Sponsored by:
Senator FRED H. MADDEN, JR.
District 4 (Camden and Gloucester)
SYNOPSIS
Restricts sale, lease, and use of certain ultrasound equipment and distribution of images created by ultrasound equipment; establishes registration requirements for certain organizations using such equipment.
CURRENT VERSION OF TEXT
As introduced.
An Act concerning ultrasound equipment and supplementing Title 26 of the Revised Statutes.
Be It Enacted by the Senate and General Assembly of the State of New Jersey:
1. a. A person shall not sell, offer to sell, offer for promotional purposes, lease, or otherwise distribute in this State an obstetric-gynecologic ultrasonic imager, except to any of the following:
(1) a health care professional licensed pursuant to Title 45 of the Revised Statutes;
(2) a health care facility licensed pursuant to P.L.1971, c.136 (C.26:2H-1 et seq.);
(3) a dealer, distributor, manufacturer's representative, or sales agent that purchases an obstetric-gynecologic ultrasonic imager for the sole purpose of selling, leasing, or otherwise distributing the equipment in accordance with this act;
(4) a bank, leasing company, or financial institution that purchases an obstetric-gynecologic ultrasonic imager from a manufacturer or other person for the sole purpose of leasing the system in accordance with this act;
(5) an educational or research facility that purchases, leases, or otherwise obtains an obstetric-gynecologic ultrasonic imager for training or research purposes; or
(6) a non-profit charitable organization incorporated under State law that provides ultrasound services at no cost to patients, under the supervision of a physician or other health care professional licensed pursuant to Title 45 of the Revised Statutes.
b. A person shall not sell, offer to sell, offer for promotional purposes, or otherwise distribute in this State any image, or other product, produced by an obstetric-gynecologic ultrasonic imager, except any of the following individuals:
(1) a health care professional licensed pursuant to Title 45 of the Revised Statutes; or
(2) an employee of a health care facility licensed pursuant to P.L.1971, c.136 (C.26:2H-1 et seq.), who has been certified by the facility to operate an obstetric-gynecologic ultrasonic imager.
c. Notwithstanding the provisions of subsection b. of this section, the following individuals may distribute, without cost, an image, or other product, produced by an obstetric-gynecologic ultrasonic imager:
(1) a dealer, distributor, manufacturer's representative, or sales agent that purchases an obstetric-gynecologic ultrasonic imager for the sole purpose of selling, leasing, or otherwise distributing the equipment in accordance with this act;
(2) an employee of an educational or research facility that purchases, leases, or otherwise obtains an obstetric-gynecologic ultrasonic imager for training or research purposes; or
(3) an employee of a non-profit charitable organization incorporated under State law that provides ultrasound services at no cost to patients, under the supervision of a physician or other health care professional licensed pursuant to Title 45 of the Revised Statutes.
d. Nothing in this section shall be construed to permit a person to buy, lease, or use an obstetric-gynecologic ultrasonic imager if the person is not authorized to do so under federal law or regulations.
e. For the purposes of this section, "obstetric-gynecologic ultrasonic imager" means a prescription medical device defined by the federal Food and Drug Administration in 21 CFR 884.2225, the use of which is regulated by the federal Food and Drug Administration in the U.S. Department of Health and Human Services.
2. Any non-profit charitable organization incorporated under State law that provides or offers to provide ultrasound services, and which is not otherwise registered or licensed with the Department of Health, shall register and provide documentation to the department regarding its ultrasound operations in accordance with regulations as prescribed by the department.
3. a. A person who violates the provisions of section 1 of this act shall be subject to a penalty of not less than $500 nor more than $1,000 for each offense, to be collected by the Commissioner of Health in a civil action through a summary proceeding under the "Penalty Enforcement Law of 1999," P.L.1999, c.274 (C.2A:58-10 et seq.). The municipal court and the Superior Court shall have jurisdiction of proceedings for the enforcement of the penalty provided by this subsection. If the violation is of a continuing nature, each day during which it continues constitutes an additional, separate, and distinct offense.
b. The Commissioner of Health may institute a civil action for injunctive relief to enforce this act and to prohibit and prevent a violation of this act, and the court may proceed in the action in a summary manner.
c. The Commissioner of Health shall revoke the registration, after notice and an opportunity for a hearing, of any non-profit charitable organization registered in accordance with section 2 of this act for a violation of this act.
4. This act shall take effect on the 180th day after enactment.
STATEMENT
This bill prohibits the sale, lease, or distribution of an obstetric-gynecologic ultrasonic imager in the State to any person other than the following:
1. a licensed health care professional;
2. a licensed health care facility;
3. a dealer, distributor, manufacturer's representative, or sales agent that purchases an obstetric-gynecologic ultrasonic imager for the sole purpose of selling, leasing, or otherwise distributing the equipment to a person pursuant to this act;
4. a bank, leasing company, or financial institution that purchases an obstetric-gynecologic ultrasonic imager from a manufacturer or other person for the sole purpose of leasing the system to a person pursuant to this act;
5. an educational or research facility that purchases, leases, or otherwise obtains an obstetric-gynecologic ultrasonic imager for training or research purposes; or
6. a non-profit charitable organization incorporated under State law that provides ultrasound services under the supervision of a physician or other health care professional licensed pursuant to Title 45 of the Revised Statutes at no cost to patients.
Furthermore, the bill prohibits the sale or distribution of any image, or other product, produced by any obstetric-gynecologic ultrasonic imager, in the State by any person other than the following:
1. a licensed health care professional; or
2. an employee of a licensed health care facility, who has been certified by the facility to operate an obstetric-gynecologic ultrasonic imager.
Additionally, the following individuals may distribute, without cost, images or other products produced by an obstetric-gynecologic ultrasonic imager:
1. a dealer, distributor, manufacturer's representative, or sales agent that purchases an obstetric-gynecologic ultrasonic imager for the sole purpose of selling, leasing, or otherwise distributing the equipment to a person pursuant to this act;
2. an educational or research facility that purchases, leases, or otherwise obtains an obstetric-gynecologic ultrasonic imager for training or research purposes; or
3. a non-profit charitable organization incorporated under State law that provides ultrasound services under the supervision of a physician or other health care professional licensed pursuant to Title 45 of the Revised Statutes at no cost to patients.
The bill requires any non-profit charitable organization that is incorporated under State law, which provides or offers to provide ultrasound services, and which is not otherwise registered or licensed with the Department of Health, to register and provide documentation to the department regarding its ultrasound operations in accordance with regulations as prescribed by the department.
A person who sells, offers to sell, offers for promotional purposes, leases, or otherwise distributes an obstetric-gynecologic ultrasonic imager, in violation of the provisions of section 1 of this bill, will be subject to a civil penalty of not less than $500 and not more than $1,000 for each offense, to be collected by the Commissioner of Health. In addition, the bill stipulates that the Commissioner of Health shall revoke the registration of any non-profit corporation that provides or offers to provide ultrasound services in violation of the provisions of this bill.
The United States Food and Drug Administration (FDA) has issued warnings against non-medical ultrasounds since 1994, and in December 2014 released updated consumer health information stressing that fetal ultrasound imaging devices are prescription devices designed to be used by trained health care professionals. The FDA strongly discourages the use of ultrasounds for creating fetal keepsake images and videos. This bill is intended to ensure that ultrasound scans are performed by appropriately trained providers and are limited to situations involving a medical need for the scans.