medical devices are tools, tools, software, materials or other articles - whether used alone or in combination, including software intended by the manufacturer to be used specifically for diagnostic and/or therapeutic purposes. and required for proper application - intended by the manufacturer to be used for humans for the purpose of:
- Diagnosis, prevention, monitoring, treatment, or alleviation of the disease;
- Diagnosis, monitoring, treatment, alleviation, or compensation for injury or disability;
- Investigation, replacement, or modification of anatomy or physiological processes;
- Conception control; and which does not achieve the primary action intended in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function in such a way
Medical devices vary according to their intended use and indication. Examples range from simple devices such as tongue presses, medical thermometers, and disposable gloves to sophisticated devices such as computers that aid in performing medical, implant and prosthesis testing. Complicated items such as homes for cochlear implants are produced through a pulled and shallow manufacturing process. The design of medical devices is a major segment of the field of biomedical engineering.
The global medical equipment market reached about $ 209 billion in 2006.
Video Medical device
Design, prototype, and product development
The manufacture of medical devices requires a degree of process control in accordance with the device classification. Higher risk; more control. When in the initial R & amp phase, manufacturers are now beginning to design for manufacturability. This means products can be more precision-engineered for production to produce shorter lead times, tighter tolerances and more sophisticated specifications and prototypes. These days, with the help of CAD or modeling platform, work is now much faster, and this can act as well as a tool for strategic design generation as well as marketing tools.
Failure to meet cost targets will cause great harm to an organization. In addition, with global competition, R & amp; D new device is not only a must, it is a must for medical device manufacturers. The realization of new designs can be very expensive, especially with shorter product life cycles. As technology advances, there is usually a level of quality, security, and reliability that increases exponentially over time.
For example, an early model of artificial pacemaker is an external support device that transmits electrical pulses to the heart muscle through electrodes leading to the chest. Electrodes contact the heart directly through the chest, allowing the stimulation pulse to pass through the body. The recipient of this infection usually suffers at the entrance of the electrode, which causes the subsequent experiment of the first internal pacemaker, with an electrode attached to the myocardium by a thoracotomy. Future developments lead to isotopic resources that will last for the lifetime of the patient.
Maps Medical device
Definition
European Union legal and definitive framework
Under the New Approach , the rules related to the safety and performance of medical devices were aligned in the EU in the 1990s. The New Approach , defined in the European Council Resolution of May 1985, is an innovative way of technical harmonization. It aims to remove technical barriers to trade and eliminate the consequent uncertainty for economic operators, to facilitate free movement of goods within the EU.
The core legal framework consists of three directives:
- Clue 90/385/EEC on implantable medical devices
- Directive 93/42/EEC related medical devices
- Directive 98/79/EC on in vitro diagnostic medical device
They aim to ensure a high level of protection for human health and safety and the functioning of the Sole Market. These three main directives have been added from time to time by some modification and implementation directives, including the latest technical revisions brought by the Directive 2007/47 EC.
The 2007/47/EC Directive defines a medical device as (paraphrasing): Other instruments, apparatus, tools, software, materials or articles, whether used alone or in combination, together with any accessory, including software intended by the manufacturer. is used exclusively for diagnostic and/or therapeutic purposes and is required for proper application, intended by the manufacturer to be used for humans for the purpose of:
- Diagnosis, prevention, monitoring, treatment, or alleviation of the disease
- Diagnosis, monitoring, treatment, alleviation, or compensation for injury or disability
- Investigation, replacement, or modification of anatomy or physiological processes
- Conception control
This includes devices that do not achieve the primary action intended in or on the human body in pharmacological, immunological or metabolic ways - but may be assisted in their functioning in such a manner.
The Government of each Member State shall designate the competent authority responsible for medical devices. The competent authority (CA) is a body authorized to act on behalf of a member state to ensure that members of the state government transition medical instrumentation requirements into national law and apply them. CA reports to health ministers in member countries. CA in one of the Member States has no jurisdiction in other member countries, but exchanges information and tries to achieve a common position.
In the UK, for example, the Agency for Drug and Health Care (MHRA) acts as CA. In Italy it is Ministryo Salute (Ministry of Health) Medical devices should not be confused with medicinal products. In the EU, all medical devices must be identified with a CE mark.
In September 2012, the European Commission proposed a new law aimed at improving safety, traceability and transparency. Definition of
in the United States by the Food and Drug Administration
Medical machinery, tools, implants, in vitro reagents, or other similar or related articles, including component parts, or accessories that:
- Recognized in official National Formulary, or US Pharmacopoeia, or any supplement to them
- Intended for use in the diagnosis of illness or other conditions, or in the treatment, mitigation, treatment or prevention of disease, in humans or other animals
- Intended to influence any structure or function of the human body or other animals, and does not achieve its ultimate goal through chemical action within or in the body of another human or animal and does not depend on metabolic actions to achieve its ultimate goal.
In August 2013, the FDA released more than 20 regulations aimed at improving data security in medical devices, in response to the increased risk of limited cybersecurity.
On September 25, 2013 the FDA released a draft guidance document for mobile medical application settings, to clarify which types of mobile applications are related to health that will not be regulated, and which ones will. The definition of
in Canada by the Food and Drug Act
The term medical device, as defined in the Food and Drug Act, covers a wide range of medical or medical devices used in the treatment, mitigation, diagnosis or prevention of disease or abnormal physical conditions. Health Canada reviews medical devices to assess their safety, effectiveness and quality before certifying their sales in Canada.
Classification
Regulatory authorities recognize the various classes of medical devices based on the complexity of their design, the characteristics of their use, and their potential hazards if misused. Each country or region defines these categories in different ways. The authorities also recognize that some devices are provided in combination with medicines, and the arrangement of these combination products takes this into consideration.
Canada
Medical Devices Bureau of Health Canada recognizes four classes of medical devices based on the level of control required to ensure the safety and effectiveness of the device. Class I devices represent the lowest risk potential and do not require a license. Class II devices require manufacturers' statements on the safety and effectiveness of devices, while Class III and IV devices present greater potential risk and are subject to in-depth monitoring. The guidance document for the device classification is published by Health Canada.
Canadian medical device class according to European Council Directive 93/42/EEC (MDD) device:
- Class IV (Canada) is generally in accordance with Class III (ECD),
- Class III (Canada) is generally in accordance with 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 scans (Class II), orthopedic implants and hemodialysis machines (Class III), and pacemakers (Class IV).
United States
Under the Food, Drug and Cosmetics Act, the US Food and Drug Administration recognizes three classes of medical devices, based on the level of control required to ensure safety and effectiveness. The classification procedure is described in the Federal Regulatory Code, Title 21, section 860 (commonly known as 21 CFR 860). The USFDA allows two regulatory pathways enabling the marketing of medical devices. The first, and by far the most common is the so-called process 510 (k) (named after the Food, Drug, and Cosmetics Act section describing the process). New medical devices that can be demonstrated "substantially equivalent" to tools previously legally marketed may be "cleaned" by the FDA to be marketed as long as general and special controls, as described below, are met. Most new medical devices (99%) enter the market through this process. Line 510 (k) rarely requires clinical trials. The second regulatory path for a new medical device is the Premarket Approval process, described below, similar to the pathway for approval of new drugs. Typically, clinical trials are required for this pre-marketing approval path.
Class I: General control
Class I devices are subject to the fewest regulatory controls. Class I devices are subject to "General Controls" such as Class II and Class III devices. General controls include provisions relating to counterfeiting; misbranding; registration and recording of devices; pre-marketing notices; forbidden devices; notices, including repair, replacement, or refund; records and reports; limited devices; and good manufacturing practices. Class I devices are not intended to help support or sustain life or are substantially important in preventing disturbances to human health, and may not present an unreasonable risk of illness or injury. Most Class I devices are exempt from premarket notices and some are also exempt from most good manufacturing practice regulations. 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 devices whose control alone can not guarantee security and effectiveness, and existing methods are available that provide such guarantees. In addition to complying with general controls, Class II devices are also subject to special controls. Some Class II devices are exempt from premarket notices. Special controls may include special labeling requirements, mandatory performance standards and post marketing surveillance. Devices in Class II are held to a higher level of assurance than Class I devices, and are designed to work as shown without causing injury or harm to patients or users. Examples of Class II devices include acupuncture needles, powered wheelchairs, infusion pumps, air purifiers, and surgical drapes.
Class III: General controls, Custom Controls and pre-marketing approval
Class III devices are devices with insufficient information to ensure security and effectiveness only through sufficient general or special controls for Class I or Class II devices. Such devices require preliminary approval, scientific reviews to ensure the safety and effectiveness of the device, in addition to the general control of Class I devices. Class III is usually the one that supports or sustains human life, is vital in preventing human health disorders, or presenting potential, disease or injury risks unwarranted. Examples of Class III devices that currently require premarket notification include implantable pacemakers, pulse generators, HIV diagnostic tests, automatic external defibrillators, and endosseous implants.
EU (European Union) and European Free Trade Association (EFTA) European Union (EU) _and_European_Free_Trade_Association_ (EU) )
The classification of medical equipment in the EU is described in Article IX of Council Directive 93/42/EEC. There are basically four classes, ranging from low risk to high risk.
- Class I (including Is & amp; Im)
- Class IIa
- Class IIb
- Class III
The medical device authorization is guaranteed by the Declaration of Conformity. This declaration is issued by the manufacturer itself, but for products in Class Is, Im, IIa, IIb or III, it shall be verified by the Conformity Certificate issued by the Announced Body. Announced Agency is a public or private organization that has been accredited to validate device compliance with European Directives. Medical devices related to class I (provided they do not require sterilization or do not measure the function) can be marketed purely by self-certification.
The European classification depends on the rules that involve the duration of medical devices from body contact, invasive characters, use of energy sources, effects on central circulation or the nervous system, the impact of diagnostics, or the incorporation of drug products. Certified medical devices must have a CE mark on the packaging, flyer inserts, etc. The package should also show harmonized images and the EN standard logo to show important features such as instructions for use, expiry date, manufacturer, sterile, not reused, etc.
Australia
The classification of medical equipment in Australia is described in section 41BD of the 1989 Therapeutic Goods Act and Regulation 3.2 of the Therapeutic Goods Regulations 2002, under the control of the Therapeutical Goods Administration. Similar to the EU classification, they rank in several categories, in order of increasing risk and the level of control required. The rules identify the device category
Technology security issues
Medical devices such as pacemakers, insulin pumps, operating room monitors, defibrillators, and surgical instruments, including deep brain stimulators, can combine the ability to transmit vital health information from a patient's body to a medical professional. Some of these devices can be controlled remotely. This has raised concerns about privacy and security issues, human error, and technical disruption with this technology. Although only a few studies have looked at the vulnerability of medical devices to hacking, there are risks. In 2008, computer scientists proved that pacemakers and defibrillators can be hacked wirelessly via radio hardware, antennas, and personal computers. The researchers showed they can turn off a combination of heart defibrillators and pacemakers and reprogram them to deliver potentially lethal surprises or run out of batteries. Jay Radcliff, a security researcher interested in the safety of medical equipment, raises concerns about the security of this device. He shares his concerns at the Black Hat security conference. Radcliff is worried that the device is vulnerable and has found that deadly attacks may occur against those who have insulin pumps and glucose monitors. Some medical device makers downplay the threat from the attack and argue that the attacks shown have been carried out by skilled and unlikely security researchers in the real world. At the same time, other authors have asked software security experts to investigate the security of their devices. As of June 2011, security experts point out that by using available hardware and user guides, a scientist can use information on a wireless insulin pump system in combination with a glucose monitor. With device PIN, scientists can wirelessly control the dosage of insulin. Anand Raghunathan, a researcher in this study, explained that medical devices are getting smaller and lighter so they can be easily used. The drawback is that additional security features will add to the load on the battery and size and raise the price. Dr. William Maisel offers some thoughts on motivation to engage in this activity. Motivations for doing this hack may include acquiring personal information for financial gain or competitive advantage; damage to the reputation of the device manufacturer; sabotage; intend to inflict financial or personal injury or just satisfaction for the attacker. The researchers suggest some safety. One way is to use a scrolling code. Another solution is to use a technology called "body-coupled communication" that uses human skin as a wave guide for wireless communication. On December 28, 2016, the US Food and Drug Administration released its legally unenforceable recommendations for how medical device manufacturers should maintain the security of devices connected to the Internet.
Standardization and setup concerns
The ISO standard for medical equipment is covered by ICS 11.100.20 and 11.040.01. Quality and risk management related to the topic for regulatory purposes is maintained by ISO 13485 and ISO 14971. ISO 13485: 2003 applies to all providers and manufacturers of medical devices, components, contract services and medical device distributors. Standards are the basis for regulatory compliance in the local market, and most of the export market. In addition, ISO 9001: 2008 sets a precedent because it signifies that the company is involved in the creation of new products. This requires that the development of the manufactured product has an approval process and a series of stringent quality standards and development notes before the product is distributed. Further standards are IEC 60601-1 which for electrical devices (electrical and battery power), EN 45502-1 which is for Active implant medical devices, and IEC 62304 for medical software. The US FDA also published a series of industry guides on this topic against 21 CFR 820 Subchapter H - Medical Devices. Subdivision B includes the requirements of the quality system, a key component of which is design control (21 CFR 820.30). To meet the demands of these industry regulatory standards, more and more distributors of medical equipment are putting complaints management processes at the forefront of their quality management practices. This approach further reduces risk and increases the visibility of quality problems.
Beginning in the late 1980s the FDA increased its involvement in reviewing the development of medical device software. The cause of change is a radiation therapy device (Therac-25) that overdoses patients due to software coding errors. The FDA now focuses on regulatory oversight on the process of developing medical device software and system-level testing.
A 2011 study by Dr. Diana Zuckerman and Paul Brown from the National Center for Women's and Family Research; Steven Nissen of the Cleveland Clinic, published in Archives of Internal Medicine, points out that most of the medical devices remembered in the last five years due to "serious health problems or deaths" have been previously approved by the FDA using the 510 process (k ) that are less tight and less expensive. In some cases the devices are considered low risk so they do not require FDA regulation. Of 113 devices withdrawn, 35 for cardiovascular problems. This may lead to a better FDA evaluation and supervision procedures.
In 2014-2015 a new international treaty, Single Medical Instrument Audit Program (MDSAP), was held with five participating countries: Australia, Brazil, Canada, Japan, and the United States. The goal of the program is to "develop a process that enables a single audit, or inspection to ensure the regulatory requirements of medical devices for all five countries are met".
Standard packaging
The medical device package is highly regulated. Often medical devices and products are sterilized in the package. Sterility must be maintained throughout the distribution to allow for immediate use by doctors. A series of special packing tests measures the packet's ability to maintain infertility. Relevant standards include:
- ASTM D1585 - Guide to the Porous Package Integrity Testing
- ASTM F2097 - Standard Guide for Flexible Main Packaging Design and Evaluation for Medical Products
- ASTM F3475-11 - Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
- EN 868 Material and packaging system for medical equipment for sterilization, General requirements and test methods
- ISO 11607 Packaging for restricted sterilized medical devices
Package document testing and ensure that the package meets the rules and end-use requirements. The manufacturing process must be controlled and validated to ensure consistent performance.
Biocompatibility standard
- ISO 10993 - Biological Evaluation of Medical Devices
Hygiene standards
The cleanliness of medical equipment has gained greater scrutiny since 2000, when Sulzer Orthopedics attracted several thousand metal hip implants containing residue-making. Based on this event, ASTM formed a new task force (F04.15.17) to establish test methods, guidance documents, and other standards to address the cleanliness of medical equipment. This task group has issued two standards for permanent implants to date: 1. ASTM F2459: Standardized test method for extracting residues from metallic medical components and measuring through gravimetric analysis 2. ASTM F2847: Standard Practices for Reporting and Assessment of Residues on Single Use Implants 3. ASTM F3172: Standard Guide to Validate Cleaning Processes Used During Medical Device Making
In addition, the cleanliness of reusable devices has led to a set of standards, including:
- ASTM E2314: Standard Test Method for Determining the Effectiveness of Cleaning Process for Reusable Medical Instruments Using Microbiological Methods (Simulation Usage Test) "
- ASTM D7225: Standard Guidelines for Blood Cleansing The Efficiency of Detergents and Washer-Disinfectants
- ASTM F3208: Standard Guide for Selecting Test Soil for the Validation of Cleaning Methods for Reusable Health Appliance
The ASTM F04.15.17 task group works on several new standards involving implant design for cleaning, selection and brush testing to clean reusable devices, and hygiene assessment of medical equipment made by additive manufacturing. In addition, the FDA is creating new guidelines for reprocessing reusable medical devices, such as orthopedic shavers, endoscopes, and suction tubes.
Mobile medical app
With the increasing use of smartphones in the medical room, by 2013, the FDA issued to regulate mobile medical applications and protect users from unwanted use, immediately followed by European and other regulatory agencies. This guide differentiates applications that are subject to the rules based on app claims claims. The establishment of guidelines during the application development phase may be considered to be the development of medical devices; regulations have to adapt and propositions to speed approval may be necessary due to the nature of the 'version' of mobile app development.
Academic resources
- Medical & amp; Biological & amp; Computing
- Medical Device Overview
- Journal of Clinical Techniques
University Based Research Institute
- University of Minnesota - Center for Medical Devices (MDC)
- Strathclyde University - Strathclyde Institute of Medical Devices (SIMD)
- Flinders University - Institute for Medical Device Research (MDRI)
- Michigan State University - Packing School (SoP)
See also
References
External links
- US Food and Drug Administration - Center for Devices and Radiological Health
- Premarket Notice (510k)
- Premarket Approval (PMA)
- FDA - What Are Medical Device Products?
- MHRA - Settings and security of medical equipment
- EC - Medical devices
- Canadian Health - List of Recognized Standards for Medical Devices (International)
- ISO - Standard catalog: 11.040.01: Medical equipment in general
- Radio Frequency Wireless Technology in Medical Devices - A Guide for Industrial Administration Staff and Food and Drug Administration. FDA (2013)
Source of the article : Wikipedia
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