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Calibration of Medical Devices: Method and Impact on Operation Quality

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DOI: 10.31531/2231-5896.1000128

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Research Article Int J Pharm Sci; ISSN: 2231-5896; Vol: 16; Issue 1

Internationale Pharmaceutica Sciencia

Available Online: https://ipharmsciencia.edwiserinternational.com/home.php

Calibration of Medical Devices: Method and Impact on Operation Quality

Rupesh Kumar1,*, Ram Kumar Choudhary1, Archana2, and Nitish Kumar Yadav3
1
Department of Pharmaceutics, Government Pharmacy Institute, Patna, Bihar-800007, India
2
Department of Pharmacy, MGM College of Pharmacy, Patna, Bihar-801105, India
3
Research Scholar, Lords University, Alwar, Rajasthan, Indian

ARTICLE INFO Abstract

Received: 19 August 2023 Medical devices play a pivotal role in modern healthcare, aiding in
Revised: 03 September 2022 accurate diagnosis, monitoring, and treatment of patients. The reliability
Available Online: 15 Sep 2023 and accuracy of these devices are indispensable for ensuring patient safety
and well-being. This project highlights the critical importance of
*Corresponding author: Rupesh calibrating medical devices to maintain their accuracy, precision, and
Kumar, Department of performance, ultimately safeguarding the lives of patients. Calibration of
Pharmaceutics, Government medical devices is a systematic process that verifies and adjusts their
Pharmacy Institute, Patna, Bihar- measurements to a known standard. This process ensures that medical
800007, India devices consistently provide accurate data and results. In the absence of
proper calibration, there is a significant risk of incorrect readings,
misdiagnoses, and inappropriate treatment plans, all of which can lead to
patient harm. Regular calibration is essential not only for maintaining
patient safety but also for meeting regulatory requirements and quality
assurance standards. It helps identify and rectify deviations or drifts in
device performance, preventing potential hazards in healthcare settings.
Compliance with calibration protocols ensures that medical institutions and
professionals can deliver reliable and effective care. Moreover, calibrated
medical devices enhance the efficiency and cost-effectiveness of healthcare
systems by minimizing the need for repeated tests and procedures due to
inaccurate results. Patients can have confidence in the reliability of the
devices used in their care, fostering trust in healthcare providers and
institutions.
Keywords: Medical device; Calibration; Patient safety; Artificial
Pacemaker; Ventilator; Defibrillators; Insulin pump; X-ray Machine.

Introduction
Medical devices are an important part of health care, device, diagnostic device and therapeutic device.
yet they are an extraordinarily heterogeneous class of Perhaps these are the unique challenges like safety
products. The term medical device includes such concerns and diversity of products coupled with the
technologically simple items as ice bags and tongue sheer number of different devices in market that makes
depressors on one end of the continuum and very the development of an effective and efficient
sophisticated items such as cardiac pacemakers and regulatory scheme a unique challenge for domestic as
proton therapy devices on the other end. Broadly based well as international regulatory bodies. Regulators and
on the function of medical device they may be governments count on standards to help develop better
classified as preventive care device, assistive care regulation [1]. There are many types of medical
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 Citation: Kumar R, Choudhary RK, Archana, et al Calibration of Medical Devices: Method and Impact
on Operation Quality. Int Pharm Sci 2023; 16(1):128. doi: 10.31531/2231-5896.1000128

devices, depending on their intended use, design, and devices in market that makes the development of an
classification. According to the World Health effective and efficient regulatory scheme a unique
Organization (WHO), a medical device can be any challenge for domestic as well as international
instrument, apparatus, implement, machine, appliance, regulatory bodies. Regulators and governments count
implant, and reagent for in vitro use, software, material on standards to help develop better regulation [9].
or other similar or related article, intended by the Medical devices are used for the diagnosis and
manufacturer to be used, alone or in combination for a treatment of disease, as well as the rehabilitation of
medical purpose [1]. The WHO estimates that there are patients during post-treatments. It can be used
an estimated 2 million different kinds of medical independently or in conjunction with any accessory,
devices on the world market, categorized into more consumable, or other pieces of medical device. The
than 7000 generic devices groups. Some examples of reliability, maintainability, availability, and safety of
medical devices are: Implantable devices, such as medical devices are the ultimate goal in maintenance
pacemakers, vascular grafts, clips, filters, and end strategy, where medical devices should not fail
osseous implants [2]. Life-saving and life-sustaining frequently and must be repaired promptly when the
devices, such as ventilators, oxygenators, failures are detected. Numerous investigations have
defibrillators, blood filters, and circulators [2]. Priority associated medical device failures with severe patient
medical devices for the COVID-19 response, such as injuries and deaths. The world health organization
oxygen therapy, pulse oximeters, patient monitors, (WHO) estimates that 50% to 80% of equipment is
thermometers, infusion and suction pumps, X-ray, non-functional due to the lack of maintenance culture,
ultrasound and CT scanners as well as personal competency, and a tendency to focus on corrective
protective equipment [3]. The growing sophistication maintenance rather than preventative maintenance.
of medical equipment has significantly improved the Ineffective medical device maintenance causes crucial
individual and society's health [4]. The advancement equipment downtime, diminished device performance,
has improved survivability in the face of disease or monetary waste, and depletion of resources. Older
injury and greatly enhanced patients' life quality technological devices require more attention due to a
through an improved diagnosis and therapeutic results. lack of service or user manuals and manufacturer
Managing assets and facilities is one of the significant guidance [10]. Medical devices range from basic
features in ensuring the continuity of primary and tongue depressors to complex radiation systems with
support business activities in healthcare services [5]. over 10,000 different types, and 1.5 million unique
The delivery of healthcare services to the communities medical devices are recorded globally. Medical device
are significantly affected without effective expenditure climbed from USD 145 billion in 1998 to
management implementation [6]. Medical equipment USD 220 billion in 2006, which indicates an annual
is a crucial asset that substantially contributes to the growth rate of more than 10% [11]. Medical devices
effectiveness and healthcare services quality maintenance market projection demonstrates that the
enhancement [7]. As the medical equipment aids medical devices maintenance market is expected to
various services in the healthcare sector, the grow at a compound annual growth rate (CAGR) of
management representative, such as clinical engineers, 10.4% to USD 74.2 billion by 2026, which will
must monitor and upkeep the assets by performing increase drastically from USD 45.2 billion in the year
several maintenances works throughout the equipment 2021 [12]. The medical devices industry has grown
life cycle [8]. Medical devices are an important part of rapidly and incessantly over the past century. The
health care, yet they are an extraordinarily sophistication and complexity of the designed
heterogeneous class of products. The term medical instrumentation is nowadays rising and, with it has
device includes such technologically simple items as also increased the need to develop some better, more
ice bags and tongue depressors on one end of the effective and efficient maintenance processes, as part
continuum and very sophisticated items such as of the safety and performance requirements [13]. For
cardiac pacemakers and proton therapy devices on the the health industry, be it hospitals or manufacturers of
other end. Broadly based on the function of medical medical devices, nothing counts more than the safety
device they may be classified as preventive care of a patient [14]. Therefore, all quality conscious
device, assistive care device, diagnostic device and hospitals consider the periodic testing and calibration
therapeutic device. Perhaps these are the unique of devices, a permanent feature in their quality control
challenges like safety concerns and diversity of regimen that they strictly adhere to. It is a significant
products coupled with the sheer number of different mark to their dedication and commitment to quality

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 Citation: Kumar R, Choudhary RK, Archana, et al Calibration of Medical Devices: Method and Impact
on Operation Quality. Int Pharm Sci 2023; 16(1):128. doi: 10.31531/2231-5896.1000128

and continuous improvement. Testing and calibration According to the International Organization for
of devices ensures accuracy, effectiveness in diagnosis Standardization calibration is the set of operations that
and treatment and long life of devices, which establish, under specified conditions, the relationship
ultimately enables one to achieve the highest degree of between values indicated by a measuring instrument, a
quality control and patient safety. Medical errors are a measuring system or values represented by a material
recognized cause of harm in the health care system, but measure, and the corresponding known values of a
clinical measurement errors are seldom, if ever, measured [18]. Accuracy and reliability of all
identified as causes of adverse events [15]. In recent measurements would be doubtful if the instruments
years, a growing number of patients have suffered used were not calibrated. Calibration ensures that a
from adverse events due to medical devices measuring instrument displays an accurate and reliable
malfunction [16]. In addition to knowledge and value of the quantity being measured. Calibration is
experience of medical doctors, correct diagnosis and the process of reporting measurement results by
appropriate patient treatment largely depend on comparing the reference measurement device, which is
accuracy and functionality of medical devices. In a ascertained to its accuracy, with another measurement
large number of serious medical situations, devices device whose accuracy cannot be ascertained.
proper functionality of medical devices is crucial for Calibration is not an adjustment operation maintenance
patients. Therefore, it is necessary to carry out as strict or the repair of a device [19]. The importance of
and independent testing of functionalities of medical calibration has been increasing in devices used in
devices as possible and to obtain the most accurate and healthcare. Since the World Health Organization
reliable diagnosis and patient treatment [17]. The (WHO) considers medical calibration measurements as
objective of this paper is to examine the impact of part of quality health care, it publishes guidelines for
calibration on medical devices performance and standard practice and seeks to ensure that health care
patient’s safety by investigating the performance of providers focus on the issue [20]. The calibration of
selected sample of medical devices against inspection, measuring, and test equipment is crucial in
international standard reference or manufacturer the medical device industry. Properly calibrated
recommendations. This paper considers several equipment ensures accurate and reliable measurement
common medical equipment’s used in hospital as the data, which directly impacts the quality of
research object, their maintenance procedure, manufactured devices. Each manufacturer is obligated
calibration methods and results before and after to ensure that their inspection, measuring, and test
calibration of the equipment. equipment, including mechanical, automated, or
electronic equipment, is suitable for its intended
Importance of Calibration
purposes and is capable of producing valid results
(Figure 1).

Figure 1: Quality control system of medical devices.

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 Citation: Kumar R, Choudhary RK, Archana, et al Calibration of Medical Devices: Method and Impact
on Operation Quality. Int Pharm Sci 2023; 16(1):128. doi: 10.31531/2231-5896.1000128

Challenges in maintenance and quality control of resources and expertise. Creating independent
medical devices standards that align with the precision and accuracy
required for medical devices can be resource-intensive
While the regulations are designed to maintain the
and time-consuming.
highest standards, the medical device industry faces
several challenges when it comes to the calibration of Documentation and Record-Keeping:
inspection, measuring, and test equipment. These
The regulation emphasizes the importance of proper
challenges can vary depending on the size of the
documentation of calibration activities, including
organization, the complexity of the equipment, and the
equipment identification, calibration dates, personnel
scope of their manufacturing operations. Some of the
responsible for calibration, and the next calibration
key challenges include:
date. Maintaining accurate and up-to-date records is
Compliance with Specific Directions and Limits: crucial but can be a labor-intensive process for
manufacturers, particularly for those with a large
Calibration procedures, as outlined in Section
number of equipment items requiring regular
820.72(b) of the QSR, require manufacturers to adhere
calibration.
to specific directions and limits for accuracy and
precision. This poses a significant challenge, Ensuring Routine Calibration and Maintenance:
particularly for companies with diverse equipment
Manufacturers must establish and maintain procedures
types and applications. Calibration requirements can
for routine calibration, inspection, and maintenance of
vary greatly based on the nature of the medical devices
equipment. This involves managing a complex
being manufactured, necessitating extensive and
schedule to ensure timely calibrations without
detailed calibration procedures tailored to each piece
disrupting the production process. The challenge lies in
of equipment [21].
effectively coordinating and scheduling calibration
Remedial Action and Impact on Device Quality: activities to minimize equipment downtime while
complying with the regulatory requirements.
In cases where calibration limits are not met, the
regulation demands provisions for remedial action to Training and Competency of Personnel:
reestablish the limits. The challenge lies in promptly
The successful implementation of calibration processes
identifying calibration deviations and initiating the
relies on the competency of personnel responsible for
appropriate corrective actions. Additionally,
conducting calibrations. Manufacturers must invest in
manufacturers must assess whether the deviation had
adequate training and qualification programs to ensure
any adverse effects on the quality of the medical
that personnel possess the necessary skills and
device produced using the equipment during the non-
knowledge to perform calibrations accurately.
conforming period.
Compliance with the regulations regarding the
Traceability to National or International
calibration of inspection, measuring, and test
Standards:
equipment is fundamental to the medical device
To ensure the accuracy and reliability of calibration, industry's success. Adherence to Subpart G, Section
the regulation mandates that calibration standards used 820.72, of the Quality System Regulation is essential
must be traceable to national or international standards. for maintaining product quality, safety, and efficacy.
However, in certain situations, achieving traceability Despite the challenges faced by the industry in meeting
may be impractical or unavailable. This challenge these requirements, it is through rigorous calibration
arises when specific calibration standards are not practices and diligent record-keeping that
readily accessible, or when medical devices require manufacturers can continue to deliver high-quality
unique and specialized calibration processes. medical devices that save and enhance lives.
Independent Reproducible Standards and In-house Calibration procedure and maintenance or quality
Standards: control outcome of some common medical devices
In the absence of applicable standards, manufacturers Artificial Cardiac Pacemaker
are required to establish independent reproducible
An artificial cardiac pacemaker (artificial pacemaker,
standards or in-house standards. Developing and
and sometimes just pacemaker, although the term is
maintaining such standards necessitates substantial
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 Citation: Kumar R, Choudhary RK, Archana, et al Calibration of Medical Devices: Method and Impact
on Operation Quality. Int Pharm Sci 2023; 16(1):128. doi: 10.31531/2231-5896.1000128

also used to refer to the body's natural cardiac patient's heart rate, rhythm, and any underlying
pacemaker) is a medical device, nowadays always abnormalities.
implanted, that generates electrical pulses delivered by
The pacemaker is then programmed to pace the heart
electrodes to one or more of the chambers of the heart,
when needed, typically by sensing the patient's
the upper atria or lower ventricles. Each pulse causes
intrinsic heart rate (atrial or ventricular) and delivering
the targeted chamber(s) to contract and pump blood,
electrical impulses when necessary to maintain an
thus regulating the function of the electrical
appropriate heart rate and rhythm.
conduction system of the heart [22].
Telemetry-Based Calibration:
The primary purpose of a pacemaker is to maintain an
adequate heart rate, either because the heart's natural Many modern pacemakers are equipped with remote
pacemaker is not fast enough, or because there is a monitoring capabilities, allowing healthcare providers
block in the heart's electrical conduction system. to adjust pacemaker settings remotely.
Modern pacemakers are externally programmable and
allow a cardiologist, particularly a cardiac Telemetry-based calibration enables healthcare
electrophysiologist, to select the optimal pacing modes professionals to monitor the patient's heart rhythm and
for individual patients. Most pacemakers are on adjust the pacemaker settings as needed without the
demand, in which the stimulation of the heart is based need for in-person visits.
on the dynamic demand of the circulatory system. Rate-Response Calibration:
Others send out a fixed rate of impulses (Figure 2).
Some pacemakers are equipped with rate-responsive
A specific type of pacemaker called an implantable sensors that can adjust the pacing rate based on the
cardioverter-defibrillator combines pacemaker and patient's physical activity and metabolic needs.
defibrillator functions in a single implantable device
[23] Others, called biventricular pacemakers, have Calibration of rate-responsive pacemakers may involve
multiple electrodes stimulating different positions setting parameters related to sensor sensitivity,
within the ventricles (the lower heart chambers) to response rate, and upper and lower rate limits.
improve their synchronization.
Threshold Testing:
Threshold testing is performed to determine the
minimum amount of electrical energy required to
capture the heart and initiate a heartbeat.
This involves gradually reducing the pacing energy
until the pacemaker no longer captures the heart. The
energy is then set slightly above this threshold to
ensure reliable pacing.
Mode Switching Calibration:
Some dual-chamber pacemakers have the ability to
switch between pacing modes (e.g., DDD, VVI) based
on the patient's natural rhythm.
Calibration for mode switching involves setting
parameters that determine when the pacemaker should
switch from one mode to another, such as detecting
Figure 2: Artificial Pacemaker.
atrial or ventricular events.
Methods for calibration of an artificial pacemaker
Sensitivity Adjustments:
ECG (Electrocardiogram) Guided Calibration:
Pacemakers are calibrated to sense the heart's intrinsic
This is the most common method for pacemaker electrical activity. Sensitivity adjustments ensure that
calibration. An ECG is performed to assess the the device accurately detects these signals.

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 Citation: Kumar R, Choudhary RK, Archana, et al Calibration of Medical Devices: Method and Impact
on Operation Quality. Int Pharm Sci 2023; 16(1):128. doi: 10.31531/2231-5896.1000128

Sensitivity settings may need to be adjusted if there are ensure it responds appropriately to changes in heart
issues with oversensing (detecting signals that are not rate and activity.
intrinsic heartbeats) or under sensing (not detecting
It's important to note that pacemaker calibration should
genuine heartbeats).
always be performed by qualified healthcare
Rate Limits and Hysteresis: professionals, such as cardiologists or
electrophysiologists, who are experienced in managing
Setting upper and lower rate limits ensures that the
cardiac devices. Regular follow-up appointments are
pacemaker paces within a predefined heart rate range.
essential to monitor the device's performance and
Hysteresis settings allow the pacemaker to maintain a make any necessary adjustments to optimize its
higher heart rate for a period after an episode of slow function for the patient's specific needs.
heart rate, reducing unnecessary pacing.
From the date obtained from Asia Hospital, Patna
Testing Under Different Conditions: between January to July 2023, out of 35 artificial
pacemakers it can be observed that a significant pass
Calibration may involve testing the pacemaker under rate is obtained after successful calibration and
various conditions, such as during exercise or sleep, to maintenance (Figure 3).

Figure 3: Graph of pass percentage before and after calibration of artificial pacemaker.
Insulin Pump who might have trouble sticking to a schedule for
insulin injections.
Insulin pumps are small, computerized devices. They
are about the size of a small cell phone. Insulin pumps Methods for calibration of an insulin pump
deliver doses of insulin on a pre-programmed
Calibrating an insulin pump is a crucial step in
schedule. Insulin is the hormone that regulates your
ensuring its accurate delivery of insulin to manage
blood sugar. People who have diabetes don’t make
blood glucose levels in individuals with diabetes. Here
enough insulin naturally. Instead, they have to use
are some common methods and considerations for
insulin injections to manage their blood sugar. Pumps
calibrating insulin pumps:
offer a steady stream of insulin so that you can have
fewer needle sticks. They’re also a good option for Blood Glucose Monitoring:
children or anyone who has trouble remembering their
insulin injections. Because insulin pumps stay attached The primary method for calibrating an insulin pump is
to the body, some people find an insulin pump more through blood glucose monitoring. Individuals with
convenient than insulin pen injections [24]. diabetes typically use a blood glucose meter to
measure their current blood sugar levels.
Insulin pumps can also be a good option for young
people with Type 1 diabetes. A pump can deliver a This measured blood glucose value is used to inform
steady supply of insulin, even for children and others the insulin pump about the appropriate insulin dosage
required to maintain target blood glucose levels.
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 Citation: Kumar R, Choudhary RK, Archana, et al Calibration of Medical Devices: Method and Impact
on Operation Quality. Int Pharm Sci 2023; 16(1):128. doi: 10.31531/2231-5896.1000128

Entering Blood Glucose Values: and maintain stable blood glucose levels. These
adjustments are typically made under the guidance of a
Most insulin pumps have a screen or interface where
healthcare provider.
users can manually enter their current blood glucose
levels. This value serves as the basis for the pump's Educating Users:
calculations. Users should follow their healthcare
Proper education and training are crucial for
provider's recommendations for how often to enter
individuals using insulin pumps. They need to
blood glucose values, which can vary depending on the
understand how to calibrate the pump, interpret blood
individual's treatment plan.
glucose data, and make informed decisions about
Continuous Glucose Monitoring (CGM) Integration: insulin dosing.
Some insulin pumps are compatible with CGM Healthcare providers and diabetes educators play a
systems that provide continuous real-time glucose significant role in providing this education.
readings. CGM-integrated insulin pumps can
Manufacturer Guidelines:
automatically adjust basal insulin rates and provide
alerts or suggestions for bolus insulin doses based on It's important to follow the specific guidelines
real-time glucose data. provided by the insulin pump manufacturer for
calibration and operation. These guidelines may vary
Insulin-to-Carbohydrate Ratio (ICR) and Correction
depending on the brand and model of the pump.
Factors:
Individuals with diabetes should work closely with
Calibration may also involve setting and periodically
their healthcare providers and diabetes care teams to
adjusting the ICR and correction factors. These
establish and maintain appropriate insulin pump
parameters help the insulin pump determine the bolus
settings and calibration methods that align with their
insulin dose needed to cover meals and correct high
unique treatment goals and needs.
blood sugar levels. Healthcare providers work with
individuals to determine these ratios based on their From the date obtained from Asia Hospital, Patna
unique insulin sensitivity and carbohydrate intake. between January to July 2023, out of 53 insulin pumps
it can be observed that a significant pass rate is
Regular Review and Adjustments:
obtained after successful calibration and maintenance
Calibrating an insulin pump is an ongoing process. It's (Figure 4).
essential to regularly review blood glucose data, pump
settings, and insulin delivery patterns. Adjustments
may be needed to fine-tune the insulin pump settings

Figure 4: Graph of pass percentage before and after calibration of insulin pumps.
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 Citation: Kumar R, Choudhary RK, Archana, et al Calibration of Medical Devices: Method and Impact
on Operation Quality. Int Pharm Sci 2023; 16(1):128. doi: 10.31531/2231-5896.1000128

Defibrillators connected to the device. Ensure that the defibrillator

confirms the pad's connectivity.
Defibrillators are devices that apply an electric charge
or current to the heart to restore a normal heartbeat. If Calibrate Energy Levels:
the heart rhythm stops due to cardiac arrest, also Many defibrillators allow for calibration of energy
known as sudden cardiac arrest (SCA), a defibrillator levels, ensuring that the device is delivering the
may help it start beating again. A sudden cardiac arrest appropriate amount of electrical energy during a shock.
is fatal unless treated right away with CPR Follow the manufacturer's instructions to calibrate the
(cardiopulmonary resuscitation) and a defibrillator energy settings, typically using a specialized
[25]. calibration tool or process.
Defibrillators can lower the risk of sudden death Test Defibrillation Shock:
among people who have a known arrhythmia or a high
In a controlled and simulated environment, perform a
risk of a life-threatening arrhythmia from causes such
defibrillation test using a mannequin or a test load to
as genetic diseases, heart failure, or a prior cardiac verify that the device delivers the correct energy levels
arrest. and monitors the patient's rhythm accurately.
Methods for calibration of defibrillators Review and Document Results:
Calibration of defibrillators is crucial to ensure that Keep detailed records of the calibration process,
these life-saving devices are operating correctly and including any adjustments made, test results, and the
delivering the appropriate electrical shocks when date of calibration. This documentation is essential for
needed. Here are the steps and considerations for regulatory compliance and quality assurance.
calibrating defibrillators:
Regular Maintenance and Recalibration: Schedule
Check Power Source and Battery: regular maintenance and recalibration according to the
manufacturer's recommendations and regulatory
Ensure that the defibrillator has a fully charged or requirements. Calibration should be performed by
properly functioning battery. Defibrillators are often trained technicians or authorized service providers.
used in emergency situations, so having a reliable
power source is critical. Compliance with Regulations:

Inspect Electrode Pads and Leads: Ensure that the calibration process complies with
applicable regulations and standards, such as those set
Examine the electrode pads and leads for any forth by health authorities or regulatory agencies in
damage or wear. Ensure that they are properly your region.
connected to the defibrillator and that the adhesive
on the pads is still effective. Replace any damaged or Training:
expired components. Ensure that healthcare professionals and emergency
Verify Proper Functionality responders who use the defibrillator are trained to
operate it correctly and understand the importance of
Turn on the defibrillator and perform a self-check or regular maintenance and calibration.
system test, if available. This test will assess the
internal components, including the electronics and Calibration of defibrillators is critical for patient
display. safety, as it ensures the device's effectiveness during
Verify that the device's alarms, indicators, and audio life- threatening situations. Regular checks and
signals are functioning correctly. maintenance help maintain the device's reliability and
readiness for use in emergencies. Always refer to the
Check Electrode Pad Expiration Date: specific guidelines provided by the defibrillator
Electrode pads typically have an expiration date. manufacturer and follow local regulations and
Ensure that the pads are within their expiration standards.
date to guarantee their effectiveness during
defibrillation. From the date obtained from Asia Hospital, Patna
between January to July 2023, out of 41 defibrillators
Check Electrode Pad Conductivity: it can be observed that a significant pass rate is
Some defibrillators have a feature that checks the obtained after successful calibration and maintenance
conductivity of the electrode pads when they are (Figure 5).

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 Citation: Kumar R, Choudhary RK, Archana, et al Calibration of Medical Devices: Method and Impact
on Operation Quality. Int Pharm Sci 2023; 16(1):128. doi: 10.31531/2231-5896.1000128

Figure 5: Graph of pass percentage before and after calibration of defibrillators.

Ventilator considerations:
A ventilator is a machine that helps you breathe. Just Preparation
like crutches support your weight, the ventilator
Ensure that the ventilator is clean and free from any
partially or completely supports your lung functions.
debris or contaminants.
Intubation and mechanical ventilation often happen
together, but they’re not the same. When a provider Confirm that the ventilator is connected to a stable
intubates, they put a tube down your throat into your power source or has a fully charged battery.
airway (trachea). Then, a provider will connect the Manufacturer's Guidelines
tube in your throat to a ventilator. Sometimes a face Refer to the manufacturer's user manual and guidelines
mask connects you to the ventilator and you don’t have for calibration procedures specific to your ventilator
to be intubated. model.
Modern mechanical ventilators use positive pressure to Follow the manufacturer's recommended maintenance
push air into your lungs. Positive pressure ventilation schedule, which typically includes calibration.
can be invasive or non-invasive [26].
Perform a Self-Test:
Invasive mechanical ventilation: This means you
have a tube in your airway connected to a ventilator. Many modern ventilators have a built-in self-test or
This tube can go through your mouth (intubation) or diagnostic mode that checks various components and
neck (tracheostomy). sensors for proper functioning.
Non-invasive ventilation: This uses a face mask Initiate the self-test according to the manufacturer's
connected to a ventilator. Straps hold the mask to your instructions and note any errors or issues detected
head to hold it tight. The ventilator pushes air into your during the test.
lungs. Forms of non-invasive ventilation include
devices you might use at home, like CPAP or Bi Level Inspect and Calibrate Sensors:
positive airway pressure. Ventilators have various sensors (e.g., pressure
sensors, flow sensors, oxygen sensors) that need
Methods for calibration of ventilators calibration to ensure accurate readings.
Follow the manufacturer's guidelines to access and
Calibration of ventilators is essential to ensure that
calibrate these sensors using calibration gases or
these medical devices deliver accurate and reliable
reference standards, if applicable.
respiratory support to patients. Proper calibration helps
maintain patient safety and ensures the ventilator Check Ventilator Display and Alarms:
functions as intended. The calibration process may
vary depending on the type and model of the Verify that the ventilator's display is functioning
ventilator, but here are some general steps and correctly and that all alarms are operational. Test alarm
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 Citation: Kumar R, Choudhary RK, Archana, et al Calibration of Medical Devices: Method and Impact
on Operation Quality. Int Pharm Sci 2023; 16(1):128. doi: 10.31531/2231-5896.1000128

limits and ensure that they trigger appropriately when made, and the technician's or operator's name.
set conditions are met. This documentation is essential for regulatory
compliance and quality assurance.
Verify Gas Delivery Accuracy
Regular Maintenance and Recalibration:
If your ventilator delivers specific gases (e.g., oxygen,
air, medical air), confirm that it accurately delivers the Schedule regular maintenance and recalibration
intended gas concentrations and flow rates. intervals as recommended by the manufacturer.
Use calibrated flow meters and gas analysers to Adhere to local regulations and standards governing
measure and verify gas delivery accuracy. medical device calibration and maintenance.
Calibrate Pressure and Flow: Training:
Check and calibrate pressure sensors and flow sensors Ensure that healthcare professionals responsible for
to ensure they provide accurate measurements. Use operating and maintaining the ventilator are properly
calibrated reference standards or tools provided by the trained in calibration procedures and understand the
manufacturer for this purpose. importance of accurate calibration for patient safety.
Proper calibration and maintenance of ventilators are
Check Inspiratory and Expiratory Valve critical for patient care, especially in critical care
Functionality settings. Following manufacturer guidelines and
Verify that the inspiratory and expiratory valves open maintaining a rigorous calibration schedule helps
and close properly, and that there are no leaks or ensure that the ventilator performs reliably and
obstructions. accurately.
Perform a leak test to ensure the system maintains the
desired pressure during inspiration and expiration. From the date obtained from Asia Hospital, Patna
between January to July 2023, out of 23 ventilators it
Document Calibration Results: can be observed that a significant pass rate is obtained
Maintain a detailed record of the calibration process, after successful calibration and maintenance (Figure
including the date, calibration values, any adjustments 6).

Figure 6: Graph of pass percentage before and after calibration of ventilators.

X- ray Machine generate images of tissues and structures inside the
body. If x-rays traveling through the body also pass
X-rays are a form of electromagnetic radiation, similar
through an x- ray detector on the other side of the
to visible light. Unlike light, however, x-rays have
patient, an image will be formed that represents the
higher energy and can pass through most objects,
“shadows” formed by the objects inside of the body
including the body. Medical x-rays are used to
[27].
10
 Citation: Kumar R, Choudhary RK, Archana, et al Calibration of Medical Devices: Method and Impact
on Operation Quality. Int Pharm Sci 2023; 16(1):128. doi: 10.31531/2231-5896.1000128

Methods for calibration of X-ray machine Automatic Exposure Control (AEC):

Calibration of X-ray machines is a crucial process to If the X-ray machine is equipped with AEC, calibrate
ensure accurate and safe medical imaging while it to ensure that it responds accurately to
minimizing radiation exposure to patients and
changes in patient anatomy and tissue density.
healthcare professionals. Calibration procedures for X-
ray machines typically involve several steps and Image Receptor Calibration:
considerations:
Calibrate the image receptor or detector to ensure it
Regulatory Compliance: accurately captures and records X-ray images. Verify
that the image receptor's exposure response is
Ensure that all calibration procedures adhere to local,
consistent and linear.
national, and international regulations and standards,
such as those set by the Food and Drug Administration Image Quality:
(FDA) in the United States, the International
Electrotechnical Commission (IEC), and the National Assess and calibrate the image quality parameters,
Council on Radiation Protection and Measurements such as contrast, resolution, and noise, to meet the
(NCRP). diagnostic requirements of specific imaging
procedures.
Manufacturer's Guidelines:
Dose Monitoring and Display:
Refer to the manufacturer's user manual and guidelines
for calibration procedures specific to your X- ray If your X-ray machine displays patient dose
machine model. Manufacturers often provide detailed information, ensure that the dose values shown on the
instructions and recommended calibration schedules. control panel are accurate and correspond to the actual
radiation exposure.
Safety Precautions:
Radiation Safety:
Ensure that the X-ray machine is turned off, and all
safety interlocks are engaged before starting Ensure that the X-ray machine is equipped with
calibration. Safety must be a top priority throughout appropriate radiation shielding and protective
the calibration process. measures for operators and patients.

Beam Quality and Output: Confirm that all safety features, such as lead aprons
and protective barriers, are in place and functioning
Calibrate the X-ray tube's beam quality and output correctly.
using a calibrated dosimeter or ionization chamber.
Measure the radiation output to ensure it meets the Documentation:
required specifications. Maintain detailed records of all calibration
Beam Collimation: procedures, including the date, calibration values, any
adjustments made, and the technician's or physicist's
Verify that the beam collimation system is functioning name. Documentation is essential for regulatory
correctly, ensuring that the X-ray beam is properly compliance and quality assurance.
aligned and focused.
Regular Calibration and Quality Assurance:
Exposure Time and Dose:
Establish a routine schedule for calibration and quality
Check and calibrate the exposure time settings to assurance checks. Regularly review and update the
ensure that the X-ray machine delivers the correct dose calibration process to account for changes in
of radiation for various imaging procedures. equipment performance or regulations.
Filtration and Half-Value Layer (HVL): Training:
Measure and verify the filtration in the X-ray beam, Ensure that qualified and trained personnel, such as
which is necessary to control the energy spectrum of medical physicists or radiologic technologists, perform
X-rays. Ensure that the X-ray machine meets the X-ray machine calibration. Continuous education and
required HVL specifications for the intended use.

11
 Citation: Kumar R, Choudhary RK, Archana, et al Calibration of Medical Devices: Method and Impact
on Operation Quality. Int Pharm Sci 2023; 16(1):128. doi: 10.31531/2231-5896.1000128

training are crucial to maintain proficiency in routine maintenance, and ongoing quality assurance to
calibration procedures. provide safe and high-quality radiological services.
X-ray machine calibration is a critical aspect of From the date obtained from Asia Hospital, Patna
ensuring the safety and accuracy of medical imaging. between January to July 2023, out of 7 X-ray machine
Healthcare facilities should have a comprehensive it can be observed that a significant pass rate is
quality control program that includes calibration, obtained after successful calibration and maintenance
(Figure 7).

Figure 7: Graph of pass percentage before and after calibration of X-ray machines.
Conclusion results. It promotes trust between patients and
healthcare providers, as patients can have confidence
In conclusion, the calibration of medical devices is of
in the reliability of the medical devices used in their
paramount importance for ensuring the safety of
care.
patients in healthcare settings. The proper functioning
and accuracy of these devices directly impact the In essence, the calibration of medical devices is an
quality of patient care, diagnosis, and treatment indispensable component of modern healthcare,
outcomes. Calibrated medical devices provide safeguarding patient well-being, maintaining the
healthcare professionals with reliable data and integrity of medical data, and upholding the highest
measurements, enabling them to make informed standards of patient safety and care. Therefore,
decisions and provide the best possible care to patients. healthcare organizations, professionals, and regulatory
Failure to calibrate medical devices can lead to bodies must prioritize and invest in the regular
incorrect readings, misdiagnoses, improper dosages, calibration of medical devices to ensure the continued
and potentially life-threatening errors. The advancement of medical practice and the protection of
consequences of such errors can be devastating for patients' lives.
patients, their families, and healthcare providers.
Funding
Regular calibration not only enhances patient safety
but also ensures compliance with regulatory standards No financial assistance was provided for this project.
and quality assurance protocols. It helps in detecting
and rectifying any deviations or drifts in device Conflict of Interest
performance, preventing potential risks and liabilities None declared.
in the healthcare industry. Furthermore, calibration
contributes to the overall efficiency and cost-
effectiveness of healthcare systems by reducing the
need for repeated tests and treatments due to inaccurate
12
 Citation: Kumar R, Choudhary RK, Archana, et al Calibration of Medical Devices: Method and Impact
on Operation Quality. Int Pharm Sci 2023; 16(1):128. doi: 10.31531/2231-5896.1000128

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