OPTHAL-PMS - CSSD PRODUCTS

gke Steri Record Opthal-BMS
Batch Monitoring System(bms)for opthalmology Instruments in steam sterilization processes

Product Description

The Ophthal-BMS is a class 2 indicator according to EN ISO 11140-1 consisting of a “specific test load“ (process challenge device = PCD) and an “indicator system”. A specifically designed external case contains an internal stainless steel tube connected with a stainless steel capsule holding the “indicator system“ (indicator strip) inside. The PCD is called gke Steri-Record® CompactPCD® and consists of patented “multi-stage” technology connecting different lengths and volumes simulating the steam penetration characteristics of ophthalmology loads. The oval cross section of the PCD with a flat height of 2,5 cm allows the PCD to be placed horizontally in a tabletop sterilizer .

Performance Characteristics

The Ophthal-BMS is validated with an “equivalence test” according to German Standard DIN 58921 using a typical ophthalmologic instrument load configuration. The “equivalence test” is carried out in a laboratory accredited according to the standard EN ISO 17025. A test report is available on request. The load configuration contains a maximum tube length of 50 cm. Long tubes are extremely critical goods to be cleaned and sterilized as well. In most cases they are exchanged as disposables. Provided that tubes of more than 50 cm length are used as disposables and not re-sterilized, complex hollow instruments e.g. phaco hand pieces are the goods most difficult to be sterilized. These instruments have been used as a reference to configure the specification of the gke Ophthal-BMS. As a test method the validation procedure according to DIN 58921 is applied. The successful sterilization of an instrument does not only depend on the efficiency of the sterilizer program but also on the construction of the instrument. There are instruments on the market which cannot be sterilized with the most efficient steam sterilization processes due to inappropriate construction which prevent steam penetration inside sealed areas and therefore result in non-sterility. These instruments cannot be reprocessed in steam sterilization processes. Therefore it is required that the instruments are validated according to EN ISO 17664 and a
verification is available from the manufacturer. If an Ophthal-BMS is used to monitor a steam sterilization process it is ensured that all typical ophthalmic instruments including phaco hand pieces are successfully penetrated with steam and sterilized. Tube material of 50 cm lengths and longer cannot be monitored with the Ophthal-BMS. Either disposable tubes or a BMS with more demanding penetration characteristics shall be used in this case. The gke application laboratory may support you.

Operational Description

If all four bars of the chemical indicator turn from yellow to black it is an indication of sufficient steam penetration inside the PCD. This result ensures air removal and steam penetration into the whole load under the condition that the PCD is representing the load configuration.

Background Information

gke presents as the next generation the gke Steri-Record® Ophthal-BMS which is especially designed for ophthalmic applications: extremely durable and resistant against mechanical stress and heat, easy to handle and usable for an unlimited number of test cycles. The Process Challenge Device (PCD) has been developed to monitor air removal and steam penetration in steam sterilization processes inside typical ophthalmologic loads. Not only the surfaces but also the interior of hollow instruments, e.g. phaco hand pieces, are checked for sterility

Benefits

The use of this Ophthal-BMS allows the monitoring of sterility inside of typical ophthalmologic instruments not provided by recording pressure, temperature and steam quality in the chamber and/or using exposed indicator strips. The PCD is validated according to DIN 58921 (typical ophthalmologic load).
The batch can be released without opening the pack to check the internal packaging indicator.
All information relevant to release the load is supplied on completion of the process so that the person authorized can release the batch.
Cost effective. Only one indicator strip is required for each sterilization process instead of one in each pack.
Indicators in each package are not anymore necessary.
Easy interpretation of the results due to precise colour change.
The graduated colour change of the indicator bars informs about the magnitude of air removal and steam penetration into the PCD.
The colour change of the chemical indicator is based on a non-reversible chemical reaction. The indicator strip can be documented for several years without changing back to its original colour.
Continuous reproducibility of the results over the lifetime of the PCD if seals are replaced precautiously.
Environmentally friendly, no unnecessary waste.
gke self-adhesive labels simplify recording with the gke Steri-Record® documentation system.
The PCD is designed with an advanced international patented “multi-stage” technology.
The screw-cap consists of a highly thermal resistant material and stainless steel sandwichconstruction that protects hands from high temperatures. The chemical indicator may be easily removed and evaluated on completion of each cycle.
The Ophthal-BMS can be used for a large number of cycles. All important parts are made of stainless steel or thermal resistant polymers. Seals are replaced easily.
Its specifications remain constant over the lifetime of the device.
All gke chemical indicators are protected from bleeding by a polymer binders and surface coating during and after sterilization

Order Information

Each start-up kit contains one Compact-PCD® Ophthal-BMS and 100 integrating indicator strips as well as a documentation sheet to be copied before daily use. Test devices are available separately as well. The indicator strips are available as refill packs without test devices since the test devices can be used for thousands of sterilization cycles. Seal rings for the screw cap are included in each refill pack.