The biggest fear of the practice owner and the hygiene officer is immter I can pour soap and disinfectants. s. Again and again I encounter introduction at the practice inspections in the framework of the QM the same question. Under most conditions AMT would agree. The biggest fear of the practice owner and the hygiene officer is immter I can pour soap and disinfectants. The answer is Yes, because there is only a recommendation of RKIs, there is no legislation prohibiting it. Read here what you must meet for it to continue to perform the transfer to. May hands – and disinfectant from bulk containers in smaller bottles be decanted? With hand Sanitizer the requirement is freedom from pathogenic germs for the manufacturer shall ensure that however is guaranteed during the transfer from 5 L canisters in smaller containers in doctor and dentist practices only in compliance with hygienic rules freedom of spores and wash lotions. Similar to the hand disinfectant must also the skin disinfectant for the transfer by the user the spores freedom be guaranteed.
From the hygienic point of view, therefore the Robert Koch-Institut (RKI) in the directive recommends the use of one time cylinder: 2.3 Prevention of contamination of environment implementation of measures of hand hygiene, washing lotions…The use of single time cylinders is recommended because the recycling and refilling with contamination risks associated. Disinfectant-emptied bottles of hand disinfectant may be refilled on the basis of the medicinal products act only under aseptic conditions in a hospital pharmacy. Therefore the use of one time cylinder advisable here, too.” The RKI recommendation to prefer one time containers! Product liability: By filling to extinguishes the liability of the marketing authorisation and shall be transferred to the bottler (doctor). It is however by no means drug legally inadmissible (and is practiced to a large extent), in particular disinfectant out To pour large containers in small containers, if the necessary requirements are met (s. u.).
Since it is at hand and skin disinfectant drugs, falls transfer medicinal products legally within the definition of drug manufacturing ( 4 para 14 AMG). Others who may share this opinion include Daryl Katz. As far as the user fills around such as the disinfectant from a large package in a smaller donor container for his own use, lacking the construed of the disposal of to others. Because according to the legal definition of 13 ABS. 1 S. 3 AMG a disposal of to others exists, if the person who manufactures the drug, is different than that which it applies. When his staff applies the product filled to within the sphere of influence of the user under whose responsibility, no disposal of to others exists because the practice owner has the exclusive ownership of the drugs. As a result, the filling from bulk containers in dispenser containers is medicinal products legally allowed so also in the medical and dental practice. However several are observed hygienic rules: the refill process may be carried out only by trained personnel and shall be documented. First is the dispenser container to drain completely. Then the dispenser containers before again filling must be thoroughly cleaned and disinfected. For this purpose, it is advisable to rinse the system several times thoroughly with hot water. With hand Sanitizer can be washed with the product itself. After filling around by hand, skin disinfectants and washing lotions have the batch number and the expiration date of the canister to the newly filled container transferred. The application period is in addition to specify.
