Md. Code Regs. 26.13.11.02

Current through Register Vol. 51, No. 25, December 13, 2024
Section 26.13.11.02 - Definitions
A. The following terms have the meanings indicated.
B. Terms Defined.
(1) "Anatomical material" means human or animal body parts, including tissues and organs.
(2) "Blood" means human blood, human blood components, and products made from human blood.
(3) "Blood-soiled article" means any article that contains blood in any form as a result of contact with blood.

(3-1) "Contaminated item" means an item for which it is known or reasonably anticipated that blood or other potentially infectious material is present on the item.

(4) "Contaminated material" means:
(a) Microbiological laboratory waste;
(b) The feces of an individual diagnosed as having a disease that may be transmitted to another human being through the feces;
(c) An article soiled with the feces of an individual diagnosed as having a disease that may be transmitted to another human being through the feces; or
(d) An article that has come into contact with a known human pathogen.
(5) "Generator" means any person whose act or process produces a special medical waste.

(5-1) "Infectious substance" means a material known or reasonably expected to contain a pathogen.

(6) "Microbiological laboratory waste" means waste from a microbiological laboratory that contains a human pathogen and includes cultures and stocks of pathogens and associated biologicals.

(6-1) "Other potentially infectious material" means:

(a) The following human body fluids:
(i) Amniotic fluid;
(ii) A body fluid that is visibly contaminated with blood;
(iii) A body fluid that cannot be readily identified;
(iv) Cerebrospinal fluid;
(v) Pericardial fluid;
(vi) Peritoneal fluid;
(vii) Pleural fluid;
(viii) Saliva generated in the performance of dental procedures;
(ix) Semen;
(x) Synovial fluid; and
(xi) Vaginal secretions;
(b) A tissue or organ from a living or dead human, not including intact skin, that has not been preserved by a chemical additive or preservative;
(c) The following items relating to human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus:
(i) HIV-containing cell, tissue, or organ cultures;
(ii) Media or other solutions containing HIV, Hepatitis B, or Hepatitis C; and
(iii) Blood, organs, or other tissues, including blood, organs or other tissues from experimental animals infected with HIV or hepatitis B virus; and
(d) Microbiological laboratory waste.

(6-2) "Pathogen" means a microorganism, including bacteria, viruses, rickettsiae, parasites, and fungi, or other agent, such as a proteinaceous infectious particle, also known as a prion, that can cause disease in humans or animals.

(7) "Person" means an individual, trust, firm, joint stock company, federal agency, corporation (including a government corporation), partnership, association, state, municipality, political subdivision of a state, any interstate body, and any combination of persons using a common disposal collection device.
(8) Sharp.
(a) "Sharp" means an object that:
(i) Is capable of cutting or penetrating skin or a packaging material, and
(ii) Either is known, suspected, or reasonably anticipated to be contaminated with a human pathogen, blood, or other potentially infectious material or may become contaminated with a human pathogen through handling or during transportation;
(b) "Sharp" includes needles, syringes with an attached needle or other sharp, scalpels, surgical instruments, broken glass, broken capillary tubes, broken rigid plastic, and exposed ends of dental wires.
(c) "Sharp" includes an item that is capable of cutting or penetrating skin or a packaging material if the item is not in its original, intact packaging unless the item:
(i) Is not commonly associated with blood, other potentially infectious material or infectious substances, such as, for example, broken glass from beverage containers or disposable blades used by a contractor in building maintenance; and
(ii) Has not been exposed to or commingled with special medical waste; and
(d) "Sharp" does not include an item in its original, intact packaging.
(9) "Shipping paper" means a shipping order, bill of lading, manifest, or other shipping document serving a similar purpose and containing the information required by 49 CFR §§ 172.202, 172.203, and 172.204, which are incorporated by reference in COMAR 26.13.12.01 s B(5) and 26.13.13.01 s G.
(10) "Solid waste" means any waste defined by COMAR 26.13.02.02 s.
(11) "Special medical waste" means a solid waste that is not excluded under Regulation .03 of this chapter and is composed of:
(a) Anatomical material;
(b) Blood that is in a liquid or semiliquid state;
(c) Blood-soiled articles that:
(i) Would release blood in a liquid or semiliquid state if compressed; or
(ii) Are caked with dried blood and are capable of releasing the blood during handling of the items;
(d) A contaminated item that:
(i) Would release other potentially infectious material in a liquid or semiliquid state if compressed; or
(ii) Is caked with other potentially infectious material and is capable of releasing the other potentially infectious material during handling of the item;
(e) Contaminated material;
(f) An infectious substance that can cause disease in humans;
(g) Microbiological laboratory waste;
(h) Other potentially infectious material that is in a liquid or semiliquid state;
(i) Pathological and microbiological waste that contains blood or other potentially infectious material; or
(j) Sharps.
(12) "Sterilize" means to use a physical or chemical procedure to destroy all microbial life including highly resistant bacterial endospores.

Md. Code Regs. 26.13.11.02

Regulations .02 adopted as an emergency provision effective September 28, 1988 (15:22 Md. R. 2549); emergency status extended at 16:4 Md. R. 493 (Emergency provisions are temporary and not printed in COMAR)
Regulations .02 adopted effective April 3, 1989 (16:6 Md. R. 733)
Regulation .02 amended effective April 20, 1998 (25:8 Md. R. 599)
Regulation .02B amended effective April 21, 2008 (35:8 Md. R. 812)