A medical device is any instrument, apparatus, appliance,
software, material or other article, whether used alone or in combination,
including the software intended by its manufacturer to be used specifically for
diagnostic and/or therapeutic purposes and necessary for its proper
application, intended by the manufacturer to be used for human beings for the
purpose of:
·Diagnosis, prevention, monitoring, treatment or alleviation
of disease;
·Diagnosis, monitoring, treatment, alleviation of or
compensation for an injury or handicap;
·Investigation, replacement or modification of the anatomy
or of a physiological process;
·Control of conception; and which does not achieve its
principal intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its function by
such means
Medical devices vary according to their intended use and
indications. 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 mechanical engineering.
The global medical device market reached roughly $209
billion in 2006.
Design, prototyping, and product development
Medical device manufacturing requires a level of process
control according to the classification of the device. Higher risk; more
controls. These days, with the aid of CAD or modelling platforms, the work is
now much faster, and this can act also as a tool for strategic design
generation as well as a marketing tool.[2]
Failure to meet cost targets will lead to substantial losses
for an organisation. In addition, with global competition, the R&D of new
devices is not just a necessity, it is an imperative for medical device
manufacturers. The realisation of a new design can be very costly, especially
with the shorter product life cycle. As technology advances, there is typically
a level of quality, safety and reliability that increases exponentially with
time.[2]
For example, initial models of the artificial cardiac
pacemaker were external support devices that transmits pulses of electricity to
the heart muscles via electrode leads on the chest. The electrodes contact the
heart directly through the chest, allowing stimulation pulses to pass through
the body. Recipients of this typically suffered infection at the entrance of
the electrodes, which led to the subsequent trial of the first internal
pacemaker, with electrodes attached to the myocardium by thoracotomy. Future
developments led to the isotope-power source that would last for the lifespan
of the patient.
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,[3] 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 three 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 three
main directives have been supplemented over time by several modifying and
implementing directives, including the last technical revision brought about by
Directive 2007/47 EC.
Directive 2007/47/EC defines a medical device as
(paraphrasing): Any instrument, apparatus, appliance, software, material or
other article, whether used alone or in combination, together with any
accessories, including the software intended by its manufacturer to be used
specifically for diagnostic and/or therapeutic purposes and necessary for its
proper application, intended by the manufacturer to be used for human beings
for the purpose of:
Diagnosis, prevention, monitoring, treatment, or alleviation
of disease
Diagnosis, monitoring, treatment, alleviation of, or
compensation for an injury or handicap
Investigation, replacement, or modification of the anatomy
or of a physiological process
Control of conception
This includes devices that do not achieve their principal
intended action in or on the human body by pharmacological, immunological, or
metabolic means—but 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 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)[5] Medical devices must not be mistaken with
medicinal products. In the EU, all medical devices must be identified with the
CE mark.
In September 2012, the European Commission proposed new
legislation aimed at enhancing safety, traceability, and transparency.
Definition in United States 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 that
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
Intended to affect the structure or any function of the body
of man or other animals, and does not achieve any of its primary purpose
through chemical action within or on the body of man or other animals and does
not depend on metabolic action to achieve its primary purpose.
In August 2013, the FDA released over 20 regulations aiming
to improve the security of data in medical devices,[8] in response to the growing
risks of limited cybersecurity.
On September 25, 2013 the FDA released a draft guidance
document for regulation of mobile medical applications, to clarify what kind of
mobile apps related to health would not be regulated, and which would be.
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 authorizing their sale in Canada.
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 recognizes four
classes of medical devices based on the level of control necessary to assure
the safety and effectiveness of the device. Class I devices present the lowest
potential risk and do not require a licence. Class II devices require the
manufacturer’s declaration of device safety and effectiveness, whereas Class
III and IV devices present a greater potential risk and are subject to in-depth
scrutiny. A guidance document for device classification is published by Health
Canada.
Canadian classes of medical devices correspond to the
European Council Directive 93/42/EEC (MDD) devices:
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).
United States
Under the Food, Drug, and Cosmetic Act, the U.S. Food and
Drug Administration recognizes three classes of medical devices, based on the
level of control necessary to assure safety and effectiveness.[14] 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
acupuncture needles, powered wheelchairs, infusion pumps, air purifiers, and
surgical drapes.
Class III: General controls, Special 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.
European Union (EU) and European Free Trade Association
(EFTA)
The classification of medical devices in the European Union
is outlined in Article 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 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
| Classification | Level of Risk |
|---|---|
| Class I | Low |
| Class I - measuring or Class I - supplied sterile or class IIa | Low - medium |
| Class IIb | Medium - high |
| Class III | High |
| Active implantable medical devices (AIMD) | High |
Medical devices and technological security issues
Medical devices such as pacemakers, insulin pumps, operating
room monitors, defibrillators, and surgical instruments, including deep-brain
stimulators, can incorporate the ability to transmit vital health information
from a patient's body to medical professionals. Some of these devices can be
remotely controlled. This has engendered concern about privacy and security
issues around human error and technical glitches with this technology. While
only a few studies have looked at the susceptibility of medical devices to
hacking, there is a risk. In 2008, computer scientists proved that pacemakers
and defibrillators can be hacked wirelessly via radio hardware, an antenna, and
a personal computer. These researchers showed they could shut down a
combination heart defibrillator and pacemaker and reprogram it to deliver
potentially lethal shocks or run out its battery. Jay Radcliff, a security
researcher interested in the security of medical devices, raised fears about
the safety of these devices. He shared his concerns at the Black Hat security
conference. Radcliff fears that the devices are vulnerable and has found that a
lethal attack is possible against those with insulin pumps and glucose
monitors. Some medical device makers downplay the threat from such attacks and
argue that the demonstrated attacks have been performed by skilled security
researchers and are unlikely to occur in the real world. At the same time,
other makers have asked software security experts to investigate the safety of
their devices. As recently as June 2011, security experts showed that by using
readily available hardware and a user manual, a scientist could both tap into
the information on the system of a wireless insulin pump in combination with a
glucose monitor. With the PIN of the device, the scientist could wirelessly
control the dosage of the insulin. Anand Raghunathan, a researcher in this
study, explains that medical devices are getting smaller and lighter so that
they can be easily worn. The downside is that additional security features would
put an extra strain on the battery and size and drive up prices. Dr. William
Maisel offered some thoughts on the motivation to engage in this activity.
Motivation to do this hacking might include acquisition of private information
for financial gain or competitive advantage; damage to a device manufacturer's
reputation; sabotage; intent to inflict financial or personal injury or just
satisfaction for the attacker. Researchers suggest a few safeguards. One would
be to use rolling codes. Another solution is to use a technology called
"body-coupled communication" that uses the human skin as a wave guide
for wireless communication.
Standardization and regulatory concerns
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 by ISO 13485 and ISO 14971. ISO 13485:2003
is applicable to all providers and manufacturers of medical devices,
components, contract services and distributors of medical devices. The standard
is the basis for regulatory compliance in local markets, and most export
markets. Additionally, ISO 9001:2008 sets precedence because it signifies that
a company engages in the creation of new products. It requires that the
development of manufactured products have an approval process and a set of
rigorous quality standards and development records before the product is
distributed. 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 820 Subchapter H—Medical Devices. To meet the demands of
these industry regulation standards, a growing number of medical device
distributors are putting the complaint management process at the forefront of
their quality management practices. This approach further mitigates risks and
increases visibility of quality issues.
Starting in the late 1980s 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. FDA is now focused on regulatory oversight on medical
device software development process and system-level testing.
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, 510(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 cardiovascular issues. This may lead to a reevaluation of
FDA procedures and better oversight.
In 2014-2015 a new international agreement, the Medical
Device Single Audit Program (MDSAP), was put in place with five participant
countries: Australia, Brazil, Canada, Japan, and the United States. The aim of
this program was to "develop a process that allows a single audit, or
inspection to ensure the medical device regulatory requirements for all five
countries are satisfied".
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. 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 2. ASTM F2847: Standard
Practice for Reporting and Assessment of Residues on Single Use Implants
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)"
ASTM D7225: Standard Guide for Blood Cleaning Efficiency of
Detergents and Washer-Disinfectors
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.[49]
Additionally, the FDA is establishing new guidelines for reprocessing reusable
medical devices, such as orthoscopic shavers, endoscopes, and suction
tubes.[50]
Mobile medical applications
With the rise of smartphone usage in the medical space, in
2013, the FDA issued to regulate mobile medical applications and protect users
from their unintended use, soon followed by European and other regulatory
agencies. This guidance distinguishes the apps subjected to regulation based on
the marketing claims of the apps. Incorporation of the guidelines during the
development phase of such apps can be considered as developing a medical
device; the regulations have to adapt and propositions for expedite approval
may be required due to the nature of 'versions' of mobile application
development.
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)[55] at the
University of Minnesota in the US, the Strathclyde Institute Of Medical Devices
(SIMD)[56] at the University of Strathclyde in Scotland and the Medical Device
Research Institute (MDRI)[57] at Flinders University in Australia.
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