> Hygiene rules & regulations

….are you familiar with this?

This question we hear most days at Trade Fairs. Reason enough to bring the matter up once again and help you with qualified advice and assistance.

The subjects:

Mucous and Skin infections at the customer (Antiseptic)

Against activities which could intend or unintended cause injury to the skin (e.g. with tattooing, piercing, ear piercing, or with Pedicure, and Manicure) is disinfection of the skin important. For this purpose, a suitable alcoholic disinfectant from the DGHM list is to be used. Making sure the skin surface is wet with the disinfectant, leave for at least 15 seconds (see manufacturer’s instructions). The skin surface must be kept moist and must not be wiped dry. A complete disinfection of the skin can only be expected when the minimum exposure and sufficient disinfection are complied with. For mucous membrane infections a suitable disinfectant is to be used. The working time of mucous membrane disinfectants is usually at least one minute (see manufacturer’s instructions). Should it come to an inadvertently or deliberate skin injury, then the wound area is to be treated with a suitable antiseptic. All unintentional accidents are to be documented. [other topics]

Instrument Treatment

Preliminary Remarks

Sterility requiring tasks as defined in § 2 section 2 of the German Hygiene Regulations, are actions that lead to a breach of the skin or mucous membrane of the customer, through tattooing, piercing and ear piercing. Due to the regular opening of the wound area or wound channel, a high risk from a local skin infection leading to a possible sepsis can accrue. These methods are only to be used when using one-way or sterilized instruments on disinfected skin surfaces. The recommendation is to use one-way instruments i.e. razorblades, scalpels, needles for ear piercing, piercing or tattooing etc, which must be thrown away after use. Reusable instruments must be processed correctly by sterilization, and kept in a sterile condition until the next application. Principle consideration regarding the subject of sterility must also include the following disinfection measures.

Disinfection specifications as defined in §2 section 2 of the German Hygiene Regulations are measures which refer to the treatment of the skin surface or the skin superficial body growths (nails, hair), in the field of Podiatry / Medical Chiropody and its abnormal changes. In this and the above mentioned methods, depending on the nature of procedure, sterility could cause a separate risk, and that possible Microorganisms from a customer (HIV, hepatitis virus, pus, wart virus etc) could land on an instrument and be passed to the next customer (chain of infection). To avoid this, appropriate disinfection measures are necessary. The following applies: Possible contamination with Microorganisms must be removed as early as possible by disinfection, so as to prevent unintended cross contamination. [other topics]

Instrument Treatment Process

Instruments which intentionally injure the skin or mucous membrane through tattooing, piercing and ear piercing, as well as instruments used by a Medical Chiropodist, are always regarded as contaminated. Instruments used by Hair Stylist, Barbers, and those use to perform basic Manicure and Pedicure procedures could also cause unintentional injury, therefore are also to be classified as contaminated. Because of the residual risk of unnoticed minor injuries, or contamination of pedicure instruments used in the foot care of customers (fungus and wart-risk), all instruments must be treated after every customer on a daily basis.

For treatment the follow steps apply: First (immediate) disinfection to prevent cross-contamination and to protect the Practitioner as part of any further treatment, usually by emerging the instruments into the appropriate disinfectant solution, then cleaning to remove dirt and disinfectant residues. If the instrument is dirty and glued solid then an active mechanical cleaning is possibly required. Since this can also lead to recontamination with remaining Microorganisms or so called “Wet Germs” through the use of cleaning agents (brushes, rinse water), a second disinfectant cannot be ruled out, again followed by a final cleaning to remove residues of the disinfectant solution. Lastly, preparation and storage: instruments with which the skin or mucous membrane is intentionally injured i.e. through ear piercing, piercing or tattooing, must be packed after disinfection and cleaning in suitable sterile sets (see Sterilization Process) and be kept sterilized between use.

Instruments of the other professional fields must be kept clean and dry after treatment. The storage containers are to be disinfected weekly. In the field of Medical as well as cosmetic foot care, particularly in the outpatient activities, preparing and carrying a sufficient number of instruments for the expected number of customers is required. Although the used instruments can and should be emerged in a disinfectant solution after each customer, (mostly due to the warts-virus exposure time) the required treatment “on the road” is not always possible, and could cause a lack of proper post-cleaning treatment. [other topics]

Disinfection Treatment

The instrument disinfection is usually done manually, for which two different methods are available, the Physical-Chemical and the Thermal process, the Thermal disinfection is preferable as it is a safer and more economical solution. Whichever method of instrument disinfection the user chooses depends, among other things, the material compatibility of the instruments. [other topics]

Thermal Instrument Disinfection

Boiling water- for a minimum of three minutes using the Steam disinfection procedure and other methods from the list issued by the Robert-Koch Institute (RKI), tested and approved disinfectants and disinfection procedures. [other topics]

Chemical Instrument Disinfection

This is a method in which the instruments are emerged in a Chemical disinfectant. Only agents from the disinfectant list the DGHM should be used. Concentrations and exposure times must be strictly observed. The instruments must be completely covered inside and out with disinfectant. Hinge instruments such as scissors are to be open. Disinfectant baths should always have a tight-fitting lid, so that vapours cannot irate the breathing. After the exposure time, disinfectant residues are to be thoroughly rinsed of under running water to avoid skin irritation. Visibly contaminated instruments must be thoroughly cleaned after disinfection. After cleaning, the instrument must again be disinfected in a freshly prepared solution, since the action of the impurities can impair disinfection. A final rinse and drying of the instrument is then carried out. Automated disinfection equipment must be examined every six month on effectiveness by means of bio-indicators. [other topics]

Sterilization Process

Precondition for a successful sterilization is an adequate disinfection, cleaning, rinsing, drying and suitable packaging of the instruments. There are two different sterilization methods to choose from, the Steam sterilization (Autoclaving) and Dry Heat sterilization. Which method is to be used depends on the material characteristics of the instruments to be sterilized. The Dry Heat method is only applicable for Heat-resistant materials such as glass and metal. Additionally Steam sterilization can also be used for certain types of rubber, plastics and textiles. [other topics]

Steam Pressure Sterilisation

Cleaned instruments are to be packed after the drying stage into breathable sterilization paper i.e. a sealed sterilized foil. Steam sterilization is usually carried out at 134ºC [273ºF] with an exposure time of five minutes at 2 bar [29 psi] above normal pressure, or at 121ºC [250ºF] with a contact time of 20 minutes at 1 bar [14,5 psi] above normal pressure. It should be noted that the operating time (about an hour) is longer than the exposure time (recommended by ERLINDA). [other topics]

Dry Air Sterilisation

For this sterilisation purpose, cleaned instruments are packaged after drying in alumunum foil or placed in small sterile containers (metal containers). The Dry Air sterilization is carried out at 180ºC [356ºF] with a contact time of 30 minutes or- less frequently- at 160ºC [320ºF] with an exposure time of 200 minutes (recommended by ERLINDA).

For both methods: The sterile items must always be provided with a sterilization date and a treatment indicator. In addition, this method of sterilization is after 400 charges or at least twice a year to be checked with a bio-indicator for effectiveness. Evidence of inspection by means of bio-indicators must be held, and on request be shown to the relevant Health Authorities – Hygienic monitoring for Infection Protection act §36 section 2 Infection Protection Act. After sterilization, the sterile items must be stored (up to a maximum of six months) in a dustproof cabinet or drawer. Both Steam and Dry Air sterilizers are subject to the regulations of the Medicinal Products Act [MPA]. On the basis of the Max Planck Society, the Medical Device Directive (MDD) was adopted. According to their regulations, sterilizers may only be operated by persons, who have received the required training in their employment and maintenance, or have the necessary knowledge and experience (§2 section 2 MDDV). The user must satisfy him/herself prior to the use of the operational capability and the proper conditions, and must comply with the instructions for its use. (§2 section 5 MDDV). The MPA and the Medical Device Directive Vigilance Notes ISO 13485 can be found on the website of the German Federal Ministry of Health and Social Security. [other topics]


Microorganisms: Bacteria, Virus, Fungi

Infectious: The ability of a Microorganism to be transferred from one organism to another i.e. from person to person, and cause an infection in sufficient concentration.

Contamination: The adherence of Microorganisms on instruments, surfaces and hands, causing a risk of retransmission.

Antiseptic: Effective means against locally infected wounds.

Disinfection: When disease causing Microorganisms are killed or made inactive by the heat-stability so they no longer cause infections diseases.

Sterilization: Unlike the disinfection method, by the sterilization all Microorganisms present, including their spores are killed or inactivated.

Treatment Indicator: Used to check whether the sterilized instruments have been exposed to the sterilization process and is based on a chemical reaction. Relatively non-specific, as this could be influenced by various factors.

Bio indicator: Microorganisms, on a supported backing material for the examination of the effectiveness of the sterilization and disinfection procedures, on the basis of the mortality of the test organisms contained in the preparation. [other topics]