Ley 37 del 2007
Resumen
Esta ley enmienda la Ley Núm. 62 de 1928 para prohibir la adquisición y operación de máquinas de ultrasonido (sonógrafos) por personas no autorizadas por el Departamento de Salud de Puerto Rico. Establece que solo laboratorios, consultorios médicos y hospitales con licencia del Departamento de Salud pueden adquirir y operar estos equipos, exclusivamente para fines médicos. Impone multas y la confiscación del equipo a quienes infrinjan esta disposición, y sanciones a quienes vendan, distribuyan o comercien máquinas de ultrasonido a personas no autorizadas.
Contenido
(No. 37)
(Approved April 24, 2007)
AN ACT
To add new Sections 5 and 6 to Act No. 62 of May 1, 1928, as amended, in order to prohibit the use of ultrasound machines (sonographs) by persons not authorized by the Department of Health, and to impose penalties.
STATEMENT OF MOTIVES
The images produced by ultrasound machines are the result of a medical procedure used to examine live images of the organs and the bloodstream. Some of the organs most frequently examined through this procedure are the heart, the liver, the gallbladder, the spleen, the pancreas, the kidneys, and the urinary bladder. Because ultrasound images are obtained in real time they are able to show the movement of the organs and internal tissues and allow doctors to observe the bloodstream, as well as the functioning of the heart valves. This helps in diagnosing various diseases and evaluating the damage caused by a heart attack or other condition. Regarding this matter see Rados, Carol, "FDA Cautions Against Ultrasound 'Keepsake’ Images," F.D.A. Consumer Magazine, January-February 2004.
However, ultrasound is mostly used to show images of the fetus within the mother's womb because it uses sound waves instead of radiation. With the passing of time, ultrasound has become an essential tool for
prenatal care since the information it provides improves the results of the labor process and allows the health professional to plan the medical attention of the woman during pregnancy.
Furthermore, because of the technological and medical advances many of these ultrasound machines have been acquired by businesses engaged in marketing photos of the fetus during pregnancy. In the most dramatic cases, persons of considerable financial means have obtained said machines for their own use as if they were merely still cameras. However, the Food and Drug Administration (FDA) has alerted about the danger this entails both for the fetus and the mother when said medical procedure is administered without the supervision of a health professional. The medical community in the United States has spoken against said practice in the belief that in spite of the fact that the procedure is rather safe, it should be conducted by persons trained to do so, and that no person should run the risk of causing possible harm to the fetus or the mother. The FDA has been in controversy with companies engaged in the business of photographing fetuses as to the length of time during which the mother and fetus are exposed to the energy generated. According to the experts, this procedure should be conducted with the least exposure possible to the energy of the sound waves.
In the United States, jurisdictions such as California and New York have already legislated to prohibit the acquisition of said machines for nonmedical purposes. See: AB 2360, amendment to Article 7, Health and Safety Code of California. On the other hand, the FDA is energetically supervising said centers to ensure that they do not propagate or that, to the degree that their prohibition is legislated; they are transferred to another jurisdiction not under said prohibition.
For all of the above and based on the power of the Reason of State, this Legislature must anticipate any action or omission that puts the health of the People of Puerto Rico at risk. To such effects, it is established through this Act, that the ultrasound medical procedure must be conducted under medical prescription and under the supervision of health professionals taught and trained to do so. Thus, it is hereby established that any person or institution not authorized to practice medicine in the Commonwealth of Puerto Rico may not acquire or operate an ultrasound machine (sonograph) under penalty of a fine of not less than $5,000 and the immediate confiscation of the equipment. Any natural or juridical person that sells, distributes or trades an ultrasound machine to an unauthorized person, shall be charged with a misdemeanor and sanctioned with a fine of not less that ten thousand dollars $($ 10,000)$ and/or the cancellation of any license issued by the Commonwealth of Puerto Rico to conduct business in Puerto Rico.
BE IT ENACTED BY THE LEGISLATURE OF PUERTO RICO:
Section 1.-To add a new Section 5 to Act No. 62 of May 1, 1928, as amended, to read as follows: "Section 5.-Ultrasound machines; prohibition As regards the laboratories, physician's offices and hospitals that conduct ultrasound procedures (sonograms), it is hereby provided that no natural or juridical person may acquire or operate an ultrasound machine (sonograph) unless they hold a license issued by the Department of Health of the Commonwealth of Puerto Rico for conducting said procedure solely and exclusively for medical purposes.
Any natural or juridical person that possesses or operates an ultrasound machine without the certifications required shall be charged with
a misdemeanor and sanctioned with a fine of not less than five thousand (5,000) dollars and the immediate confiscation of the machine.
Any natural or juridical person that sells, distributes or trades an ultrasound machine to an unauthorized person, shall be charged with a misdemeanor and sanctioned with a fine of not less that ten thousand dollars $($ 10,000)$ and/or the cancellation of any license issued by the Commonwealth of Puerto Rico to conduct business in Puerto Rico."
Section 2.-A new Section 6 is hereby added to Act No. 62 of May 1, 1928, as amended, to read as follows: "Section 6.-Any law or part of a law opposed to the present Act, is by the latter repealed."
Section 3.-The Department of Health of the Commonwealth of Puerto Rico shall adjust any regulation to this Act.
Section 4.-This Act shall take effect immediately after its approval.
CERTIFICATION
I hereby certify to the Secretary of State that the following Act No. 37 (S.B. 1509) of the $5^{ ext {th }}$ Session of the $15^{ ext {th }}$ Legislature of Puerto Rico:
AN ACT to add new Sections 5 and 6 to Act No. 62 of May 1, 1928, as amended, in order to prohibit the use of ultrasound machines (sonographs) by persons not authorized by the Department of Health, and to impose penalties, has been translated from Spanish to English and that the English version is correct.
In San Juan, Puerto Rico, today $30^{ ext {th }}$ of August of 2007.
Francisco J. Domenech Director