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Received March 12, 2025, accepted June 5, 2025, date of publication July 23, 2025.

Original Research Article

Implementing Clinical Engineering Departments in a 
Small Hospital: A 2017–2021 Regulatory Compliance and 
Organizational Analysis

Edgar González Campos*, Luis Antonio Rosas Pacheco and Arturo Vega González

Departamento de Ingenierías Química, Electrónica y Biomédica, División de Ciencias e Ingenierías, Campus León, Universidad de Guanajuato, 
León, Guanajuato, México.

* Corresponding Author Email: edgar.gonzalez@ugto.mx

ABSTRACT

The integration of clinical engineering into healthcare systems is increasingly recognized as a key factor in improving regula-
tory compliance, equipment management, and patient safety. However, many hospitals in developing countries still lack formally 
established clinical engineering departments, leading to operational inefficiencies and safety risks. This longitudinal study evalu-
ates the impact of implementing a clinical engineering department in a 10-bed secondary-level hospital between 2017 and 2021. 
Using a mixed-methods approach, regulatory compliance was assessed through two comprehensive audits conducted before 
and after the department’s implementation, based on 423 standards derived from national regulations. Regulatory compliance 
increased from 54.61% in 2017 to 78.72% in 2021. A two-sample Z-test for proportions confirmed that this improvement was 
statistically significant (Z = 7.44, p < 0.001) with a 95% confidence interval of 17.95% to 30.27%, suggesting that the change 
was unlikely because of random variation. Although the same set of standards was evaluated in both audits, the 4-year interval 
and lack of item-level tracking justified the use of this approximation. An organizational analysis revealed that while the depart-
ment contributed significantly to equipment oversight, process standardization, and regulatory compliance, its participation 
in high-level strategic decision-making remained limited. The dual role in both operational and strategic tasks posed ongoing 
challenges in prioritization and impact. Semi-structured interviews with clinical, administrative, and technical staff supported 
the quantitative findings. A total of 93% of participants were aware of the department, 87% understood its functions, and 86% 
rated its performance as “Good” or “Very Good”. The majority also considered it essential or considerably necessary for hospital 
operations. Together, the quantitative and qualitative findings confirm that the creation of a clinical engineering department can 
significantly enhance hospital regulatory compliance, operational performance, and staff engagement with safety processes. 
These results provide a replicable model for healthcare institutions in similar contexts seeking to strengthen medical technology 
management and regulatory alignment.

Keywords—Clinical engineering, Regulatory compliance, Medical equipment management, Patient safety, Longitudinal 
study, Healthcare quality.     

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Campos, Pacheco, González : Implementing Clinical Engineering Departments in a Small Hospital: A 2017–2021 Regulatory 
Compliance and Organizational Analysis

J Global Clinical Engineering Vol.7 Issue 3: 2025 24

INTRODUCTION

Clinical engineering plays a fundamental role in the 
quality of hospital care, patient safety, and the optimiza-
tion of both administrative and healthcare processes. Its 
importance has grown exponentially as medical technology 
has become an essential component for the proper func-
tioning of healthcare institutions.1 However, in developing 
countries, such as Mexico, the implementation of clinical 
engineering departments in hospitals faces major chal-
lenges because of the absence of standardized regulations, 
resource limitations, and a general lack of awareness about 
their impact on healthcare service delivery.2

In the context of the COVID-19 pandemic, the relevance 
of clinical engineering in Mexico became more evident than 
ever, demonstrating its critical role in medical technology 
management, the maintenance of essential equipment, 
and the implementation of strategies to optimize hospital 
resources.3 The World Health Organization (WHO) has 
recognized that the presence of trained clinical engineers 
is key to ensuring effective investment in healthcare 
technology and achieving better patient care outcomes.4 
Furthermore, international studies have shown that the 
participation of clinical engineers in hospitals has a direct 
and positive impact on indicators of patient safety and 
efficiency of care.5

Despite the growing evidence on the benefits of clini-
cal engineering, healthcare technology management in 
Mexico still faces structural and administrative barriers. 
Previous research has identified that many private hos-
pitals lack formalized clinical engineering departments, 
leading to inefficient management of medical devices 
and posing a risk to the quality of care.2 Moreover, the 
absence of clear regulations and standardized data on 
the operation of these departments has hindered their 
effective integration into the public sector.6

This longitudinal study builds upon prior research 
evaluating regulatory compliance with healthcare stan-
dards,7 which analyzed compliance with Mexican Official 
Standards (Norma Oficial Mexicana, NOM) in infrastructure 
and equipment before the implementation of a clinical 
engineering department in a private hospital. In 2021, 
these standards were reevaluated, revealing significant 

improvements in regulatory compliance, which translated 
into safer and more efficient medical care. These findings 
reinforce the importance of clinical engineering as an es-
sential component for the modernization of the healthcare 
sector in Mexico and other developing countries.

Recent literature confirms that regulatory frameworks, 
especially when aligned with accreditation programs or 
national standards, can significantly improve safety, pro-
cess efficiency, and equipment reliability.8 Studies have 
shown that hospital accreditation and standardized main-
tenance protocols not only reduce equipment downtime 
but also improve risk management, patient outcomes, 
and resource utilization.9,10 In this regard, the presence 
of trained clinical engineers and the implementation of 
comprehensive medical device management systems, 
grounded in national and international standards, are 
considered fundamental to quality assurance in modern 
healthcare systems.8

This paper aims to provide evidence on the need to 
standardize healthcare technology management and 
promote the establishment of clinical engineering depart-
ments in hospitals as an effective strategy to improve the 
quality of care and patient safety.

MATERIALS AND METHODS

This longitudinal study employed a mixed-methods 
approach to evaluate the impact of establishing a clinical 
engineering department in a secondary-level hospital 
in a developing country, between 2017 and 2021. The 
hospital is a privately managed institution operating as a 
secondary-level facility with a capacity of 10 beds, serv-
ing a population of medium to low socioeconomic status. 
Before 2017, the absence of a formal clinical engineering 
department resulted in deficiencies in medical device 
management and regulatory compliance.

Regulatory Audits and Compliance Assessment

The analysis was based on two comprehensive au-
dits, conducted in 2017 (pre-implementation) and 2021 
(post-implementation), following the guidelines of the 
applicable Mexican Official Standards (NOMs) for hos-
pital infrastructure and equipment (Table 1). A total of 



25 J Global Clinical Engineering Vol.7 Issue 3: 2025

Campos, Pacheco, González : Implementing Clinical Engineering Departments in a Small Hospital: A 2017–2021 Regulatory 
Compliance and Organizational Analysis

423 regulatory standards were assessed, covering key 
aspects of medical equipment, infrastructure, safety, and 
hygiene in critical hospital areas. The selection of the 423 
NOM items focused on infrastructure, equipment, and 
regulatory criteria that fall within the typical scope of 
clinical engineering responsibilities in hospitals. Standards 
were drawn from six Mexican Official Standards (NOMs) 
covering areas such as electrical safety, intensive care, 
emergency services, anesthesiology, and hazardous waste 
management. Emphasis was placed on items related to 
the physical environment, medical devices, and safety 
procedures, where clinical engineering interventions are 
most relevant. In addition, selected regulatory aspects 
were included to reflect areas where the department may 
influence institutional regulatory compliance.

On-site inspections of equipment and infrastructure 
were performed using checklists derived from the NOMs 
to evaluate the physical condition of devices and the 
adequacy of facilities. In addition, document reviews of 
records, logs, and service orders were conducted to assess 
the management and maintenance of medical devices.

The first regulatory audit was conducted in September 
2017, prior to the establishment of the clinical engineering 
department. The department was formally implemented 
in June 2018, and the follow-up audit was conducted in 
February 2021, resulting in a total observation period 
of 3 years and 5 months between the baseline and the 
post-implementation assessment.

No major organizational changes occurred during the 
implementation of the clinical engineering department 
that could have influenced the audit results or staff percep-
tion. The hospital’s leadership, governance structure, and 
departmental management remained stable throughout 
the observation period, ensuring continuity in operational 
processes.

To ensure methodological consistency across both 
time points, the audits conducted in 2017 and 2021 were 
carried out by the same evaluation team, using identical 
checklists and assessment procedures. The 423 regula-
tory standards assessed remained unchanged throughout 
the study period, as no modifications were introduced to 
the applicable national regulations. Both audits followed 
a standardized protocol involving documentary review, 

on-site inspections, and structured interviews. This 
consistency in evaluators, instruments, and regulatory 
criteria minimized the potential for measurement bias 
and ensured a reliable longitudinal comparison. 

Organizational Analysis

To complement the regulatory audits, a qualitative 
organizational analysis was performed to assess the im-
pact of the clinical engineering department on hospital 
structure, roles, and operational processes. Three key 
aspects were evaluated:

1. Structure: The organizational hierarchy of the hos-
pital was reviewed to determine the position and influ-
ence of the clinical engineering department in strategic 
and operational activities.

2. Responsibilities: The roles and delegated tasks 
of the clinical engineering department were analyzed, 
focusing on its contributions to infrastructure manage-
ment, regulatory compliance, and interdepartmental 
collaboration.

TABLE 1. List of Mexican Official Standards (NOM) used to evalu-
ate regulatory compliance in hospital infrastructure, medical 
devices, and safety procedures relevant to clinical engineering.

Standard Field of Study

NOM-001-SEDE-2012 Electrical Installations (use).

NOM-016-SSA3-2012

Establishes the minimum 
infrastructure and equipment 
requirements for hospitals and 
specialized medical consultation 
facilities.

NOM-025-SSA3-2013 For the organization and operation 
of intensive care units.

NOM-087-ECOL-
SSA1-2002

Biological-infectious hazardous 
waste classification and handling 
specifications.

NOM-006-SSA3-2011 For the practice of anesthesiology.

NOM-027-SSA3-2013
Establishes the criteria for operation 
and care in emergency services of 
medical facilities.



Campos, Pacheco, González : Implementing Clinical Engineering Departments in a Small Hospital: A 2017–2021 Regulatory 
Compliance and Organizational Analysis

J Global Clinical Engineering Vol.7 Issue 3: 2025 26

observation period, the clinical engineering department 
was composed of one full-time staff member and two 
interns. The sample of 15 interviewees includes all three 
technical staff members, two administrative staff, and a 
substantial portion of the clinical team.

Given the hospital’s small size and the deliberate in-
clusion of all functional roles and operational shifts, the 
sample is considered sufficiently diverse and representa-
tive to support meaningful qualitative insights.

Study Design and Statistical Analysis

The study design is illustrated in Figure 1, which out-
lines the main stages of the investigation. The process 
began with an initial audit in 2017 to establish a baseline 
for regulatory compliance. Following the implementa-
tion of the clinical engineering department, key actions 
included the appointment of specialized staff, the creation 
of internal policies, and the adoption of management 
systems. In 2021, a final audit was conducted to evaluate 
the effectiveness of these interventions.

To assess the statistical significance of the observed 
improvements, we compared regulatory compliance rates 
between the 2017 and 2021 audits using a two-sample 
Z-test for proportions. Although both audits assessed 
the same set of 423 regulatory standards, they were 
conducted 4 years apart under distinct operational condi-
tions and with separate data collection processes. Given 

3. Processes: The study examined how hospital work-
flows evolved following the implementation of the clinical 
engineering department, specifically improvements in 
medical device oversight, standardization of procedures, 
and staff training programs.

Semi-Structured Interviews

To further explore the perception of these changes, 
semi-structured interviews were conducted with clini-
cal, technical, and administrative staff selected based on 
their involvement in hospital operations. These inter-
views examined staff perceptions regarding operational 
improvements, safety culture, and interactions with the 
clinical engineering department. The questions were 
designed to capture both individual experiences and 
broader perspectives on the department’s contribution 
to hospital efficiency and patient safety.

A total of 15 hospital staff members participated in 
the interviews, which were conducted anonymously to 
promote candid responses. Participants were selected 
from all shifts, including weekends, to ensure extensive 
representation. The interviewees included clinical, techni-
cal, and administrative personnel, covering a wide range 
of services and time blocks.

Based on institutional records and operational estimates, 
the hospital operates with a total staff of approximately 
40 members, including all departments. During the 

FIGURE 1.  Study methodology outlining the main phases of the intervention, including baseline audit, implementation of the 
clinical engineering department, follow-up audit, and staff perception analysis.



27 J Global Clinical Engineering Vol.7 Issue 3: 2025

Campos, Pacheco, González : Implementing Clinical Engineering Departments in a Small Hospital: A 2017–2021 Regulatory 
Compliance and Organizational Analysis

the absence of item-level longitudinal tracking, the audits 
were treated as independent cross-sectional evaluations. 
We recognize that this method assumes independence 
and may slightly underestimate the standard error. A 95% 
confidence interval for the change in compliance propor-
tion was also calculated. This methodology provides a 
model that can be replicated by other institutions facing 
similar challenges in medical technology management 
and regulatory compliance. The results offer empirical 
evidence on how the integration of clinical engineering 
contributes to enhancing hospital safety, operational ef-
ficiency, and regulatory alignment.

RESULTS

Normative Assessment

In the emergency department, regulatory compliance 
showed significant improvement between 2017 and 2021. 
During the initial evaluation in 2017, compliance was at 
49%, while by 2021, it increased to 91%. This improvement 
was achieved through targeted interventions in critical 
infrastructure and processes, particularly regulatory com-
pliance with key standards such as NOM-016-SSA3-2012 
and NOM-025-SSA3-2013. These advancements are sum-
marized in Table 2, which consolidates compliance data 
for the emergency department, intensive care unit (ICU), 
and the overall hospital level between 2017 and 2021

In the case of the ICU, the initial situation also presented 
significant deficiencies, with regulatory compliance at 
39% in 2017. Following the implementation of correc-
tive actions, including infrastructure improvements and 
strengthened operational protocols, compliance reached 
79.27% in 2021. This progress highlights the importance 
of prioritizing standards related to critical infrastructure, 
particularly NOM-025-SSA3-2013. These values are included 
in Table 3, highlighting the ICU’s significant improvement 
alongside other key hospital areas.

At the general level, the hospital’s regulatory compli-
ance increased from 54.61% in 2017 to 78.72% in 2021, 
evaluating a total of 423 regulatory standards. This cor-
responds to an increase from 231 regulatory standards 
of compliance in 2017 to 333 regulatory standards of 
compliance in 2021, reflecting an absolute improvement 
of 102 items. This significant progress resulted from 
strategic interventions in the most critical areas, such 
as the emergency department and ICU, as well as the 
implementation of corrective measures related to stan-
dards like NOM-016-SSA3-2012 and NOM-025-SSA3-20. 
The overall evolution of regulatory compliance is also 
reflected in Table 2, providing a comparative overview 
of key improvements across hospital areas.

Furthermore, an analysis of noncompliances by type 
revealed that 63% of deficiencies were related to materials, 

TABLE 2. Summary of regulatory compliance improve-
ment in key hospital areas between 2017 and 2021.

Area/Level
2017 

Compliance 
(%)

2021 
Compliance 

(%)

Change 
(%)

Emergency Department 49 91 + 42

Intensive Care Unit (ICU) 39 79 + 40

General Hospital 54.61 78.72 + 24.11
Note: The emergency department and ICU showed the most 
substantial gains, with increases of 42% and 40%, respec-
tively. The overall hospital compliance improved by 24.11%, 
reflecting the impact of structured interventions in infrastruc-
ture, equipment management, and process standardization.

TABLE 3. Regulatory compliance with NOM-016-SSA3-2012 
and NOM-025-SSA3-2013 in the intensive care unit.

Standard Evaluated 
Standards Compliant Non-

compliant Percentage

NOM-016-
SSA3-2012 59 50 9 84.75%

NOM-025-
SSA3-2013 23 15 8 65.22%

Total 82 65 17 79.27%
Note: Compliance improved to 84.75% and 65.22%, respectively, 
following the implementation of corrective actions in infra-
structure, safety protocols, and medical device oversight. The 
combined compliance rate for both standards reached 79.27%.



Campos, Pacheco, González : Implementing Clinical Engineering Departments in a Small Hospital: A 2017–2021 Regulatory 
Compliance and Organizational Analysis

J Global Clinical Engineering Vol.7 Issue 3: 2025 28

34% to infrastructure, and only 3% to processes. This 
breakdown allowed prioritization of areas with the greatest 
potential impact on hospital safety and operability. Details 
of this distribution are shown in Figure 2 (Breakdown of 
noncompliances by type).

A Pareto analysis demonstrated that addressing 
deficiencies related to NOM-016-SSA3-2012 and NOM-
027-SSA3-2013 would resolve over 80% of the identified 
noncompliances. This highlights the criticality of these 
standards in achieving overall regulatory adherence and 
improving hospital performance. The Pareto distribution 
is presented in Figure 3.

NOM-016-SSA3 accounts for the highest number of 
noncompliances, significantly impacting overall compli-
ance. The cumulative percentage curve indicates that 
addressing the top three noncompliant standards—NOM-
016-SSA3, NOM-027-SSA3, and NOM-001-SEDE—would 
resolve a majority of regulatory gaps.

Overall, the results demonstrate how the most critical 
areas, such as the emergency department and ICU, served 
as examples of the impact that implementing a clinical 
engineering department can have. These advancements 
contributed significantly to improving overall regulatory 
compliance and provided a roadmap that can be replicated 
by other institutions with similar characteristics.

Statistical Analysis: Impact of the Clinical Engineering 
Department on Regulatory Compliance

To determine whether the observed improvement in 
regulatory compliance was statistically significant, we 
conducted a two-sample Z-test for proportions. This test 
evaluated whether the difference in compliance between 
2017 (prior to the implementation of the clinical engineering 
department) and 2021 (following its implementation) was 
due to chance or represented a meaningful improvement.

Hypothesis Formulation

Null hypothesis (H0): There is no significant difference 
in regulatory compliance between 2017 and 2021 (p1 = p2).

Alternative hypothesis (Ha): There is a significant 
difference in regulatory compliance between 2017 and 
2021 (p1  ≠ p2).

Statistical Test and Results

Using the total number of regulatory standards evaluated 
in both years (n1 = n2 = 423), the proportion of compliant 
standards was calculated:

                      

1
2312017 : 54.61%
423

p = =

                       
(1)

                     2
3332021: 78.72%
423

p = =             (2)

FIGURE 2.  Distribution of noncompliances by type in the 2017 
audit. Material-related issues represented 63%, infrastructure 
34%, and process-related only 3%, guiding targeted corrective 
actions.

FIGURE 3.  This chart illustrates the distribution of noncompliant 
standards, highlighting the most critical areas for improvement. 



29 J Global Clinical Engineering Vol.7 Issue 3: 2025

Campos, Pacheco, González : Implementing Clinical Engineering Departments in a Small Hospital: A 2017–2021 Regulatory 
Compliance and Organizational Analysis

A two-tailed Z-test for proportions was performed at 
a 95% confidence level, yielding the following results:

• Z-score = 7.44
• Critical value (Zcritical): ± 1.96
• p-value: 8.96 × 10−14

• Confidence interval (95%) for the difference in 
proportions: 24.11% (95% CI: 17.95% to 30.27%)

Since the Z-score (7.44) exceeds the critical value 
(1.96) and the p-value is significantly lower than 0.05, we 
reject the null hypothesis. This indicates that the increase 
in regulatory compliance is statistically significant and 
unlikely to be because of random variation.

However, although the same set of standards was as-
sessed in both audits, the lack of item-level tracking and 
the 4-year interval justified the use of an approximate 
method based on cross-sectional comparisons. This 
limitation is further discussed in the Discussion section.

Interpretation and Conclusion

The statistical analysis confirms that the implementation 
of the clinical engineering department had a measurable 
impact on regulatory compliance. The rate of compliance 
increased from 54.61% in 2017 to 78.72% in 2021, a 
difference of 24.11 percentage points. This change was 
found to be statistically significant (Z = 7.44, p < 0.001), 
with a 95% confidence interval ranging from 17.95% to 
30.27%, indicating that the observed improvement is 
unlikely to be because of random variation.

Although the same set of regulatory standards was as-
sessed in both audits, the absence of item-level tracking 
and the time gap between evaluations justified the use 
of a cross-sectional approximation. This finding aligns 
with improvements observed in critical areas, such as the 
emergency department and the ICU, further enhancing 
hospital regulatory performance and ensuring sustained 
improvement of quality.

Results of the Organizational Analysis

Organizational analysis was conducted through qualita-
tive interviews with collaborators from the administration, 
clinical engineering, and hospital management areas. Key 

areas of inquiry included the organizational structure, 
departmental responsibilities, and the impact of new 
processes implemented by the clinical engineering depart-
ment. The investigated aspects are summarized below:

Investigated Aspects

1. Structure: Reviewed current and previous organiza-
tional charts, departmental hierarchy, and participation in 
strategic activities such as acquisitions and decision-making.

2. Responsibilities: Analyzed the current and delegated 
responsibilities of the clinical engineering department.

3. Processes: Compared operational processes before 
and after the creation of the department, focusing on the 
changes implemented and interdepartmental impacts.

The analysis revealed the following findings:

1. Structural Challenges: The hospital lacks a formally 
defined and approved organizational chart. The clinical 
engineering department operates with dual roles, contrib-
uting to strategic functions such as technology evaluation 
and acquisitions, while simultaneously managing opera-
tional tasks like equipment repairs and supplier manage-
ment. This duality often limits the department’s ability to 
optimally focus on either strategic or operational tasks.

2. Limited Strategic Participation: Although the 
clinical engineering department is integral to specific deci-
sions, such as technology acquisitions, its participation in 
high-level meetings is restricted. This limits its ability to 
influence broader hospital policies and initiatives.

3. Process Improvements: Before the creation of the 
department, different hospital areas managed equipment 
needs independently, leading to inconsistent approaches. 
The introduction of systematic routines, such as equipment 
verifications and staff training sessions, has standardized 
processes, improving equipment safety and operational 
efficiency.

A detailed representation of these findings is provided 
in Table 4, which illustrates the comparative roles of the 
department before and after its formal establishment. 



Campos, Pacheco, González : Implementing Clinical Engineering Departments in a Small Hospital: A 2017–2021 Regulatory 
Compliance and Organizational Analysis

J Global Clinical Engineering Vol.7 Issue 3: 2025 30

This analysis underscores the critical need for institu-
tional support to address structural and strategic gaps, 
enabling the department to maximize its contributions 
to hospital operations and patient safety.

Results of the Situational Analysis

The situational analysis was conducted to assess the 
level of knowledge and perception among hospital staff 
regarding the clinical engineering department. Key stake-
holders from administration, technical staff, and clinical 
personnel were included to provide a comprehensive 
view of the department’s relevance and performance in 
hospital operations.

Interviews were conducted anonymously with staff 
from all operational shifts, including weekends, to ensure 
a representative sample across the hospital. A total of 15 
staff members, covering all technical staff, two administra-
tive personnel, and a diverse portion of the clinical team 
participated. Based on staffing estimates, this sample 
represents approximately 40–50% of the total hospital 
workforce.

Interview questions focused on staff perception of 
equipment management, operational efficiency, and safety 
culture, including prompts such as: “What changes have 
you noticed in equipment availability?” or “How would 
you rate the department’s support in your daily work?”

Awareness and Understanding

Most respondents (93%) were aware of the depart-
ment’s existence, and 87% understood its core functions. 
These results highlight a generally high level of visibility, 
though the gap between awareness and understanding 
suggests a potential opportunity to strengthen internal 
communication.

Perceived Contribution and Necessity

Participants broadly recognized the department’s 
value, with 84% rating its contribution to workplace 
safety as “Significant” or “Considerable”. Furthermore, 
80% considered the clinical engineering department to 
be “Significantly” or “Considerably” necessary for hospital 
operations (Figure 4).

TABLE 4. Comparison of the clinical engineering department’s role before (2017) and after (2021) its formal implementation.

Point of Analysis Before Implementation (2017) After Implementation (2021)

Structure

No defined or authorized organizational 
chart. Previous charts were unavailable, 

and the department lacked a clear position 
within the hospital. Its participation in 

strategic decisions was limited.

The clinical engineering department now has 
a mixed hierarchy, combining strategic and 

operational levels. It participates in technology 
evaluations and acquisitions, although its 

presence in management meetings remains 
limited.

Responsibilities

No formal assignment of responsibilities. 
Decisions regarding medical equipment 
were made in a dispersed manner across 

different areas without a defined responsible 
party.

The clinical engineering department now plays 
a key role in medical equipment management 

and contributes knowledge in infrastructure and 
regulations. It collaborates with other areas such 

as quality, administration, and IT.

Processes

Corrective maintenance was handled 
by various areas without a designated 

responsible party. There were no 
structured verification routines or 

training plans for the use of medical 
devices.

The clinical engineering department now 
supervises maintenance, provides medical 

equipment training, and ensures regulatory 
compliance, consolidating more structured 

and efficient processes.

Note: Key improvements include a defined organizational structure, clearer responsibilities, and more structured processes for 
the management of medical equipment and regulatory compliance.



31 J Global Clinical Engineering Vol.7 Issue 3: 2025

Campos, Pacheco, González : Implementing Clinical Engineering Departments in a Small Hospital: A 2017–2021 Regulatory 
Compliance and Organizational Analysis

A total of 80% of respondents considered the depart-
ment to be “Significantly” (60%) or “Considerably” (20%) 
necessary for the hospital’s functioning, while only 7% 
selected “Moderate” and 13% “Little”. These results high-
light the strategic value attributed to the department by 
the hospital staff.

Staff Satisfaction

Satisfaction with the performance of the department 
was high: 86% rated it as “Very Good” or “Good”, while only 
14% rated it as “Fair” or “Poor”. This overall positive per-
ception reinforces the credibility of the department within 
the institution, though there is room for improvement in 
specific areas such as clinical training on equipment use.

Summary of Results

The full set of response distributions is summarized 
in Table 5, showing detailed percentages across each 
topic assessed.

FIGURE 4.  Perceived necessity of the clinical engineering 
department for hospital operations. 

DISCUSSION

This methodology provides a model that can be replicated 
by other institutions facing similar challenges in medical 
technology management and regulatory compliance. The 
results offer empirical evidence on how the integration 
of clinical engineering contributes to enhancing hospital 
safety, operational efficiency, and regulatory alignment.

The findings of this study provide clear evidence of 
the positive impact that the implementation of a clinical 
engineering department has on regulatory compliance, 
operational efficiency, and staff perception in a second-
ary-level hospital in Mexico. The increase in regulatory 
compliance from 54.61% in 2017 to 78.72% in 2021 is a 
direct result of structured processes in medical technol-
ogy management, infrastructure audits, and staff training.

The improvement in adherence to Mexican Official 
Standards (NOMs) is one of the key outcomes of this study. 

TABLE 5. Summary of staff perceptions regarding the clini-
cal engineering department.

Topic Response Options Result (%)

Awareness of CE 
Department existence Yes/No 93% | 7%

Awareness of CE
Department functions Yes/No 87% | 13%

Contribution to 
workplace safety

Significant/
Considerable/

Moderate/ Low

50% | 34% 
| 8% | 8%

Necessity for
 hospital operations

Significant/
Considerable/

Moderate/ Low

60% | 20% 
| 7% | 13%

Evaluation of 
CE staff performance

Very Good/Good/
Fair/Poor

46% | 40% 
| 7% | 7%

Note: The table presents the response distributions for key 
dimensions evaluated in the situational analysis, including 
awareness, perceived contribution, institutional necessity, 
and performance evaluation. Percentages reflect the propor-
tion of respondents selecting each option in a sample repre-
senting approximately 40–50% of the hospital workforce.



Campos, Pacheco, González : Implementing Clinical Engineering Departments in a Small Hospital: A 2017–2021 Regulatory 
Compliance and Organizational Analysis

J Global Clinical Engineering Vol.7 Issue 3: 2025 32

necessary. This level of recognition suggests that the 
work of the department has generated a tangible impact 
on organizational culture and the perception of hospital 
safety. However, the results also revealed areas for im-
provement. Fourteen percent of respondents perceived 
the department’s performance as “fair” or “poor”, sug-
gesting that certain aspects, particularly in training and 
communication with clinical and administrative staff, 
require further optimization.

Although the findings are encouraging, the applicabil-
ity of this model to other types of healthcare institutions 
requires further consideration. While the results of this 
study are promising, they must be interpreted within 
the context of a small, secondary-level hospital with a 
capacity of 10 beds. The operational dynamics, staffing 
patterns, and regulatory oversight in such a facility differ 
significantly from those in larger hospitals with higher 
patient volume, broader departmental structures, and 
more complex governance systems. However, the struc-
tured methodology used for implementing the clinical 
engineering department—focusing on regulatory align-
ment, equipment management, and process standard-
ization—offers a foundation that can be replicated and 
adapted to institutions of greater scale. Future multisite 
studies, particularly those involving tertiary care hospitals 
and diverse healthcare systems, would provide valuable 
comparative data to validate and refine the model pre-
sented in this study.

It is also important to consider the broader healthcare 
context in which this study was conducted. Between 
2019 and 2021, the COVID-19 pandemic introduced 
unprecedented changes in hospital operations, resource 
allocation, and regulatory enforcement. These changes 
may have influenced the results observed in the post-
implementation audit, particularly in critical departments 
such as the ICU and emergency room, which were directly 
impacted by the pandemic. While the observed improve-
ment in regulatory compliance can largely be attributed to 
the establishment of the clinical engineering department, 
it is possible that heightened regulatory scrutiny, emer-
gency preparedness protocols, and resource mobilization 
related to COVID-19 contributed in part to this progress. 
However, the absence of a parallel audit in a comparable 

The application of critical standards such as NOM-016-
SSA3-2012 and NOM-025-SSA3-2013 has been fundamen-
tal in strengthening hospital safety. A deeper analysis of 
noncompliance issues showed that 63% of deficiencies 
were related to materials, 34% to infrastructure, and only 
3% to processes, indicating that most problems can be 
addressed through investments in equipment and struc-
tural maintenance.

The observed improvement in regulatory compliance 
reflects a meaningful institutional change following the 
implementation of the clinical engineering department. 
While statistical analysis supports this interpretation, the 
absence of item-level tracking and the 4-year gap between 
assessments required treating both audits as independent 
observations. This approach, though limited, was meth-
odologically justified as a cross-sectional approximation.

A Pareto analysis further demonstrated that addressing 
deficiencies in just three key standards (NOM-016-SSA3, 
NOM-027-SSA3, and NOM-001-SEDE) would resolve 
over 80% of the identified regulatory compliance issues, 
highlighting the importance of a strategic approach in 
prioritizing regulatory efforts.

Beyond regulatory compliance, the creation of the 
clinical engineering department has driven significant 
organizational changes. The standardization of procedures 
and the introduction of periodic equipment verifications 
have strengthened patient safety and operational effi-
ciency. However, structural challenges remain, particularly 
regarding the department’s integration into high-level 
hospital decision-making.

Despite its critical role in medical technology manage-
ment, the clinical engineering department continues to 
operate under a hybrid model, balancing both operational 
and strategic responsibilities. This dual role may limit its 
ability to influence high-level decisions and maximize its 
potential impact on the quality of hospital service.

The semi-structured interviews reflect a high level of 
acceptance and recognition of the department among 
hospital staff. A total of 93% of respondents acknowledged 
the department’s existence, 87% understood its func-
tions, while 84% considered it essential or significantly 



33 J Global Clinical Engineering Vol.7 Issue 3: 2025

Campos, Pacheco, González : Implementing Clinical Engineering Departments in a Small Hospital: A 2017–2021 Regulatory 
Compliance and Organizational Analysis

2017 to 78.72% in 2021 demonstrates the effectiveness of 
structured interventions in medical technology manage-
ment, infrastructure standardization, and staff training.

These findings reinforce the effectiveness of the inter-
vention and its direct impact on regulatory performance. 
Although both audits assessed the same set of standards, 
they were conducted under different operational condi-
tions and without item-level tracking, warranting the use 
of a cross-sectional approach. Future studies should ap-
ply paired-data statistical methods—such as McNemar’s 
test—supported by longitudinal tracking, to strengthen 
the attribution of observed improvements.

Beyond compliance metrics, the study highlights the 
positive impact of the department on hospital workflows 
and organizational structure. The standardization of 
medical equipment management and verification pro-
cesses contributed to a safer and more efficient hospital 
environment. However, despite these improvements, the 
department’s limited participation in strategic decision-
making remains a challenge that could hinder its long-
term effectiveness.

Staff perception of the clinical engineering department 
was overwhelmingly positive, with 93% of the hospital 
personnel acknowledging its role and 86% rating its per-
formance as “Good” or “Very Good”. However, the study 
also identified areas for further optimization, particularly 
in training programs and internal communication strate-
gies to ensure a deeper understanding of the functions 
and contributions of the department.

The findings suggest that the successful integration of 
clinical engineering into hospital systems can serve as a 
model that can be replicated by other healthcare institu-
tions facing similar challenges in regulatory compliance and 
medical equipment management. However, for long-term 
sustainability, hospitals must ensure institutional support, 
continuous staff training, and periodic evaluations to 
maintain compliance and drive continuous improvement.

Although this study presents a compelling case for the 
role of clinical engineering in hospital optimization, it is 
not without limitations. The research was conducted in 
a single hospital, which may limit the generalizability of 

hospital without a clinical engineering department limits 
the ability to isolate these external influences. Future 
studies incorporating multicenter comparisons could 
help clarify the independent effect of clinical engineering 
interventions under varying external conditions.

Despite these positive results, this study has certain 
limitations. The analysis was conducted in a single sec-
ondary-level hospital, which may limit the generalization 
of the findings to other healthcare settings. In addition, 
although the same 423 standards were evaluated in both 
audits, they were assessed independently without item-
level tracking. This limits the ability to apply paired-data 
statistical tests such as McNemar’s test, which could have 
provided a more precise estimation of the intervention’s 
effect. Future research should consider structured item-
by-item longitudinal tracking to enable the use of paired 
analyses and strengthen the causal attribution of observed 
improvements. Furthermore, while the study included 
both quantitative and qualitative methods, future research 
could benefit from a longer follow-up period to assess the 
sustainability of the implemented improvements.

The implementation of a clinical engineering depart-
ment has proven to be an effective strategy for enhanc-
ing regulatory compliance, optimizing processes, and 
strengthening hospital safety. The statistical validation 
and confidence interval analysis confirm that the impact 
of the intervention is both meaningful and statistically 
significant. To maximize its long-term contribution, it is 
essential to promote the department’s integration into 
hospital governance and ensure its consolidation as a 
strategic actor within the organizational structure. This 
study provides a transferable model that may inform future 
initiatives aimed at strengthening healthcare systems in 
Mexico and other developing regions.

CONCLUSIONS

This study provides strong empirical evidence that the 
implementation of a clinical engineering department in a 
secondary-level hospital in Mexico significantly improves 
regulatory compliance, operational efficiency, and staff 
perception of hospital safety. The increase in compliance 
with Mexican Official Standards (NOMs) from 54.61% in 



Campos, Pacheco, González : Implementing Clinical Engineering Departments in a Small Hospital: A 2017–2021 Regulatory 
Compliance and Organizational Analysis

J Global Clinical Engineering Vol.7 Issue 3: 2025 34

CONFLICTS OF INTEREST

The authors declare no conflicts of interest related to 
this study.

ETHICS APPROVAL AND CONSENT TO PARTICIPATE 

This study did not involve human subjects, animals, 
or identifiable personal data. Ethical approval was not 
required.

CONSENT FOR PUBLICATION

Not applicable.

FURTHER DISCLOSURE

Not applicable.

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upon these results.

In conclusion, the integration of a clinical engineering 
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AUTHOR CONTRIBUTIONS

Conceptualization, G.C.E. and R.P.L.A.; Methodology, 
G.C.E.; Validation, G.C.E., R.P.L.A., and V.G.A.; Formal 
Analysis, G.C.E.; Investigation, G.C.E. and R.P.L.A.; Re-
sources, V.G.A.; Data Curation, G.C.E.; Writing – Original 
Draft Preparation, G.C.E.; Writing – Review & Editing, 
R.P.L.A. and V.G.A.; Visualization, R.P.L.A.; Supervision, 
G.C.E.; Project Administration, G.C.E.

ACKNOWLEDGMENTS

The authors would like to thank engineer Daniela 
Castro for her invaluable support during the execution 
of this study.

FUNDING

This research received no external funding.

DATA AVAILABILITY STATEMENT

Because of ethical and institutional restrictions, the 
datasets generated during this study are not publicly 
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