Healthcare Management: Fluid Warmer Cabinet Evaluation Report

This report analyzes the implementation of fluid warmer cabinets in healthcare, focusing on the Clinical Investigation Department's (CED) decision to replace outdated equipment. It outlines a four-step configuration process, including diagnostic needs assessment, stakeholder verification, equipment evaluation, and auditing. The report emphasizes the importance of a risk-benefit analysis, considering both financial and patient safety implications, and recommends utilizing FDA guidelines for assessment. It stresses the need for a multidisciplinary team, including healthcare staff, physicians, and management, to ensure comprehensive evaluation. The report also highlights the importance of training programs and ongoing monitoring to optimize the benefits and mitigate the risks associated with the new fluid warming cabinet equipment, referencing key literature in healthcare technology management and regulatory standards.

Running head: HEALTHCARE MANAGEMENT: FLUID WARMER CABINET
HEALTHCARE MANAGEMENT: FLUID WARMER CABINET
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1HEALTHCARE MANAGEMENT: FLUID WARMER CABINET
Question 1
From the given case scenario, it can be observed that the Clinical Investigation
Department (CED) as agreed upon the need to replace all the outdated, bottled fluid warming
cabinets used at the facility with the most upgraded version, which is in compliance with the IEC
60601-1 Standards for Medical Equipment. To prevent further complications related to patient
safety and financial losses, it is recommended that the CED purchase, install and implement this
equipment based upon the ‘4 Step Configuration Process’ outlined in Hegarty et al., (2017).
Based on this process, it is first recommended that the CED detect the configuration or
diagnostic and clinical needs required for the purchasing the equipment (Hegarty et al., 2017).
This can be done with the aid of a proceed analysis or quality audit conducted by the CED. After
purchasing or deciding upon the equipment complying to this configuration, it is recommended
that the CED verify or discuss its decisions with multiple stakeholders (Semer, 2015). This can
be done through formation of a joint collaboration or healthcare technology management team
comprising of clinical engineers, clinical staff handling the equipment and supporting staff
supplying the equipment, in addition to CED members (Ullman et al., 2017). This must then be
followed by a short evaluation or a test run of the new fluid warming cabinet equipment where in
addition to monitoring the performance the technology management team, must measured its
compliance to the selected clinical configuration and legal standards of medical equipment
decided upon by the CED previously (Hegarty et al., 2017). Care must be taken to ensure that
the CED document the date and details of these processes and instruct the staff handling the
same to maintain records of dates, patient details and results (or mishaps) observed for every
time the fluid warming cabinet equipment is run during clinical examinations and surgical

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procedures (Fry, M Romero & Berry, 2016). After obtaining approval for using this warming
cabinet equipment by the management of the healthcare organization, the CED, along with each
member of the healthcare technology team formulated earlier must engage in conducting timely
auditing (Hegarty et al., 2017). This can involve another process analysis comprising of auditing
the functioning of the novel fluid warming cabinet equipment with the relevant legal standards,
the quality standards of the organization, the configuration identified by the CED and technical
support staff and the safety and quality standards established by the manufacturing staff of this
equipment Press, D. (2018). In addition to maintaining documentation for the processes, the
CED is expected to regularly report these results to the Medical Devices Committee and Clinical
Managers of the organization for obtaining views on the progress, deterioration and the potential
need for any improvement regarding this new kind of fluid warming cabinet equipment (Hegarty
et al., 2017).
Question 2
In addition to installation and ensuring functioning of the fluid warming cabinet device in
compliance to configuration and organizational equipment, a risk benefit analysis must be
conducted to ensure that the benefits of the newly implement device outweighs the associated
risks and costs (Ritchey et al., 2018). Taking insights from the findings by Hegarty et al., (2017),
the risk benefit analysis for the new fluid warming cabinet equipment must ensure that the
overall cost of organizational reputation and patient health associated with its usage is higher in
terms of organizational monetary and financial resources utilized for the same. To however,
mitigate the high costs associated with installation of the new warming device, the CED staff and
communicate with the management to implement a training program for workers as well the

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need to install the most upgraded version of the device. This will hence save costs by ensuring
smooth functioning and minimal errors which in turn will result in an increase in the benefits of
patient safety outweighing the risks associated with the new fluid warming cabinet device
(Todaka et al., 2017).
To ensure optimum implementation of a risk benefit analysis of the newly installed fluid
warming cabinet device, the Food and Drug Administration’s (FDA, 2016) regulatory
assessment worksheets on ‘Factors to Consider Regarding Benefit-Risk in Medical Device
Product Availability, Compliance, and Enforcement Decisions’ can prove to be useful. This will
involve assessing the benefits of the warming device based on the type, magnitude and duration
of benefits, likelihood of experiencing the benefits and perspectives of both healthcare personnel
and patients on the impact of the benefits experienced. Additionally, the risks associated with the
new fluid warming cabinet device will be based upon evaluation on deaths, adverse events,
harms and the likelihood of all these occurrences associated with installation and functioning
(FDA, 2016). To ensure comprehensive and holistic risk benefit analysis, it is recommended that
in addition to CED staff, a multidisciplinary auditing team comprising of healthcare staff,
physicians, the management and patient’s feedback be involved prior to final installation or after
test running of the fluid warming cabinet (Bai et al., 2019).

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References
Bai, T., Huang, L., Li, M., & Tiwari, R. (2019). Benefit-risk assessment for binary diagnostic
tests. Journal of biopharmaceutical statistics, 1-16.
FDA. (2016). Factors to Consider Regarding Benefit-Risk in Medical Device Product
Availability, Compliance, and Enforcement Decisions. Retrieved 9 October 2019, from
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/factors-
consider-regarding-benefit-risk-medical-device-product-availability-compliance-and.
Fry, M., Romero, B., & Berry, A. (2016). Utility of peripheral intravenous cannulae inserted in
one tertiary referral emergency department: A medical record audit. Australasian
Emergency Nursing Journal, 19(1), 20-25.
Hegarty, F., Amoore, J., Blackett, P., McCarthy, J., & Scott, R. (2017). Healthcare Technology
Management–A Systematic Approach. CRC Press.
Press, D. (2018). Guidelines for failure modes and effects analysis for medical devices. CRC
Press.
Ritchey, M. E., Hollis, K. A., Hauber, A. B., Gilsenan, A., & Krueger, W. S. (2018). Reporting
of" Benefit-Risk" Studies for Medical Devices in Published Literature. Value in
Health, 21, S175.
Semer, L. J. (2015). Medical device cybersecurity: internal auditors can help health-care
providers ensure their devices benefit patients-not threaten them. Internal Auditor, 72(6),
20-22.

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Todaka, K., Kishimoto, J., Ikeda, M., Ikeda, K., & Yamamoto, H. (2018). Impact of Risk-Benefit
Perception and Trust on Medical Technology Acceptance in Relation to Drug and Device
Lag: A Tripartite Cross-Sectional Survey. Therapeutic innovation & regulatory
science, 52(5), 629-640.
Ullman, A. J., Cooke, M., Kleidon, T., & Rickard, C. M. (2017). Road map for improvement:
point prevalence audit and survey of central venous access devices in paediatric acute
care. Journal of paediatrics and child health, 53(2), 123-130.