Medical device

From Wikipedia, the free encyclopedia

This article needs additional citations for verification.
Please help improve this article by adding reliable references. Unsourced material may
be challenged and removed. (April 2010)

A medical device is a product which is used for medical purposes in patients,

in diagnosis, therapy or surgery[citation needed]. If applied to the body, the effect of the medical device is primarily
physical, in contrast to pharmaceutical drugs, 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 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.

Contents
[hide]

 1 Definitions

o 1.1 European Union legal framework and definition

o 1.2 Definition in USA by the Food and Drug Administration

o 1.3 Definition in Canada by the Food and Drugs Act

 2 Classification

o 2.1 Canada

o 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

o 2.3 European Union (EU) and European Free Trade Association (EFTA)

 3 Radio-frequency identification

o 3.1 Medical devices incorporating RFID

o 3.2 Practical and information security considerations

o 3.3 Four components of information security

 4 List of medical devices

o 4.1 High-risk devices

o 4.2 Medium-risk devices

 o 4.3 Low-risk devices

 5 Standardization and regulatory concerns

o 5.1 Packaging standards

 6 Academic resources

 7 Industrial resources

 8 Notes and references

 9 See also

 10 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)[1]

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

A medical device, according to the U.S. Food and Drug Administration (FDA), is an instrument, apparatus,
implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a
component part, or accessory which is[citation needed]:

 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 human 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.

as defined by the Federal Food, Drug, and Cosmetic Act, 21 United States Code [321] (h). Medical devices are
regulated by the FDA Center for Devices and Radiological Health (CDRH).

[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. [2]. A guidance document for device classification is published by Heath Canada [3]
.

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) [4]. Examples are surgical instruments (Class I);
contact lenses, ultrasound scanners (Class II); orthopedic implants, hemodialysis machines (Class III); and
cardiac pacemakers (Class IV) [5].

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

[edit]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 through normal usage. Devices in this category include tongue
depressors, bedpans, elastic bandages, 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 anendoscope 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."

[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 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 machines, PACS, powered wheelchairs, infusion pumps, surgical drapes, surgical needles and suture
material, acupuncture needles.

[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. 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, silicone gel-filled breast implants, implanted cerebral stimulators, implantablepacemaker pulse
generators and endosseous (intra-bone) implants (with the exception of root-form endosseous dental implants
which were recently reclassified as Class II).

[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.[6]

[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.[7]

[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.[8]

[edit]List of medical devices

[edit]High-risk devices
High-risk devices are life supports, critical monitoring, energy emitting and other devices whose failure or
misuse is reasonably likely to seriously injure patient or staff. Examples include:

 Anesthesia units

 Anesthesia ventilators
 Apnea monitors

 Argon enhanced coagulation units

 Aspirators

 Auto transfusion units

 Cardiac defibrillator, external or internal

 Electrosurgical units

 External pacemaker

 Fetal monitors

 Heart-lung machine

 Incubators

 Infusion pump

 Invasive blood pressure units

 Pulse oximeters

 Radiation-therapy machines

 Ventilator

 Stent

An example of the stent used in an EVAR procedure

[edit]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, but would not be likely
to cause direct serious injury. Examples include:

 ECG

 EEG

 Treadmills

 Ultrasound sensors

 Phototherapy units

 Endoscopes
 Human-implantable RFID chips

 Surgical drill and saws

 Laparoscopic insufflators

 Phonocardiographs

 radiant warmers (adult)

 Zoophagous agents (e.g., medicinal leeches; medicinal maggots)

 Lytic bacteriophages
[edit]Low-risk devices
Devices in this category are those whose failure or misuse is unlikely to result in serious consequences.
Examples include:

 Electronic thermometer,

 Breast pumps

 Surgical microscope

 Ultrasonic nebulizers

 Sphygmomanometers

 Surgical table

 Surgical lights.

 Temperature monitor

 Aspirators

 X-ray diagnostic equipment

 Lensometer

 keratometer

 LifeGuard30
[edit]Standardization and regulatory concerns
[9], [10]
The ISO standards for medical devices are covered by ICS 11.100.20 and 11.040.01 . The quality and risk
management regarding the topic for regulatory purposes is convened byISO 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.[11]

[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.

"Regulation will help growth of medical devices sector in India"

Wednesday, March 29, 2006 08:00 IST

Medtronic Inc., a global medical technology company provides

therapies for the world's 20 most challenging diseases which
include Parkinson's, cardiovascular disorders, spine injuries,
diabetes and neurological problems. Milind Shah, managing
director, heads Medtronic's Indian operations. He is
responsible for the entire sales/marketing operations and
expansion projects in South Asia. Armed with an MBA from
IIM, Kolkata and B.Tech from IIT, Delhi, Shah served Henkel
Group, as managing director prior to the present posting and
worked in executive positions at 3M, Electro & Telecom group and NOCIL.

In an interview with Nandita Vijay of Chronicle Pharmabiz, Milind

Shah provides an overview of the sector and says that regulatory approval for
medical devices has to be made mandatory in India. Excerpts:

The Union government has notified 10 medical devices including cardiac and
drug eluting stents as drugs that require central clearance prior to import,
manufacture or marketing in the country. In your opinion what would be the
impact of this new rule?

The notification will allow market to grow and help patients access the best
available to diagnosis, monitor and recover at a faster pace. There is a need
for regulation in India as globally all medical devices undergo stringent quality
norms.
What would be the efforts by Medtronic's to seek approval from the
Government of India for marketing its whole range of medical devices
because these include not only cardiac stents, drug eluting stents, but
catheters, intra ocular lenses, IV Cannulae, bone cements, heart valves, scalp
vein set, orthopaedic implants and internal prosthetic replacements?

Medtronic already has approvals from US FDA and Europe CE and all its
products are marketed in India. The American Chamber of Commerce,
medical devices sector, Europe's UCOMED and the Confederation of Indian
Industry and National Committee for Medical Equipment are in talks with the
Government of India's ministry of health and family welfare to provide a list of
the medical devices that require Central clearance prior to import,
manufacture and marketing in the country. These dialogues would also
ensure framing of guidelines for medical devices accreditation, in addition to
establishment of required infrastructure to undertake product testing in India,
certification and quality standard evaluation. The efforts to appoint a
regulatory authority will fuel the growth of the sector.

What is the size of the medical devices that Medtronic Inc and Medtronic India
are targeting globally and nationally respectively?

The medical devices market is showing a double-digit growth. The cardiac

devices alone are growing at 20 per cent. In India, the growth of the market is
estimated to be between 10-15 per cent. There is a clear indication that the
penetration levels are higher in the country. This is because of affordability by
patients, increased awareness on health care, improved hospital infrastructure
and the increased disease patterns.

What are the key drivers of this market? Is it innovative technology, simple to
use techniques or pricing?

For Medtronic's the key driver for growth is innovation. Annually the company
also pumps in 10 per cent of its annual turnover into research and
development. It employs 33,000 personnel of which 9,000 are into product
development and research. From an Indian context, the company believes
that constant training and awareness programmes are crucial factors to
increase sales.

What is the competition faced by the company and its ranking globally and in
India for stents and medical devices?

We have a diversified product offering and therefore, there is competition at

different levels. In cardiac devices we compete with Johnson & Johnson,
Boston Scientific and St. Jude Medicals. Under spinal disorders, Johnson &
Johnson and Synthes are the competitors. In neurology, we are the pioneers
for devices to treat and control Parkinson disease. In India, we have around 6
installations, which includes National Institute of Mental Health and Neuro
Sciences (NIMHANS) and All India Institute of Medical Sciences (AIIMS).

Currently, what is the manpower strength at Medtronic India and any hiring on
the anvil, how many and by when?

Hiring is on and we are scouting for biomedical engineers. We also allocate

resources for training, which is a comprehensive education programme. We
also have doctors on our rolls and this is because they are familiar with
medical sciences and devices are an extension of their specialisations.

What are the current trends in the medical devices sector?

The current trend is the convergence of biotechnology, information technology

and medical technology. In addition to diagnosis and monitoring, the company
has linked information technology and communications to launch Care Link,
which is a connection between the patient and doctors miles away on a
remote basis. Around 600 hospitals in the US, which have been linked to this
service.

Another trend is that health care providers are now convinced that investment
in medical devices would bring down cost of treatment for patients because
accurate diagnosis can simplify procedures, reduce hospitalisation, decrease
discomfort and promote faster recovery.

What are the future prospects for the medical devices sector?
The future holds immense potential for this sector. Companies like Medtronic's
India are looking providing the patients affordable healthcare with a range of
medical devices. The focus is to grow the market, which is a challenge.