1

Running Head: TECHNOLOGY HAZARD OF HEATER-COOLING DEVICES

Technology Hazard of Heater-Cooler

Devices

University of San Diego

Maab S. Khalil
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TECHNOLOGY HAZARD OF HEATER COOLING DEVICE

Introduction

Health technology continues to get more advanced, and while this can improve patient

care, it also opens up hospitals to a new set of dangers they may not have imagined (White,

J.,2017). Health care organization need to be on the lookout in specific areas to reduce the risk of

adverse events related to the use of technology, particularly with cardiac surgeries using heater-

cooling devices (HCD) (White, J.,2017).

More than 250,000 heart bypass procedures using HCD are performed in the United

States annually. These devices are a fundamental part of these operations because they help keep

a patient’s blood and organs circulated at a specific temperature during the procedure. Recently,

these machines recognized as a source of mycobacteria occupants which can ultimately cause

infection during cardiac surgeries, eventually causing life-threatening complications. HCD

circulate warm or cold water through a closed circuit causing aerosolization due to incomplete

closure of exhaust vents. Hence, the U.S. Food and Drug Administration (FDA) has issued

disinfection guidelines for all heater-cooler devices intended to help prevent device

contamination and to minimize patient exposure to heater-cooler exhaust air, which may contain

aerosolized contaminated water, and hence cause a hindrance to patient health (CDC, 2018).

The solution to this safety hazard is to implement a high-level solution through Failure

Mode and Effects Analysis (FMEA) that challenges these hazards, identify and reduce the

failures that occur in its recommended pre-operative disinfection program to produce a high-

level pre-operative disinfection program that will protect a patient from postoperative

complication and death.

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TECHNOLOGY HAZARD OF HEATER COOLING DEVICE

Literature Review

The technology hazard literature review on HCD yielded four articles for interpretation

and analysis. These analyses will provide valid information about the current safety solution

trends that will help reduce the number of post-operative complication and death related to the

use of HCD.

In the first article analysis, the U.S Food and Administration in 2015 issued a

recommendation to help reduce the risk of infection to patients. These recommendations

provided awareness and importance of selected patients that benefits with temperature regulation

during open heart surgery and the risk of infection transmission associated with the use of the

device. It also provides guidelines to adhere to the cleaning and disinfection instructions

provided in the manufacturer’s device labeling and ensure that the guidelines are the most

current version available. FDA gives caution to specific HCD's in the market that are suspected

of contamination and contain visible biofilm. They recommend a “deep-cleaning” maintenance

to those devices (Center for Devices and Radiological Health, n.d.).

The second article analysis describes the inherent HCD design characteristics capable of

aerosol formation and the potential for NTM infection. The cleaning and disinfection protocols

also vary, and failure to follow the Instructions-For-Use (IFU) may result in inadequate

decontamination and early degradation of the device components. The cleaning process for most

HCD follows the Environmental Protection Agency National Primary Drinking Water standards

reducing Colony Forming Units (CFU) to 500 CFU per 100 mL of water. Furthermore, human

factor elements also play a role in device maintenance with failure to follow the manufacturers'
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TECHNOLOGY HAZARD OF HEATER COOLING DEVICE

IFU resulting in sub-adequate cleaning and contamination of the units (Stammers & Riley,

2016).

The third article (Allen, K.B et al., 2017) analysis discusses the potential for NTM

transmission from the HCD to a patient via aerosolization in the operating room, although

uncommon, remains a serious public health concern and has resulted in severe illness and death.

Public health agencies including the FDA and CDC will continue to offer strategies to mitigate

the risk of HCD contamination and reduce the potential for its airborne transmission as the

investigation continues. Ultimately innovation and modifications to HCD design will be needed

to overcome the inherent difficulties in cleaning and disinfection that can reduce or eliminate the

propensity for NTM contamination and aerosolization.

The last article (Association for Professionals in Infection Control,2017) stated that the

U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention

(CDC) previously had issued safety warnings that a widely used brand of HCUs might be

contaminated during manufacturing, putting patients at risk for life-threatening infections.

Approximately 60 percent of heart bypass procedures performed in the U.S. use the brand of the

device associated with these infections.

All these articles highlight the importance of disinfection program to be used in HCD, the

FDA, CDC give a failure to head the recommendation, and EPA will result in the contamination

of the operational room resulting in postoperative complication and death.

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TECHNOLOGY HAZARD OF HEATER COOLING DEVICE

Identified Solution

Nosocomial contagions during cardiac operation and hospitalization can have

unfavorable patient outcomes, and Heater-Cooler Devices (HCD) used in cardiac surgery has

become a reservoir for Nontuberculous Mycobacteria (NTM). The solution of this technology

hazard is to implement strict guidelines to disinfect and clean the devices before surgical

procedures. The Food and Drug Administration (FDA) is working with hospitals to identify

appropriate standards that are used to analyze and evaluate the effectiveness of the disinfection

and cleaning process. This includes the end user conduct cleaning and disinfection process listed

in the manufacturer's guidelines and the devices used according to labeling instructions. Hence,

hospitals must implement strict training of staff and maintenance of operational room before the

start of cardiac surgeries to protect the patient from a complication (Stammers & Riley, 2016).

Therefore, the FDA disinfection steps reduce the risk of Non-tuberculous mycobacteria

(NTM) infection overall, proper maintenance, cleaning and even design of heater-cooler devices

are required. Additionally, it is essential to use sterile or distilled water in your heater-cooler

device. Use unfiltered water and not regular tap water could contain NTM bacteria. Double

checking venting valve closure is considered when implementing the disinfection program and

repeating the disinfection cycle will safeguard HCD before the surgical procedure.

Recommended guidance for healthcare facilities and staff provided by the FDA, CDC

and the Joint Commission. The key recommendations provided by all three agencies is to ensure

most up-to-date instructions for cleaning and disinfecting of HCD. The facility must keep a

maintenance log for each device and the log should indicate who performed the cleaning and

when it took place. The Joint Commission requirement is that the maintenance and cleaning done
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TECHNOLOGY HAZARD OF HEATER COOLING DEVICE

at the time and frequency stated in the hospital’s protocols,100% of the time. Lastly, if NTM

found within HCD it should be reported to the FDA via MedWatch (CSZ, A. G., n.d.).

Failure Mode Effect Analysis

WEAKNESS TO HCD PREOPERATIVE DISINFECTION

WEAKNESS IN THE WORKFLOW DESCRIPTION OF THE WEAKNESS
Step 1: Hand Wash  Not washing hands due to human

error.

 Not having antibacterial soap.

 Not drying off your hand completely.

Step 2: Draining Water Tank  Forgetting to drain water tank (Human

error).

 Incomplete water draining.

 Forgetting to rinse out sediments.

Step 3: Closure of Venting Valve Securely  Inadequate closure of the Venting

Valve.
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TECHNOLOGY HAZARD OF HEATER COOLING DEVICE

 Forgetting to close venting valve.

 Pressure valve sealing notification.

Step 4: Pouring Sterilant in Water Tank  Inadequate quantity of sterilant

solution in the water.

 Non-antibacterial solution.

 Not knowing the shelf-life of sterilant.

Step 5: Establishing Homogenous  Forgetting to establish connection.

Disinfection in all Tube System.  Forgetting to securely close water

tank.

 Water tank closure seal notification.

Step 6: Removing Residual Solution and re-  Forgetting to remove residual solution.

sterilization of HCD.  Not repeating the sterilization cycle.

 Failing to follow disinfection

guidance.

FMEA for Heater Cooler Device Pre-Op Disinfection Procedure

P 1 Process Step Washing hands with disinfection solution before entering the operating room (OR).
r
o 2 Potential Failure Forget to wash hands. No antibacterial soap. Hands not dried completely.
c Mode
e
s
s 3 Potential Cause(s) Not following pre- No guidelines for Human error due to washing
disinfection guidelines. antibacterial soap hands in haste.
S
t 4 Severity Minor Minor Minor
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TECHNOLOGY HAZARD OF HEATER COOLING DEVICE

e 5 Probability Occasional Occasional Occasional

p 6 Hazard Score 3 3 3

# 7 Action (Eliminate, Accept Accept Accept

1 Control, or Accept)

8 Description of Action
1. Write down hand wash 1. Develop a guideline 1. Develop a guideline for
guidelines for antibacterial effective hand dryness
2. Inform staff about the soap. after wash.
importance of hand 2. Inform staff about 2. Inform staff of hand
hygiene before entering effective antibacterial dryness.
the OR. soap wash. 3. Implement Hand dryness
3. Implement hand wash 3. Standardize old notification before entering
guideline poster in front antibacterial soap OR.
of hand wash facility. disposal and
placement of new
soap.

P 1 Process Step Draining the water valve by opening rear drain valves.
r 2 Potential Failure Forgetting to drain the water Incomplete water Not washing out residual water
o Mode tank drainage. sediments.
c
e
s 3 Potential Cause(s) Understaffing of OR OR staff not checking the OR staff not checking residual
s water tank is completely sediment clearance.
drained.
S 4 Severity Major Major Moderate
t
5 Probability Uncommon Uncommon Uncommon
e
p 6 Hazard Score 6 6 4
7 Action (Eliminate, Control control control
Control, or Accept)
#
2 8 Description of 1. Assign enough workload 1. Use activity log 1. Activity log to track
Action OR staff. completion to track residual sediment
2. Efficient staffing HCD drainage. appearance and removal in
3. Design HCD activity log 2. Proper training of OR HCD.
for OR staff. staff in proper HCD 2. Inform and train staff.
drainage. 3. Enter completion log in the
3. Notification label for activity log.
a reminder.

P 1 Process Step Closure of Venting Valve Securely

r 2 Potential Failure Failure to close the venting Inadequate closure of venting No venting valve
o Mode valve. valve notification
c
e
s 3 Potential Cause(s) Human error No emphasis on the risk of Lack of notification, lack
s aerosolization. of knowledge

S 4 Severity Catastrophic Catastrophic Catastrophic

t 5 Probability Occasional Uncommon Remote
e
6 Hazard Score 12 8 4
p
7 Action (Eliminate, Eliminate Eliminate Accept
Control, or Accept)
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TECHNOLOGY HAZARD OF HEATER COOLING DEVICE

# 8 Description of 1. Design easy guideline for 1. Implement aerosolization 1. Implement

3 Action OR staff warning labels. notification sign.
2. Implementing notification 2. Train OR staff in patient 2. Design activity log
labels safety from aerosol notification.
3. Train OR staff contamination 3. Train staff to double
3. Recognizing insecure check venting.
venting valve

P 1 Process Step Pouring sterilant solution in water tank

r 2 Potential Failure Inadequate quantity of Non-antibacterial solution Not knowing the shelf-life of
o Mode sterilant solution in the sterilant solution.
c water tank.
e
s 3 Potential Human error, lack of Human error forget to measure Human error, lack of
s Cause(s) knowledge the quality of the antibacterial knowledge
solution
S
t 4 Severity Moderate Catastrophic Catastrophic
e 5 Probability Uncommon Occasional Uncommon
p
6 Hazard Score 4 12 8
7 Action Accept Eliminate Eliminate
# (Eliminate,
4 Control, or
Accept)
8 Description of 1. Inform OR staff the 1. Inform staff to inspect the 1. Inform the team to
Action importance of the quality of the sterilant inspect the shelf life of
quantity of sterilant solution. the sterilant solution.
solution. 2. Replace sterilant with new. 2. Send alert to OR staff to
2. Implement Sterilant 3. Teach OR staff to check replace expired sterilant
guidelines label near sterilant solution label solution.
HCD. 3. Teach staff proper
3. Train staff and provide replacement of sterilant
easily accessible solution.
guidelines in the
workplace.
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TECHNOLOGY HAZARD OF HEATER COOLING DEVICE

P 1 Process Step Establishing Homogenous Disinfection in all Tube System.

r 2 Potential Failure Forgetting to establish Forgetting to securely close Water tank closure seal
o Mode connection water tank notification
c
e
s 3 Potential Human error, lack of Human error, lack of Human error, lack of
s Cause(s) knowledge knowledge knowledge

S
t 4 Severity Catastrophic Catastrophic Catastrophic
e 5 Probability Uncommon Uncommon Uncommon
p
6 Hazard Score 8 8 8
7 Action Eliminate Eliminate Eliminate
# (Eliminate,
5 Control, or
Accept)
8 Description of 1. Adequate training of staff. 1. Educating staff of insecure 1. Educating staff of insecure
Action 2. Accessible guidelines of water tank lid and risk or water tank lid and risk or
HCD connection. aerosol contamination in aerosol contamination in
3. Recognize champions to the OR. the OR.
motive OR staff for proper 2. Acknowledge OR staff the 2. Implement seal
HCD connection. correct way to secure notification and alert.
water lid 3. Promote a culture of zero
3. Promote a culture of zero tolerance to errors
tolerance to errors
P 1 Process Step Removing Residual Solution and re-sterilization of HCD.
r 2 Potential Failure Not removing residual solution. Not repeating the sterilization Failing to follow disinfection
o Mode cycle guidance
c
e
s 3 Potential Human error, lack of knowledge Due to increase workload and Lack of knowledge of
s Cause(s) understaffing the OR disinfection procedure

S
t 4 Severity Major Major Major
e
p 5 Probability Uncommon Uncommon Uncommon
6 Hazard Score 6 6 6
#
5 7 Action Control Control Control
(Eliminate,
Control, or
Accept)
8 Description of 1. Install measurements that 1. Implement re- 1. Real-time monitoring that
Action sends alerts to staff sterilization activity log provides quality
2. Educate staff on the separately. measurements that will
importance of removing 2. Implement efficient staff improve the standards of
residual elements and reduce the workload disinfection.
3. Promote a culture of zero of disinfectant staff. 2. Create checklist
tolerance to errors 3. Promote a culture of 3. Promote a culture of zero
zero tolerance to errors tolerance to errors
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TECHNOLOGY HAZARD OF HEATER COOLING DEVICE

Quality Measures

The proposed solution for our HCD system help protects cardiac patients from

postoperative complication and infection. This safety solution ensures an improved standard of

pre-operative disinfection program that prepares the HCD for cardiac surgery, from hand wash

until the last disinfection step. For the pre-operative HCD disinfection program to be cemented

indicators are considered. These indicators are performance and chemical indicators.

Performance indicators monitor the adherence of a high-level disinfection and

sterilization guidelines for HCD system during pre-operative preparation. This monitoring should

include ensuring the precise training of staff performing sterilization and their adherence to all

HCD disinfection guidelines. The indicator supports developing mechanisms for the operating

room (OR) staff to report all adverse health events that could cause aerosolization during cardiac

surgery; this helps review and implement newer guidelines that help prevent future exposures.

The performance indicator monitors possible sterilization failures resulting in pre-op disinfection

education recall, assessing additional training of personnel and the maintenance of equipment.

The chemical indicator measures the sterilization process monitoring the HCD system. It

is used to detect sterilizer malfunction and failures resulting from improper loading of the

sterilizer, incorrect packaging, deficiencies of the sterilizing agent, or malfunction of the

sterilizer itself. This indicator is designed to measure the parameters for the sterilization. These

quality measurements are monitored by the OR staff and the head nurse. All perioperative

cleaning staff should receive initial training, ongoing education and a competency review on

proper procedures, equipment, chemical selection/usage, and safety. Quality measurement

review needs to be conducted once a week and collected from hospital inpatient discharge
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TECHNOLOGY HAZARD OF HEATER COOLING DEVICE

providing a screening tool to help alert the OR staff with healthcare quality problem that needs

investigation.

Conclusion

Health technology of HCD continues to get more advanced, and while this can improve

patient care, it also opens up hospitals to a new set of dangers. These dangers are in the form of

NTM contamination during cardiac surgery resulting in postoperative infection and death. With

the guidelines of the FDA, CDC, and the Joint Commission strict adherence to high-level HCD

disinfection program can benefit healthcare organization from medical litigation, patient

outcome, and assure a standard of public care in the community. The FMEA analysis showed

weaknesses in the current workflow disinfection steps, hence, failing patient safety and care.

These failures provide direction to strengthen the current disinfection steps to a newer and

modified program that can secure the patient's safety.

Reference
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TECHNOLOGY HAZARD OF HEATER COOLING DEVICE

Allen K.B., Yuh D.D., Schwartz S.B., Lange R.A., Hopkins R., Bauer K., Marders J.A., Wentz

C. (2017). Nontuberculous Mycobacterium Infections Associated with Heater-Cooler

Devices. Annals of Thoracic Surgery, 104 (4), pp. 1237-1242.

Association for Professionals in Infection Control. (2017, June 14). More than a third of heater-

cooler devices used in open heart surgery may be contaminated with deadly bacteria.

ScienceDaily.

Center for Devices and Radiological Health. (n.d.). Heater-Cooler Devices - Information for

Health Care Providers and Staff at Health Care Facilities. Retrieved from

https://www.fda.gov/medicaldevices/productsandmedicalprocedures/cardiovasculardevic

es/heater-coolerdevices/ucm492583.htm

CSZ, A. G. (n.d.). FDA Guidance on NTM Infection and Heater-Cooler Devices. TRAINING

MODULE. Retrieved from https://www.cszmedical.com/training-module-ntm-infection-

and-heater-cooler-devices

Healthcare-associated Infections. (2018, April 17). Center of Disease Control and Prevention.

Retrieved from https://www.cdc.gov/hai/outbreaks/heater-cooler.html

Stammers, A. H., & Riley, J. B. (2016). The Heater Cooler as a Source of Infection from

Nontuberculous Mycobacteria. The journal of extra-corporeal technology, 48(2), 55-9.

White, J. (2017, January 08). Top 10 hospital technology hazards for 2017. Retrieved from

http://www.healthcarebusinesstech.com/hospital-technology-hazard-17/

Appendix
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TECHNOLOGY HAZARD OF HEATER COOLING DEVICE

1. HCD Disinfection Process Workflow.

2. Table highlighting workflow process weaknesses.

WEAKNESS TO HCD PREOPERATIVE DISINFECTION

WEAKNESS IN THE WORKFLOW DESCRIPTION OF THE WEAKNESS
Step 1: Hand Wash  Not washing hands due to human

error.

 Not having antibacterial soap.

 Not drying off your hand completely.

Step 2: Draining Water Tank  Forgetting to drain water tank (Human

error).

 Incomplete water draining.

 Forgetting to rinse out sediments.

Step 3: Closure of Venting Valve Securely  Inadequate closure of the Venting

Valve.

 Forgetting to close venting valve.

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TECHNOLOGY HAZARD OF HEATER COOLING DEVICE

 Pressure valve sealing notification.

Step 4: Pouring Sterilant in Water Tank  Inadequate quantity of sterilant

solution in the water.

 Non-antibacterial solution.

 Not knowing the shelf-life of sterilant.

Step 5: Establishing Homogenous  Forgetting to establish connection.

Disinfection in all Tube System.  Forgetting to securely close water

tank.

 Water tank closure seal notification.

Step 6: Removing Residual Solution and re-  Forgetting to remove residual solution.

sterilization of HCD.  Not repeating the sterilization cycle.

 Failing to follow disinfection

guidance.

Appendix (Cont.)

3. The six tables below highlight the FMEA of the disinfection workflow process.

P 1 Process Step Washing hands with disinfection solution before entering the operating room (OR).
r
o 2 Potential Failure Forget to wash hands. No antibacterial soap. Hands not dried completely.
c Mode
e
s
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TECHNOLOGY HAZARD OF HEATER COOLING DEVICE

s 3 Potential Cause(s) Not following pre- No guidelines for Human error due to washing
disinfection guidelines. antibacterial soap hands in haste.
S
t 4 Severity Minor Minor Minor
e 5 Probability Occasional Occasional Occasional
p 6 Hazard Score 3 3 3

# 7 Action (Eliminate, Accept Accept Accept

1 Control, or Accept)

8 Description of Action 4. Write down hand wash 4.

Develop a guideline 4. Develop a guideline for
guidelines for antibacterial effective hand dryness
5. Inform staff about the soap. after wash.
importance of hand 5. Inform staff about 5. Inform staff of hand
hygiene before entering effective antibacterial dryness.
the OR. soap wash. 6. Implement Hand dryness
6. Implement hand wash 6. Standardize old notification before entering
guideline poster in front antibacterial soap OR.
of hand wash facility. disposal and
placement of new
soap.
P 1 Process Step Draining the water valve by opening rear drain valves.
r 2 Potential Failure Forgetting to drain the water Incomplete water Not washing out residual water
o Mode tank drainage. sediments.
c
e
s 3 Potential Cause(s) Understaffing of OR OR staff not checking the OR staff not checking residual
s water tank is completely sediment clearance.
drained.
S 4 Severity Major Major Moderate
t 5 Probability Uncommon Uncommon Uncommon
e
p 6 Hazard Score 6 6 4
7 Action (Eliminate, Control control control
Control, or Accept)
#
2 8 Description of 4. Assign enough workload 4. Use activity log 1. Activity log to track
Action OR staff. completion to track residual sediment
5. Efficient staffing HCD drainage. appearance and removal in
6. Design HCD activity log 5. Proper training of OR HCD.
for OR staff. staff in proper HCD 2. Inform and train staff.
drainage. 3. Enter completion log in the
6. Notification label for activity log.
a reminder.

P 1 Process Step Closure of Venting Valve Securely

r 2 Potential Failure Failure to close the venting Inadequate closure of venting No venting valve
o Mode valve. valve notification
c
e
s 3 Potential Cause(s) Human error No emphasis on the risk of Lack of notification, lack
s aerosolization. of knowledge

S 4 Severity Catastrophic Catastrophic Catastrophic

t 5 Probability Occasional Uncommon Remote
e
6 Hazard Score 12 8 4
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TECHNOLOGY HAZARD OF HEATER COOLING DEVICE

p 7 Action (Eliminate, Eliminate Eliminate Accept

Control, or Accept)
# 8 Description of 4. Design easy guideline for 4. Implement aerosolization 4. Implement
3 Action OR staff warning labels. notification sign.
5. Implementing notification 5. Train OR staff in patient 5. Design activity log
labels safety from aerosol notification.
6. Train OR staff contamination 6. Train staff to double
6. Recognizing insecure check venting.
venting valve
P 1 Process Step Pouring sterilant solution in water tank
r 2 Potential Failure Inadequate quantity of Non-antibacterial solution Not knowing the shelf-life of
o Mode sterilant solution in the sterilant solution.
c water tank.
e
s 3 Potential Human error, lack of Human error forget to measure Human error, lack of
s Cause(s) knowledge the quality of the antibacterial knowledge
solution
S
t 4 Severity Moderate Catastrophic Catastrophic
e 5 Probability Uncommon Occasional Uncommon
p
6 Hazard Score 4 12 8
7 Action Accept Eliminate Eliminate
# (Eliminate,
4 Control, or
Accept)
8 Description of 4. Inform OR staff the 4. Inform staff to inspect the 4. Inform the team to
Action importance of the quality of the sterilant inspect the shelf life of
quantity of sterilant solution. the sterilant solution.
solution. 5. Replace sterilant with new. 5. Send alert to OR staff to
5. Implement Sterilant 6. Teach OR staff to check replace expired sterilant
guidelines label near sterilant solution label solution.
HCD. 6. Teach staff proper
6. Train staff and provide replacement of sterilant
easily accessible solution.
guidelines in the
workplace.

Appendix (Cont.)
P 1 Process Step Establishing Homogenous Disinfection in all Tube System.
r 2 Potential Failure Forgetting to establish Forgetting to securely close Water tank closure seal
o Mode connection water tank notification
c
e
s 3 Potential Human error, lack of Human error, lack of Human error, lack of
s Cause(s) knowledge knowledge knowledge

S
t 4 Severity Catastrophic Catastrophic Catastrophic
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TECHNOLOGY HAZARD OF HEATER COOLING DEVICE

e 5 Probability Uncommon Uncommon Uncommon

p 6 Hazard Score 8 8 8
7 Action Eliminate Eliminate Eliminate
# (Eliminate,
5 Control, or
Accept)
8 Description of 4. Adequate training of staff. 4. Educating staff of insecure 4. Educating staff of insecure
Action 5. Accessible guidelines of water tank lid and risk or water tank lid and risk or
HCD connection. aerosol contamination in aerosol contamination in
6. Recognize champions to the OR. the OR.
motive OR staff for proper 5. Acknowledge OR staff the 5. Implement seal
HCD connection. correct way to secure notification and alert.
water lid 6. Promote a culture of zero
6. Promote a culture of zero tolerance to errors
tolerance to errors
P 1 Process Step Removing Residual Solution and re-sterilization of HCD.
r 2 Potential Failure Not removing residual solution. Not repeating the sterilization Failing to follow disinfection
o Mode cycle guidance
c
e
s 3 Potential Human error, lack of knowledge Due to increase workload and Lack of knowledge of
s Cause(s) understaffing the OR disinfection procedure

S
t 4 Severity Major Major Major
e
p 5 Probability Uncommon Uncommon Uncommon
6 Hazard Score 6 6 6
#
5 7 Action Control Control Control
(Eliminate,
Control, or
Accept)
8 Description of 4. Install measurements that 4. Implement re- 4. Real-time monitoring that
Action sends alerts to staff sterilization activity log provides quality
5. Educate staff on the separately. measurements that will
importance of removing 5. Implement efficient staff improve the standards of
residual elements and reduce the workload disinfection.
6. Promote a culture of zero of disinfectant staff. 5. Create checklist
tolerance to errors 6. Promote a culture of 6. Promote a culture of zero
zero tolerance to errors tolerance to errors