N.J. Admin. Code § 8:41-3.7

Current through Register Vol. 56, No. 21, November 4, 2024

Section 8:41-3.7 - Biomedical equipment testing and maintenance

(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.

(c) The required testing and maintenance shall be conducted by:

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.

N.J. Admin. Code § 8:41-3.7