Medical device
Encyclopedia
A medical device is a product which is used for medical purposes in patients, in diagnosis
, therapy
or surgery
. 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, thermal, 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 thermometer
s, and blood sugar meter
s.
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.
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:
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:
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)
Medical devices must not be mistaken with medicinal product
s. In the EU, all medical devices must be identified with the CE mark
.
-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 <<<
, 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 .
. A guidance document for
device classification is published by Heath Canada
.
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)
.
Examples are surgical instruments (Class I); contact lenses, ultrasound scanners (Class II);
orthopedic implants, hemodialysis machines (Class III); and cardiac pacemakers (Class IV)
.
, Title 21, part 860 (usually known as 21 CFR 860).
. 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.
, 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 which present a potential, unreasonable risk of illness or injury. 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.
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.
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.
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.
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.
including deep-brain stimulators are being made with the ability to transmit vital health information from a patient's body to doctors and other professionals.Some of these devices can be remotely controlled by medical professionals. There has been concern about privacy and security issues around human error and technical glitches with this technology. While only a few studies have been done on the susceptibility of medical devices to hacking, there is a risk.In 2008, computer scientists proved that pacemakers and defibrillators can be hacked wirelessly through the use of of radio hardware, an antenna and a personal computer. These researchers showed that they could shut do
wn 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, raises 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 a PIN access code 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.
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.
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 cardiovacular issues. This may lead to a reevaluation of FDA procedures and better oversight.
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.
Diagnosis
Diagnosis is the identification of the nature and cause of anything. Diagnosis is used in many different disciplines with variations in the use of logics, analytics, and experience to determine the cause and effect relationships...
, therapy
Therapy
This is a list of types of therapy .* Adventure therapy* Animal-assisted therapy* Aquatic therapy* Aromatherapy* Art and dementia* Art therapy* Authentic Movement* Behavioral therapy* Bibliotherapy* Buteyko Method* Chemotherapy...
or surgery
Surgery
Surgery is an ancient 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, or to help improve bodily function or appearance.An act of performing surgery may be called a surgical...
. 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, thermal, physico-chemical or chemical means. Medical devices are included in the category: Medical technology
Medical technology
Medical Technology encompasses a wide range of healthcare products and is used to diagnose, monitor or treat diseases or medical conditions affecting humans. Such technologies are intended to improve the quality of healthcare delivered through earlier diagnosis, less invasive treatment options and...
.
Medical devices include a wide range of products varying in complexity and application. Examples include tongue depressors, medical thermometer
Medical thermometer
Medical thermometers are used for measuring human body temperature, with the tip of the thermometer being inserted either into the mouth under the tongue , under the armpit , or into the rectum via the anus .-Liquid-filled:The traditional thermometer is a glass tube with a bulb at one end...
s, and blood sugar meter
Blood glucose monitoring
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 to draw blood, then applying the blood to a chemically active disposable 'test-strip'...
s.
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.
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
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) acts as a CA, in Italy it is the Ministero Salute (Ministry of Health)
Medical devices must not be mistaken with medicinal product
Medicinal product
A medicinal product is defined in the European Union as any substance or combination of substances presented for treating or preventing disease in human beings...
s. In the EU, all medical devices must be identified with the CE mark
CE mark
CE marking is a mandatory conformity mark for products placed on the market in the European Economic Area . With the CE marking on a product the manufacturer ensures that the product conforms with the essential requirements of the applicable EC directives...
.
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 <<<
Definition in Canada by the Food and Drugs Act
The term medical devices, as defined in the Food and Drugs ActFood and Drugs Act
Food and Drugs Act is an Act of the Parliament of Canada regarding the production, import, export, transport across provinces and sale of food, drugs, contraceptive devices and cosmetics...
, 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 .
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.. A guidance document for
device classification is published by Heath Canada
.
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)
.
Examples are surgical instruments (Class I); contact lenses, ultrasound scanners (Class II);
orthopedic implants, hemodialysis machines (Class III); and cardiac pacemakers (Class IV)
.
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. The classification procedures are described in the Code of Federal RegulationsCode of Federal Regulations
The Code of Federal Regulations is the codification of the general and permanent rules and regulations 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...
, Title 21, part 860 (usually known as 21 CFR 860).
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 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. Most Class I devices are exempt from the premarket notification and/or 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 are insufficient to assure safety and effectiveness, and existing methods are available to 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 surveillancePostmarketing surveillance
Postmarketing surveillance is the practice of monitoring the safety of a pharmaceutical drug or device after it has been released on the market and is an important part of the science of pharmacovigilance...
. 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.
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 approvalPremarket approval
Premarket approval is the U.S. Food and Drug Administration process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices and is significantly different from the Premarket Notification process known as 510...
, 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 which present a potential, unreasonable risk of illness or injury. 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.
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
Notified Body
A Notified Body, in the European Union, is an organisation that has been accredited by a Member State to assess whether a product meets certain preordained standards. Assessment can include inspection and examination of a product, its design and manufacture...
. 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
CE mark
CE marking is a mandatory conformity mark for products placed on the market in the European Economic Area . With the CE marking on a product the manufacturer ensures that the product conforms with the essential requirements of the applicable EC directives...
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.
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
VeriChip
VeriChip was the only Food and Drug Administration -approved human-implantable radio-frequency identification microchip. It was marketed by PositiveID, a subsidiary of Applied Digital Solutions, and it received United States FDA approval in 2004. Its manufacture and marketing were discontinued in...
, 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.
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.
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.
Medical devices and technological security issues
Medical devices such as pacemakers, insulin pumps, operating room monitors, defibrillators, surgical instrumentsSurgical instruments
A surgical instrument is a specially designed tool or device for performing specific actions of carrying out desired effects during a surgery or operation, such as modifying biological tissue, or to provide access for viewing it. Over time, many different kinds of surgical instruments and tools...
including deep-brain stimulators are being made with the ability to transmit vital health information from a patient's body to doctors and other professionals.Some of these devices can be remotely controlled by medical professionals. There has been concern about privacy and security issues around human error and technical glitches with this technology. While only a few studies have been done on the susceptibility of medical devices to hacking, there is a risk.In 2008, computer scientists proved that pacemakers and defibrillators can be hacked wirelessly through the use of of radio hardware, an antenna and a personal computer. These researchers showed that they could shut do
wn 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, raises 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 a PIN access code 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 13485ISO 13485
ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices...
and ISO 14971
ISO 14971
ISO 14971 is an ISO standard, of which the latest revision was published in 2007, that represents the requirements for a risk management system for medical devices....
. Further standards are IEC 60601-1, for electrical devices (mains-powered as well as battery powered) and IEC 62304
IEC 62304
The international standard IEC 62304 - medical device software – software life cycle processes is a standard which specifies life cycle requirements for the development of medical software and software within medical devices...
for medical software. The US FDA also published a series of guidances for industry regarding this topic against 21 CFR Subchapter H—Medical Devices.
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
Therac-25
The Therac-25 was a radiation therapy machine produced by Atomic Energy of Canada Limited after the Therac-6 and Therac-20 units ....
) 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
Diana Zuckerman
Diana M. Zuckerman is an expert on national health policy, particularly in women's health. She is the President of the National Research Center for Women & Families as well as the Cancer Prevention and Treatment Fund.-Life and work:...
and Paul Brown of the National Research Center for Women and Families
National Research Center for Women and Families
The National Research Center for Women & Families is a Washington, DC-based non-profit organization founded in 1999. It uses objective, research-based information to encourage new, more effective programs and policies that promote the health and safety of women, children, and families. The...
, and Dr. Steven Nissen of the Cleveland Clinic
Cleveland Clinic
The Cleveland Clinic is a multispecialty academic medical center located in Cleveland, Ohio, United States. The Cleveland Clinic is currently regarded as one of the top 4 hospitals in the United States as rated by U.S. News & World Report...
, 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 cardiovacular issues. This may lead to a reevaluation of FDA procedures and better oversight.
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
Package testing
Package testing or packaging testing involves the measurement of a characteristic or property involved with packaging. This includes packaging materials, packaging components, primary packages, shipping containers, and unit loads, as well as the associated processes.Testing measures the effects...
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.
Academic resources
- Medical & Biological Engineering & ComputingMedical & Biological Engineering & ComputingMedical & Biological Engineering & Computing is the official publication of the International Federation of Medical and Biological Engineering , and published by Springer.This monthly journal is dedicated to biomedical and clinical engineering...
- Expert Review of Medical Devices
- Journal of Clinical Engineering
See also
- Biomedical engineeringBiomedical engineeringBiomedical Engineering is the application of engineering principles and design concepts to medicine and biology. This field seeks to close the gap between engineering and medicine: It combines the design and problem solving skills of engineering with medical and biological sciences to improve...
- Biomedical equipment technicianBiomedical Equipment TechnicianA Bio-Medical Equipment Technician, also referred to as a Biomed, Biomedical Engineering Technologist , Biomed Equipment Technician, a Biomedical Equipment Specialist or Electronics and Biomedical Engineer is a highly skilled electromechanical technologist that ensures that medical equipment is...
- Clinical engineeringClinical engineeringClinical engineering is a specialty within Biomedical engineering responsible primarily for applying and implementing medical technology to optimize healthcare delivery...
- Design history fileDesign history fileDesign History File is a compilation of documentation that describes the design history of a finished medical device. The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical...
- Durable medical equipmentDurable medical equipmentDurable medical equipment is a term of art used to describe any medical equipment used in the home to aid in a better quality of living. It is a benefit included in most insurances. In some cases certain Medicare benefits, that is, whether Medicare may pay for the item...
- Electronic medical recordElectronic medical recordAn electronic medical record is a computerized medical record created in an organization that delivers care, such as a hospital or physician's office...
- In vitro diagnosticsIn vitro diagnosticsIn vitro diagnostic tests are medical devices intended to perform diagnoses from assays in a test tube, or more generally in a controlled environment outside a living organism...
- GHTF
- HL7
- Home medical equipmentHome medical equipmentThis article discusses the definitions and types of home medical equipment , also known as durable medical equipment , prosthetics and orthotics .- HME / DMEPOS :...
- Implant (medicine)Implant (medicine)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...
- ISO 690ISO 690ISO 690 is an ISO standard for bibliographic referencing in documents of all sorts. It includes electronic documents, and specifies the elements to be included in references to published documents, and the order in which the elements of the reference should be stated...
- ISO 13485ISO 13485ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices...
- Journal of Medical Device Regulation
- Medical device management
- Section 201(h) of Federal Food, Drug, and Cosmetic ActFederal Food, Drug, and Cosmetic ActThe United States Federal Food, Drug, and Cosmetic Act , is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration to oversee the safety of food, drugs, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from...
- Federal Institute for Drugs and Medical DevicesFederal Institute for Drugs and Medical DevicesThe Federal Institute for Drugs and Medical Devices is a medical regulatory body in Germany.It operates under the Federal Ministry of Health.It is headquartered in Bonn....
- Medical Devices DirectiveMedical Devices DirectiveThe Medical Device Directive is intended to harmonise the laws relating to medical devices within the European Union...
- U.S. Food and Drug Administration
- Section 201(h) of Federal Food, Drug, and Cosmetic Act
- Medical equipmentMedical equipmentMedical equipment is designed to aid in the diagnosis, monitoring or treatment of medical conditions.-Types:There are several basic types:* Diagnostic equipment includes medical imaging machines, used to aid in diagnosis...
- Medical logisticsMedical logisticsMedical logistics is the logistics of pharmaceuticals, medical and surgical supplies, medical devices and equipment, and other products needed to support doctors, nurses, and other health and dental care providers...
- Which Medical DeviceWhich Medical DeviceWhich Medical Device is a review site for medical devices with reviews, medical device news and videos of medical procedures. Users can rate and review medical devices listed on the website, or suggest devices for inclusion and review. The website also publishes device reviews from an editorial...
- Medical softwareMedical softwareIn computers, medical software is a significant branch of software engineering. Many medical devices that monitor or control patients are predominantly controlled by software. Medical devices are frequently regulated and must comply with local and regional laws. In the European Union, these...
- PharmacovigilancePharmacovigilancePharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines...
- TelemedicineTelemedicineTelemedicine is the use of telecommunication and information technologies in order to provide clinical health care at a distance. It helps eliminate distance barriers and can improve access to medical services that would often not be consistently available in distant rural communities...
- Safety engineeringSafety engineeringSafety engineering is an applied science strongly related to systems engineering / industrial engineering and the subset System Safety Engineering...
External links
- US Food and Drug Administration - Center for Devices and Radiological Health
- 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'