Professional FAQs

Dear customers,

Here, you find questions and answers, which occur in our profession on a daily basis regarding the topic “hygiene”.

Do you have a question?
Just write you an e-mail:
hygiene-experten@hellmut-ruck.de

Book recommendation:

Many questions are answered in our book “Praxishygiene” (Only available in German)

Go to shop
Praxishygiene - ein Leitfaden für Podologie und Fußpflege
 

FAQ

....what I always wanted to ask regarding hygiene:

How can I correctly prepare the Podolog Nova handpiece? Details

(as of 06/2016)

According to the German RKI/BfArM recommendation “Hygiene requirements for the medical device preparation 2012”, the RUCK handpiece is classified as non-critical since it does neither get in contact with pathologically altered skin nor penetrate the skin. Based on the RKI/ BfArM recommendation, the manufacturers are obliged to provide information on the cleaning and disinfection of their non-critical medical devices. There are no special disinfection requirements for non-critical medical devices as to the above-mentioned recommendation. The manufacturer’s instruction manual for the cleaning and disinfection of the RUCK Podolog Nova handpiece applies and takes the risk of use into account for the approved utilisation.

Here an excerpt from the instruction manual: After each use, the outer surfaces of the handpiece.... are wiped down with a suitable surface disinfectant. After the work of the day is finished, the handpiece's sleeve is removed and all accessible surfaces (insides of the handpiece and the sleeve, outside of the sleeve) are cleaned and disinfected by wiping.

For handpiece preparation, is there a difference between the wet and dry method? Details

(as of 06/2016)

The “dry method” is a suction technique that immediately suctions grinding dusts, opposed to the “wet method” were a fine mist is sprayed for cooling. The spray mist binds the dust particles.

The elbow of a wet technology unit is supplied through a tube with cooling water. When using elbows as they are intended, they can be contaminated with a mixture of water, skin particles, and germs, both on the inside and outside. They require increased cleaning and disinfection effort due to their complex structure. For the inside of the elbow, specific adapters are necessary to apply a mechanical cleaning method, making sure that the cleaning of water and air ducts, forced air and return air ducts is guaranteed. The same applies for cooling water ducts and the inside of the heads.

In contrast to a suction technology device, the ablated material will be removed by air suction. The structure of these handpieces is rather simple in comparison, since no spray mist needs to be produced and the airflow is always directed away from the treatment area. Unscrewing the handpiece reveals all relevant parts, which then can be easily cleaned and disinfected by wiping.

The public health authority no longer provides me with biological indicators. What can I do now? Details

(as of 07/2013)

UNTIL NOW

In the past, biological indicators (spore-packs) were used routinely to verify successful sterilization of autoclaves and hot air sterilizers. These indicators were subject to semi-annual ordering from the Public Health Authority and were returned after use for analysis.

NEW! Biological indicators for steam sterilizers (autoclaves)

As of 31st December 2011, biological indicators are no longer distributed by the Public Health Authority for the control of steam sterilization processes (sometimes customers report that they still receive biological indicators from Public Health Authorities). The control of successful sterilization in medical applications is now subject to physical measurement methods based on the German Medical Devices Operator Ordinance (Medizinprodukte-Betreiber-Verordnung). The validation of the autoclave serves as proof of operability and therefore guarantees safe sterilization processes. Sample validations are also permitted, e.g. as provided by RUCK for Melatronic 15 EN+ and Euroklav 29 VS+. Please refer to “Hygiene experts” on our website to download the sample validation form and the equivalence declaration form. Chemical indicators are still required when sterilizing packed products. For easy documentation we offer our RUCK documentation system / note block with 100 sheets (art. no. 26442).

NEW! Biological indicators for hot air sterilizers

As of 1st July 2013, the Public Health Authorities have discontinued the provision of biological indicators. (Here, customers also report that they still receive biological indicators from Public Health Authorities). Validated procedures are not required since hot air sterilization is only applicable in non-medical areas (foot care, cosmetics), which are not subject to the German Medical Devices Operator Ordinance (MPBetreibV - Medizinprodukte-Betreiber-Verordnung). Following the recommendations of the MPBetreibV also in non-medical applications can only be voluntary and not be made mandatory. This would fail in any case due to the fact that hot air sterilizers cannot be validated and sample validations are not available.

WHAT DOES RUCK RECOMMEND?

For medical foot care / podiatry:

  • Class S autoclave (Euroklav 29 VS+ or MELAtronic 15 EN+)
  • Regular autoclave maintenance as per manufacturer specifications, filing of the maintenance records
  • When using Euroklav 29VS+ or Melatronic 15 EN+, download the sample validation and equivalence declaration, fill in the forms and file them for reference.
  • Daily optical control of the device
  • Use a chemical indicator (art. no. 2605702) for each load of packed products
  • MELAflash (art. no. 26067) or report printer (art. no. 26407)
  • Documentation of the preparation with the help of RUCK’s documentation system (art. no. 26442)

For cosmetic foot care / cosmetics

  • Usage of a hot air sterilizer / this is not mandatory, final disinfection is sufficient
  • Maintenance of the device as per manufacturer specifications. Many devices are maintenance-free.
  • Daily optical control of the device
  • Use a chemical indicator (art. no. 2605701) for each loading
  • Documentation of the preparation with documentation form
How can I check my autoclave’s operability and how often should this be done? Details

Several checks are necessary to confirm operability:

  1. Daily control of the device’s display and its electric lines, e.g. cable, plug
  2. Using a chemical indicator for each load of packed products
  3. Regular autoclave maintenance through Melag Customer Service (every two years or after 1,000 cylces)

In addition, it is advisable to download, print, fill in, and file away the respective sample validations and equivalence declarations for Melatronic 15 EN+ or Euroklav VS29+ for further reference. Click here for the forms (in German).

What to consider when establishing my hygiene plan? Details
RUCK Hygieneplan

Every practice has its own specific hygiene plan. The hygiene plan clearly details all necessary hygiene measurements. The plan needs to be updated as soon as something changes in your daily routine (change of the disinfectant or its application concentration, changing the frequency of hygiene measures). If nothing changes, your plan also remains unchanged. The plan gives the date of its creation and - if applicable - when employees received their instructions. The hygiene plan is to be displayed in a clearly visible or easily accessible position. If you provide home foot care services, you do not need to take the plan with you.

Click HERE for RUCK’s HYGIENE PLAN (in German) ready to print and fill in!

What is a “sterilization record”? Details

All sterilization processes are documented in the sterilization record. The practice owner is obliged to keep this data in an orderly manner and at all times available for at least five years. Often, the sterilization record is kept in form of a file containing all documentation forms.

You will find further information below: "What does the term preparation documentation mean?"

What does the term “preparation documentation mean”? Details

Documentation means that all steps of the preparation process need to be documented in a comprehensible manner.

This comprises both the manual (preparing, disinfecting, and cleaning) and the mechanical part (sterilization) of the process. Manual processes will be documented with the help of work instructions or the information from the hygiene plan, respectively. The mechanical processes of the sterilizer’s protocol are supplemented by the personnel’s instrument release.

WHAT COMPRISES A COMPLETE DOCUMENTATION?

The documentation comprises:

  • The sterilization process steps = sterilizer’s protocol
  • When sterilizing wrapped articles: control of the chemical indicator and the wrapping
  • The responsible person decides on release

These steps are documented and archived in the sterilization record.

HOW IS THE DOCUMENTATION DONE?

1. OPTION: FULL PAPER-BASED RECORD

Documentation with “HAND ON PAPER”. This documentation method is applicable if the sterilizer cannot be connected to a protocol or card printer. This is often the case with hot air sterilizers or older autoclaves.

Documentation templates:

a. For hot air sterilizers:

  • Documentation form for hot air sterilization (click HERE for German template).
  • All relevant data for each sterilization cycle need to be entered manually.
  • The form will be filed in the sterilization record.

b. For steam sterilizers (autoclave):

  • RUCK’s documentation system (art. no. 26442)
  • All relevant data for each sterilization cycle need to be entered manually.
  • The form will be filed in the sterilization record.

Documentation with “PROTOCOL PRINTER ON PAPER”.

This documentation method is applicable if the autoclave can be connected to a printer and the printouts are to be filed away instead of being saved on a hard-drive (e.g. because there is no computer available in the practice).
In general practice, this method is currently the most common one.

Documentation templates:

  • RUCK’s documentation system (art. no. 26442))

The following data needs to be documented for each sterilization cycle:

  • Date
  • Person responsible
  • Successful completion of the programme - yes or no
  • Chemical indicator with correctly coloured envelope - yes or no
  • Instrument release with signature of the responsible person

This information will be filed together with the protocol printout. The form will be filed in the sterilization record.

2. OPTION: PARTIALLY PAPERLESS

This documentation method is carried out with card printer / reader and computer and supplements the information the device cannot record itself. The only difference to the full paper documentation method lies in the paperless protocol alone; all other information needs to be recorded manually.

The sterilizer’s protocol is then saved to the PC’s hard-drive or to an external medium and is kept for archiving. The other documentation parts (control of the chemical indicators, wrapping, release decision) are recorded on paper. Here, RUCK’s documentation system comes in useful to register the following data:

  • Date
  • Person responsible
  • Successful completion of the program - yes or no
  • Chemical indicator with correctly coloured envelope - yes or no
  • Instrument release with signature of the responsible person

This documentation method requires clearly linking the manually recorded information to the saved protocols.

However, this is easily done using the Melaflash systems in combination with RUCK’s documentation system.

3. OPTION: PAPERLESS DOCUMENTATION

If this is the documentation method of choice, a card reader / printer and software are required to complete the additional data (control of chemical indicator, wrapping, instrument release) which should only be accessible by a personal password.
Paper can completely be dispensed with when combining MELAflash and MELAsoft.

Is it still allowed to use hot air sterilizers? Details

The MPBetreibV (German Medical Devices Operator Ordinance) demands that medical devices are only prepared with validated procedures. Only treatments bearing the additional designation "medical”, i.e. medical foot care, are subject to the German Medical Devices Operator Ordinance (MPBetreibV). Non-medical treatments, i.e. (cosmetic) foot-care, do not apply, however, they are subject to the requirements of the hygiene regulations. Germany’s current hygiene regulations do not require validated procedures for instrument preparation. Therefore, hot air sterilizers are allowed and suitable for non-medical treatments, since the instrument preparation is finalized with a wipe-down disinfection.

The German Medical Devices Operator Ordinance (MPBetreibV) is fully valid and applicable for all treatments with the additional designation “medical”. The German RKI/BfArM recommendation “Hygiene requirements for the medical device preparation 2012” further details the recommendation of the MPBetreibV and also elaborates on hot air sterilization. „Given the current state of technology, hot air sterilization (“-disinfection“) can only be considered for semi-critical A (unwrapped) or critical A articles “. (...) In order to eliminate the risks of this method, "the operator is obliged to validate the procedure, to define and standardize both the load (instrument volume) and the wrappings, and to properly document this information. Furthermore, she needs to continually document the temperature-time-relations. The frequently heard statement “hot air sterilization is not allowed” or even "forbidden” is not true. The legislators still allow this procedure albeit the respective conditions apply.

On 10 August 2012, the work group “instrument preparation” (see also www.a-k-i.org) revised the brochure “How to prepare instruments while retaining their value”. The work group aims at creating and providing practice-oriented information on the correct preparation of re-usable medical products with a focus on medical instruments. The work group comprises of researchers and manufacturers of instruments, disinfectants, and cleaning/disinfecting devices and sterilizers.

In the above mentioned brochure, hot air sterilization is categorized as “no longer state-of-the-art, however, still in use occasionally.” “As long as hot air sterilizers are still in use, it is mandatory to observe manufacturers’ specifications as to the loading volume in order to guarantee the uniform distribution of the sterilization temperature for optimum sterilization of the items.” There is no question that hot air sterilizers are no longer permitted or may only be used after respective validation.

CONCLUSION: Although both publications describe hot air sterilization as a permitted procedure, it is still regarded a critical procedure since precise validation specifications are (still) missing. For this reason, we recommend using an autoclave for medical treatments.

Class S or class B – what does a podiatrist really need? Details

Hygienic requirements will focus more and more on instrument preparation. Much money can be made from selling autoclaves, washer/disinfectors, and continuous sealing devices. Which are the suitable podiatric standards?

Preparation depends on the instruments’ risk-based classification. The much-cited German RKI/BfArM recommendation “Hygiene requirements for the medical device preparation” details the risk-assessment of medical devices and provides examples. Retractors are rated as critical A. The maximum classification of instruments applicable for foot care / podiatry is critical A, as set out in the hygiene framework published in 2010. Critical A instruments “are those used to penetrate skin and mucous membranes, or enter into or contact the bloodstream or other normally sterile tissue, including wounds” (see also German RKI/BfArM recommendation) and their preparation can be done without specific requirements. Correct preparation requires disinfection followed by sterilization in an autoclave. Although it is not necessary to disinfect the instruments in a washer/disinfector, however, depending on the practice size, it could be more economic opposed to manual cleaning and disinfection.

Due to its reliable efficacy, thermal sterilization with saturated steam (121°C or 134°C) is to be preferred (see also German RKI/BfArM recommendation). Ideally, sterilizers feature a pre-vacuum cycle to evacuate the chamber and finally, an active drying cycle to avoid residual moisture on the instruments. Class S autoclaves fulfil all these requirements.

All investigations on steam sterilization of hollow items assume tubes and narrow-lumened long instruments with a diameter of 1 to 5mm and lengths from 0.5 to 4.5 meters.

Such instruments are not used in foot care. For this reason, it is unnecessary to invest in a class B autoclave. Class B autoclaves are intended for the preparation of medical devices with narrow-lumened hollows or porous items, like textiles. The preparation of handpieces and elbows of wet technology units is subject to manufacturers’ specifications. Cleaning mills and grinders can be problematic due to their rough surfaces, therefore, it is recommended to use an ultrasonic washer prior to sterilization.

Foot care and podiatry are not part of the paramedical or medical professional group. For this reason, they are not subject to the German Medical Devices Operator Ordinance (MPBetreibV) and are not legally bound to the RKI/BfArM recommendation. Cosmetic foot care does not involve piercing the skin. Thus, a final anti-viral disinfection is sufficient (see hygiene regulations). Thermal disinfection with dry heat (180°C and 30 minutes exposure time) is a valid procedure to sterilize instruments. For this reason, hot air sterilization is sufficient for cosmetic foot care.

Is it allowed to decant hand disinfectants from bulk containers into bottles? Details

In Germany, hand disinfectants are either authorized as medicinal or biocidal products. Due to the German “Medicinal Product Act”, medicinal products are only allowed to be decanted under aseptic conditions. This, however, does not apply to biocidal products. Regardless of the authorization, decanting might involve certain risks, which could be legally relevant because the health safety of the hand disinfectants would be compromised.

  • There is a risk that containers might be used which are neither suitable nor properly prepared
  • Risk of mixing the batches if pump bottles are re-filled before being completely empty
  • Risk of product mix-up when re-filling
  • Re-filled bottles are not or only inadequately labelled

For this reason, we suggest our customers purchase one-way bottles.

When is a disinfected surface ready for further use? Details

After a routine disinfection procedure, surfaces are generally ready for further use when visibly dry. In risk areas (e.g. intensive care units, OR) in point-of-care areas, and when contamination is obvious, the 1-hour-value for disinfection applies.

What exactly does the lifetime of disinfectant solutions mean? Details

The lifetime describes the use-by date of unused working solutions, i.e. how long the proven effectiveness of a disinfectant solution is sustained when it has been prepared and kept covered up over the allowed period of time, according to manufacturer specifications.

What is the lifetime of a prepared working solution of a surface disinfectant? Details

Generally, working solutions need to be prepared freshly. Left over working solutions cannot be kept uncovered over an extended period of time. (1 working day max.) However, some manufacturers specify longer lifetimes for their working solutions. Considering that these specifications are based on corresponding tests, it is to be noted that these apply to unused solutions only.

What is the lifetime of wipe dispenser systems with a pre-soaking system? Details

Most manufacturers specify a lifetime of 28 days. The following points need to be adhered to: If the lid is not closed, disinfectant wipes protruding from the bin could dry out and consequently lose their effectiveness. Another risk lies in the wearing of contaminated gloves when taking a wipe out. This would significantly contaminate the wipes with germs. Closing the bin’s lid is mandatory. When the wipes have all been used and the bin is empty, it is to be cleaned and disinfected prior to re-filling it with a new wipe-roll and disinfectant solutions.

What exactly is the usage time of disinfectant solutions? Details

The usage time describes the use-by date of used working solutions, i.e. how long the proven effectiveness of a disinfectant solution is sustained when it has been prepared and used for disinfection purposes for the period of time specified in the manufacturer specifications.

Is it allowed to dispose of disinfectant solutions via the sewage system? Details

It is prohibited to dispose of concentrates into the sewage system; they are to be diluted or, for larger quantities, disposed of as hazardous waste in appropriate containers (either original or properly labelled). The safety data sheets inform (in German) on proper waste disposal. If in doubt, contact the manufacturer for more information. Disinfectant solutions based on quarternary ammonium compounds are biodegradable and can therefore be disposed of in to the public sewage system.

When preparing instruments, is it necessary to use a virucidal disinfectant for the manual disinfection after to sterilization? Details

A final disinfection is sufficient for the preparation of non-critical and semi-critical instruments. Is the manual disinfection followed by a sterilisation cycle, a bactericidal, fungicidal and partially virucidal disinfectant suffices. If the instruments are not to be sterilized, a virucidal disinfection is mandatory.

Are specific disinfectants necessary to inactivate MRSA (Methicillin resistant Staphylococcus aureus)? Details

It is easy to confuse a resistance to antibiotics with a resistance to chemical procedures. Pathogens resistant to antibiotics, like MRSA, are to be inactivated with disinfectants which are demonstrably bactericidal according to the European testing procedures or the testing methods of VAH e.V. (The Association for Applied Hygiene). All disinfectants, listed in the VAH lists, fulfil these requirements.