(a) Each
facility seeking to operate an autoclave shall develop an operation plan, and
shall submit such plan to the department for review and approval prior to using
the autoclave to treat regulated medical waste. Any change in procedures
related to the operation of the autoclave shall be reflected in a modified
plan, which shall be dated with each revision.
(b) No autoclave shall be used to treat
regulated medical waste without department approval of the facility's operation
plan and any modifications made to such plan on or after the effective date of
this regulation.
(c) The operation
plan shall be designed to promote safe and effective operation of the
autoclave. The operation plan shall include, minimally, procedures to ensure:
(1) the autoclave meets department criteria
for effective treatment of regulated medical waste (i.e., the protocol for
validation testing and a summary of the results);
(2) loads contain only those items or types
of waste for which effective treatment has been demonstrated by validation
testing; and exclude waste materials for which effective treatment by the
system has not been demonstrated and/or is prohibited pursuant to section
70-2.3 of
this Part, and, as applicable, materials expressly excluded in the
commissioner's notice of approval;
(3) each load is treated using residence
time, temperature and pressure that have been validated as effective for the
treatment of regulated medical waste, and conditions of treatment are monitored
and documented for each load;
(4)
the effectiveness of treatment is maintained, by including, as applicable,
procedures for and frequency of: calibration verification and recalibration of
parametric controls; monitoring by challenge testing or other demonstration
that treatment has been attained; and preventative maintenance of engineering
controls (e.g., charcoal and/or HEPA filters) and diagnostic procedures for
electronic controls (e.g., integrated computers and mechanical
components);
(5) occupational
exposure is minimized, and physical injury to operators is prevented during
loading, the cycle, and unloading the autoclave; and
(6) personnel are knowledgeable about routine
operation of the autoclave, are kept current with manufacturer recommendations
for operation, and have been instructed in emergency procedures for handling
malfunctioning systems and untreated waste. Training programs shall mandate
initial training and retraining at least once per calendar year and as
necessary for presenting updates on operational information.
(d) Any modification of an
approved operation plan with potential to substantially alter treatment
efficacy shall be submitted to the department for approval. Prior to approving
a modified plan, the department may require that validation testing be
conducted again by the facility, and the results submitted for department
review.
(e) Whenever an autoclave
fails to operate in accordance with pre-established operating parameters, the
facility shall:
(1) discontinue use of the
autoclave, using emergency shutdown procedures if appropriate until corrective
action has been taken and validation testing has verified that effective
treatment can resume;
(2) handle as
untreated all regulated medical waste processed by the system since the last
previous run under documented compliance with such requirements;
(3) document the failure, including date and
autoclave identifier;
(4) document
the facility response, including corrective action; and
(5) whenever a facility has reason to believe
untreated waste certified as treated waste has left the facility, notify the
waste transporter as soon as practicable, and notify the department within 72
hours of the waste's leaving the facility.
(f) Monitoring autoclave operator.
(1) parametric controls shall be employed to
monitor operating parameters automatically and continuously throughout the
entire cycle, and generate a record of operating parameters for each
cycle.
(2) In the absence of
parametric controls, routine operational performance of an autoclave shall be
monitored by:
(i) challenge testing,
conducted every 40 hours of autoclave operation or once a week, whichever
occurs first, using the same protocol as was approved by the department for
validation testing; and
(ii)
time/temperature-sensitive materials used in each load.
No autoclave that fails to attain 4 log
10 reduction in viable spores concentration upon
challenge testing shall be used to treat regulated medical waste. Whenever
time/temperature-sensitive materials fail to show expected results (i.e., a
color change), the load shall be handled as untreated waste, and the facility
shall demonstrate, through a repeat of validation testing, that the autoclave
effectively treats regulated medical waste before resuming its use for
treatment purposes.
(g) Containment of regulated medical waste
for treatment by autoclaving shall be by a container or containment system
designed to withstand the temperature and pressure of autoclaving, and may,
except for sharps, consist soley of a red bag.
(h) If the container or containment system
does not, by design, allow steam to come into direct contact with waste
material, the operator shall take action to ensure such contact.
(i) Sharps treated by autoclaving shall be
destroyed prior to disposal.