electrical Safety and Essential Electrical Systems
in Health Care Facilities
Z32.2 Electrical Safety in Patient Care Areas
Z32.4 Essential Electrical Systems for Hospitals
C22.1 Canadian Electrical Code Part I (Section 24,
Patient Care Areas)
*C22.2 No. 601.1 Medical Electrical Equipment, Part 1:
General Requirements for Safety
C22.2 No. 601.1S1 Supplement to No. 1-94 C22.2 No.601.1
C22.2 No. 601.1.1 Medical Electrical Equipment - Part
I: General Requirements for Safety - 1. Collateral Standard: Safety
Requirements for Medical Electrical Systems
C22.2 No 601.1B Amendment to C22.2 No.601.1
C22.2 No. 601.1.2 Medical Electrical Equipment, Part 1:
General Requirements for Safety - 2. Collateral Standard: Electromagnetic
Compatability Requirements and Tests
C22.2 No. 601.2.4 Medical Electrical Equipment, Part 2:
Particular Requirements for the Safety of Cardiac Defibrillators and
Cardiac Defibrillator-Monitors
C22.2 No. 601.2.12 Medical Electrical Equipment, Part
2: Particular Requirements for the Safety of Lung Ventilators for Medical
Use
C22.2 No. 601.2.13 Medical Electrical Equipment, Part
2: Particular Requirements for the Safety of Anaesthetic Machines
C22.2 No. 601.2.22 Particular Requirements for the
Safety of Diagnostic and Therapeutic Laser Equipment
Note: Z168.3 is directed primarily at pneumatically
operated anaesthetic machines.The CSA Technical Commitee on Anaesthetic
Equipment, respiratory Technology and Critical Care Equipment is currently
developing a standard for integrated anaesthetic workstations, and this is
expected to be completed in late 2000. in the interim, some manufacturers
are submitting their workstation for approval under Z168.3. For the
purpose of these 1999 guidelines, the essential requirements for these
systems is compliance with C22.2 Electrical Standards.
DIR003-1997 List of CSA Certified Health Care Products and Services
Z441 Terminology and Definitions Used in CSA Health Care Technology
Standards
C22.2 No. 601.2.10 Medical Equipment, Part 2: Particular Requirements for
the Safety of Nerve and Muscle Stimulators
No. 601.2.18 Particular Requirements for the Safety of Endoscopic
Equipment
No. 601.2.19 Particular Requirements for the Safety of Baby Incubators
No. 601.2.20 Particular Requirements for the Safety of Transport
Incubators
No. 601.2.25 Particular Requirements for the Safety of Electrocardiographs
Copies of standards may be obtained by writing to:
Canadian Standards Association
178 Rexdale Boulevard, Rexdale, Ontario, M9W 1R3
I - Normal healthy patient
II - A patient with mild systemic disease
III - A patient with severe systemic disease limiting activity but not
incapacitating
IV - A patient with incapacitating systemic disease that is a
constant threat to life
V - Moribund patients not expected to live 24 hours with or without
operation
(Emergency operation designated by "E" after
appropriate classification.)
- [ ] Secure connections between terminal units
(outlets) and anesthetic machine.
- [ ] Turn on machine master switch and all other
necessary electrical equipment
- [ ] Line Oxygen (40-60psi) (275-415 KPa)
- [ ] Line Nitrous Oxide (40-60 psi) (275-415KPa)
- [ ] Adequate reserve cylinder Oxygen pressure
- [ ] Adequate reserve cylinder Nitrous Oxide
content
- [ ] Check for leaks and turn off cylinders
- [ ] Flow meter function of Oxygen and Nitrous
Oxide over the working range
- [ ] Vaporiser filled
- [ ] Filling ports pin-indexed and closed
- [ ] Ensure "on/off" function and turn off
- [ ] Functioning Oxygen bypass (flush)
- [ ] Functioning Oxygen fail-safe device
- [ ] Oxygen analyser calibrated and turned on
Functioning mixer (where available)
- [ ] Attempt to create a hypoxic O2/N2O mixture and
verify correct changes in flow and/or alarm
- [ ] Functioning common fresh gas outlet
- [ ] Ventilator function verified
- [ ] Backup ventilation equipment available and
functioning
If an anesthesiologist uses the same machine in
successive cases, departmental policy may permit performing an abbreviated
checklist between cases.
- [ ] Correct assembly of circuit to be used
- [ ] Patient circuit connected to common fresh gas
outlet
- [ ] Oxygen flow meter turned on
- [ ] Check for exit of fresh gas at face mask
- [ ] Pressurize. Check for leaks, and integrity of
circuit (e.g. Pethick test for co-axial)
- [ ] Functioning high pressure relief valve
- [ ] Unidirectional valves and soda lime
- [ ] Functioning adjustable pressure relief valve
- [ ] Suction adequate
- [ ] Correctly connected to patient circuit and
functioning
- [ ] Airway
- [ ] Functioning laryngoscope (back-up available)
- [ ] Appropriate tracheal tubes: patency of lumen
and integrity of cuff
- [ ] Appropriate oropharyngeal airways
- [ ] Stylet
- [ ] Magill forceps
- [ ] I.V. supplies
- [ ] B.P. cuff of appropriate size
- [ ] Stethoscope
- [ ] E.C.G. monitor
- [ ] Pulse oximeter
- [ ] Capnograph
- [ ] Temperature monitor
- [ ] Functioning low and high pressure alarm
- [ ] Adequate supply of frequently used drugs and
intravenous solutions
- [ ] Appropriate doses of drugs in labeled syringes
- [ ] Defibrillators
- [ ] Emergency Drugs
- [ ] Difficult Intubation Kit
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