ISO 14971

ISO 14971 is an ISO standard for the application of risk management to medical devices.[1] The ISO Technical Committee responsible for the maintenance of this standard is ISO TC 210 working with IEC/SC62A through Joint Working Group one (JWG1). This standard is the culmination of the work starting in ISO/IEC Guide 51,[2] and ISO/IEC Guide 63.[3] The latest significant revision was published in 2007 with a minor update published in 2009. In 2013, a technical report ISO/TR 24971[4] was published by ISO TC 210 to provide expert guidance on the application of this standard.

This standard establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle. Such activity is required by higher level regulation and other quality management system standards such as ISO 13485. Specifically, ISO 14971 is a nine-part standard which first establishes a framework for risk analysis, evaluation, control, and management, and also specifies a procedure for review and monitoring during production and post-production.[5][6]

In 2012, a European harmonized version of this standard was adopted by CEN as EN ISO 14971:2012. This version is harmonized with respect to the three European Directives associated with medical devices Active Implantable Medical Device Directive 90/385/EEC[7], Medical Devices Directive 93/42/EEC,[8] and In-vitro Diagnostic Medical Device Directive 98/79/EC,[9] through the three 'Zed' Annexes (ZA, ZB & ZC). This was done to address the presumed compliance with the 3 Directives that is obtained through notified body certification audits and regulatory submissions that claim compliance to this standard.

EN ISO 14971:2012 applies only to manufacturers with devices intended for the European market; for the rest of the world, ISO 14971:2007 remains the standard recommended for medical device risk management purposes.

ISO 14971 risk management options

Inherent safety by design

For example:

  • Use specific connectors that cannot be connected to the wrong component.
  • Remove features that can be mistakenly selected or eliminate an interaction when it could lead to use error.
  • Improve the detectability or readability of controls, labels, and displays.
  • Automate device functions that are prone to use error when users perform the task manually.[10]

Protective measures in the medical device itself or in the manufacturing process

For example:

  • Incorporate safety mechanisms such as physical safety guards, shielded elements, or software or hardware interlocks.
  • Include warning screens to advise the user of essential conditions that should exist prior to proceeding with device use, such as specific data entry.
  • Use alerts for hazardous conditions, such as a “low battery” alert when an unexpected loss of the device’s operation could cause harm or death.
  • Use device technologies that require less maintenance or are “maintenance free.” [10]

Information for safety

For example:

  • Provide written information, such as warning or caution statements in the user manual that highlight and clearly discuss the use-related hazard.
  • Train users to avoid the use error.[10][11]

See also

References

  1. ^ ISO Catalogue: Medical devices -- Application of risk management to medical devices
  2. ^ "ISO/IEC Guide 51:2014 - Safety aspects -- Guidelines for their inclusion in standards". www.iso.org.
  3. ^ "ISO/IEC Guide 63:2012 - Guide to the development and inclusion of safety aspects in International Standards for medical devices". www.iso.org.
  4. ^ "ISO/TR 24971:2013 - Medical devices -- Guidance on the application of ISO 14971". www.iso.org.
  5. ^ "Medical devices -- Application of risk management to medical devices". ISO. Retrieved 13 September 2015.
  6. ^ Manookian, Brian. "Technical Information About ISO 14971". Cummings Manookian. Retrieved 13 September 2015.
  7. ^ Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
  8. ^ Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
  9. ^ Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
  10. ^ a b c "Applying Human Factors and Usability Engineering to Medical Devices" (PDF). U.S. Department of Health and Human Services Food and Drug Administration. February 3, 2016. This article incorporates text from this source, which is in the public domain.
  11. ^ One or more of the preceding sentences incorporates text from a work now in the public domain: Applying Human Factors and Usability Engineering to Medical Devices, U.S. Department of Health and Human Services Food and Drug Administration

External links

  • ISO 13485—Medical devices—Quality management systems—Requirements for regulatory purposes
  • ISO TC 210—Quality management and corresponding general aspects for medical devices
Hazard analysis

Note: Parts of this article are written from the perspective of aircraft safety analysis techniques and definitions; these may not represent current best practice and the article needs to be updated to represent a more generic description of hazard analysis and discussion of more modern standards and techniques.

A hazard analysis is used as the first step in a process used to assess risk. The result of a hazard analysis is the identification of different type of hazards. A hazard is a potential condition and exists or not (probability is 1 or 0). It may in single existence or in combination with other hazards (sometimes called events) and conditions become an actual Functional Failure or Accident (Mishap). The way this exactly happens in one particular sequence is called a scenario. This scenario has a probability (between 1 and 0) of occurrence. Often a system has many potential failure scenarios. It also is assigned a classification, based on the worst case severity of the end condition. Risk is the combination of probability and severity. Preliminary risk levels can be provided in the hazard analysis. The validation, more precise prediction (verification) and acceptance of risk is determined in the Risk assessment (analysis). The main goal of both is to provide the best selection of means of controlling or eliminating the risk. The term is used in several engineering specialties, including avionics, chemical process safety, safety engineering, reliability engineering and food safety.[1]

IEC 62304

The international standard IEC 62304 – medical device software – software life cycle processes is a standard which specifies life cycle requirements for the development of medical software and software within medical devices. It is harmonized by the European Union (EU) and the United States (US), and therefore can be used as a benchmark to comply with regulatory requirements from both these markets.

ISO 13485

ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996). ISO 13485:2016 Certificates meets the requirement of IEC 60601-2-25 : 1993 + A1: 1999 safety of Electrocardiograms.

The current ISO 13485 effective edition was published on 1 March 2016.

List of International Organization for Standardization standards

This is a list of published International Organization for Standardization (ISO) standards and other deliverables. For a complete and up-to-date list of all the ISO standards, see the ISO catalogue.The standards are protected by copyright and most of them must be purchased. However, about 300 of the standards produced by ISO and IEC's Joint Technical Committee 1 (JTC1) have been made freely and publicly available.

List of International Organization for Standardization standards, 14000-14999

This is a list of published International Organization for Standardization (ISO) standards and other deliverables. For a complete and up-to-date list of all the ISO standards, see the ISO catalogue.The standards are protected by copyright and most of them must be purchased. However, about 300 of the standards produced by ISO and IEC's Joint Technical Committee 1 (JTC1) have been made freely and publicly available.

List of International Organization for Standardization standards, 24000-25999

This is a list of published International Organization for Standardization (ISO) standards and other deliverables. For a complete and up-to-date list of all the ISO standards, see the ISO catalogue.The standards are protected by copyright and most of them must be purchased. However, about 300 of the standards produced by ISO and IEC's Joint Technical Committee 1 (JTC1) have been made freely and publicly available.

Medical device

A medical device is any device intended to be used for medical purposes. Thus what differentiates a medical device from an everyday device is its intended use. Medical devices benefit patients by helping health care providers diagnose and treat patients and helping patients overcome sickness or disease, improving their quality of life. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.

Discovery of what would be considered a medical device by modern standards dates as far back as c. 7000 BC in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States it wasn't until the Federal Food, Drug, and Cosmetic Act (FD&C Act) in 1938 that medical devices were regulated. Later in 1976, the Medical Device Amendments to the FD&C Act established medical device regulation and oversight as we know it today in the United States. Medical device regulation in Europe as we know it today came into effect in the 1993 by what is collectively know as the Medical Device Directive (MDD). On May 26th, 2017 the Medical Device Regulation (MDR) replaced the MDD.

Medical devices vary in both their intended use and indications for use. Examples range from simple, low-risk devices such as tongue depressors, medical thermometers, disposable gloves, and bedpans to complex, high-risk devices that are implanted and sustain life. One example of high-risk devices are those with Embedded software such as pacemakers, and which assist in the conduct of medical testing, implants, and prostheses. Items as intricate as housings for cochlear implants are manufactured through the deep drawn and shallow drawn manufacturing processes. The design of medical devices constitutes a major segment of the field of biomedical engineering.

The global medical device market reached roughly $209 billion USD in 2006 and was estimated to be between $220 and $250 billion USD in 2013. The United States controls ~40% of the global market followed by Europe (25%), Japan (15%), and the rest of the world (20%). Although collectively Europe has a larger share, Japan has the second largest country market share. The largest market shares in Europe (in order of market share size) belong to Germany, Italy, France, and the United Kingdom. The rest of the world comprises regions like (in no particular order) Australia, Canada, China, India, and Iran. This article discusses what constitutes a medical device in these different regions and throughout the article these regions will be discussed in order of their global market share.

Medical equipment management

Healthcare Technology Management (sometimes referred to as clinical engineering, clinical engineering management, clinical technology management, healthcare technology management, medical equipment management, biomedical maintenance, biomedical equipment management, and biomedical engineering) is a term for the professionals who manage operations, analyze and improve utilization and safety, and support servicing healthcare technology. These healthcare technology managers are, much like other healthcare professionals referred to by various specialty or organizational hierarchy names.

Some of the titles of healthcare technology management professionals are biomed, biomedical equipment technician, biomedical engineering technician, biomedical engineer, BMET, biomedical equipment management, biomedical equipment services, imaging service engineer, imaging specialist, clinical engineer technician, clinical engineering equipment technician, field service engineer, field clinical engineer, clinical engineer, and medical equipment repair person. Regardless of the various titles, these professionals offer services within and outside of healthcare settings to enhance the safety, utilization, and performance on medical devices, applications, and systems.

They are a fundamental part of managing, maintaining, and/or designing medical devices, applications, and systems for use in various healthcare settings, from the home and the field to the doctor's office and the hospital.

HTM includes the business processes used in interaction and oversight of the technology involved in the diagnosis, treatment, and monitoring of patients. The related policies and procedures govern activities such as the selection, planning, and acquisition of medical devices, and the inspection, acceptance, maintenance, and eventual retirement and disposal of medical equipment.

Nursing care bed

A nursing care bed (also nursing bed or care bed) is a bed that has been adapted to the particular needs of people who are ill or disabled. Nursing care beds are used in private home care as well as in inpatient care (retirement and nursing homes).

Risk management

Risk management is the identification, evaluation, and prioritization of risks (defined in ISO 31000 as the effect of uncertainty on objectives) followed by coordinated and economical application of resources to minimize, monitor, and control the probability or impact of unfortunate events or to maximize the realization of opportunities.

Risks can come from various sources including uncertainty in financial markets, threats from project failures (at any phase in design, development, production, or sustainment life-cycles), legal liabilities, credit risk, accidents, natural causes and disasters, deliberate attack from an adversary, or events of uncertain or unpredictable root-cause. There are two types of events i.e. negative events can be classified as risks while positive events are classified as opportunities. Several risk management standards have been developed including the Project Management Institute, the National Institute of Standards and Technology, actuarial societies, and ISO standards. Methods, definitions and goals vary widely according to whether the risk management method is in the context of project management, security, engineering, industrial processes, financial portfolios, actuarial assessments, or public health and safety.

Strategies to manage threats (uncertainties with negative consequences) typically include avoiding the threat, reducing the negative effect or probability of the threat, transferring all or part of the threat to another party, and even retaining some or all of the potential or actual consequences of a particular threat, and the opposites for opportunities (uncertain future states with benefits).

Certain aspects of many of the risk management standards have come under criticism for having no measurable improvement on risk; whereas the confidence in estimates and decisions seem to increase. For example, one study found that one in six IT projects were "black swans" with gigantic overruns (cost overruns averaged 200%, and schedule overruns 70%).

Use error

The term use error has recently been introduced to replace the commonly used terms human error and user error. The new term, which has already been adopted by international standards organizations for medical devices (see #Use errors in health care below for references), suggests that accidents should be attributed to the circumstances, rather than to the human beings who happened to be there.

ISO standards by standard number
1–9999
10000–19999
20000+

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