Safety during CPBSafety during CPB
Manu Jacob
Perfusionist
KMCT MCH
Bypass safetyBypass safety
Concept of safety is subjective.
Fatal perfusion accidents occurred 1/1800
cases.(1981)
Serious incident 1/130 procedures (1981)
With better saftey features and perfusion
techniques standards has improved
considerably.
Organizational aspectsOrganizational aspects
Most important and fundamental aspect of
cardiac surgery.
Describes the quality required of the unit
members and their responsibilities.
Describes the components required for an
open-heart unit.
Emphasizes team work.
Emphasizes co-operation,co-ordination
and effective communication.
Perfusion department safetyPerfusion department safety
organizationorganization
 Establishment of equipment records:
1. Identification and location of each
individual device.
2. Record of maintenance and repair of
each device.
3. Establishment of routine preventive
maintenance protocols.
 Faults book
Perfusion protocolPerfusion protocol
 Establish agreed protocols to be followed by all
perfusionists
1. Basis for selction of equipments
2. Pre-operative machine checks
3. Priming solutions and techniques
4. Case record which should include
a) patient statistics
b) equipments used
c) fluids and drugs used.
d) measured parameters.
e) frequency of entries.
Perfusion protocol contd.,Perfusion protocol contd.,
 Pre-bypass check list.
 Basic guideline for perfusion
management
1. Blood flows
2. Pressure limits
3. Fluid replacements
4. Blood gas and electrolyte limits
5. Anticoagulation and temperature control
Perfusion protocol contd.,Perfusion protocol contd.,
 Procedures to be followed in the event
of equipment failure
1. Electrical power
2. Mechanical pump failure
3. Reservoir failure
4. Gas supply failure
5. Temperature control
6. Circuit rupture
Perfusion protocol contd.,Perfusion protocol contd.,
 Team responsibility and communication
1. Establish agreed areas of responsibility
and systems of communication
2. Establish a procedure in the event of
failure
 Establish protocol for cleaning and
decontamination of all non-disposable
equipments.
Patient specific safety protocolsPatient specific safety protocols
 Identification of patient
1. Patient statistics
2. Diagnosis
3. Pre-operative
haematology,biochemistry,drug
theraphy
4. Cardiac investigative results
5. Proposed opertation
Patient specific protocols contd.,Patient specific protocols contd.,
 Selection of equipment according to
protocol
 Machine checks
a) Availability of alternate systems
b) Calibration checks
c) Occlusion checks
 Circuit components
a) Sterility b) visual check for defects
c) Availability of alternatives
Protocol contd.,Protocol contd.,
Prime according to protocol
Double check all fluids and drugs
Institute case record
Ensure record of identification data on
equipment and fluids used
Follow protocols for cleaning and
decontamination.
Accidents OR Mishaps In PerfusionAccidents OR Mishaps In Perfusion
Occasional
Often
TWO Categories:
Human error
Equipment failuresTerumo conf.Dubai June 2002
Human errorHuman error
Inadequate knowledge
Carelessness
Overconfidence
Poor investigations
Poor communications
Human errorHuman error
Critical situation
Odd times
Poor medical ethics
interdepartmental politics or ego
Untidiness or disorganized setups
Non-human elementsNon-human elements
Mechanical defects
Environmental factors
Lighting conditions
Human factors of accidentsHuman factors of accidents
Adventurous spirit
Inadequate training
Negligence and irresponsibilities
Fatigue
Stress
Impatience
Carlessness
The ageing process
Equipment failuresEquipment failures
Equipment failures:
Attention, resolve at the earliest
Failure attracts the attention of many
Too many opinions
Confusion - Perfusionist - Diversion
Accidents only to medical field?Accidents only to medical field?
Common to any given speciality.
More common in teaching institutions
Interns and Students
Does not spare even the most
experienced and in the hands of
observers.
TO Err is human
Acceptance gains knowledge
Denial fools self
Knowledge gets ignored
Reduced oxygenationReduced oxygenation
Most frequent incident
Gas delivery system may develop leak or
blockage.
Forgetting to turn on the gas before going
on cpb
Gas line not connected to oxygenator.
Defective oxygenator
Blood flows more than the rated flow
Arterial line air embolismArterial line air embolism
Most sudden and distressing incident
during CPB.
Mostly occurs due to non usage of safety
devices
Level alarm is a usefull aid but not a
substitue for proper vigilance.
The use of arterial filter and bubble traps.
Other perfusion related causesOther perfusion related causes
of gross air embolismof gross air embolism
 Oxygenator related.
1. Break in the integrity of oxygenator
connections
2. Detachment of oxygenator from holder
3. Non-venting of oxygenator
4. Clotted oxygenator
Pump related causes of grossPump related causes of gross
air embolismair embolism
runaway arterial pump head.
Reversal of arterial pump
Occluded line proximal to arterial pump
head.
Reversal of vent pump
Ruptured pump boot due to
overocclussion.
Foreign bodies entering pump head.
Cardiotomy reservoir relatedCardiotomy reservoir related
Production of positive pressure at the
input to the reservoir.
Air forced back up an arterial filter purge
line
Air forced back along vent system through
a non-occlusive pump
Large amount of air entrained in the
cardiotomy reservoir
Management of gross airManagement of gross air
embolismembolism
Prevention is the best form management.
Guidelines and procedures should be
setup and practiced by perfusionist.
Stop arterial pump immediatley.
Clamp venous line.
Place patient in a steep head down
position.
Cannula removed and circuit purged of
air.
Management of air embolismManagement of air embolism
contd.,contd.,
Arterial line is connected to venous
cannula to facilitate retrograde perfusion.
Start flow at 1 to 2lts/mt with flow
directed up the SVC.
Try to cool the patient to 20 degrees.
Suction system is to retrieve blood from
aortotomy.
Anesthetist exerts pressure on carotids.
Air embolism contd.,Air embolism contd.,
Retrograde perfusion is continued until
the arterial system is cleared of air.
Standard bypass is resumed with
hypothermia.
Air from the coronary system is also
removed by pharmocological elevation of
perfusion pressure.
Dexamethasone and thiopentone are
administered.
Contd.,Contd.,
Rewarming accomplished slowly to core
temp of 35 deg and bypass discontd.
Patient ventilated on 100% oxygen
Deep barbiturate anesthesia may be
useful.
Hyperbaric treatment is useful with good
results especially within 48 hrs of injury.
Mean arterial pressure at 100 to 130
mmhg
How to avoid accidents?How to avoid accidents?
Sound Knowledge
Regular updates
Regular Maintenance of equipments.
Build up of trust and team spirit
How to avoid accidents? Contd.,How to avoid accidents? Contd.,
Follow the standards of perfusion
Good data management
Check list and double check
Reconfirmation of settings
Vigilant always
Never be overconfident
Contd.,Contd.,
Good communication
Sharpness in sight, hearing and
reasoning
Engage all the saftey gadgets on the
HLM
Widens the saftey window
Machines have alarm, alert
 and auto shut off
Contd.,Contd.,
Saftey gadgets gives relaxation to the
operating perfusionist
Keep the safe timing limits
Develop good organising skills
Methodic approach
Standards to followStandards to follow
Document all the vital parameters,
history of the Patient
Appropriate the equipment selection
and the disposables as per the
patients need
Never go with blind approaches
DrugsDrugs
Always read the drug label
Never follow the color or shape of the
vial or container
May lead to increase in Morbidity and
mortality
Overcoming accidentsOvercoming accidents
Learning
◦ An ongoing process
◦ Universal
◦ No age limit
◦ Do not deny the opportunity
Dedicate your time and age for
achievements.
Ultimate goalUltimate goal
Save the life inspite of all the odd
situations
Prevent the re-occurrence
Draft protocols and applications
Be committed to the profession
Contd.,Contd.,
Do not work for rewards alone
Earn the confidence of the team
Knowledge, hard work and efficiency
Earns a better living
Terumo conf.Dubai June 2002
 Sincereity, punctuality, honesty, vigilance, dedication, thorough knowledge and
good communication
 Earns a good professional
 Terumo conf.Dubai June 2002
Constant updateConstant update
Text books
Media
CME
Conferences National, International
Medical exhibitions
Help to develop the management
skills of the perfusionist
Worldwide experience shows :
Human errors > 90%
Equipmental errors <10%
Perfusion management andPerfusion management and
perfusion systemsperfusion systems
inspite of advanced technologies,
monitoring the adequacy of perfusion is
not reliable.
Oxygen delivery to the vital organs
depends on multi-faceted interaction of
perfusion conditions.
There are no easily measured indicators of
adequacy avilable to us in OT
Perfusion systemsPerfusion systems
the CPB machine,patient and perfusionist
constitute a system.
Systems performance is a science
employed by diverse agencies such as
atomic energy commission and NASA.
From the perfusionist point of view it is
important that the fundamental priciples
of system performance are recoganised.
Perfusion system contd.,Perfusion system contd.,
 An FDA sponsored study identified four
broad areas as the cause of
unsatisfactory perfusion.
1. Inadequacy of current perfusion
management technique.
2. Pre-bypass pathalogical problems in
patient
3. Bypass device inadequacy or failure
4. User error-accounts 80% of all errors.
Safety for the perfusionistSafety for the perfusionist
Awareness of safety factors related to
hepatitis B infection and HIV has
prompted concern among the team.
Protection of health care staff is the
responsibility of management to help in
the vaccination
Avoidance of skin, mucus membrane and
skin puncture contact with affected blood.

Complications and safety during cpb

  • 1.
    Safety during CPBSafetyduring CPB Manu Jacob Perfusionist KMCT MCH
  • 2.
    Bypass safetyBypass safety Conceptof safety is subjective. Fatal perfusion accidents occurred 1/1800 cases.(1981) Serious incident 1/130 procedures (1981) With better saftey features and perfusion techniques standards has improved considerably.
  • 3.
    Organizational aspectsOrganizational aspects Mostimportant and fundamental aspect of cardiac surgery. Describes the quality required of the unit members and their responsibilities. Describes the components required for an open-heart unit. Emphasizes team work. Emphasizes co-operation,co-ordination and effective communication.
  • 4.
    Perfusion department safetyPerfusiondepartment safety organizationorganization  Establishment of equipment records: 1. Identification and location of each individual device. 2. Record of maintenance and repair of each device. 3. Establishment of routine preventive maintenance protocols.  Faults book
  • 5.
    Perfusion protocolPerfusion protocol Establish agreed protocols to be followed by all perfusionists 1. Basis for selction of equipments 2. Pre-operative machine checks 3. Priming solutions and techniques 4. Case record which should include a) patient statistics b) equipments used c) fluids and drugs used. d) measured parameters. e) frequency of entries.
  • 6.
    Perfusion protocol contd.,Perfusionprotocol contd.,  Pre-bypass check list.  Basic guideline for perfusion management 1. Blood flows 2. Pressure limits 3. Fluid replacements 4. Blood gas and electrolyte limits 5. Anticoagulation and temperature control
  • 7.
    Perfusion protocol contd.,Perfusionprotocol contd.,  Procedures to be followed in the event of equipment failure 1. Electrical power 2. Mechanical pump failure 3. Reservoir failure 4. Gas supply failure 5. Temperature control 6. Circuit rupture
  • 8.
    Perfusion protocol contd.,Perfusionprotocol contd.,  Team responsibility and communication 1. Establish agreed areas of responsibility and systems of communication 2. Establish a procedure in the event of failure  Establish protocol for cleaning and decontamination of all non-disposable equipments.
  • 9.
    Patient specific safetyprotocolsPatient specific safety protocols  Identification of patient 1. Patient statistics 2. Diagnosis 3. Pre-operative haematology,biochemistry,drug theraphy 4. Cardiac investigative results 5. Proposed opertation
  • 10.
    Patient specific protocolscontd.,Patient specific protocols contd.,  Selection of equipment according to protocol  Machine checks a) Availability of alternate systems b) Calibration checks c) Occlusion checks  Circuit components a) Sterility b) visual check for defects c) Availability of alternatives
  • 11.
    Protocol contd.,Protocol contd., Primeaccording to protocol Double check all fluids and drugs Institute case record Ensure record of identification data on equipment and fluids used Follow protocols for cleaning and decontamination.
  • 12.
    Accidents OR MishapsIn PerfusionAccidents OR Mishaps In Perfusion Occasional Often TWO Categories: Human error Equipment failuresTerumo conf.Dubai June 2002
  • 13.
    Human errorHuman error Inadequateknowledge Carelessness Overconfidence Poor investigations Poor communications
  • 14.
    Human errorHuman error Criticalsituation Odd times Poor medical ethics interdepartmental politics or ego Untidiness or disorganized setups
  • 15.
    Non-human elementsNon-human elements Mechanicaldefects Environmental factors Lighting conditions
  • 16.
    Human factors ofaccidentsHuman factors of accidents Adventurous spirit Inadequate training Negligence and irresponsibilities Fatigue Stress Impatience Carlessness The ageing process
  • 17.
    Equipment failuresEquipment failures Equipmentfailures: Attention, resolve at the earliest Failure attracts the attention of many Too many opinions Confusion - Perfusionist - Diversion
  • 18.
    Accidents only tomedical field?Accidents only to medical field? Common to any given speciality. More common in teaching institutions Interns and Students Does not spare even the most experienced and in the hands of observers.
  • 19.
    TO Err ishuman Acceptance gains knowledge Denial fools self Knowledge gets ignored
  • 20.
    Reduced oxygenationReduced oxygenation Mostfrequent incident Gas delivery system may develop leak or blockage. Forgetting to turn on the gas before going on cpb Gas line not connected to oxygenator. Defective oxygenator Blood flows more than the rated flow
  • 21.
    Arterial line airembolismArterial line air embolism Most sudden and distressing incident during CPB. Mostly occurs due to non usage of safety devices Level alarm is a usefull aid but not a substitue for proper vigilance. The use of arterial filter and bubble traps.
  • 22.
    Other perfusion relatedcausesOther perfusion related causes of gross air embolismof gross air embolism  Oxygenator related. 1. Break in the integrity of oxygenator connections 2. Detachment of oxygenator from holder 3. Non-venting of oxygenator 4. Clotted oxygenator
  • 23.
    Pump related causesof grossPump related causes of gross air embolismair embolism runaway arterial pump head. Reversal of arterial pump Occluded line proximal to arterial pump head. Reversal of vent pump Ruptured pump boot due to overocclussion. Foreign bodies entering pump head.
  • 24.
    Cardiotomy reservoir relatedCardiotomyreservoir related Production of positive pressure at the input to the reservoir. Air forced back up an arterial filter purge line Air forced back along vent system through a non-occlusive pump Large amount of air entrained in the cardiotomy reservoir
  • 25.
    Management of grossairManagement of gross air embolismembolism Prevention is the best form management. Guidelines and procedures should be setup and practiced by perfusionist. Stop arterial pump immediatley. Clamp venous line. Place patient in a steep head down position. Cannula removed and circuit purged of air.
  • 26.
    Management of airembolismManagement of air embolism contd.,contd., Arterial line is connected to venous cannula to facilitate retrograde perfusion. Start flow at 1 to 2lts/mt with flow directed up the SVC. Try to cool the patient to 20 degrees. Suction system is to retrieve blood from aortotomy. Anesthetist exerts pressure on carotids.
  • 27.
    Air embolism contd.,Airembolism contd., Retrograde perfusion is continued until the arterial system is cleared of air. Standard bypass is resumed with hypothermia. Air from the coronary system is also removed by pharmocological elevation of perfusion pressure. Dexamethasone and thiopentone are administered.
  • 28.
    Contd.,Contd., Rewarming accomplished slowlyto core temp of 35 deg and bypass discontd. Patient ventilated on 100% oxygen Deep barbiturate anesthesia may be useful. Hyperbaric treatment is useful with good results especially within 48 hrs of injury. Mean arterial pressure at 100 to 130 mmhg
  • 29.
    How to avoidaccidents?How to avoid accidents? Sound Knowledge Regular updates Regular Maintenance of equipments. Build up of trust and team spirit
  • 30.
    How to avoidaccidents? Contd.,How to avoid accidents? Contd., Follow the standards of perfusion Good data management Check list and double check Reconfirmation of settings Vigilant always Never be overconfident
  • 31.
    Contd.,Contd., Good communication Sharpness insight, hearing and reasoning Engage all the saftey gadgets on the HLM Widens the saftey window Machines have alarm, alert  and auto shut off
  • 32.
    Contd.,Contd., Saftey gadgets givesrelaxation to the operating perfusionist Keep the safe timing limits Develop good organising skills Methodic approach
  • 33.
    Standards to followStandardsto follow Document all the vital parameters, history of the Patient Appropriate the equipment selection and the disposables as per the patients need Never go with blind approaches
  • 34.
    DrugsDrugs Always read thedrug label Never follow the color or shape of the vial or container May lead to increase in Morbidity and mortality
  • 35.
    Overcoming accidentsOvercoming accidents Learning ◦An ongoing process ◦ Universal ◦ No age limit ◦ Do not deny the opportunity Dedicate your time and age for achievements.
  • 36.
    Ultimate goalUltimate goal Savethe life inspite of all the odd situations Prevent the re-occurrence Draft protocols and applications Be committed to the profession
  • 37.
    Contd.,Contd., Do not workfor rewards alone Earn the confidence of the team Knowledge, hard work and efficiency Earns a better living Terumo conf.Dubai June 2002
  • 38.
     Sincereity, punctuality,honesty, vigilance, dedication, thorough knowledge and good communication  Earns a good professional  Terumo conf.Dubai June 2002
  • 39.
    Constant updateConstant update Textbooks Media CME Conferences National, International Medical exhibitions Help to develop the management skills of the perfusionist
  • 40.
    Worldwide experience shows: Human errors > 90% Equipmental errors <10%
  • 41.
    Perfusion management andPerfusionmanagement and perfusion systemsperfusion systems inspite of advanced technologies, monitoring the adequacy of perfusion is not reliable. Oxygen delivery to the vital organs depends on multi-faceted interaction of perfusion conditions. There are no easily measured indicators of adequacy avilable to us in OT
  • 42.
    Perfusion systemsPerfusion systems theCPB machine,patient and perfusionist constitute a system. Systems performance is a science employed by diverse agencies such as atomic energy commission and NASA. From the perfusionist point of view it is important that the fundamental priciples of system performance are recoganised.
  • 43.
    Perfusion system contd.,Perfusionsystem contd.,  An FDA sponsored study identified four broad areas as the cause of unsatisfactory perfusion. 1. Inadequacy of current perfusion management technique. 2. Pre-bypass pathalogical problems in patient 3. Bypass device inadequacy or failure 4. User error-accounts 80% of all errors.
  • 44.
    Safety for theperfusionistSafety for the perfusionist Awareness of safety factors related to hepatitis B infection and HIV has prompted concern among the team. Protection of health care staff is the responsibility of management to help in the vaccination Avoidance of skin, mucus membrane and skin puncture contact with affected blood.