Bill Text: NJ S1203 | 2012-2013 | Regular Session | Introduced
Bill Title: Requires health care providers to obtain informed consent from patients for use of certain reprocessed medical devices.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Introduced - Dead) 2012-01-23 - Introduced in the Senate, Referred to Senate Health, Human Services and Senior Citizens Committee [S1203 Detail]
Download: New_Jersey-2012-S1203-Introduced.html
Sponsored by:
Senator NIA H. GILL
District 34 (Essex and Passaic)
SYNOPSIS
Requires health care providers to obtain informed consent from patients for use of certain reprocessed medical devices.
CURRENT VERSION OF TEXT
As introduced.
An Act concerning the use of certain reprocessed medical devices and supplementing Title 26 of the Revised Statutes.
Be It Enacted by the Senate and General Assembly of the State of New Jersey:
1. The Legislature finds and declares that:
a. Patient safety is the most important priority in the delivery of health care and should never be compromised by financial interests;
b. The statutory bill of rights for hospital patients in New Jersey provides that hospital patients have the right to make informed decisions about their care and that health care professionals and facilities are required to disclose all requisite information regarding a patient's proposed course of treatment so that patients can make fully informed decisions regarding their treatment;
c. Patient health may be jeopardized when medical devices that are manufactured and approved by the federal Food and Drug Administration for a single use on one patient are reprocessed for use on another patient;
d. Reprocessed single-use devices cannot be deemed to be 100% sterile, and the structural integrity of a single-use device can be compromised by reprocessing procedures;
e. More than 90,000 people in the United States die each year due to hospital-based infections, which in most cases cannot be explained; and
f. It is incumbent on the health care community to appropriately address any practice that may contribute to the spread of infection, which in some cases can have life-threatening consequences for patients.
2. As used in this act:
"Commissioner" means the Commissioner of Health and Senior Services.
"Department" means the Department of Health and Senior Services.
"Health care facility" means a health care facility licensed pursuant to P.L.1971, c.136 (C.26:2H-1 et seq.).
"Health care professional" means a health care professional licensed pursuant to Title 45 of the Revised Statutes.
"Informed consent" means a patient's written agreement to the use of reprocessed devices to treat or care for that patient.
"Medical emergency" means a condition which, on the basis of the attending physician's good faith clinical judgment, so complicates a patient's medical condition as to necessitate the immediate provision of medical care to the patient in order to avert the patient's death, or for which a delay will create serious risk of substantial and irreversible impairment of a major bodily function.
"Original device" means a new, unused single-use device.
"Original equipment manufacturer" means a person, company, or other entity that designs, manufactures, fabricates, assembles, or processes an original device.
"Reprocessed device" means an original device that has previously been used on a patient and has been subjected to additional processing and manufacturing for the purpose of additional use on a different patient. The subsequent processing and manufacture of a reprocessed device shall result in a device that is reprocessed within the meaning of this definition; and any single-use device that meets the definition under this meaning shall be considered a reprocessed device without regard to any description of the device used by the manufacturer of the device or another person or entity, including a description that uses the term "recycled," "refurbished," or "reused," rather than the term "reprocessed."
"Reprocessor" means a person, company, or other entity that undertakes procedures, including, but not limited to, additional processing, manufacturing, re-labeling, or re-packaging of an original device after it has been used on a patient for the purpose of creating a reprocessed device to be used on a different patient, or provides a means for the sale or distribution of reprocessed devices.
"Single-use device" means a medical device that is designed, manufactured, and approved by the federal Food and Drug Administration for one use on a single patient during a single procedure and is intended to penetrate normally sterile tissue or body spaces or contact intact mucous membranes during use.
3. a. A health care facility or health care professional shall not use a reprocessed device in the treatment or care of a patient without first having obtained the patient's informed consent in accordance with the provisions of this act and on a form and in a manner prescribed by regulation of the Commissioner of Health and Senior Services.
b. A health care facility shall require that upon each admission or registration of a patient at a health care facility:
(1) a representative of the health care facility provide each patient with a written notice that describes:
(a) the policy of the health care facility regarding the use of reprocessed devices, including the circumstances under which these devices are used and the safeguards taken by the health care facility to ensure the safety of the patient under those circumstances; and
(b) the potential risks of using reprocessed devices generally and in the specific application for that patient, which shall be consistent with the contents of the informed consent form adopted by the commissioner pursuant to section 4 of this act; and
(2) the patient's attending physician, or the attending physician's designee:
(a) verbally describe the patient's opportunity to indicate his consent or refusal to consent to the use of reprocessed devices in his treatment or care, and explain the contents of the informed consent form adopted by the commissioner pursuant to section 4 of this act; and
(b) make every reasonable effort to ensure that the patient understands the informed consent form, including arranging for the use of an interpreter to facilitate the patient's comprehension of the form, as necessary.
c. Before providing treatment or care to a patient in a setting outside a health care facility, a health care professional shall:
(1) provide the patient with a written notice that describes:
(a) the policy of the health care professional regarding the use of reprocessed devices, including the circumstances under which these devices are used and the safeguards taken by the health care professional to ensure the safety of the patient under those circumstances; and
(b) the potential risks of using reprocessed devices generally and in the specific application for that patient, which shall be consistent with the contents of the informed consent form adopted by the commissioner pursuant to section 4 of this act;
(2) verbally describe the patient's opportunity to indicate his consent or refusal to consent to the use of reprocessed devices in his treatment or care, and explain the contents of the informed consent form adopted by the commissioner pursuant to section 4 of this act; and
(3) make every reasonable effort to ensure that the patient understands the informed consent form.
d. The provisions of subsections a., b., and c. of this section shall not apply in the case of a medical emergency.
e. A patient's refusal to provide informed consent shall not, in any way, limit the patient's access to health care, including treatment or care that includes the use of an original device.
f. An informed consent form signed by a patient pursuant to this section shall be included as part of the patient's permanent medical record.
4. The commissioner shall adopt a uniform form for obtaining informed consent from patients for required use pursuant to this act. a. The form shall be designed to ensure that the patient is provided with information, in a manner and in terms the patient understands, which is necessary for the patient to determine whether or not to provide written consent to the use of reprocessed devices in the patient's treatment or care. The information shall include, but not be limited to, any risk to the patient from the use of reprocessed devices and the fact that the patient's refusal to provide informed consent will not, in any way, limit the patient's access to health care. The form shall specifically include a notice to the patient that reprocessed devices may undergo structural or chemical degradation and may contain more than trace amounts of biological or chemical residue.
b. The form shall include a place for the patient to indicate his consent or refusal to consent to the use of reprocessed devices in the patient's treatment or care.
5. a. A health care facility shall provide each health care professional who is employed or has privileges at the facility with:
(1) a written copy of the policy adopted by the facility on using reprocessed devices;
(2) written notification if a specific device that the facility makes available for the use of the health care professional is a reprocessed device; and
(3) written notification, prior to the rendering of a service or procedure with respect to a patient, that the patient has provided informed consent.
b. A health care professional who is employed or has privileges at a health care facility shall file a disclosure form with the facility acknowledging that the professional has been notified of the policy adopted by that facility on using reprocessed devices.
c. A health care facility shall provide each health care professional who is employed or has privileges at the facility with the opportunity to file an objection to using a reprocessed device. A health care facility shall not force a health care professional who files such an objection to use a reprocessed device, and shall not take any disciplinary or punitive action against a health care professional for filing such an objection.
6. A patient's attending physician shall record in a patient's permanent medical record an inventory of each reprocessed device that is utilized in the course of a patient's treatment, and shall indicate the procedure in which the device was used. This inventory shall include, but not be limited to: the type of device used; the name of the reprocessor that supplied the reprocessed device; and the reprocessor's lot number from which the reprocessed device came.
7. A health care facility, at its own expense and in accordance with a protocol prescribed by regulation of the commissioner, shall, after the discharge from the facility of a patient for whom a reprocessed device was utilized in the course of the patient's treatment at the facility, monitor the patient for infection and disease. If the patient develops an infection or disease, the facility shall notify the Department of Health and Senior Services on a form and in a manner determined by the commissioner, and the department shall investigate and determine if the infection or disease was caused by the use of a reprocessed device. The monitoring protocol prescribed by the commissioner shall include, but not be limited to, the period of time that the patient is to be monitored and the tests that the monitoring is to include.
8. a. A reprocessor that provides reprocessed devices to a health care facility or health care professional in this State shall:
(1) register with the department, for which purpose the reprocessor shall furnish to the department such information as the commissioner requires, including, but not limited to: the reprocessors's name, address, phone number, list of corporate officers, and list of reprocessed devices that the reprocessor distributes to health care facilities or health care professionals; and
(2) provide the department with:
(a) notice of any inspection conducted by any governmental entity;
(b) a copy of any report produced as a result of that inspection;
(c) immediate notice of any violation discovered through such an inspection;
(d) a copy of any remedial plan prepared by the reprocessor to correct any violation; and
(e) proof of liability insurance or a statement that the reprocessor is self-insured.
b. The commissioner shall issue a distinct identification number to each reprocessor that registers with the department.
c. The commissioner may charge a registration fee to a reprocessor in an amount not to exceed the reasonable costs incurred by the department to process and record the registration.
d. A reprocessor shall notify the commissioner of any reprocessed device, which the reprocessor intends to distribute to a health care facility or health care professional in this State, not less than 30 days prior to distribution of the reprocessed device.
9. a. A reprocessor shall be liable for the safety and effectiveness of each reprocessed device that the reprocessor distributes to a health care facility or health care professional. In no event shall an original manufacturer be held liable for the use, safety, or effectiveness of a reprocessed device, unless the original manufacturer has expressly and specifically consented to the use of the reprocessed device in that specific instance.
b. A person who reuses, recycles, reprocesses, refurbishes, reconditions, rebuilds, or otherwise provides for the reuse of a single-use device, who becomes aware of information based upon which that person reasonably believes that the single-use device that was reused, recycled, reprocessed, refurbished, reconditioned, or rebuilt may have caused or contributed to a death or serious injury or has malfunctioned and would be likely to cause a death or serious injury if the malfunction were to recur, shall report that information to the department on a form and in a manner prescribed by regulation of the commissioner.
c. The failure of a reprocessor, health care professional, or health care facility to comply with the provisions of this section shall be prima facie evidence that the reprocessing of a single-use device has rendered the reprocessed device unreasonably dangerous and unfit for its intended use.
10. a. The commissioner shall develop standards for the packaging of reprocessed devices distributed to health care facilities and health care professionals in this State, in order to ensure an easy and immediate visual means of identifying a device as a reprocessed device, including, but not limited to, a requirement that the packaging bear a prominently-displayed statement that the enclosed device is a reprocessed device.
b. Each reprocessed device distributed to a health care facility or health care professional in this State shall:
(1) bear the identification number issued to the reprocessor by the department pursuant to section 8 of this act; and
(2) include documentation as to:
(a) the source from which the reprocessor received the previously-used device;
(b) the number of times that the device has been reprocessed; and
(c) a description of the means by which the device was reprocessed.
11. A health care facility that uses reprocessed devices shall file an annual report with the commissioner, on a form and in a manner prescribed by the commissioner, which includes, but is not limited to:
a. a list of the reprocessors from which the facility purchases reprocessed devices; and
b. an inventory of all purchases by the facility of reprocessed devices, and of the procedures in which reprocessed devices were used within the facility, during the preceding 12 months.
12. a. The commissioner shall develop a list of all reprocessed devices distributed to health care facilities and health care professionals based upon the information obtained by the department pursuant to section 8 of this act, and shall update the list whenever a reprocessor notifies the commissioner that it intends to distribute additional reprocessed devices to a health care facility or health care professional pursuant to section 8 of this act.
b. The commissioner shall make available to the public on the Internet website of the department: the list of reprocessed devices distributed to health care facilities and health care professionals; and each annual report filed by a health care facility pursuant to section 11 of this bill.
13. a. It is an unlawful practice and a violation of P.L.1960, c.39 (C.56:8-1 et seq.) to violate any provision of this act.
b. A health care facility that fails to comply with the provisions of this act, or any rules or regulations adopted pursuant thereto, shall be subject to a penalty as determined by the commissioner pursuant to sections 13, 14, and 16 of P.L.1971, c.136 (C.26:2H-13, C.26:2H-14, and C.26:2H-16).
c. A health care professional who fails to comply with the provisions of this act, or any rules or regulations adopted pursuant thereto, shall be subject to disciplinary action by the appropriate professional licensing board.
d. The provisions of this section shall not be construed to preclude any other remedy that may be pursued against a reprocessor or a health care facility or health care professional.
14. The commissioner shall adopt rules and regulations pursuant to the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.), to carry out the purposes of this act.
15. This act shall take effect on the 180th day after enactment, except that the commissioner may take such anticipatory administrative action in advance as shall be necessary for the implementation of the act.
STATEMENT
This bill is designed to ensure that patients being treated by health care facilities or health care professionals in New Jersey are fully informed about the use of reprocessed medical devices used in their treatment and care.
The bill provides specifically as follows:
· A licensed health care facility or health care professional is not to use a reprocessed device in the treatment or care of a patient without first having obtained the patient's written informed consent to the use of reprocessed devices.
· A health care facility is to require that, upon each admission or registration of a patient at the facility, a representative of the facility provide each patient a written notice that describes the policy of the facility regarding the use of reprocessed devices and the potential risks of using reprocessed devices generally and in the specific application for that patient.
· A health care facility is to require that a patient's attending physician, or the attending physician's designee, upon the patient's admission to or registration at the facility:
-- verbally describe the patient's opportunity to indicate his consent or refusal to consent to the use of reprocessed devices in his treatment or care, and explain the contents of the informed consent form used pursuant to the bill; and
-- make every reasonable effort to ensure that the patient understands the informed consent form, including arranging for the use of an interpreter to facilitate the patient's comprehension of the form, as necessary.
· Before providing treatment or care to a patient in a setting outside a health care facility, a health care professional is to:
-- provide the patient with a written notice that describes the policy of the health care professional regarding the use of reprocessed devices and the potential risks of using reprocessed devices generally and in the specific application for that patient;
-- verbally describe the patient's opportunity to indicate his consent or refusal to consent to the use of reprocessed devices in his treatment or care, and explain the contents of the informed consent form used pursuant to the bill; and
-- make every reasonable effort to ensure that the patient understands the informed consent form.
· A patient's refusal to provide informed consent is not, in any way, to limit the patient's access to health care, including treatment or care that includes the use of an original device.
· An informed consent form signed by a patient pursuant to the bill is to be included as part of the patient's permanent record.
· The Commissioner of Health and Senior Services is to adopt a uniform form for obtaining informed consent from patients for required use pursuant to the bill.
· A health care facility is to provide each health care professional who is employed or has privileges at the facility with:
-- a written copy of the policy adopted by that facility on using reprocessed devices;
-- written notification if a specific device that the facility makes available for the use of the health care professional is a reprocessed device; and
-- written notification, prior to the rendering of a service or procedure with respect to a patient, that the patient has provided informed consent to the use of reprocessed devices to the use of reprocessed devices in the patient's treatment or care.
· A health care facility may not force a health care professional who files an objection to using a reprocessed device to use such a device, and may not take any disciplinary or punitive action against a health care professional for filing such an objection.
· A patient's attending physician is to record in a patient's permanent medical record an inventory of each reprocessed device utilized in the course of a patient's treatment, and indicate the procedure in which the device was used.
· A health care facility, at its own expense and in accordance with a protocol prescribed by regulation of the commissioner, is required, after the discharge from the facility of a patient for whom a reprocessed device was utilized in the course of the patient's treatment at the facility, to monitor the patient for infection and disease. If the patient develops an infection or disease, the facility is to notify the Department of Health and Senior Services (DHSS), on a form and in a manner determined by the commissioner, and DHSS is to investigate and determine if the infection or disease was caused by the use of a reprocessed device.
· A reprocessor that provides reprocessed devices to a health care facility or health care professional in this State is to register with DHSS, and provide DHSS with the information stipulated in the bill.
· A reprocessor is to notify the commissioner of any reprocessed device, which the reprocessor intends to distribute to a health care facility or health care professional in this State, not less than 30 days prior to distribution of the reprocessed device.
· A reprocessor is to be liable for the safety and effectiveness of each reprocessed device that the reprocessor distributes to a health care facility or health care professional.
· A person who reuses, recycles, reprocesses, refurbishes, reconditions, rebuilds, or otherwise provides for the reuse of a single-use device, who becomes aware of information based upon which that person reasonably believes that the device may have caused or contributed to a death or serious injury or has malfunctioned and would be likely to cause a death or serious injury if the malfunction were to recur, is to report that information to DHSS.
· The commissioner is to develop standards for the packaging of reprocessed devices distributed to health care facilities and health care professionals in this State to ensure an easy and immediate visual means of identifying a device as a reprocessed device.
· A health care facility that uses reprocessed devices is to file an annual report with the commissioner, on a form and in a manner prescribed by the commissioner, concerning its purchase and use of these devices.
· The commissioner is to develop and continuously update a list of all reprocessed devices distributed to health care facilities and health care professionals.
· The commissioner is to make available to the public on DHSS Internet website: the list of reprocessed devices distributed to health care facilities and health care professionals; and each annual report filed by a health care facility pursuant to the bill.
· A person who violates any provision of the bill commits an "unlawful practice" under the consumer fraud law, P.L.1960, c.39 (C.56:8-1 et seq.), which is punishable by a monetary penalty of not more than $10,000 for a first offense and not more than $20,000 for a second or any subsequent offense. In addition, a violation can result in cease and desist orders issued by the Attorney General, the assessment of punitive damages, and the awarding of treble damages and costs to the injured party.
· A health care facility that fails to comply with the provisions of the bill, or any rules or regulations adopted pursuant thereto, is subject to a penalty as determined by the commissioner pursuant to N.J.S.A.26:2H-13, 14, and 16.
· A health care professional who fails to comply with the provisions of the bill, or any rules or regulations adopted pursuant thereto, is subject to disciplinary action by the appropriate professional licensing board.
· The bill takes effect on the 180th day after enactment, but authorizes the commissioner to take anticipatory administrative action in advance as necessary for its implementation.
