TITLE 77: PUBLIC HEALTH
CHAPTER I: DEPARTMENT OF PUBLIC HEALTH
SUBCHAPTER f: EMERGENCY SERVICES AND HIGHWAY SAFETY
PART 515 EMERGENCY MEDICAL SERVICES, TRAUMA CENTER, COMPREHENSIVE STROKE CENTER, PRIMARY STROKE CENTER AND ACUTE STROKE READY HOSPITAL CODE
SECTION 515.360 APPROVAL OF ADDITIONAL DRUGS AND EQUIPMENT


 

Section 515.360  Approval of Additional Drugs and Equipment

 

a)         All drugs and equipment, other than those covered by the United States Department of Transportation National Standard Curriculum for each EMT level of licensure, must be approved by the Department in accordance with subsections (b), (c) and (d) of this Section before being used in a System.

 

b)         To apply for approval to add drugs and/or equipment, the EMSMD shall submit to the Department documentation covering the following:

 

1)         Training program including a description of practical training for equipment and the number of contact hours;

 

2)         A curriculum for each new drug or equipment, which includes at least the following (as applicable):

 

A)        Usage,

 

B)        Complications,

 

C)        Adverse reactions,

 

D)        Equipment maintenance and use;

 

3)         New written standing orders.

 

c)         Upon receipt of the application from the System, the Director or his/her designee shall either approve the drug and/or equipment, approve the drug and/or equipment on a conditional basis, or disapprove the drug and/or equipment. The Director's/designee's decision shall be based on a review and evaluation of the documentation submitted under subsection (b) of this Section; the application of technical and medical knowledge and expertise; consideration of relevant literature and published studies on the subject; and whether the drug and/or equipment has been reviewed or tested in the field. The Director may seek the recommendations of medical specialists and/or other professional consultants to determine whether to approve or disapprove the specific drug(s) and/or equipment.

 

d)         The Director or designee shall consider whether the drugs and equipment may be used safely and with proper training by the pre-hospital care provider and shall disapprove any drugs and/or equipment that he/she finds are generally unsafe or dangerous in the pre-hospital care setting.

 

e)         When a drug and/or equipment is approved on a conditional basis, the System shall submit to the Department, on a quarterly basis (January 1, April 1, July 1 and October 1) the following information:

 

1)         Indications for use;

 

2)         Number of times used;

 

3)         Number and types of complications that occurred;

 

4)         Outcome of patient after use of drug and/or equipment; and

 

5)         Description of follow-up actions taken by the System on each case in which complications occurred.

 

f)         When a death or complication that results in a deterioration of a patient's condition occurs, involving a drug and/or equipment approved on a conditional basis, the System shall notify the Department within three business days, followed by a written report of the situation submitted to the Department within 10 business days.

 

g)         Failure of the System to submit the information required under subsection (e) of this Section shall be considered as a basis for withdrawal of approval of the drug or equipment on a conditional basis. Failure of the System to notify the Department as required under subsection (f) of this Section shall be considered as a basis for withdrawal of approval of the drug or equipment on a conditional basis.

 

h)         The Director or designee shall evaluate the information submitted under subsection (e) of this Section and any notification required under subsection (f) of this Section. The Department will notify the System that a drug or equipment is disapproved and may no longer be performed on a conditional basis when the evaluation of the information submitted pursuant to this subsection (h) indicates that the safety of the drug or equipment has not been established for use in the pre-hospital setting.

 

i)          An EMSMD shall not approve an EMT to use new drugs or equipment unless that EMT has completed the Department-approved training program and examination, and has demonstrated the required knowledge and skill to use that drug or equipment safely and effectively.

 

j)          An EMSMD shall not be required to provide new drug or equipment training to System EMTs who will not be using the new drugs or equipment.

 

(Source:  Added at 21 Ill. Reg. 5170, effective April 15, 1997)