EFHSS Questions and Answers - Question Q00108

Hi all,
I have just visited a GP Surgery and been shown a sterilizer called a "STATIM". It has a cassette which may be loaded with instruments and pushed into an opening in the front of the machine. The machine has a water reservoir, and is a similar size to a domestic VCR. Has anyone seen one of these machines, and does anyone know how they are supposed to work, finally does anyone believe this machine and its use can comply with current UK guidance? Looking forward to receiving your responses.

Paul HUGHES,
Head of Sterile Services.

Paul, About your Statim sterilizer, why don't you call Alfa Medical 800 748-1259 and ask them for a list of users, a demonstration, and ask how they validate a sterilizer cycle. There is a lot of information on the internet that you can get by just typing in Statim Sterilizer in a search engine. Make the manufacturer Prove it.
Rita Barnes
Fort Dodge, Iowa

Paul,
Statim is a cassette autoclave type S (prEN 13060-1-4, see CEN Standards). The certificate of testing - 19 sept 2000 - says it's suitable for sterilizing:

• solid metal instruments.
• solid metal instruments wrapped in paper/paper or plastic/paper sterile wraps.
• solid and hollow metallic and non-metallic surgical and dental instruments.
• wrapped hollow instruments, as above.
• unwrapped dental handpieces.

The problem is that a previous certificate of testing - 1 december 1998 - describes "hollow" as follows: solid and hollow metallic and non-metallic surgical and dental instruments, whose aspects ratios fall within single ended open rigid plastic or metal tubes with a depth to inner diameter ratio of no more than 5 : 1, or double open ended rigid plastic or metal tubes with a length to inner diameter ratio of no more than 10 : 1. Therefor, for me anyway, question marks can be placed behind the efficacy of steam penetration in hollow medical devices and behind the kind of hollow medical devices you can sterilize in a statim. As Rita says: it's up to the manufacturer to prove his claims.

Kind regards
Wim Renders

In the US, sterilizers are Class II medical Devices and therefore require premarket clearance of labeling claims. If you want to review the claims of Mfg, go to this site and search by company name. Frequently, the 510(k) will have a summary statement that provides additional info.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

Chip Moore
Senior Market Manager
Sterilization Products
Getinge/Castle
Rochester, NY
800 475 9040 x5123
Visit our Website: www.getingecastle.com

Hi All,

have you any further information about statim and its capabilities.

michelle

The SciCan Statim 2000 and 5000 use a smart system (removable chamber/cassette), very common 10 years ago but now a little bit "old fashioned", not aligned with the "state of the art" devices using quick fractionated vacuum cycles dedicated to sterilization of hollow and porous loads.
Despite of the indications, Scican 2000 and 5000 are not suitable for hollow and porous loads (at least according to the standard requirements of EN 13060 new european norm), and the wrapped load is also a critical issue, either for steam penetration or for drying efficiency (and also cycle time lenght, since the drying phase takes over 20 minutes).
Nowadays other systems are definitely more safe, effective and time/money saving for the sterilization within medical/dental practice.

Hi Paul,

I have some experience with the Statim. In my opinion they are not capable of sterilising lumen devices, as for wrapped items, I would like to see more validation reports to be convinced. On the other hand the cassette is a more hygienic and safer way of transfering unwrapped items from steriliser to point of use.

For an independent, expert opinion I suggest you contact Stuart Line, Authorised Person, UK. He has run independant tests on these machines and can tell you what he thinks their limitations are.

Best regards
Linda