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ISO 14971-Medical Device Risk Management Standard

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Even if there are slight variations, different countries set strict regulation procedures on medical devices so as to secure safety of patients and users. The Therapeutic Goods Administration (TGA) is responsible government body, which administers medical devices regulation in Australia. One of the core aspects mentioned under TGA regulation is compliance to ISO 14971 – medical devices risk management standard. Consequently, the purpose of this paper is to elaborate the importance of ISO 14971 – medical devices risk management standard, in the medical world. Beginning with a succinct introduction, the paper clearly provides scrutiny information about the aim and structure of the standard. It also shows the impact of the standard on ICT and Engineering practices and finally it concludes that, if implemented properly, ISO 14971 prevents customers from impending hazards by providing effective risk management procedures.
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International Journal of Latest Research in Engineering and Technology (IJLRET)
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ISO 14971 - Medical Device Risk Management Standard
Meseret N. Teferra1
1(Biomedical Engineering Department, Flinders University, Australia)
Abstract: Even if there are slight variations, different countries set strict regulation procedures on medical
devices so as to secure safety of patients and users. The Therapeutic Goods Administration (TGA) is responsible
government body, which administers medical devices regulation in Australia. One of the core aspects mentioned
under TGA regulation is compliance to ISO 14971 medical devices risk management standard. Consequently,
the purpose of this paper is to elaborate the importance of ISO 14971 medical devices risk management
standard, in the medical world. Beginning with a succinct introduction, the paper clearly provides scrutiny
information about the aim and structure of the standard. It also shows the impact of the standard on ICT and
Engineering practices and finally it concludes that, if implemented properly, ISO 14971 prevents customers
from impending hazards by providing effective risk management procedures.
Keywords: Medical device, risk management, risk analysis, risk mitigation, standards
I. INTRODUCTION
According to TGA, a medical device is defined as “any instrument, apparatus, appliance, material or
software intended to diagnose, prevent, monitor, treat, and alleviate disease” [3].
One of the challenges of medical device producers and suppliers is to pass through the complex
regulatory requirements and get approval from the respective authority of the particular country [12]. On top of
regulatory requirements and innovative nature of their products, they should also deal with inevitable associated
risks [15]. Risk is defined as “the probability that a hazard will turn into a disaster” [9] whereas risk
management is “the systematic application of management policies, procedures, and practices to the tasks of
analyzing, evaluating, and controlling risk” [2, 11]. Though risks cannot be avoided completely, they can be
greatly minimized if companies are aware of those impending risks and follow effective risk management
systems [8].
Under such circumstances, standards play a significant role so as to create common understanding and
procedures that can be shared by producers, customers as well as regulating authorities (Why do we need
standards? 2011b). However, what are standards? Standards are to [7]:
Published documents setting out specifications and procedures designed to ensure products, services
and systems are safe, reliable and consistently perform the way they were intended.
This definition is equally valid to medical devices as well [10]. Regarding risk management,
International Organization for Standardization (ISO) has three standards; ISO 14971 for medical devices and
two general purpose risk management standards (ISO 31000 and ISO 31010) [8]. However, this paper only
covers ISO 14971-medical; device risk management standard.
II. AIM AND STRUCTURE OF ISO 14971
Medical devices are life saving devices. Hence, stakeholders should know the associated risks and how
to manage them that are supposed to be applied throughout the life cycle of the product. One of the aims of ISO
14971 is to provide a risk management frame work for manufacturers to predict the probability of occurrence of
risks and their consequences. Additionally it provides guidelines for regulating authorities to confirm whether
the manufacturers go through proper risk management procedures or not, to make sure the safety of the public
[2]. III. GENERAL REQUIREMENTS FOR RISK MANAGEMENT
This is the section where the overall procedures of risk management are elucidated. It states that the
manufacturer should establish a document of risk analysis, risk evaluation, risk control, production and post
production information which is used throughout the life cycle of the medical device (from initial conception to
disposal of the medical device). It also provides information about expectations of top managements,
personnel’s qualification who perform the risk management, the risk management plan they develop and follow
as well as documentation of the overall procedures [2].
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IV. RISK ANALYSIS
ISO 14971 defines risk analysis as “a systematic use of available information to identify hazards and to
estimate the risk” (2007, p. 4). As per the definition, the standard provides a framework for the process of risk
analysis. Medical devices manufacturers are expected to identify and analyze all possible risks to optimize
efficiency and reduce incurred costs [2, 8].
Figure 1: Risk Optimization vs. Quality and Cost [8].
On top of this, the producer should document the intended use, safety procedures and hazards of its
medical devices [2].
a. ESTIMATING PROBABILITY (P) AND SEVERITY (S)
Even if varied techniques are used, it is common to determine the probability or likelihood of
occurrence of risks and if it happens how big, the risk is (severity). The inference can be in terms of qualitative,
quantitative or semi-quantitative scales [8].
Figure 2: Graphical determination of risk [8].
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b. RISK PROBABILITY NUMBER
Assigning values to the qualitative values; high (3), medium (2) and low (1) the overall risk can be
determined from risk priority numbers (RPNs). RPNs are calculated from the severity and occurrence of risk
using the following relation [8].
Figure 3: Graphical Determination of Risk including Detectability [8].
RPN = Severity (S) x Probability (P) ………………………………….. (1)
V. RISK EVALUATION AND RISK CONTROL
According to ISO 14971 [2]:
Risk evaluation is the process of comparing the estimated risk against given risk criteria to
determine the acceptability of the risk. On the other hand controlling the risk involves
decisions making and taking appropriate action to reduce or maintain the risk within the
specified levels.
Risks can be kept within the accepted limit by applying proper risk evaluation and control techniques,
which can be documented for later use. The manufacturer is also expected to verify the effectiveness of
implemented control mechanisms [2].
a. DETERMINING RISK THRESHOLD
The first step in risk evaluation and control is determining risk threshold value (RT) that measures the
amount of risk that the company can tolerate. These numbers should be communicated to all concerned parties
of the company and to higher officials for decision-making [8].
b. RISK MITIGATION
Risk mitigation is defined as “the process by which an organization introduces specific measures to
minimize or eliminate unacceptable risks associated with its operations” [6]. Though risk mitigation is essential,
it is not always the case; hence, it can be optional and may lead to unnecessary costs [1]. One of the best ways to
implement cost-effective risk improvement procedures is by comparing the risk probability number with the
predetermine risk criteria [8].
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ISSN: 2454-5031
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Figure 4: Figure 4: Risk Priority Number vs. Risk Threshold [8].
According to figure 4 above, risk mitigation is necessary whenever the risk factor is higher than the
risk threshold in order to keep the overall residual risk below the threshold value [2, 8].
c. RISK MANAGEMENT REPORT, PRODUCTION AND POST-
PRODUCTION INFORMATION
Review and filing of the risk management process is the end step before the medical device is
commercialized. Additionally production or post production information about the same or similar medical
device can be collected using files and documents prepared throughout the risk management process [2].
VI. IMPACT OF THE ISO 14971 ON ICT AND ENGINEERING PRACTICES
“A poor understanding of standards issues regarding engineering design, product development,
marketing, and market acceptance has undesirable consequences” [14]. In this regard, ISO 14971 provides risk
management framework for medical devices stakeholders, customers and regulating authorities [2].
Engineers as well as ICT professionals who work in medical device manufacturing company are
expected to note this framework to reduce the manufacturing cost, minimize associated hazards and to get
approval of marketing [2]. As integral part of a medical device, the ISO 14971 grants the mechanism to assess
the risks and manage associated hazards of software [13].
VII. CONCLUSION
Medical devices are used by humans and should be safe to use. However, risks cannot be avoided
completely, they can be greatly minimized if companies are aware of those impending hazards and follow
effective risk management systems. ISO 14971 is a risk management standard for medical devices that provides
systematic framework of risk management policies, procedures and practices.
The standard states that the manufacturer should establish a document of risk analysis, risk evaluation,
risk control, production and post production information, which is used throughout the life cycle of the medical
device. It also provides information about expectations of top managements, personnel’s qualification who
perform the risk management, the risk management plan they develop and follow as well as documentation of
the overall procedures.
Engineers as well as ICT professionals who work in medical device manufacturing company are
expected to note this framework to reduce the manufacturing cost, minimize associated hazards and to get
approval of marketing by government authorities. To sum up, ISO 14971 prevents customers from impending
hazards by providing effective risk management procedures.
IJLRET
International Journal of Latest Research in Engineering and Technology (IJLRET)
ISSN: 2454-5031
www.ijlret.com || Volume 03 - Issue 03 || March 2017 || PP. 83-87
www.ijlret.com 87 | Page
REFERENCES
[1]. 2004, What is Risk Mitigation? [Online]: Risk Mitigation Associates, Available:
http://www.riskmitigationassoc.com/cgs.aspx?id=wirm1[Accessed August 31, 2012].
[2]. 2007, ISO 14971 [Online], International organization for standardization (ISO)
Available:http://www.isosert.ru/isosert_iso_14971.pdf[Accessed August 8, 2012].
[3]. 2011a, Australian regulatory guidelines for medical devices (ARGMD) [Online], Available:
http://www.tga.gov.au/pdf/devicesargmd.pdf[Accessed August 10, 2012].
[4]. 2011b, why do we need standards? [Online]: European Telecommunications Standards Institute - ETSI
Available: http://www.etsi.org/WebSite/Standards/WhyWeNeedStandards.aspx [Accessed August 17,
2012].
[5]. 2012a, ISO 14971 Medical Devices [Online]: The British Standards Institution Available:
http://www.bsigroup.ca/enca/assessmentandcertification/managementsystems/standards-
schemes/iso14971/[Accessed August 24, 2012].
[6]. 2012b, Risk mitigation [Online]: WebFinance, Inc., Available:
http://www.investorwords.com/19332/risk_mitigation.html[Accessed August 31, 2012].
[7]. 2012c, What is a Standard? [Online]: Standards Australia,
Available:http://www.standards.org.au/StandardsDevelopment/What_is_a_Standard/Pages/default.aspx
[Accessed August15, 2012].
[8]. n.d. -a, Risk Management in the (Bio) Pharmaceutical and Device Industry [Online]: Labcompliance
Available:http://www.labcompliance.com/tutorial/risk/default.aspx[Accessed August17, 2012].
[9]. n.d. -b, What is Risk? [Online], Available: http://www.unisdr.org/2004/campaign/booklet-
eng/Pagina9ing.pdf
[10]. Bandar F. Al-Mifgai n.d., Medical Device Standards [Online],
Available:http://www.strategicstandards.com/files/MedicalDeviceStandards.pdf[Accessed August 08,
2012].
[11]. Begoña Narvaez & Hyman, William A. n.d., Prospective Risk Management:Analysis, Evaluation, and
Control [Online], Available:http://www.psqh.com/septemberoctober-2010/633-prospective-
riskmanagement-.html[Accessed August8, 2012].
[12]. Sandra Brolin n.d., Global Regulatory Requirements for Medical Devices Mälardalen University
Available:http://mdh.divaportal.org/smash/get/diva2:121327/FULLTEXT01[Accessed August
12,2012].
[13]. Peter Jordan n.d.,Medical Device Software Standards [Online]: The IEEE
Available:http://ieeexplore.ieee.org.ezproxy.flinders.edu.au/ielx5/5674129/5679193/05679198.pdf?tp=
&arnumber=5679198&isnumber=5679193[AccessedAugust 18, 2012].
[14]. Daniel Schultz 2005, Standards in Education [Online],
Available:http://www.astm.org/SNEWS/JULY_2005/schultz_jul05.html[AccessedAugust 24, 2012].
[15]. Trend lines International and Donawa Consulting 2008, A Regulatory Primer [Online]: The Trendlines
Group Ltd.,
Available:http://www.donawa.com/medicaldevice/donawa/files/A%20Regulatory%20Primer.pdf[Acce
ssed July 24,2012].
... The management of unavoidable risk associated with the product is the minimum requirement for its safety assurance for designing a product of innovative nature and in compliance with the regulatory requirement. (3) Risk can be defined as the combination of the probability in association with the severity and occurrence of harm that can change into a disaster. (4) Whereas the risk management is a technique of systematically applying the management approaches, procedures and practices including undertaking the assessment, evaluation and control of the associated risk. ...
... Under such condition, standards play a very important role in developing a e-ISSN: 2321-6794 [16] methodology which provides a common understanding among various producers, regulatory authorities and consumers. (3) ISO 14971 mentions about such standards. However there are certain influences of medical devices which affect the environment with toxic emissions of materials, chemical hazards and biological threats. ...
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Australian regulatory guidelines for medical devices (ARGMD), why do we need standards? [Online]: European Telecommunications Standards Institute-ETSI Available: http://www.etsi.org Medical Devices [Online]: The British Standards Institution Available What is a Standard?
[1]. 2004, What is Risk Mitigation? [Online]: Risk Mitigation Associates, Available: http://www.riskmitigationassoc.com/cgs.aspx?id=wirm1[Accessed August 31, 2012]. [2]. 2007, ISO 14971 [Online], International organization for standardization (ISO) Available:http://www.isosert.ru/isosert_iso_14971.pdf[Accessed August 8, 2012]. [3]. 2011a, Australian regulatory guidelines for medical devices (ARGMD) [Online], Available: http://www.tga.gov.au/pdf/devicesargmd.pdf[Accessed August 10, 2012]. [4]. 2011b, why do we need standards? [Online]: European Telecommunications Standards Institute-ETSI Available: http://www.etsi.org/WebSite/Standards/WhyWeNeedStandards.aspx [Accessed August 17, 2012]. [5]. 2012a, ISO 14971 Medical Devices [Online]: The British Standards Institution Available: http://www.bsigroup.ca/enca/assessmentandcertification/managementsystems/standardsschemes/iso14971/[Accessed August 24, 2012]. [6]. 2012b, Risk mitigation [Online]: WebFinance, Inc., Available: http://www.investorwords.com/19332/risk_mitigation.html[Accessed August 31, 2012]. [7]. 2012c, What is a Standard? [Online]: Standards Australia,
[8]. n.d.-a, Risk Management in the (Bio) Pharmaceutical and Device Industry [Online]: Labcompliance Available:http://www.labcompliance.com/tutorial/risk/default.aspx[Accessed August17, 2012]. [9]. n.d.-b, What is Risk?
  • Available
Available:http://www.standards.org.au/StandardsDevelopment/What_is_a_Standard/Pages/default.aspx [Accessed August15, 2012]. [8]. n.d.-a, Risk Management in the (Bio) Pharmaceutical and Device Industry [Online]: Labcompliance Available:http://www.labcompliance.com/tutorial/risk/default.aspx[Accessed August17, 2012]. [9]. n.d.-b, What is Risk? [Online], Available: http://www.unisdr.org/2004/campaign/bookleteng/Pagina9ing.pdf [10]. Bandar F.
Medical Device Standards
  • D Al-Mifgai N
Al-Mifgai n.d., Medical Device Standards [Online],
Global Regulatory Requirements for Medical Devices Mälardalen University Available:http://mdh.divaportal.org/smash/get/diva2:121327/FULLTEXT01Medical Device Software Standards [Online]: The IEEE Available
  • Sandra D Brolin N
Sandra Brolin n.d., Global Regulatory Requirements for Medical Devices Mälardalen University Available:http://mdh.divaportal.org/smash/get/diva2:121327/FULLTEXT01[Accessed August 12,2012]. [13]. Peter Jordan n.d.,Medical Device Software Standards [Online]: The IEEE Available:http://ieeexplore.ieee.org.ezproxy.flinders.edu.au/ielx5/5674129/5679193/05679198.pdf?tp= &arnumber=5679198&isnumber=5679193[AccessedAugust 18, 2012]. [14]. Daniel Schultz 2005, Standards in Education [Online],
]. [15]. Trend lines International and Donawa Consulting 2008, A Regulatory Primer [Online]: The Trendlines Group Ltd
  • Available
Available:http://www.astm.org/SNEWS/JULY_2005/schultz_jul05.html[AccessedAugust 24, 2012]. [15]. Trend lines International and Donawa Consulting 2008, A Regulatory Primer [Online]: The Trendlines Group Ltd., Available:http://www.donawa.com/medicaldevice/donawa/files/A%20Regulatory%20Primer.pdf[Acce ssed July 24,2012].
Medical Device Standards
  • F Bandar
  • Al-Mifgai N.D
Bandar F. Al-Mifgai n.d., Medical Device Standards [Online], Available:http://www.strategicstandards.com/files/MedicalDeviceStandards.pdf[Accessed August 08, 2012].