Медициналық құралдар: тарихы, реттелуі және нарығы

Device to be used for medical purposes

A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase. Discovery of what would be considered a medical device by modern standards dates as far back as c. 7000 BC in Baluchistan where Neolithic dentists used flint tipped drills and bowstrings. Study of archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States it was not until the Federal Food, Drug, and Cosmetic Act (FD&C Act) in 1938 that medical devices were regulated. Later in 1976, the Medical Device Amendments to the FD&C Act established medical device regulation and oversight as we know it today in the United States. Medical device regulation in Europe as we know it today came into effect in 1993 by what is collectively known as the Medical Device Directive (MDD). On May 26, 2017, the Medical Device Regulation (MDR) replaced the MDD. Medical devices vary in both their intended use and indications for use. Examples range from simple, low risk devices such as tongue depressors, medical thermometers, disposable gloves, and bedpans to complex, high risk devices that are implanted and sustain life. One example of high risk devices are those with embedded software such as pacemakers, and which assist in the conduct of medical testing, implants, and prostheses. The design of medical devices constitutes a major segment of the field of biomedical engineering. The global medical device market was estimated to be between $220 and US$250 billion in 2013. The United States controls ~40% of the global market followed by Europe (25%), Japan (15%), and the rest of the world (20%). Although collectively Europe has a larger share, Japan has the second largest country market share. The largest market shares in Europe (in order of market share size) belong to Germany, Italy, France, and the United Kingdom. The rest of the world comprises regions like (in no particular order) Australia, Canada, China, India, and Iran. This article discusses what constitutes a medical device in these different regions and throughout the article these regions will be discussed in order of their global market share.

A global definition for medical device is difficult to establish because there are numerous regulatory bodies worldwide overseeing the marketing of medical devices. Although these bodies often collaborate and discuss the definition in general, there are subtle differences in wording that prevent a global harmonization of the definition of a medical device, thus the appropriate definition of a medical device depends on the region. Often a portion of the definition of a medical device is intended to differentiate between medical devices and drugs, as the regulatory requirements of the two are different. Definitions also often recognize In vitro diagnostics as a subclass of medical devices and establish accessories as medical devices.

Article 2, Paragraph 4, of the Pharmaceutical Affairs Law (PAL) defines medical devices as "instruments and apparatus intended for use in diagnosis, cure or prevention of diseases in humans or other animals; intended to affect the structure or functions of the body of man or other animals."

The term medical device, as defined in the Food and Drugs Act, is "any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in: the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in a human being; the restoration, correction or modification of a body function or the body structure of a human being; the diagnosis of pregnancy in a human being; or the care of a human being during pregnancy and at and after the birth of a child, including the care of the child. It also includes a contraceptive device but does not include a drug." The term 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. According to the Act, medical device does not include any device that is intended for use in relation to animals.

There is no specific definition of the term 'medical devices' in Indian law. However, certain medical devices are notified as DRUGS under the Drugs & Cosmetics Act. Section 3 (b) (iv) relating to definition of "drugs" holds that "Devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals" are also drugs. As of April 2022, 14 classes of devices are classified as drugs.

The regulatory authorities recognize different classes of medical devices based on their potential for harm if misused, design complexity, and their use characteristics. 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. Classifying medical devices based on their risk is essential for maintaining patient and staff safety while simultaneously facilitating the marketing of medical products. By establishing different risk classifications, lower risk devices, for example, a stethoscope or tongue depressor, are not required to undergo the same level of testing that higher risk devices such as artificial pacemakers undergo. Establishing a hierarchy of risk classification allows regulatory bodies to provide flexibility when reviewing medical devices.

For the remaining regions in the world, the risk classifications are generally similar to the United States, European Union, and Japan or are a variant combining two or more of the three countries' risk classifications.

Iran produces about 2,000 types of medical devices and medical supplies, such as appliances, dental supplies, disposable sterile medical items, laboratory machines, various biomaterials and dental implants. 400 Medical products are produced at the C and D risk class with all of them licensed by the Iranian Health Ministry in terms of safety and performance based on EU standards. Some Iranian medical devices are produced according to the European Union standards. Some producers in Iran export medical devices and supplies which adhere to European Union standards to applicant countries, including 40 Asian and European countries. Some Iranian producers export their products to foreign countries.

Validation and verification of medical devices ensure that they fulfil their intended purpose. Validation or verification is generally needed when a health facility acquires a new device to perform medical tests. The main difference between the two is that validation is focused on ensuring that the device meets the needs and requirements of its intended users and the intended use environment, whereas verification is focused on ensuring that the device meets its specified design requirements.

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 13485:2016 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 which is for electrical devices (mains powered as well as battery powered), EN 45502 1 which is for Active implantable medical devices, 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. Subpart B includes quality system requirements, an important component of which are design controls (21 CFR 820.30). 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 Center for Health Research, 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 they did not undergo any FDA regulatory review. Of the 113 devices recalled, 35 were for cardiovascular issues. This study was the topic of Congressional hearings re evaluating FDA procedures and oversight. A 2014 study by Dr. Diana Zuckerman, Paul Brown, and Dr. Aditi Das of the National Center for Health Research, published in JAMA Internal Medicine, examined the scientific evidence that is publicly available about medical implants that were cleared by the FDA 510(k) process from 2008 to 2012. They found that scientific evidence supporting "substantial equivalence" to other devices already on the market was required by law to be publicly available, but the information was available for only 16% of the randomly selected implants, and only 10% provided clinical data. Of the more than 1,100 predicate implants that the new implants were substantially equivalent to, only 3% had any publicly available scientific evidence, and only 1% had clinical evidence of safety or effectiveness. The researchers concluded that publicly available scientific evidence on implants was needed to protect the public health. 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". In 2017, a study by Dr. Jay Ronquillo and Dr. Diana Zuckerman published in the peer reviewed policy journal Milbank Quarterly found that electronic health records and other device software were recalled due to life threatening flaws. The article pointed out the lack of safeguards against hacking and other cybersecurity threats, stating "current regulations are necessary but not sufficient for ensuring patient safety by identifying and eliminating dangerous defects in software currently on the market". They added that legislative changes resulting from the law entitled the 21st Century Cures Act "will further deregulate health IT, reducing safeguards that facilitate the reporting and timely recall of flawed medical software that could harm patients". A study by Dr. Stephanie Fox Rawlings and colleagues at the National Center for Health Research, published in 2018 in the policy journal Milbank Quarterly, investigated whether studies reviewed by the FDA for high risk medical devices are proven safe and effective for women, minorities, or patients over 65 years of age. The law encourages patient diversity in clinical trials submitted to the FDA for review, but does not require it. The study determined that most high risk medical devices are not tested and analyzed to ensure that they are safe and effective for all major demographic groups, particularly racial and ethnic minorities and people over 65. Therefore, they do not provide information about safety or effectiveness that would help patients and physicians make well informed decisions. In 2018, an investigation involving journalists across 36 countries coordinated by the International Consortium of Investigative Journalists (ICIJ) prompted calls for reform in the United States, particularly around the 510(k) substantial equivalence process; the investigation prompted similar calls in the UK and Europe Union.

Medical device manufacturing requires a level of process control according to the classification of the device. Higher risk; more controls. When in the initial R&D phase, manufacturers are now beginning to design for manufacturability. This means products can be more precision engineered to for production to result in shorter lead times, tighter tolerances and more advanced specifications and prototypes. 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. 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. 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. 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.

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, 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. On 28 December 2016, the US Food and Drug Administration released its recommendations that are not legally enforceable for how medical device manufacturers should maintain the security of Internet connected devices. Similar to hazards, cybersecurity threats and vulnerabilities cannot be eliminated but must be managed and reduced to a reasonable level. When designing medical devices, the tier of cybersecurity risk should be determined early in the process in order to establish a cybersecurity vulnerability and management approach (including a set of cybersecurity design controls). The medical device design approach employed should be consistent with the NIST Cybersecurity Framework for managing cybersecurity related risks. In August 2013, the FDA released over 20 regulations aiming to improve the security of data in medical devices, in response to the growing risks of limited cybersecurity.

The number of approved medical devices using artificial intelligence or machine learning (AI/ML) is increasing. As of 2020, there were several hundred AI/ML medical devices approved by the US FDA or CE marked devices in Europe. Most AI/ML devices focus upon radiology. As of 2020, there was no specific regulatory pathway for AI/ML based medical devices in the US or Europe. and the EU medical device regulation which replaces the EU Medical Device Directive in May 2021, defines regulatory requirements for medical devices, including AI/ML software.

Medical equipment (also known as armamentarium) is designed to aid in the diagnosis, monitoring or treatment of medical conditions.

There are challenges surrounding the availability of medical equipment from a global health perspective, with low resource countries unable to obtain or afford essential and life saving equipment. In these settings, well intentioned equipment donation from high to low resource settings is a frequently used strategy to address this through individuals, organisations, manufacturers and charities. However, issues with maintenance, availability of biomedical equipment technicians (BMET), supply chains, user education and the appropriateness of donations means these frequently fail to deliver the intended benefits. The WHO estimates that 95% of medical equipment in low and middle income countries (LMICs) is imported and 80% of it is funded by international donors or foreign governments. While up to 70% of medical equipment in sub Saharan Africa is donated, only 10%–30% of donated equipment becomes operational. A review of current practice and guidelines for the donation of medical equipment for surgical and anaesthesia care in LMICs has demonstrated a high level of complexity within the donation process and numerous shortcomings. Greater collaboration and planning between donors and recipients is required together with evaluation of donation programs and concerted advocacy to educate donors and recipients on existing equipment donation guidelines and policies. The circulation of medical equipment is not limited to donations. The rise of reuse and recycle based solutions, where gently used medical equipment is donated and redistributed to communities in need, is another form of equipment distribution. An interest in reusing and recycling emerged in the 1980s when the potential health hazards of medical waste on the East Coast beaches became highlighted by the media. Connecting the large demand for medical equipment and single use medical devices, with a need for waste reduction, as well as the problem of unequal access for low income communities led to the Congress enacting the Medical Waste Tracking Act of 1988. Medical equipment can be donated either by governments or non governmental organizations, domestic or international. Donated equipment ranges from bedside assistance to radiological equipment. Medical equipment donation has come under scrutiny with regard to donated device failure and loss of warranty in the case of previous ownership. Most medical devices and production company warranties to do not extend to reused or donated devices, or to devices donated by initial owners/patients. Such reuse raises matters of patient autonomy, medical ethics, and legality.