Md. Code Regs. 30.06.02.03

Current through Register Vol. 51, No. 12, June 14, 2024

Section 30.06.02.03 - Quality Assurance and Maintenance

Each registered facility shall:

A. Comply the federal Safe Medical Devices Act of 1990 and the Medical Device Amendments of 1992;

B. Maintain:

(1) The certificate issued by MIEMSS in a place where it is readily available;

(2) Each AED and all related equipment and supplies in accordance with the standards established by the device manufacturer and the federal Food and Drug Administration;

(3) Supplemental equipment with the AED at all times as follows:

(a) Two sets of defibrillator chest pads;

(b) Disposable gloves; and

(c) Maryland Facility AED Report Forms for Cardiac Arrest;

C. Submit:

(1) A report for each incident of suspected cardiac arrest at the facility on the Maryland Facility AED Report Form for Cardiac Arrests, including, when available, any event (code) summary, recording, or tape created by the AED to MIEMSS, and be available for follow up as necessary; and

(2) If the AED fails when operated, in addition to submitting the required report to the federal Food and Drug Administration, a copy of the report to MIEMSS; and

D. Ensure the confidentiality of any medical records maintained by the registered facility as required by law.

Md. Code Regs. 30.06.02.03

Regulations .03 adopted as an emergency provision effective January 1, 2000 (27:2 Md. R. 142); adopted permanently effective April 17, 2000 (27:7 Md. R. 707)
Regulation .03 amended effective May 4, 2009 (36:9 Md. R. 654)