Medical device
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.
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.
[citation needed] Section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act[5] defines a device as an "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: which does not achieve 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 its primary intended purposes.
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 conformity of a medium or high risk medical device with relevant regulations is also assessed by an external entity, the Notified Body, before it can be placed on the market.
"[13] 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.
The regulatory authorities recognize different classes of medical devices based on their potential for harm if misused, design complexity, and their use characteristics.
[19] Class I devices are subject to the least regulatory control and 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.
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.
These packagings should also show harmonised pictograms and EN standardised logos to indicate essential features such as instructions for use, expiry date, manufacturer, sterile, do not reuse, etc.
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.
[44] 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.
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.
[citation needed] 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".
[47] 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.
[48] 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".
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.
Medical device cleanliness has come under greater scrutiny since 2000, when Sulzer Orthopedics recalled several thousand metal hip implants that contained a manufacturing residue.
[62] Additionally, the FDA is establishing new guidelines for reprocessing reusable medical devices, such as orthoscopic shavers, endoscopes, and suction tubes.
[65] 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.
[77][78][79] 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.
[81] 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.
[82] Anand Raghunathan, a researcher in this study, explains that medical devices are getting smaller and lighter so that they can be easily worn.
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,[87] in response to the growing risks of limited cybersecurity.
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.
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.
