Approved Disinfection Methods

(A) The following disinfection methods are approved, subject to any additional conditions that may be specified by the Department, to render medical or biological waste noninfectious, excluding pathological waste and contaminated animal waste which shall be disposed of at an approved incineration facility, by interment, or by an alternative method approved in writing by the Department, pursuant to 105 CMR 480.200: (1) Steam disinfection/autoclaving; (2) Chemical disinfection; (3) Incineration at an approved incineration facility; or (4) Any other method approved in writing by the Department. (B) The methods which rely on heat shall be evaluated for each load or cycle by using a recording thermometer, thermocouple, parametric monitoring device, thermal indicator strip, or by an equivalent method approved in writing by the Department. (C) For any wastes that are rendered noninfectious by chemical disinfection, the chemical used shall be of demonstrated efficacy, as determined by the Department, against the challenge testing target or indicator organism and registered with: (1) The U.S. Environmental Protection Agency, Office of Pesticide Programs pursuant to the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA); and (2) The Massachusetts Department of Agricultural Resources, Pesticide Bureau. (D) All parametric monitoring equipment utilized in conjunction with any approved disinfection methods, including autoclaves, shall be calibrated at a minimum annually, by an individual who has received training from the manufacturer in the operations and maintenance of the equipment. (E) Quarterly qualitative (growth/no growth) biological challenge testing shall be conducted during standard operations for all approved disinfection methods including autoclaves, but not incineration. (1) Testing shall consist of spore strips or a retrievable alternative medium approved by the 4 Department, which contain a 1.0 x 10 minimum challenge population of a bacterial indicator organism that is most resistant to any aspect of the treatment technology as outlined in the most recent medical waste treatment technology guidelines established by The State and Territorial Association on Alternative Treatment Technologies (STAATT) or its successor, The International Society of Analytical Analysis of Treatment Technologies (IStAATT); (2) Testing methodologies including the number, type and locations shall be in accordance with manufacturers’ guidelines and procedures approved by the Department; (3) Analytical testing results (growth/no growth) should demonstrate a minimum bacterial spore reduction of 4 log 10 ; (4) When a 4 log 10 bacterial spore reduction has not been demonstrated (results indicate bacterial growth), an operations and mechanical systems assessment shall be conducted by a qualified individual who has received training from the manufacturer in the operations and maintenance of the equipment. Appropriate corrective actions shall be implemented, when warranted, including but not limited to mechanical adjustments and when applicable, recalibration of all parametric monitoring devices followed by re-treatment of the waste and additional challenge testing to confirm the effectiveness of any implemented corrective action; (5) In accordance with 105 CMR 480.500(B)(1)(f), the analytical test results shall be documented on the required record-keeping log form for medical or biological waste treated on site in conjunction with the date and all applicable corresponding process parameter results. (6) When implemented, corrective actions pursuant to 105 CMR 480.150(E)(4) shall be documented in detail including the date, name of the individual implementing the corrective actions and a description of the work performed, on the back of the applicable record-keeping log form for medical or biological waste treated on-site. (7) All analytical test results shall be retained in the required record-keeping log for a period of three years.