Is the operator obliged to use original accessories only, i.e. instruments made by the manufacturer of the power system, or is the use of instruments made by third party suppliers permissible?
Gebr. Brasseler GmbH & Co. KG has been renowned as a reliable manufacturer of tools for use in power surgical handpieces for many years. Our range includes rotary instruments, saw blades and surgical precision tools. These are distributed under the brand “Komet Medical”. Our products are destined for use in the power systems made by various third party manufacturers.
The compatibility of our instruments with the different power systems is indicated in the current catalog (see www.kometmedical.de) or on the labels of the packaging. These declarations are based on the work of our engineers who carefully measure the original instruments and tools in regular intervals and test the Komet products in the original power systems during their development. Only then the product will be released for launch on the market.
Still, some users are not sure whether or not it is permitted to use Komet Medical products (third party product) with their power systems, or if they are obliged to use the “original accessories” provided by the manufacturer of the power system. This uncertainty has arisen in the past from ambiguous statements in the instructions enclosed with some power systems or from misleading information given by the employees of individual power system manufacturers or distributors.
In this context, we would like to reiterate that the use of our tools in the power systems specified by us is definitely permitted.
In the event of a defect of the power system, you are of course entitled to assert the usual warranty claims against the seller of the power system. On principle, the implied warranty in pre-worded sales conditions must not be made dependent on whether “original accessories” or accessories made by other manufacturers were used (§309, sect. 8b) aa) BGB1). Any disclaimers of warranty in the purchase agreement and/or misleading information in the instructions are therefore legally void.
If the power system has a defect according to §433 et seqq. BGB, the seller of the power system is held liable for the defect even if accessories made by a third party manufacturer – such as products of the brand “Komet” – were used.
Likewise, it is not permitted to make the product liability of the manu-facturer for damage to person or property according to §1 of the “ProdHaftG2” categorically dependent on the use of “original accessories”. Pursuant to §14 of the ProdHaftG, the liability of the manufacturer to pay damages must not be restricted in advance. Due to the stan-dardization of the Product Liability Act in Europe (EC Directive of 25/07/1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products), these principles are valid in the other European Member States as well.
Please feel free to contact us at any time should you have further queries regarding the above.
Which surgical power systems does Komet Medical supply compatible instruments for?
Komet Medical specializes in the development and manufacture of cutting instruments for ENT and neurosurgery, orthopaedics, traumatology and arthroscopy.
The Komet Medical range comprises compatible instruments for all power systems established on the market, such as Synthes, Aesculap, Stryker, Linvatec, MicroAire, DeSoutter, Nouvag, Bien Air and many more. Komet Medical is not affiliated with any of these companies.
Instruments in sterile packaging
Which part of the packaging is sterile and can be handed over to the surgical staff in the sterile zone?
Case 1: Double tubular bag KM, PC series
The circulating nurse opens the outer tubular bag with the lug provided.
The circulating nurse passes the sufficiently opened tubular bag to his/her sterile colleague at the operating table. The nurse at the operating table removes the inner, sterile bag. The inner bag is then opened at the lug provided, so that the saw blade can be removed without problems.
Case 2: Blister EZ-, KMS-Serie
The circulating nurse opens the blister with the lug provided.
The circulating nurse turns the open side of the blister towards the operating table and lets the inner clamshell containing the saw blade drop onto the operating table. Do not touch the contents of the blister as these are sterile.
Case 2: Blister EZ-, KMS-Serie
The circulating nurse opens the blister with the lug provided.
The circulating nurse passes the sufficiently opened blister to his/her sterile colleague at the operating table. The clamshell inside the blister is then opened so that the saw blade can be removed without problems. As an alternative, the saw blade can be taken out together with the clamshell. It then has to be removed from the sterile clamshell.
Which instruments made by Komet Medical can be reprocessed?
Generally spoken, all instruments that are not marked ‘disposable’ on the label can be reprocessed. Instruments supplied in a non-sterile condition have to undergo the entire reprocessing procedure prior to first use. Please refer to our instructions for use. For further information, see our reprocessing brochure and our informative sheet on instrument reprocessing (click on Product Information and select Reprocessing of Instruments).
Does Komet Medical provide validated reprocessing method suitable for its the entire product range?
Yes, we do. You can find informative sheets on the reprocessing of instruments on our website, one for each product group. In addition, there is information on the reprocessing of auxiliaries such as bur blocks and our GENIUSadapters (see Product Information Reprocessing of Instruments).
It is important to note that the validation only applies to the equipment and materials mentioned in the informative sheets. Any deviations from the provided methods have to be checked by the person reprocessing the instruments to make sure that this is still effective and that there are no adverse effects.
What are the criteria GENIUS shaver blades should be controlled by?
The correct and complete control of the instruments is a decisive factor for the success of any operation. Blunt Shaver Blades remove very little substance, bent Shaver Blades cause metal abrasion and corrosion significantly increases the risk of fracture.
Our GENIUS Shaver Blades should be controlled according to the check list of the Sterile Service Department we have specially developed for this purpose. The parameters to be checked in detail include cleanness, surface condition as well as correct shape and function. The GENIUS Shaver Blade should only be passed to sterilisation or packaging if it has satisfied all the relevant criteria.
The check list provides concrete examples for defects and gives you advice on how to proceed next, i.e. another cleaning cycle, disposal or packaging.
How can GENIUS Shaver Blades be protected from shocks during transport and storage?
The GENIUSbox is part of the GENIUS concept of the Shaver Blades. The Shaver Blades’ inner and outer tubes can be stored in separate supports which can be closed with a lid. The GENIUSbox can be sterilised.
How do you reprocess reusable Komet Medical instruments?
The entire Komet Medical product range can be reprocessed without problems in the gentle cycle of a cleaning and disinfection unit, provided that the detergent/disinfectant used is compatible with the material. We recommend subsequent sterilisation in the autoclave at 134°C. For further details please refer to our brochure on reprocessing and our validated manufacturer’s information.
How must I treat multi-use instruments to ensure maximum service life?
For economic reasons, Komet Medical/Gebr. Brasseler’s basic philosophy is to provide hospitals with instruments that can be reprocessed.
Therefore, the manufacturer is required to design instruments that are able to withstand stresses and strains as well as repeated reprocessing cycles. This means for example that they must be stable and should not have hard-to-clean areas. A validated method for reprocessing can be viewed under the menu bar, clicking on Product Information and Instrument reprocessing
On the other hand, the user or reprocessing division is required to treat multi-use instruments with the reasonable care. This means that they must not be thrown or used as a lever and they have to be reprocessed immediately after the operation. They must be submitted to a detailed control to eliminate instruments that are no longer serviceable. Provided that all requirements are met, you can use the full potential of a multi-use instrument!
Are the products made in Germany?
All products from the Komet Medical range are developed and manufactured in Germany. Almost 1000 staff are employed at the company’s main headquarter in Lemgo.
Who is liable when reprocessing is carried out by a third party?
The operator is the one who will reuse the medical product reprocessed by a third party. He is obliged to ascertain if the external person who carries out the reprocessing is in fact competent and if he delivers the required quality. In addition, the surgeon guarantees safety and is therefore categorically obliged to keep the risk for the patient at “0”. He may only employ an instrument if he is convinced that the use of that instrument involves no potential risk whatsoever – no matter how small.
Komet Medical instruments are designed for multiple use. Our validated methods have shown that our instruments can be reprocessed several times without any damage to the material.