Professional Documents
Culture Documents
Devices
Maab S. Khalil
2
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-
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
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
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
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
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
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
Approximately 60 percent of heart bypass procedures performed in the U.S. use the brand of the
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
Identified Solution
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.).
error.
error).
Valve.
7
TECHNOLOGY HAZARD OF HEATER COOLING DEVICE
Non-antibacterial solution.
tank.
guidance.
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.
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.
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 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
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
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
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
and-heater-cooler-devices
Healthcare-associated Infections. (2018, April 17). Center of Disease Control and Prevention.
Stammers, A. H., & Riley, J. B. (2016). The Heater Cooler as a Source of Infection from
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
error.
error).
Valve.
Non-antibacterial solution.
tank.
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
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
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