Hydroclave Is Sole Technology to attain STAATT Level IV Compliance in UK
US concerns appeased...
July, 2006
Hydroclave & STATTS Compliance
Following information is the outcome of an audit of clinical waste treatment
facilities conducted by Health Protection Agency (HPA), a very influential UK
Government department that advises and works with the Environment Agency.
Concerns were raised in the USA about 12 months ago regarding the ability of
alternative treatment technologies to effectively sterilise 'suction containers', which
are strong, rigid flasks designed to hold body fluids or similar. As well as the
physical strength issues, the containers frequently contain a solidifying gel that is
thermally stable and could protect infected material and enable it to survive the
sterilisation process.
The HPA requested a number of UK operators to participate in a rigorous audit of
various technologies to test how well they coped with suction containers. Grundon (using Hydroclave technology)
participated in the audit and has received the report, which shows that the
Hydroclave was completely effective in breaking up and sterilising the contents of the
containers. Every other technology tested failed the audit
to varying degrees
most failed almost completely. ...Hydroclave technology is the best available both in terms of meeting the
most stringent regulatory requirements (STATT Level IV) and also in terms of the
quality of design and engineering.
Attached are extracts from the
Report...
EXTRACTS FROM: SUCTION CONTAINER TESTING PROGRAMME
HYDROCLAVE SYSTEM, GRUNDON STAR WORKS FACILITY, MAIDENHEAD
APRIL 2005
B) INTRODUCTION
B.1.1. Following current Environment Agency (EA) and NHS Estates (HTM 2075)
guidelines, the levels of inactivation defined by the US State and Territorial Association on
Alternate Treatment Technologies (STAAT) are accepted as valid and clinical waste
treatment facilities in the UK should meet at least level III inactivation criteria.
B.1.2. Level III inactivation requires the demonstration of a 4 log10 reduction in
numbers of Bacillus atrophaeus (subtilis)) or Geobacillus stearothermophilus spores while
level IV requires a 6 log10 reduction in numbers of Bacillus atrophaeus or Geobacillus
stearothermophilus spores.
C) AIM OF THE STUDY
C.1.1. To investigate the efficacy of the Hydroclave system in killing bacterial
spores inside suction containers . A reduction in Bacillus atrophaeus and Geobacillus
stearothermophilus spores by 4 log10 is the target required, representing STAATT level III
inactivation.
C.1.2. To investigate the effects of the treatment process on a range of containers
both in the waste itself and inside a sealed theatre bin.
J) CONCLUSIONS
A.1.1. The Grundon Hydroclave clinical waste treatment plant at Knowl Hill,
Maidenhead has achieved STAATT level IV inactivation (6 log10 inactivation of Bacillus
atrophaeus (subtilis) spores or G stearothermophilus spores) under standard conditions of
testing using normal operating conditions and the stated operating parameters of 130°C for a
holding time of 30 minutes. This inactivation is 100 times the level of inactivation required in
the UK for clinical waste treatment processes.
A.1.2. Following concerns about the effectiveness of the process in treating microorganisms
in suction containers containing solidifying gel, spore strip challenge tests were
carried out using a range of containers to assess the level of inactivation achieved.
A.1.3. The Hydroclave process melts or destroys disposable suction liners and rigid
sealed suction containers and effectively removes the lids from all thermostable plastic snaptop
rigid suction containers. This allows the solidified gel and contents inside to be dispersed
throughout the body of the waste and thus achieve the same treatment conditions and spore
inactivation levels as the rest of the waste (i.e. 6 log10 inactivation of Bacillus atrophaeus
spores or G stearothermophilus spores). The process also removes the lids from sealed theatre
bins and forces the contents out into the body of the waste.
A.1.4. The Hydroclave process proved capable of melting or destroying the sealed
rigid containers used in these trials and dispersing the solidifying gel and contents in all cases
but one, where most but not all, of the gel had been emptied. Spore challenge tests from this
container showed <1 log10 inactivation of G stearothermophilus spores. It is interesting to
note that the container with the G stearothermophilus strip that showed <1 log kill (no 8) also
had temperature strips present which indicated that temperatures of 134°C for 18 minutes had
been achieved, conditions which are more than adequate to produce a>^log10 kill. The
reasons for this discrepancy are not clear. This result must be viewed with caution as it is
anomalous and does not fit with the rest of the results obtained.
A.1.5. The Hydroclave process also proved capable of achieving 6 log10
inactivation of Bacillus atrophaeus spores or G stearothermophilus spores inside Dialysis
filters, proving that the system could successfully treat these containers.
A.1.6. The Hydroclave process can successfully treat disposable suction liners, low
grade plastic disposable suction containers and snap-top suction containers, even when
contained inside sealed theatre bins. The Hydroclave can also successfully treat sealed rigid
suction containers and dialysis filters under the current operating conditions.
Contact GRUNDON WASTE MANAGEMENT LTD
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662 Norris Court · Kingston, Ontario, Canada · K7P 2R9
Tel: (613) 389-8373 · Fax: (613) 389-8554 · Email: info@hydroclave.com
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