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发帖数: 25265 | 1 A medical device is a product which is used for medical purposes in patients
, in diagnosis, therapy or surgery[citation needed]. 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, physico-chemical or chemical means.
Medical devices are included in the category: Medical technology.
Medical devices include a wide range of products varying in complexity and
application. Examples include tongue depressors, medical thermometers, blood
sugar meters, total artificial hearts, fibrin scaffolds, stents and X-ray
machines.
The global market of medical devices reached roughly 209 billion US Dollar
in 2006 and is expected to grow with an average annual rate of 6 - 9%
through 2010.[1]
Contents
[hide]
1 Definitions
1.1 European Union legal framework and definition
1.2 Definition in USA by the Food and Drug Administration
1.3 Definition in Canada by the Food and Drugs Act
2 Classification
2.1 Canada
2.2 United States
2.2.1 Class I: General controls
2.2.2 Class II: General controls with special controls
2.2.3 Class III: General controls and premarket approval
2.3 European Union (EU) and European Free Trade Association (EFTA)
3 Radio-frequency identification
3.1 Medical devices incorporating RFID
3.2 Practical and information security considerations
3.3 Four components of information security
4 Standardization and regulatory concerns
4.1 Packaging standards
5 Academic resources
6 See also
7 References
8 External links
[edit] Definitions
[edit] European Union legal framework and definition
Based on the "New Approach", rules relating to the 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, represents an
innovative way of technical harmonisation. It aims to remove technical
barriers to trade and dispel the consequent uncertainty for economic
operators allowing for the 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.
Directive 2007/47/ec 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:
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 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 government of each Member State is required to appoint a Competent
Authority responsible for medical devices. The Competent Authority (CA) is a
body with authority to act on behalf of the government of the Member State
to ensure that the requirements of the Medical Device Directives are
transposed into National Law and are applied. The Competent Authority
reports to the Minister of Health in the Member State. • The Competent
Authority in one Member State does not have jurisdiction in any other
Member State, but they do exchange information and try to reach common
positions.
In UK the Medicines and Healthcare products Regulatory Agency (MHRA) acts as
a CA, in Italy it is the Ministero Salute (Ministry of Health)[2]
Medical devices must not be mistaken with medicinal products. In the EU, all
medical devices must be identified with the CE mark.
[edit] Definition in USA by the Food and Drug Administration
Medical machine, contrivance, implant, in vitro reagent, or other similar or
related article, including a component part, or accessory which is:
-recognized in the official National Formulary, or the 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 any of 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 any of its primary intended purposes.
>>> Medical Device Definition US FDA <<<
[edit] 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].
[edit] 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.
[edit] 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. .[3] A guidance document for device classification is
published by Heath Canada .[4]
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)
.[5] Examples are surgical instruments (Class I); contact lenses,
ultrasound scanners (Class II); orthopedic implants, hemodialysis machines (
Class III); and cardiac pacemakers (Class IV) .[6]
[edit] 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.[7] The classification procedures are described
in the Code of Federal Regulations, Title 21, part 860 (usually known as 21
CFR 860).[8]
[edit] 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.[7]
[9][10] 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.[10] Class
I devices are not intended for use in supporting or sustaining life or to
be of substantial importance in preventing impairment to human health, and
they may not present a potential unreasonable risk of illness or injury.[10]
Most Class I devices are exempt from the premarket notification and/or good
manufacturing practices regulation.[7][9][10] Examples of Class I devices
include elastic bandages, examination gloves, and hand-held surgical
instruments.[9]
[edit] 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 existing methods are available to
provide such assurances.[7][9] In addition to complying with general
controls, Class II devices are also subject to special controls.[9] A few
Class II devices are exempt from the premarket notification.[9] Special
controls may include special labeling requirements, mandatory performance
standards and postmarket surveillance.[9] 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.[7][9]
[edit] 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.[7][9] 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.[7][9]
Class III devices are usually those that support or sustain human life, are
of substantial importance in preventing impairment of human health, or which
present a potential, unreasonable risk of illness or injury.[9] Examples of
Class III devices which currently require a premarket notification include
implantable pacemaker, pulse generators, HIV diagnostic tests, automated
external defibrillators, and endosseous implants.[9]
[edit] 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.
Class I (including Is & Im)
Class IIa
Class IIb
Class III
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 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.
[edit] Radio-frequency identification
[edit] Medical devices incorporating RFID
In 2004, the FDA authorized marketing of two different types of medical
devices that incorporate radio-frequency identification, or RFID. 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, 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.[11]
[edit] 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.[11]
[edit] 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).
Confidentiality means data and information are disclosed only to
authorized persons, entities and processes at authorized times and in the
authorized manner. This ensures that no unauthorized users have access to
the information.
Integrity means data and information are accurate and complete, and the
accuracy and completeness are preserved. This ensures that the information
is correct and has not been improperly modified.
Availability means data, information and information systems are
accessible and usable on a timely basis in the required manner. This ensures
that the information will be available when needed.
Accountability is the application of identification and authentication
to ensure that the prescribed access process is followed by an authorized
user.
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.[11]
[edit] Standardization and regulatory concerns
The ISO standards for medical devices are covered by ICS 11.100.20 and 11.
040.01 [12],.[13] 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, for electrical devices (mains-powered as well as
battery powered) and IEC 62304 for medical software. The US FDA also
published a series of guidances for industry regarding this topic against 21
CFR Subchapter H—Medical Devices.[14]
Starting in the late 1980s [15] 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.[16] FDA is now focused on regulatory
oversight on medical device software development process and system-level
testing.[17]
A 2011 study by Dr. Diana Zuckerman and Paul Brown of the National Research
Center for Women and Families, and Dr. Steven Nissen of the Cleveland Clinic
, published in the Archives of Internal Medicine, showed that most medical
devices recalled in the last five years for “serious health problems or
death” had been previously approved by the FDA using the less stringent,
and cheaper, 501(k) process. In a few cases the devices had been deemed so
low-risk that they did not need FDA regulation. Of the 113 devices recalled,
35 were for cardiovacular issues.[18] This may lead to a reevaluation of
FDA procedures and better oversight.
[edit] Packaging standards
Medical device packaging is highly regulated. Often medical devices and
products are sterilized in the package. The sterility must be maintained
throughout distribution to allow immediate use by physicians. A series of
special packaging tests is used to 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 which are to be
sterilized. General requirements and test methods, ISO 11607 Packaging for
terminally sterilized medical devices, and others.
Package testing needs to conducted and documented to ensure that packages
meet regulations and all end-use requirements. Manufacturing processes need
to be controlled and validated to ensure consistent performance.
[edit] Academic resources
Medical & Biological Engineering & Computing
Expert Review of Medical Devices
Journal of Clinical Engineering [19]
[edit] See also
Biomedical engineering
Biomedical equipment technician
Clinical engineering
Design history file
Durable medical equipment
Electronic medical record
In vitro diagnostics
GHTF
HL7
Home medical equipment
Implant (medicine)
ISO 690
ISO 13485
Journal of Medical Device Regulation
Medical device management
Section 201(h) of Federal Food, Drug, and Cosmetic Act
Federal Institute for Drugs and Medical Devices
Medical Devices Directive
U.S. Food and Drug Administration
Medical equipment
Medical logistics
Which Medical Device
Medical software
Pharmacovigilance
Telemedicine
Safety engineering
[edit] References
^ "Market Report: Wt". Acmite Market Intelligence.
^ http://ec.europa.eu/consumers/sectors/medical-devices/files/list-of-contact-points-within-the-national_en.pdf
^ Department of Justice Canada, "Medical Devices Regulations", SOR/98-
282, Feb 21, 2006
^ Heath Canada, Guidance for the Risk-based Classification System
^ Industry Canada, "Canadian Medical Devices Industry"
^ Canadian Agency for Drugs and Technology in Health, "Medical Device
Regulation In Canada: A Primer"
^ a b c d e f g "Device Classification". Medical Devices. U.S. Food and
Drug Administration. Retrieved 2010-10-15.
^ "TITLE 21--FOOD AND DRUGS: CHAPTER I--FOOD AND DRUG ADMINISTRATION:
DEPARTMENT OF HEALTH AND HUMAN SERVICES: SUBCHAPTER H--MEDICAL DEVICES: PART
860 MEDICAL DEVICE CLASSIFICATION PROCEDURES". CFR - Code of Federal
Regulations Title 21. U.S. Food and Drug Administration. Retrieved 2010-10-
15.
^ a b c d e f g h i j k l "General and Special Controls". Medical
Devices. U.S. Food and Drug Administration. Retrieved 2010-10-15.
^ a b c d "General Controls for Medical Devices". Medical Devices. U.S.
Food and Drug Administration. Retrieved 2010-10-15.
^ a b c http://wistechnology.com/articles/2384/
^ International Organization for Standardization. "11.100.20: Biological
evaluation of medical devices". Retrieved 10 April 2009.
^ International Organization for Standardization. "11.040: Medical
equipment". Retrieved 26 April 2009.
^ USFDA (2009). "Device Publications". Retrieved 26 April 2009.[dead
link]
^ "Therac-25 Timeline". Computingcases.org. Retrieved 2011-01-04.
^ Jones, Paul (2010-02-09). "A Formal Methods-based verification
approach to medical device software analysis". Embedded Systems Design.
Retrieved 2010-09-09.
^ FDA (2010-09-08). "Infusion Pump Software Safety Research at FDA". FDA
. Retrieved 2010-09-09.
^ [1]
^ Lippincott Williams & Wilkins. "Journal Information". Retrieved 10
April 2009.
[edit] External links
US Food and Drug Administration - Center for Devices and Radiological
Health
Premarket Notification (510k)
Premarket Approval (PMA)
Device Advice - Is the Product a Medical Device?
11.040.01: Medical equipment in general - ISO standard series
Orthopedic Biomedical Engineering Committee - AAOS
UK Medicines and Healthcare products Regulatory Agency: 'How we regulate
medical devices'
The Advanced Medical Technology Association (AdvaMed)
Which Medical Device - independent medical device reviews
http://en.wikipedia.org/wiki/Medical_device | f******w
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