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Medical device
A medical device is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body (which would make it a drug).[1] Whereas medicinal products (also called pharmaceuticals) achieve their principal action by pharmacological, metabolic or immunological means, medical devices act by other means like physical, mechanical, or thermal means. Medical devices vary greatly in complexity and application. Examples range from simple devices such as tongue depressors, medical thermometers, and disposable gloves to advanced devices such as computers 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 reached roughly 209 billion US Dollar in 2006.
Definitions
European Union legal framework and definition
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 [2], 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. The core legal framework consists of 3 directives: 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 They aim at ensuring a high level of protection of human health and safety and the good functioning of the Single Market. These 3 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 [3].
Medical device Directive 2007/47/ec defines a medical device as (paraphrasing): Any instrument, apparatus, appliance, software, material or other article that is used alone or in combination, including software specifically for diagnostic or therapeutic purposes, that the manufacturer intends for use in human beings. Such devices are used for: 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
This includes devices that do not achieve their principal intended action in or on the human body by pharmacological, immunological, or metabolic meansbut may be assisted in their function by such means. The government of each Member State must appoint a competent authority responsible for medical devices. The competent authority (CA) is a body with authority to act on behalf of the member state government 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 Medicines and Healthcare products Regulatory Agency (MHRA) acts as a CA. in Italy it is the Ministero Salute (Ministry of Health)[4] Medical devices must not be mistaken with medicinal products. In the EU, all medical devices must be identified with the CE mark.
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.
Medical device
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 manufacturers declaration of device safety and effectiveness, whereas Class III and IV devices present a greater potential risk and are subject to in-depth scrutiny.[7] A guidance document for device classification is published by Health Canada .[8] Canadian classes of medical devices correspond to the European Council Directive 93/42/EEC (MDD) devices:
[9]
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)
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).[10]
United States
Under the Food, Drug, and Cosmetic Act, the Food and Drug Administration recognizes three classes of medical devices, based on the level of control necessary to assure safety and effectiveness. The classification procedures are described in the Code of Federal Regulations, Title 21, part 860 (usually known as 21 CFR 860). The USFDA allows for two regulatory pathways that allow the marketing of medical devices. The first, and by far the most common is the so-called 510(k) process (named after the CFR section that describes the process). A new medical device that can be demonstrated to be "substantially equivalent" to a previously legally marketed device can be "cleared" by the FDA for marketing as long as the general and special controls, as described below, are met. The vast majority of new medical devices (99%) enter the marketplace via this process. The 510(k) pathway rarely requires clinical trials. The second regulatory pathway for new medical devices is the Premarket Approval process, described below, which is similar to the pathway for a new drug approval. Typically, clinical trials are required for this premarket approval pathway. Class I: General controls Class I devices are subject to the least regulatory control. Class I devices are subject to "General Controls" as are Class II and Class III devices. General controls include provisions that relate to adulteration; misbranding; device registration and listing; premarket notification; banned devices; notification, including repair, replacement, or refund; records and reports; restricted devices; and good manufacturing practices. Class I devices 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. Most Class I devices are exempt from the premarket notification and a few are also exempted from most good manufacturing practices regulation. Examples of Class I devices include elastic bandages, examination gloves, and hand-held surgical instruments. Class II: General controls with special controls Class II devices are those for which general controls alone cannot assure safety and effectiveness, and existing methods are available that provide such assurances. In addition to complying with general controls, Class II devices are also subject to special controls. A few Class II devices are exempt from the premarket notification. Special controls may include special labeling requirements, mandatory performance standards and postmarket surveillance. 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. Examples of Class II devices include powered wheelchairs, infusion pumps, and surgical drapes.
Medical device 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 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. Examples of Class III devices that currently require a premarket notification include implantable pacemaker, pulse generators, HIV diagnostic tests, automated external defibrillators, and endosseous implants.
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 require sterilization or do not measure a function) can be marketed purely by self-certification. The European classification depends on rules that involve the medical device's duration of body contact, invasive character, use of an energy source, effect on the central circulation or nervous system, diagnostic impact, or incorporation of a medicinal product. Certified medical devices should have the CE mark on the packaging, insert leaflets, etc.. These packagings should also show harmonised pictograms and EN standardised logos to indicate essential features such as instructions for use, expiry date, manufacturer, sterile, don't reuse, etc.
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[11]
Class I - measuring or Class I - supplied sterile or class IIa Low - medium Class IIb Class III Active implantable medical devices (AIMD) Medium - high High High
Medical device
Medical device
Packaging standards
Medical device packaging is highly regulated. Often medical devices and products are sterilized in the package. Sterility must be maintained throughout distribution to allow immediate use by physicians. A series of special packaging tests measure the ability of the package to maintain sterility. Relevant standards include: ASTM D1585 Guide for Integrity Testing of Porous Medical Packages ASTM F2097 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products 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 documents and ensures that packages meet regulations and end-use requirements. Manufacturing processes must be controlled and validated to ensure consistent performance.
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.[21] 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[22] 2. ASTM F2847: Standard Practice for Reporting and Assessment of Residues on Single Use Implants[23] 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)"[24] ASTM D7225: Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors[25] The ASTM F04.15.17 task group is working on several new standards that involve designing implants for cleaning, validation of cleanliness, and recipes for test soils to establish cleaning efficacy.[26] Additionally, the FDA is establishing new guidelines for reprocessing reusable medical devices, such as orthoscopic shavers, endoscopes, and suction tubes.[27]
Academic resources
Medical & Biological Engineering & Computing Expert Review of Medical Devices Journal of Clinical Engineering A number of specialist University-based research institutes have been established such as the Medical Devices Center (MDC) [28] at the University of Minnesota in the US, the Strathclyde Institute Of Medical Devices (SIMD) [29] at the University of Strathclyde in Scotland and the Medical Device Research Institute (MDRI) [30] at Flinders University in Australia.
Medical device
References
[1] Summarised from the FDA's definition as per http:/ / www. fda. gov/ medicaldevices/ deviceregulationandguidance/ overview/ classifyyourdevice/ ucm051512. htm [2] http:/ / eur-lex. europa. eu/ LexUriServ/ LexUriServ. do?uri=CELEX:31985Y0604%2801%29:EN:HTML [3] http:/ / eur-lex. europa. eu/ LexUriServ/ LexUriServ. do?uri=OJ:L:2007:247:0021:0055:en:PDF [4] http:/ / ec. europa. eu/ consumers/ sectors/ medical-devices/ files/ list-of-contact-points-within-the-national_en. pdf [5] US Food and Drug Administration, "Is The Product A Medical Device?" (http:/ / www. fda. gov/ MedicalDevices/ DeviceRegulationandGuidance/ Overview/ ClassifyYourDevice/ ucm051512. htm) [6] Department of Justice Canada, "Medical Devices Regulations", SOR/98-282 (http:/ / www. emergogroup. com/ files/ canada-medical-devices-regulations-sor-98-282-april-2-2012. pdf), May 26, 2013 [7] Department of Justice Canada, "Medical Devices Regulations", SOR/98-282 (http:/ / laws-lois. justice. gc. ca/ PDF/ SOR-98-282. pdf), May 26, 2013 [8] Health Canada, Guidance for the Risk-based Classification System (http:/ / www. hc-sc. gc. ca/ dhp-mps/ md-im/ applic-demande/ guide-ld/ risk5_risque5_main_principal-eng. php) [9] Industry Canada, "Canadian Medical Devices Industry" (http:/ / www. ic. gc. ca/ eic/ site/ md-am. nsf/ eng/ hi00038. html) [10] Canadian Agency for Drugs and Technology in Health, "Medical Device Regulation In Canada: A Primer" (http:/ / www. cadth. ca/ index. php/ en/ hta/ reports-publications/ health-technology-update/ health-technology-update-issue5/ medical-device) [11] TGA, Australian regulatory guidelines for medical devices (ARGMD) Version 1.1, May 2011, http:/ / www. tga. gov. au/ pdf/ devices-argmd. pdf [12] Jordon Roberston. Associated Press 8/4/2011 [13] New Health Hazard:Hackable Medical Implants. MSNBC.com's Technology [14] Hacking Medical Devices for Fun and Insulin: Breaking the Human SCADA System [15] Globe and Mail. Thursday Oct. 27, 2011 Jim Finkle. Insulin Pumps Vulnerable to Attacks by Hackers [16] Daily Tech June 15, 2011 Nidhi Subbaraman [17] Daily Tech June 15, 2011 Nidhi SubbaramanDaily Tech [18] ISO 13485:2003 (http:/ / www. iso. org/ iso/ catalogue_detail?csnumber=36786) [19] ISO 13485 in Canada (http:/ / www. hc-sc. gc. ca/ dhp-mps/ md-im/ qualsys/ index-eng. php) [20] ISO 13485 in USA (http:/ / www. fda. gov/ downloads/ MedicalDevices/ DeviceRegulationandGuidance/ PostmarketRequirements/ QualitySystemsRegulations/ UCM134625. pdf) [21] Spiegelberg, S.H., Deluzio, K.J., Muratoglu, O.K., "Extractable residue from recalled Inter-Op acetabular shells," 49th Annual Meeting of the Orthopaedic Research Society, 2003 [22] http:/ / www. astm. org/ Standards/ F2459. htm [23] http:/ / www. astm. org/ Standards/ F2847. htm [24] http:/ / www. astm. org/ Standards/ E2314. htm [25] http:/ / www. astm. org/ Standards/ D7225. htm [26] http:/ / www. astm. org/ COMMIT/ COMMITTEE/ F04. htm [27] http:/ / www. fda. gov/ MedicalDevices/ DeviceRegulationandGuidance/ ReprocessingofReusableMedicalDevices/ default. htm [28] http:/ / www. mdc. umn. edu/ [29] http:/ / www. strath. ac. uk/ simd/ [30] http:/ / flinders. edu. au/ science_engineering/ csem/ research/ centres/ mdri. cfm
External links
US Food and Drug Administration Center for Devices and Radiological Health (http://www.fda.gov/cdrh/) Premarket Notification (510k) (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm) Premarket Approval (PMA) (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/ucm2007514.htm) Device Advice Is the Product a Medical Device? (http://www.fda.gov/cdrh/devadvice/312.html) 11.040.01: Medical equipment in general (http://www.iso.org/iso/products/standards/catalogue_ics_browse. htm?ICS1=11&ICS2=040&ICS3=01&) ISO standard series UK Medicines and Healthcare products Regulatory Agency: 'How we regulate medical devices' (http://www. mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=48)
License
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