A medical device is a product which is used for medical purposes in patients, in diagnosis Diagnosis (plural diagnoses) is the identification of the nature of anything, either by process of elimination or other analytical methods. Diagnosis is used in many different disciplines, with slightly different implementations on the application of logic and experience to determine the cause and effect relationships. Below are given as examples, therapy Therapy , or treatment, is the attempted remediation of a health problem, usually following a diagnosis. In the medical field, it is synonymous with the word "treatment". Among psychologists, the term may refer specifically to psychotherapy or "talk therapy" or surgery Surgery is a medical specialty that uses operative manual and instrumental techniques on a patient to investigate and/or treat a pathological condition such as disease or injury, to help improve bodily function or appearance, and sometimes for religious reasons. An act of performing surgery may be called a surgical procedure, operation, or simply[citation needed]. If applied to the body, the effect of the medical device is primarily physical, in contrast to pharmaceutical drugs A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease, which exert a biochemical effect. Specific regional definitions of medical device vary slightly as detailed below. The medical devices are included in the category: Medical technology Medical technology is a part of the Health technology which encompasses a wide range of health care products and, in one form or another, is used to diagnose, monitor or treat every disease or condition that affects humans. These innovative technologies are improving the quality of health care delivered and patient outcomes through earlier.

Medical devices include a wide range of products varying in complexity and application. Examples include tongue depressors A tongue depressor is a device used in medical practice to depress the tongue to allow for examination of the mouth and throat. The most common modern tongue depressors have thin wooden blade, smoothed and rounded at both ends, but historically tongue depressors have been made of a variety of materials. Since they are inexpensive and difficult to, medical thermometers Medical thermometers are used for measuring human body temperature, with the tip of the thermometer being inserted either into the mouth , under the armpit (axillary temperature), or into the rectum via the anus (rectal temperature), blood sugar meters Blood glucose monitoring is a way of testing the concentration of glucose in the blood . Particularly important in the care of diabetes mellitus, a blood glucose test is performed by piercing the skin (typically, on the finger) to draw blood, then applying the blood to a chemically active disposable 'test-strip'. Different manufacturers use, total artificial hearts The term "artificial hearts" has often inaccurately been used to describe ventricular assist devices , which are pumps that assist the heart but do not replace it, fibrin scaffolds, stents In medicine, a stent is an artificial 'tube' inserted into a natural passage/conduit in the body to prevent, or counteract, a disease-induced, localized flow constriction. The term may also refer to a tube used to temporarily hold such a natural conduit open to allow access for surgery and X-ray machines An X-ray generator is a device used to generate X-rays. These devices are commonly used by radiographers to acquire an x-ray image of the inside of an object but they are also used in sterilization or fluorescence.

Contents

Definitions

European Union definition

Directive 2007/47/ec of the European Parliament The European Parliament is the directly elected parliamentary institution of the European Union (EU). Together with the Council of the European Union (the Council), it forms the bicameral legislative branch of the EU and has been described as one of the most powerful legislatures in the world. The Parliament and Council form the highest and of the council of 5 September, 2007, which amended the Council Directive 93/42/EEC of 14 June, 1993 concerning medical devices, defines a medical device as 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. Devices are to be used for the purpose of[citation needed]:

This includes devices that do 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.

The Medicines and Healthcare products Regulatory Agency The Medicines and Healthcare products Regulatory Agency is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe (MHRA) regulates medical devices in the UK under European legislation. Medical devices must not be mistaken with medicinal products. In the EU, all medical devices must be identified with the CE mark The CE marking is a mandatory conformance mark on many products placed on the single market in the European Economic Area (EEA). The CE marking certifies that a product has met EU consumer safety, health or environmental requirements. CE stands for conformité européenne, French for "European conformity". By affixing the CE marking to a.

Definition in USA by the Food and Drug Administration

A medical device, according to the U.S. Food and Drug Administration The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments, responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter (FDA), is an instrument A tool is a device that can be used to produce or achieve something, but that is not consumed in the process. Colloquially a tool can also be a procedure or process used for a specific purpose. Tools that are used in particular fields or activities may have different assignations such as Instrument, Utensil, Implement, Machine, Apparatus, apparatus, implement, machine A machine is a device that uses energy to perform some activity. In common usage, the meaning is that of a device having parts that perform or assist in performing any type of work. A simple machine is a device that transforms the direction or magnitude of a force without consuming any energy. The word "machine" is derived from the Latin, contrivance, implant An implant is a medical device manufactured to replace a missing biological structure, support a damaged biological structure, or enhance an existing biological structure. Medical implants are man-made devices, in contrast to a transplant, which is a transplanted biomedical tissue. The surface of implants that contact the body might be made of a, in vitro A procedure performed in vitro is performed not in a living organism but in a controlled environment, such as in a test tube or Petri dish. Many experiments in cellular biology are conducted outside of organisms or cells; because the test conditions may not correspond to the conditions inside of the organism, this may lead to results that do not reagent A reagent is a "substance or compound that is added to a system in order to bring about a chemical reaction or is added to see if a reaction occurs". Such a reaction is used to confirm the presence of another substance. Examples of such analytical reagents include Fehling's reagent, Millon's reagent and Tollens' reagent, or other similar or related article, including a component part, or accessory which is[citation needed]:

as defined by the Federal Food, Drug, and Cosmetic Act, 21 United States Code The United States Code is a compilation and codification of the general and permanent federal law of the United States. It contains 50 titles and is published every six years by the Office of the Law Revision Counsel of the House of Representatives [321] (h). Medical devices are regulated by the FDA Center for Devices and Radiological Health The Center for Devices and Radiological Health is the branch of the United States Food and Drug Administration responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices. The CDRH also oversees the radiation safety performance of non-medical devices which emit (CDRH).

Definition in Canada by the Food and Drugs Act

The term medical devices, as defined in the Food and Drugs Act, 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 being authorized for sale in Canada[citation needed].

Classification

The regulatory authorities recognize different classes of medical devices, based on their design complexity, their use characteristics, and their potential for harm if misused. 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 combination products takes this factor into consideration.

Canada

The Medical Devices Bureau of Health Canada has recognized 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. [1]. A guidance document for device classification is published by Heath Canada [2].

Canadian classes of medical devices generally correspond to the European Council Directive 93/42/EEC (MDD) devices as follows: Class IV (Canada) generally corresponds to Class III (ECD), Class III (Canada) generally corresponds to Class IIb (ECD), Class II (Canada) generally corresponds to Class IIa (ECD), and Class I (Canada) generally corresponds to Class I (ECD) [3]. Examples are surgical instruments (Class I); contact lenses, ultrasound scanners (Class II); orthopedic implants, hemodialysis machines (Class III); and cardiac pacemakers (Class IV) [4].

United States

The Food and Drug Administration has recognized three classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the device.[1] The classification procedures are described in the Code of Federal Regulations The Code of Federal Regulations is the codification of the general and permanent rules and regulations (sometimes called administrative law) published in the Federal Register by the executive departments and agencies of the Federal Government of the United States. The CFR is published by the Office of the Federal Register, an agency of the, Title 21, part 860 (usually known as 21 CFR 860).

Class I: General Controls

Class I devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. These devices are subject only to general controls. General controls cover such issues as manufacturer registration with the FDA, good manufacturing techniques, proper branding and labeling, notification of the FDA before marketing the device, and general reporting procedures.[2] (Most Class I devices are exempt from the good manufacturing practices and/or the FDA notification regulations.)[2] These controls are deemed sufficient to provide reasonable assurance of the safety and effectiveness of the device; or the device is not life-supporting or life-sustaining and does not present a reasonable source of injury Injury is damage or harm caused to the structure or function of the body caused by an outside agent or force, which may be physical or chemical, and either by accident or intentional. Personal Injury also refers to damage caused to the reputation of another rather than physical harm to the body. A severe and life-threatening injury is referred to through normal usage. Devices in this category include tongue depressors, bedpans A bedpan or bed pan is an object used for the toileting of a bedridden patient in a health care facility, usually made of a metal, glass, or plastic receptacle. A bed pan can be used for both urinary and fecal discharge. Many diseases can confine a patient to bed, necessitating the use of bedpans, including Alzheimer's disease, Parkinson's disease,, elastic bandages A bandage is a piece of material used either to support a medical device such as a dressing or splint, or on its own to provide support to the body. Bandages are available in a wide range of types, from generic cloth strips, to specialised shaped bandages designed for a specific limb or part of the body, although bandages can often be improvised, most hand-held dental instruments, examination gloves, and hand-held surgical instruments and other similar types of common equipment. Depending on the "stated/purported use" of a device, it may be necessary to obtain a Premarket Approval or 510K for the device, which is otherwise classifiable as a Class 1 device. Such devices are referred to as "reserved devices". The electrically-powered arthroscope (which is really an endoscope Endoscopy means looking inside and typically refers to looking inside the body for medical reasons using an endoscope (pronounced /ˈɛndəskoʊp/), an instrument used to examine the interior of a hollow organ or cavity of the body. Unlike most other medical imaging devices, endoscopes are inserted directly into the organ. Endoscopy can also refer powered electrically) is a case in point. While endoscopes are Class 1 devices, the electrically-powered arthroscopes need a pre-market notification (510K) although the manual arthroscopes do not. Pre-market notified devices are marketed as "at least as safe and effective, that is, substantially equivalent, to a legally marketed device."

Class II: General Controls with Special Controls

Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and additional existing methods are available to provide such assurances. Therefore, Class II devices are also subject to special controls in addition to the general controls of Class I devices. Special controls may include special labeling requirements, mandatory performance standards, and postmarket surveillance.[2] Devices in Class II are held to a higher level of assurance than Class I devices, and are designed to perform as indicated without causing injury or harm to patient or user. Devices in this class are typically non-invasive and include: x-ray X-radiation is a form of electromagnetic radiation. X-rays have a wavelength in the range of 0.01 to 10 nanometers, corresponding to frequencies in the range 30 petahertz to 30 exahertz (3 × 1016 Hz to 3 × 1019 Hz) and energies in the range 120 eV to 120 keV. They are shorter in wavelength than UV rays and longer than gamma rays. In many machines, PACS, powered wheelchairs A wheelchair is a chair with wheels, designed to be a replacement for walking. The device comes in variations where it's propelled by motors or by the seated occupant turning the rear wheels by hand. Often there are handles behind the seat for someone else to do the pushing. Wheelchairs are used by people for whom walking is difficult or, infusion pumps An infusion pump infuses fluids, medication or nutrients into a patient's circulatory system. It is generally used intravenously, although subcutaneous, arterial and epidural infusions are occasionally used, surgical drapes, surgical needles and suture material, acupuncture Acupuncture is the procedure of inserting and manipulating needles into various points on the body to relieve pain or for therapeutic purposes. The earliest written record of acupuncture is the Chinese text Shiji with elaboration of its history in the second century BCE medical text Huangdi Neijing (黃帝內經, English: Yellow Emperor's Inner needles.

Class III: General Controls and Premarket Approval

A Class III device is one for which insufficient information exists to assure safety and effectiveness solely through the general or special controls sufficient for Class I or Class II devices. Such a device needs premarket approval, a scientific review to ensure the device's safety and effectiveness, in addition to the general controls of Class I. Class III devices are described as those for which "insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of its safety and effectiveness or that application of special controls ... would provide such assurance and if, in addition, the device is life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury."[3]

Examples of Class III devices which require a premarket approval include replacement heart valves An artificial heart valve is a device implanted in the heart of a patient with heart valvular disease. When one of the four heart valves malfunctions, the medical choice may be to replace the natural valve with an artificial valve. This requires open-heart surgery, silicone Silicones are inert, synthetic compounds with a wide variety of forms and uses. Typically heat-resistant and rubber-like, they are commonly used in cookware, medical applications, sealants, adhesives, lubricants, insulation, and breast implants gel-filled breast implants, implanted cerebral stimulators, implantable pacemaker A pacemaker is a medical device which uses electrical impulses, delivered by electrodes contacting the heart muscles, to regulate the beating of the heart. The primary purpose of a pacemaker is to maintain an adequate heart rate, either because the heart's native pacemaker is not fast enough, or there is a block in the heart's electrical pulse generators and endosseous (intra-bone) implants (with the exception of root-form endosseous dental implants which were recently reclassified as Class II).

European Union (EU) and European Free Trade Association (EFTA)

The classification of medical devices in the European Union is outlined in Annex IX of the Council Directive 93/42/EEC. There are basically four classes, ranging from low risk to high risk.

The authorization of medical devices is guaranteed by a Declaration of Conformity. This declaration is issued by the manufacturer itself, but for products in Class Is, Im, IIa, IIb or III, it must be verified by a Certificate of Conformity issued by a Notified Body. A Notified Body is a public or private organisation that has been accredited to validate the compliance of the device to the European Directive. Medical devices that pertain to class I (on condition they do not need to be sterilised or are not used to measure a function) can be put on the market purely by self-certification.

The European classification depends on rules that involve the medical device's duration of body contact, its invasive character, its use of an energy source, its effect on the central circulation or nervous system, its diagnostic impact or its incorporation of a medicinal product.

Certified medical devices should have the CE mark The CE marking is a mandatory conformance mark on many products placed on the single market in the European Economic Area (EEA). The CE marking certifies that a product has met EU consumer safety, health or environmental requirements. CE stands for conformité européenne, French for "European conformity". By affixing the CE marking to a on the packaging, insert leaflets, etc.. These packagings should also show harmonised pictograms and EN This is an incomplete list of European standards maintained by CEN , CENELEC (European Committee for Electrotechnical Standardization) and ETSI (European Telecommunications Standards Institute): standardised logos to indicate essential features such as instructions for use, expiry date, manufacturer, sterile, don't reuse, etc.

Radio-Frequency Identification

Medical devices incorporating RFID

In 2004, the FDA authorized marketing of two different types of medical devices that incorporate radio-frequency identification, or RFID Radio-frequency identification is the use of an object (typically referred to as an RFID tag) applied to or incorporated into a product, animal, or person for the purpose of identification and tracking using radio waves. Some tags can be read from several meters away and beyond the line of sight of the reader. The first type is the SurgiChip tag, an external surgical marker that is intended to minimize the likelihood of wrong-site, wrong-procedure and wrong-patient surgeries. The tag consists of a label with passive transponder, along with a printer, an encoder and a RFID reader. The tag is labeled and encoded with the patient's name and the details of the planned surgery, and then placed in the patient's chart. On the day of surgery, the adhesive-backed tag is placed on the patient's body near the surgical site. In the operating room the tag is scanned and the information is verified with the patient's chart. Just before surgery, the tag is removed and placed back in the chart.

The second type of RFID medical device is the implantable radiofrequency transponder system for patient identification and health information. One example of this type of medical device is the VeriChip VeriChip is the only Food and Drug Administration -approved human-implantable radio-frequency identification (RFID) microchip. It is marketed by VeriChip Corporation, a subsidiary of Applied Digital Solutions, and it received United States FDA approval in 2004. About twice the length of a dime, the device is typically implanted between the, which includes a passive implanted transponder, inserter and scanner. The chip stores a unique electronic identification code that can be used to access patient identification and corresponding health information in a database. The chip itself does not store health information or a patient's name.[5]

Practical and information security considerations

Companies developing RFID-containing medical devices must consider product development issues common to other medical devices that come into contact with the body, are implanted in the body, or use computer software. For example, as part of product development, a company must implement controls and conduct testing on issues such as product performance, sterility, adverse tissue reactions, migration of the implanted transponder, electromagnetic interference, and software validation.

Medical devices that use RFID technology to store, access, and/or transfer patient information also raise significant issues regarding information security. The FDA defines "information security" as the process of preventing the modification, misuse or denial of use, or the unauthorized use of that information. At its core, this means ensuring the privacy of patient information.[6]

Four components of information security

The FDA has recommended that a company's specifications for implantable RFID-containing medical devices address the following four components of information security: confidentiality, integrity, availability and accountability (CIAA).

Although the FDA made these recommendations in the context of implantable RFID-containing medical devices, these principles are relevant to all uses of RFID in connection with pharmaceuticals and medical devices.[7]

List of medical devices

High risk devices

High risk devices are life supports Life support, in medicine is a broad term that applies to any therapy used to sustain a patients life while they are critically ill or injured. There are many therapies and techniques that may be used by clinicians to achieve the goal of sustaining life. Some examples include:, critical monitoring, energy emitting and other devices whose failure or misuse is reasonably likely to seriously injure Injury is damage or harm caused to the structure or function of the body caused by an outside agent or force, which may be physical or chemical, and either by accident or intentional. Personal Injury also refers to damage caused to the reputation of another rather than physical harm to the body. A severe and life-threatening injury is referred to patient or staff. Examples include:

An example of the stent used in an EVAR procedure

Medium risk devices

These are devices including many diagnostic instruments whose misuse, failure or absence (e.g. out of service) with no replacement available would have a significant impact on patient care Health care or healthcare is the treatment and prevention of illness. Health care is delivered by professionals in medicine, dentistry, allied health, and nursing, but would not be likely to cause direct serious injury. Examples include:

Low risk devices

Devices in this category are those whose failure or misuse is unlikely to result in serious consequences. Examples include:

Standardization & regulatory concerns

The ISO standards for medical devices are covered by ICS 11.100.20 and 11.040.01 [8], [9]. The quality and risk management regarding the topic for regulatory purposes is convened by ISO 13485 and ISO 14971. Further standards are IEC 60601-1 and for medical software IEC 62304. USFDA also published a series of guidances for industry regarding this topic against 21 CFR Subchapter H—Medical Devices.[10]

Academic resources

Industrial resources

Notes and references

  1. ^ Department of Justice Canada, "Medical Devices Regulations", SOR/98-282, Feb 21, 2006
  2. ^ Heath Canada, Guidance for the Risk-based Classification System
  3. ^ Industry Canada, "Canadian Medical Devices Industry"
  4. ^ Canadian Agency for Drugs and Technology in Health, "Medical Device Regulation In Canada: A Primer"
  5. ^ http://wistechnology.com/articles/2384/
  6. ^ http://wistechnology.com/articles/2384/
  7. ^ http://wistechnology.com/articles/2384/
  8. ^ International Organization for Standardization. "11.100.20: Biological evaluation of medical devices". http://www.iso.org/iso/products/standards/catalogue_ics_browse.htm?ICS1=11&ICS2=100&ICS3=20&. Retrieved 10 April 2009.
  9. ^ International Organization for Standardization. "11.040: Medical equipment". http://www.iso.org/iso/iso_catalogue/catalogue_ics/catalogue_ics_browse.htm?ICS1=11&ICS2=040. Retrieved 26 April 2009.
  10. ^ USFDA (2009). "Device Publications". http://www.fda.gov/CbER/dap/devpubs.htm. Retrieved 26 April 2009.
  11. ^ Lippincott Williams & Wilkins. "Journal Information". http://pt.wkhealth.com/pt/re/jce/home.htm;jsessionid=JpYXfLlnQ8TLpH1QhcM0T2HSpsQLFJLTSBcHHmC0QjzGgpPJ9V9Q!-707522149!181195629!8091!-1. Retrieved 10 April 2009.
  1. ^ FDA website: Classify your Medical Device
  2. ^ FDA Device Classification
  3. ^ Title 21 Food and Drugs Subchapter-H Medical Devices

See also

External links

Categories: Medical equipment | Medical technology

 

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