Editing Medical ultrasound (section)

== Regulation ==
Diagnostic and [[therapeutic ultrasound]] equipment is regulated in the US by the [[Food and Drug Administration]], and worldwide by other national regulatory agencies. The FDA limits acoustic output using several metrics; generally, other agencies accept the FDA-established guidelines.

Currently, [[New Mexico]], [[Oregon]], and [[North Dakota]] are the only US states that regulate diagnostic medical sonographers.<ref>[http://www.ardms.org/Discover-ARDMS/about-us/Pages/Legislation.aspx Legislation]. ardms.org</ref> Certification examinations for sonographers are available in the US from three organizations: the [[American Registry for Diagnostic Medical Sonography]], [[Cardiovascular Credentialing International]] and the [[American Registry of Radiologic Technologists]].<ref>{{Cite web|title=Medical Technologist Certification & Degree Programs|url=https://www.medicaltechnologyschools.com/|website=MTS|language=en-US|access-date=2020-05-19}}</ref>

The primary regulated metrics are [[Mechanical Index]] (MI), a metric associated with the cavitation bio-effect, and Thermal Index (TI) a metric associated with the tissue heating bio-effect. The FDA requires that the machine not exceed established limits, which are reasonably conservative in an effort to maintain diagnostic ultrasound as a safe imaging modality. This requires [[Industry self-regulation|self-regulation]] on the part of the manufacturer in terms of machine calibration.<ref>{{cite book |chapter-url=http://sonoworld.com/Client/Fetus/html/doppler/capitulos-html/chapter_02.htm |chapter=Safety of diagnostic ultrasound in fetal scanning |author=Deane, Collin |year=2002 |title=Doppler in Obstetrics |editor-first1=Kypros |editor-last1=Nicolaides |editor-first2=Giuseppe |editor-last2=Rizzo |editor-first3=Kurt |editor-last3=Hecker |editor-first4=Renato |editor-last4=Ximenes |access-date=December 4, 2014 |archive-date=January 4, 2022 |archive-url=https://web.archive.org/web/20220104181032/https://sonoworld.com/Client/Fetus/html/doppler/capitulos-html/chapter_02.htm |url-status=dead }}</ref>

Ultrasound-based pre-natal care and sex screening technologies were launched in India in the 1980s. With concerns about its misuse for [[sex-selective abortion]], the Government of India passed the [[Pre-Conception and Pre-Natal Diagnostic Techniques Act, 1994|Pre-natal Diagnostic Techniques Act (PNDT)]] in 1994 to distinguish and regulate legal and illegal uses of ultrasound equipment.<ref>[http://jskvrc.gov.in/ipas/2.pdf MTP and PCPNDT Initiatives Report] {{Webarchive|url=https://web.archive.org/web/20140601012501/http://jskvrc.gov.in/ipas/2.pdf |date=2014-06-01 }} Government of India (2011)</ref> The law was further amended as the Pre-Conception and Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) (PCPNDT) Act in 2004 to deter and punish prenatal sex screening and sex selective abortion.<ref>[https://web.archive.org/web/20170502044453/http://www.wbhealth.gov.in/download/IMPLEMENTATION%20OF%20THE%20PCPNDT%20ACT%20IN%20INDIA.pdf IMPLEMENTATION OF THE PCPNDT ACT IN INDIA – Perspectives and Challenges]. Public Health Foundation of India, Supported by United Nations FPA (2010)</ref> It is currently illegal and a punishable crime in India to determine or disclose the sex of a fetus using ultrasound equipment.<ref>{{cite web|url=http://mohfw.nic.in/THE%20PNDT%20ACT%20%28PRINCIPAL%20ACT%291994.htm |title=THE PRE-NATAL DIAGNOSTIC TECHNIQUES (REGULATION AND PREVENTION OF MISUSE) ACT, 1994 |date=20 September 1994 |website=mohfw.nic.in |url-status=dead |archive-url=https://web.archive.org/web/20050124122932/http://mohfw.nic.in/THE%20PNDT%20ACT%20%28PRINCIPAL%20ACT%291994.htm |archive-date=24 January 2005 }}</ref>