Medical device

This article needs to be updated. The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own regulatory framework); but more updates are triggered as also the relation related to the recognition of conformity assessment certificates between the European Union and Switzerland changed since 26 May 2021. Please help update this article to reflect recent events or newly available information. (April 2022)

A medical device is any device intended to be used for medical purposes. 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

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. The design of medical devices constitutes a major segment of the field of biomedical engineering.

The global medical device market was estimated to be between $220 and US$250 billion in 2013.^[4] 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.

Definition

A global definition for medical device is difficult to establish because there are numerous regulatory bodies worldwide overseeing the marketing of medical devices. Although these bodies often collaborate and discuss the definition in general, there are subtle differences in wording that prevent a

Definitions by region

United States (Food and Drug Administration)

Section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act^[5] defines a device as an "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

• recognized in the official
  United States Pharmacopoeia
  , or any supplement to them
• Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
• Intended to affect the structure or any function of the body of man or other animals, and

which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term 'device' does not include software functions excluded pursuant to section 520(o)."

European Union

According to Article 1 of Council Directive 93/42/EEC,^[6] 'medical device' means any "instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
• investigation, replacement or modification of the anatomy or of a physiological process,
• control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;"

EU Legal framework

Based on the New Approach, rules that relate to safety and performance of medical devices were harmonised in the EU in the 1990s. The New Approach, defined in a European Council Resolution of May 1985,^[7] represents an innovative way of technical harmonisation. It aims to remove technical barriers to trade and dispel the consequent uncertainty for economic operators, to facilitate free movement of goods inside the EU.^{[citation needed]}

The previous core legal framework consisted of three directives:^{[citation needed]}

• Directive 90/385/EEC regarding active implantable medical devices
• Directive 93/42/EEC regarding medical devices
• Directive 98/79/EC regarding in vitro diagnostic medical devices (Until 2022, the In Vitro Diagnosis Regulation (IVDR) will replace the EU's current Directive on In-Vitro Diagnostic (98/79/EC)).

They aim at ensuring a high level of protection of human health and safety and the good functioning of the Single Market. These three main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive 2007/47 EC.^[8]

The government of each Member State must appoint a competent authority responsible for medical devices.^[9] The competent authority (CA) is a body with authority to act on behalf of the member state to ensure that member state government transposes requirements of medical device directives into national law and applies them. The CA reports to the minister of health in the member state. The CA in one Member State has no jurisdiction in any other member state, but exchanges information and tries to reach common positions.

In the UK, for example, the

In September 2012, the European Commission proposed new legislation aimed at enhancing safety, traceability, and transparency.^[10] The regulation was adopted in 2017.

The future core legal framework consists of two regulations, replacing the previous three directives:

• The
  Medical Devices Regulation
  (MDR (EU) 2017/745)
• The In Vitro Diagnostic medical devices regulation (IVDR (EU) 2017/746)

Japan

Article 2, Paragraph 4, of the

The term medical device, as defined in the Food and Drugs Act, is "any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in: the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in a human being; the restoration, correction or modification of a body function or the body structure of a human being; the diagnosis of pregnancy in a human being; or the care of a human being during pregnancy and at and after the birth of a child, including the care of the child. It also includes a contraceptive device but does not include a drug."^[12]

The term covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. Health Canada reviews medical devices to assess their safety, effectiveness, and quality before authorizing their sale in Canada.^[13] According to the Act, medical device does not include any device that is intended for use in relation to animals.^[14]

India

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There is no specific definition of the term 'medical devices' in Indian law. However, certain medical devices are notified as DRUGS under the Drugs & Cosmetics Act. Section 3 (b) (iv) relating to definition of "drugs" holds that "Devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals" are also drugs.^[15] As of April 2022, 14 classes of devices are classified as drugs.

Regulation and oversight

Risk classification

The regulatory authorities recognize different classes of medical devices based on their potential for harm if misused, design complexity, and their use characteristics. Each country or region defines these categories in different ways. The authorities also recognize that some devices are provided in combination with drugs, and regulation of these

Classifying medical devices based on their risk is essential for maintaining patient and staff safety while simultaneously facilitating the marketing of medical products. By establishing different risk classifications, lower risk devices, for example, a stethoscope or tongue depressor, are not required to undergo the same level of testing that higher risk devices such as artificial pacemakers undergo. Establishing a hierarchy of risk classification allows regulatory bodies to provide flexibility when reviewing medical devices.^{[citation needed]}

Classification by region

United States

This section splitting the content into a new article. (March 2019)

Under the

The classification procedures are described in the Code of Federal Regulations, Title 21, part 860 (usually known as 21 CFR 860).^[17]

Class I devices are subject to the least regulatory control and are not intended to help support or sustain life or be substantially important in preventing impairment to human health, and may not present an unreasonable risk of illness or injury.^[18] Examples of Class I devices include elastic bandages, examination gloves, and hand-held surgical instruments.^[19]

Class II devices are subject to special labeling requirements, mandatory performance standards and postmarket surveillance.^[19] Examples of Class II devices include acupuncture needles, powered wheelchairs, infusion pumps, air purifiers, surgical drapes, stereotaxic navigation systems, and surgical robots.^{[16][19][20][21][22]}

Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury and require

In November 2018, the Federal Administrative Court of Switzerland decided that the "Sympto" app, used to analyze a woman's menstrual cycle, was a medical device because it calculates a fertility window for each woman using personal data. The manufacturer, Sympto-Therm Foundation, argued that this was a didactic, not a medical process. the court laid down that an app is a medical device if it is to be used for any of the medical purposes provided by law, and creates or modifies health information by calculations or comparison, providing information about an individual patient.^[24]

Japan

Medical devices (excluding in vitro diagnostics) in Japan are classified into four classes based on risk:^[11]

Classes I and II distinguish between extremely low and low risk devices. Classes III and IV, moderate and high risk respectively, are highly and specially controlled medical devices. In vitro diagnostics have three risk classifications.^[25]

Rest of the world

For the remaining regions in the world, the risk classifications are generally similar to the United States, European Union, and Japan or are a variant combining two or more of the three countries' risk classifications.^{[citation needed]}

Australia

The classification of medical devices in Australia is outlined in section 41BD of the Therapeutic Goods Act 1989 and Regulation 3.2 of the Therapeutic Goods Regulations 2002, under control of the Therapeutic Goods Administration. Similarly to the EU classification, they rank in several categories, by order of increasing risk and associated required level of control. Various rules identify the device's category^[26]

Canada

The Medical Devices Bureau of Health Canada recognizes four classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the device. Class I devices present the lowest potential risk and do not require a licence. Class II devices require the manufacturer's declaration of device safety and effectiveness, whereas Class III and IV devices present a greater potential risk and are subject to in-depth scrutiny.^[13] A guidance document for device classification is published by Health Canada.^[27]

Canadian classes of medical devices correspond to the European Council Directive 93/42/EEC (MDD) devices:^[27]

• Class I (Canada) generally corresponds to Class I (ECD)
• Class II (Canada) generally corresponds to Class IIa (ECD)
• Class III (Canada) generally corresponds to Class IIb (ECD)
• Class IV (Canada) generally corresponds to Class III (ECD)

Examples include surgical instruments (Class I), contact lenses and ultrasound scanners (Class II), orthopedic implants and hemodialysis machines (Class III), and cardiac pacemakers (Class IV).^[28]

India

Medical devices in India are regulated by Central Drugs Standard Control Organisation (

The CDSCO classifications of medical devices govern alongside the regulatory approval and registration by the CDSCO is under the DCGI. Every single medical device in India pursues a regulatory framework that depends on the drug guidelines under the Drug and Cosmetics Act (1940) and the Drugs and Cosmetics runs under 1945. CDSCO classification for medical devices has a set of risk classifications for numerous products planned for notification and guidelines as medical devices.^{[citation needed]}

Iran

Iran produces about 2,000 types of medical devices and medical supplies, such as appliances, dental supplies, disposable sterile medical items, laboratory machines, various biomaterials and dental implants. 400 Medical products are produced at the C and D risk class with all of them licensed by the Iranian Health Ministry in terms of safety and performance based on EU-standards.

Some Iranian medical devices are produced according to the European Union standards.

Some producers in Iran export medical devices and supplies which adhere to European Union standards to applicant countries, including 40 Asian and European countries.

Some Iranian producers export their products to foreign countries.^[29]

Validation and verification

The main difference between the two is that validation is focused on ensuring that the device meets the needs and requirements of its intended users and the intended use environment, whereas verification is focused on ensuring that the device meets its specified design requirements.^[citation needed]

Standardization and regulatory concerns

The

Starting in the late 1980s,[38] the FDA increased its involvement in reviewing the development of medical device software. The precipitant for change was a radiation therapy device (Therac-25) that overdosed patients because of software coding errors.^[39] FDA is now focused on regulatory oversight on medical device software development process and system-level testing.^[40]

A 2011 study by Dr.

A 2014 study by Dr. Diana Zuckerman, Paul Brown, and Dr. Aditi Das of the National Center for Health Research, published in JAMA Internal Medicine, examined the scientific evidence that is publicly available about medical implants that were cleared by the FDA 510(k) process from 2008 to 2012. They found that scientific evidence supporting "substantial equivalence" to other devices already on the market was required by law to be publicly available, but the information was available for only 16% of the randomly selected implants, and only 10% provided clinical data. Of the more than 1,100 predicate implants that the new implants were substantially equivalent to, only 3% had any publicly available scientific evidence, and only 1% had clinical evidence of safety or effectiveness.^[42] The researchers concluded that publicly available scientific evidence on implants was needed to protect the public health.^{[citation needed]}

In 2014-2015, a new international agreement, the Medical Device Single Audit Program (MDSAP), was put in place with five participant countries: Australia, Brazil, Canada, Japan, and the United States. The aim of this program was to "develop a process that allows a single audit, or inspection to ensure the medical device regulatory requirements for all five countries are satisfied".^[43]

In 2017, a study by Dr. Jay Ronquillo and Dr. Diana Zuckerman published in the peer-reviewed policy journal Milbank Quarterly found that electronic health records and other device software were recalled due to life-threatening flaws. The article pointed out the lack of safeguards against hacking and other cybersecurity threats, stating "current regulations are necessary but not sufficient for ensuring patient safety by identifying and eliminating dangerous defects in software currently on the market".^[44] They added that legislative changes resulting from the law entitled the 21st Century Cures Act "will further deregulate health IT, reducing safeguards that facilitate the reporting and timely recall of flawed medical software that could harm patients".

A study by Dr. Stephanie Fox-Rawlings and colleagues at the National Center for Health Research, published in 2018 in the policy journal Milbank Quarterly, investigated whether studies reviewed by the FDA for high-risk medical devices are proven safe and effective for women, minorities, or patients over 65 years of age.^[45] The law encourages patient diversity in clinical trials submitted to the FDA for review, but does not require it. The study determined that most high-risk medical devices are not tested and analyzed to ensure that they are safe and effective for all major demographic groups, particularly racial and ethnic minorities and people over 65. Therefore, they do not provide information about safety or effectiveness that would help patients and physicians make well informed decisions.

In 2018, an investigation involving journalists across 36 countries coordinated by the International Consortium of Investigative Journalists (ICIJ) prompted calls for reform in the United States, particularly around the 510(k) substantial equivalence process;^[46] the investigation prompted similar calls in the UK and Europe Union.^[47]

Packaging standards

Medical device packaging is highly regulated. Often medical devices and products are sterilized in the package.^[48] Sterility must be maintained throughout distribution to allow immediate use by physicians. A series of special

• ASTM F2097 – Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
• ASTM F2475-11 – Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials^[49]
• EN 868 Packaging materials and systems for medical devices to be sterilized, General requirements and test methods
• ISO 11607 Packaging for terminally sterilized medical devices

Package testing is part of a quality management system including verification and validation. It is important to document and ensure that packages meet regulations and end-use requirements. Manufacturing processes must be controlled and validated to ensure consistent performance.^[50][51] EN ISO 15223-1 defines symbols that can be used to convey important information on packaging and labeling.

Biocompatibility standards

• ISO 10993 - Biological Evaluation of Medical Devices

Cleanliness standards

Medical device cleanliness has come under greater scrutiny since 2000, when Sulzer Orthopedics recalled several thousand metal hip implants that contained a manufacturing residue.^[52] Based on this event, ASTM established a new task group (F04.15.17) for established test methods, guidance documents, and other standards to address cleanliness of medical devices. This task group has issued two standards for permanent implants to date: 1. ASTM F2459: Standard test method for extracting residue from metallic medical components and quantifying via gravimetric analysis^[53] 2. ASTM F2847: Standard Practice for Reporting and Assessment of Residues on Single Use Implants^[54] 3. ASTM F3172: Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices^[55]

In addition, the cleanliness of re-usable devices has led to a series of standards, including:

• ASTM E2314: Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)"^[56]
• ASTM D7225: Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors^[57]
• ASTM F3208: Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices^[55]

The ASTM F04.15.17 task group is working on several new standards that involve designing implants for cleaning, selection and testing of brushes for cleaning reusable devices, and cleaning assessment of medical devices made by additive manufacturing.^[58] Additionally, the FDA is establishing new guidelines for reprocessing reusable medical devices, such as orthoscopic shavers, endoscopes, and suction tubes.^[59] New research was published in ACS Applied Interfaces and Material to keep Medical Tools pathogen free.^[60]

Safety standards

Design, prototyping, and product development

Medical device manufacturing requires a level of process control according to the classification of the device. Higher risk; more controls. When in the initial R&D phase, manufacturers are now beginning to design for manufacturability. This means products can be more precision-engineered to for production to result in shorter lead times, tighter tolerances and more advanced specifications and prototypes. These days, with the aid of CAD or modelling platforms, the work is now much faster, and this can act also as a tool for strategic design generation as well as a marketing tool.^[61]

Failure to meet cost targets will lead to substantial losses for an organisation. In addition, with global competition, the R&D of new devices is not just a necessity, it is an imperative for medical device manufacturers. The realisation of a new design can be very costly, especially with the shorter product life cycle. As technology advances, there is typically a level of quality, safety and reliability that increases exponentially with time.^[61]

For example, initial models of the artificial cardiac pacemaker were external support devices that transmits pulses of electricity to the heart muscles via electrode leads on the chest. The electrodes contact the heart directly through the chest, allowing stimulation pulses to pass through the body. Recipients of this typically developed an infection at the entrance of the electrodes, which led to the subsequent trial of the first internal pacemaker, with electrodes attached to the myocardium by thoracotomy. Future developments led to the isotope-power source that would last for the lifespan of the patient.^{[page needed]}

Software

Mobile medical applications

With the rise of smartphone usage in the medical space, in 2013, the FDA issued to regulate

On September 25, 2013, the FDA released a draft guidance document for regulation of mobile medical applications, to clarify what kind of mobile apps related to health would not be regulated, and which would be.[65]^[66]

Cybersecurity

Medical devices such as

Similar to hazards, cybersecurity threats and vulnerabilities cannot be eliminated but must be managed and reduced to a reasonable level.[82] When designing medical devices, the tier of cybersecurity risk should be determined early in the process in order to establish a cybersecurity vulnerability and management approach (including a set of cybersecurity design controls). The medical device design approach employed should be consistent with the NIST Cybersecurity Framework for managing cybersecurity-related risks.

In August 2013, the FDA released over 20 regulations aiming to improve the security of data in medical devices,

Artificial intelligence

The number of approved medical devices using artificial intelligence or machine learning (AI/ML) is increasing. As of 2020, there were several hundred AI/ML medical devices approved by the US FDA or CE-marked devices in Europe.

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Medical equipment (also known as armamentarium

Types

There are several basic types:

• CT scanners, and x-ray machines
  .
• Treatment equipment includes infusion pumps, medical lasers and LASIK surgical machines.
• dialysis machines
  .
• ECG, EEG, and blood pressure
  .
• Medical laboratory equipment automates or helps analyze
  dissolved gases
  in the blood.
• Diagnostic medical equipment may also be used in the home for certain purposes, e.g. for the control of diabetes mellitus, such as in the case of continuous glucose monitoring.
• Therapeutic: physical therapy machines like continuous passive range of motion (CPM) machines
• Air purifying equipment may be used in the periphery of the operating room^[92] or at point sources including near the surgical site for the removal of surgical plume.^[93]

The identification of medical devices has been recently improved by the introduction of Unique Device Identification (UDI) and standardised naming using the Global Medical Device Nomenclature (GMDN) which have been endorsed by the International Medical Device Regulatory Forum (IMDRF).^[94]

A

Medical equipment donation

There are challenges surrounding the availability of medical equipment from a

The circulation of medical equipment is not limited to donations. The rise of reuse and recycle-based solutions, where gently-used medical equipment is donated and redistributed to communities in need, is another form of equipment distribution. An interest in reusing and recycling emerged in the 1980s when the potential health hazards of medical waste on the East Coast beaches became highlighted by the media.[97] Connecting the large demand for medical equipment and single-use medical devices, with a need for waste reduction, as well as the problem of unequal access for low-income communities led to the Congress enacting the Medical Waste Tracking Act of 1988.^[98] Medical equipment can be donated either by governments or non-governmental organizations, domestic or international.^[99] Donated equipment ranges from bedside assistance to radiological equipment.

Medical equipment donation has come under scrutiny with regard to donated-device failure and loss of warranty in the case of previous-ownership. Most medical devices and production company warranties to do not extend to reused or donated devices, or to devices donated by initial owners/patients. Such reuse raises matters of patient autonomy, medical ethics, and legality.^[99] Such concerns conflict with the importance of equal access to healthcare resources, and the goal of serving the greatest good for the greatest number.^[100]

Academic resources

• Medical & Biological Engineering & Computing journal
• Expert Review of Medical Devices journal

University-based research packaging institutes

• University of Minnesota - Medical Devices Center (MDC)
• University of Strathclyde - Strathclyde Institute of Medical Devices (SIMD)
• Flinders University - Medical Device Research Institute (MDRI)
• Michigan State University - School of Packaging (SoP)^[101]
• IIT Bombay - Biomedical Engineering and Technology (incubation) Centre
  (BETiC)

• Assistive technology
• Clinical engineer
• Design history file
• Durable medical equipment
• Electromagnetic compatibility
• Electronic health record
• Federal Institute for Drugs and Medical Devices
• GHTF
• Health Level 7
• Home medical equipment
• Instruments used in general medicine
• Instruments used in obstetrics and gynecology
• List of common EMC test standards
• Medical grade silicone
• Medical logistics
• Medical technology
• Pharmacopoeia
• Safety engineer
• Telemedicine

References