P.R. Laws tit. 12, § 1336d
It shall be understood as treatment the methods, techniques or processes designed to change the composition or biological features of the waste, without altering the physical features of the waste, so as to eliminate the hazard associated to an infectious agent that may be present in such waste. It shall be understood that this process has been completed when more than eighty percent (80%) of efficiency is guaranteed, in each type of RBW (Regulated Biomedical Waste), when ruined, mutilated or broken into pieces in such a way that these are not recognizable or reusable as regulated biomedical waste.
(a) Except as provided in subsections (b) and (c) of this section, a person that generates or treats biomedical waste shall ensure that such biomedical waste has been processed by one of the following methods before disposing of the same:
(A) Incineration in a facility authorized for treatment of biomedical waste with air control or some other method of incineration approved by the Board, which provides for the full combustion of the waste until it turns into ashes, whether carbonized or mineralized.
(B) A treatment that guarantees that the waste may not be recognizable and reused after being ruined, broken into pieces, mutilated, melted, or compacted and encapsulated after melted, and it is free of infectious agents in such a way that its capacity to cause diseases has been eliminated.
(1) The sterilization or disinfection by steam in a facility certified for the treatment of biomedical waste or by other method of sterilization that follows the operating procedures below for steam sterilization or some other type of sterilization:
(A) Written standard operating procedures shall be established for the biological indicators or for other indicators of adequate sterilization, which have been approved by the Board for each steam sterilization facility, including the duration, temperature, pressure, type of waste, container lock, load pattern, water content, and maximum amount to be loaded.
(B) The thermometer indicators and the temperature log shall be verified after each full cycle to ensure that 121 Celsius (250 Fahrenheit) [has] been reached at least half (½) an hour after, depending on the amount and density of the load, in order to achieve full sterilization of the load. Thermometer calibration shall be annually verified. The records of thermometer calibration verification shall be kept as part of the installation files for a three (3)-year period or that specified by regulations.
(C) The biological indicator Bacillus stearothermophilus or other indicator of adequate sterilization as it has been approved by the regulatory agency, shall be placed at the center of the processed load under the standard operating conditions at least once every forty-eight (48) hours, to confirm that the conditions for adequate sterilization have been met.
(D) The records of the procedures specified in paragraphs (A), (B), and (C) shall be [kept] for a period of not less than three (3) years.
(2) Water steam sterilization with a suction system. Through this method, all regulated biomedical waste are submitted to a thermal treatment in the autoclave systems, and are melted and encapsulated during the sterilization process, which renders them into a final unrecognizable plastic mass product that when exposed to the environment temperature hardens permanently, preventing the waste to be potentially reused. In such cases, the material thus treated shall be deemed to be destroyed for all corresponding legal purposes, insofar as the same shall not be reusable.
(A) Other alternative methods to treat biomedical waste are:
(i) The ones approved by the Board.
(ii) The ones resulting in the destruction of pathogens.
(B) Any other alternative method for the disposal of biomedical waste shall be evaluated by the Board and approved or rejected pursuant to the criteria established by this section.
(b) Medical waste may be disposed of through the public sewer system without being treated, if it is not waste that poses a biological risk, as defined, which is in a liquid or semi-liquid state, and its disposal is consistent with the requirements for waste disposal through the public sewer system imposed by the Aqueduct and Sewer Authority.
(1) Medical waste that poses biological risks may be treated through chemical disinfection, if the medical waste is in a liquid or semi-liquid state, and the chemical disinfection method used is recognized, as well as if the use of chemical disinfection as a treatment method has been identified in the plan for the management of biomedical waste of such a facility.
(2) If the waste is not treated through chemical disinfection pursuant to clause (1) of this subsection, the waste may be treated through one of the methods specified in subsection (a) of this section.
(3) Upon chemical disinfection treatment, the medical waste may be disposed of through the public sewer system, if its disposal is consistent with the requirements for waste disposal through the public sewer system as established by the Aqueduct and Sewer Authority, and such disposal is in compliance with the requirements imposed by the owner or operators of the public sewer system.
(c) Recognizable body parts shall be disposed, with the exception of teeth that are not considered infectious by the physician and surgeon or dentist who handled the case, through their burial or pursuant to subsection (a) of this section, unless they pose a risk, in which case they should be sterilized or disinfected in such a way that prior to their disposal they be rendered free of infectious diseases. This provision shall not apply to carcasses.
(d) Sharp waste shall become non-infectious prior to its disposal through one of the following methods:
(1) Incineration.
(2) Steam sterilization.
(3) Destruction, mutilation, breakage into pieces, encapsulation or compaction after it has been melted.
(4) Disinfection though alternative methods approved by the Board.
(5) Sharp objects turned into non-infectious pursuant to this section may be disposed of as if they were non-hazardous solid waste, if these are not hazardous for any other cause.
(6) Treatment of sharp waste, in compliance with clauses (2) and (3) of this subsection, within the facilities for treatment of biomedical waste in the structure shall ensure that, prior to the disposal of treated sharp waste, these have been destroyed or the access of the public to such sharp waste has been hindered.
(e) Each authorized facility for the treatment of biomedical waste shall provide the Board with an emergency action plan, which shall be followed by the facility in order to ensure the adequate disposal of medical waste in the event of equipment breakdown, a natural disaster or other circumstances.
(f) Carcasses shall be treated pursuant to the provisions of this section, when the cause of death of the animal was an infectious disease, if according to the opinion of the veterinarian or the local health official who treated the animal, the carcass poses a risk of infection to human beings, in which case it shall be treated prior to its disposal as non-hazardous solid waste.
History —Aug. 6, 2008, No. 180, § 6.