New Jersey Administrative Code
Title 8 - HEALTH
Chapter 41 - ADVANCED LIFE SUPPORT SERVICES; MOBILE INTENSIVE CARE PROGRAMS, SPECIALTY CARE TRANSPORT SERVICES AND AIR MEDICAL SERVICES
Subchapter 3 - GENERAL ADMINISTRATIVE, CREWMEMBER AND VEHICLE REQUIREMENTS
Section 8:41-3.7 - Biomedical equipment testing and maintenance

Universal Citation: NJ Admin Code 8:41-3.7

Current through Register Vol. 56, No. 6, March 18, 2024

(a) Each provider shall develop and maintain a testing and maintenance schedule for its biomedical equipment in accordance with the manufacturer's recommendations or in compliance with Federal standards, whichever is more frequent. All biomedical equipment and devices shall comply with all applicable provisions set forth by the Federal Food and Drug Administration for safe care, utilization and maintenance of medical devices.

(b) For the purposes of this section, biomedical equipment includes, but is not limited to:

1. Cardiac resuscitators (that is, Thumpers[R]);

2. Cardiac defibrillators and/or pacers;

3. Automatic ventilators;

4. Incubators;

5. Specialized respirators;

6. External pacemakers;

7. IV pumps; and

8. Balloon pumps.

1. Qualified employees of the firm that manufactured the equipment;

2. Qualified employees of a firm approved or authorized by the manufacturer;

3. Biomedical engineering staff of an acute care hospital;

4. Biomedical engineering staff of the New Jersey Hospital Association (or of an affiliate);

5. A recognized independent laboratory; or

6. Crewmembers or other employees of the provider who have been qualified by the equipment manufacturer to perform such testing and maintenance.

(d) The requirements of (a) above shall not apply to biomedical equipment that is:

1. In the physical possession of an acute care hospital or other validly licensed health care facility;

2. Is placed in the provider's vehicle for treatment, during transportation, of that hospital's or facility's patient; and

3. Is operated by that hospital or facility's personnel.

(e) The results of the biomedical equipment tests shall be kept on file at the provider's principal place of business and shall be made available to Department staff upon demand.

Disclaimer: These regulations may not be the most recent version. New Jersey may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.