So you thought a 30-page hygiene plan was detailed? Barbara Wellbrock has been meticulously monitoring compliance with the strictest international hygiene regulations for more than two decades at Swiss dental specialist COLTENE. In her job as Director QM/QC/RA, she is more than well aware as of what is important when validating sterile products and which details are crucial for clean work in everyday routines.
The pharmacist began her career more than 20 years ago, when COLTENE was still producing classic pharmaceuticals. Barbara Wellbrock has therefore accompanied the development of the Medical Devices Act right from the very beginning. As technical capabilities have advanced, the demands on hygiene in general and the approval of critical products in particular have grown continuously. The international regulations which a global player like COLTENE has to comply with are correspondingly extensive. In this interview, the hygiene expert reveals what can be learned from the Swiss dental specialists for the next practice audit and where the small but subtle difference lies in supposedly safe products.
Ms. Wellbrock, when exactly is a dental product "microbiologically harmless"?
The microbiological quality of a dental material or dental instrument above all depends on the number of viable microorganisms such as bacteria and fungi that are detected during laboratory testing. The growth of certain pathogens is extrapolated from the sample in the culture medium to the corresponding pack size. Crucial when considering the so-called "bioburden" is however, that no pathogenic or potentially dangerous pathogens are present that would not be found ubiquitously under normal circumstances. Unfortunately, it is not only contamination which can be detected with the naked eye in the practice that is dangerous, which is why the validation and definition of such standardised test procedures is of such enormous importance...
Why are all medical devices not manufactured sterile as a matter of principle?
Every owner of a dental practice knows from their own experience how complex meticulous hygiene management is, and the level of consistency required. The necessity of sterile products therefore also results from the indication and the site of application, because even despite good oral hygiene, the oral cavity still contains most bacteria in the human body: our classic, the ROEKO Luna cotton roll for retracting the cheek must therefore first and foremost be soft, stable and safe to remove again and must not pose any microbiological risk; it does not have to be sterile, but low in bacteria. However, during a surgical procedure, a gelatine sponge such as the sterile Gelatamp should be completely resorbed without introducing any additional pathogens into the open wound.
Due to the constantly growing volume of evidence to be provided and the strict documentation requirements for dental practices, it is of course at times of stressful daily treatment routines easier to buy directly sterilised products. The requirements for products declared "sterile" are becoming increasingly more exacting in terms of production, raw materials used, validation and approval, so that such products offer the dentist an extremely high level of safety. From the point of view of the regulatory authorities, sterile products are highly critical products: as they can cause immense damage to patients with a weakened immune system in the event of contamination, they are particularly prone to detailed inspection during audits.
Are dental products manufactured here in Europe essentially not all equally "safe"?
The standards for medical devices in the EU are of course constantly being raised, and not just since the last health scandal about cheap breast implants. Furthermore, dentists know this phenomenon from their own practice audits: suddenly laws are understood literally that were previously interpreted differently. Like teachers at school, the authorities only check compliance with the rules; the responsibility for high-quality, reliable products lies with the respective manufacturers themselves.
As an internationally successful company, COLTENE is guided worldwide by a whole series of global quality standards: in Europe, for example, the DIN EN ISO 13485 standard applies, while in the USA, the GMP (Good Manufacturing Practice) requirements from the pharmaceutical sector apply to medical devices. Add to this is our many years of innovation leadership, which is reflected in our unique production know-how: whereas gauze swabs used to be wound by hand, today many manufacturing processes are fully automated. The advantage is more than obvious: when sterilising instruments previously handled by humans, they produced "dead dirt"; so it is far better to avoid contamination from manual processing right from the outset. For the same reason, our endodontic irrigation solution stations can be operated with one hand in the dental practice as can the sliding boxes of gutta-percha tips - under the motto "Upgrade Dentistry" we have always developed clever working auxiliaries and materials that virtually think for themselves and always make work a little faster, easier or more reliable.
In Germany, only few dental companies manufacture sterile products in specially designed clean rooms. In part, of course, this has been due to historic reasons resulting from the existing product range. Others therefore do not have the technical equipment or shy away from the enormous effort required, as numerous dental products have so far always been sterilised again before use anyway. As a manufacturer of sterile products, we have to establish completely separate production areas and cannot - same as in spatially limited dental practices - simply convert a treatment room with a "Processing, entry prohibited!" sign.
How can I recognise "safe" products in practice?
Certainly from a visual point of view by the high quality packaging: the production of sterile products is far from finished when they leave the clean room! For example, very special cartons are required for transport for the subsequent gamma sterilisation of blisters.
To obtain medical approval of sterile products, we as a company must validate the entire manufacturing process, including packaging and transport.
Among other things, our Quality Assurance Department conducts storage tests which assess the condition of the product over a period of up to five years - the period the product has to be safe for use.
Why are sterile products used in the first place on "unsterile patients"?
Sterile products are particularly suitable for surgical procedures. It is remarkable that, according to estimates, around two kilos of bacteria (i.e. around 39 trillion!) live on and in every human being. Recent headlines on the development of multi-resistant pathogens have once again vividly demonstrated to the public that maximum pathogen reduction is desirable, especially for older patients or children with a weaker immune system who often face an increased risk of infection. Conversely, the practice team in particular has to "survive" in the job and protect itself in terms optimal health and liability issues.
And how do I create an effective hygiene plan for the next practice audit?
It is important to firmly establish the topic of hygiene in everyday routine and not only to scrutinise the situation when an inspection is imminent. The creation of a hygiene plan also offers the opportunity to fundamentally question one's own time management and to discover improvement potentials that would otherwise never have been identified due to the natural "blindness of routine". A systematic approach helps enormously, otherwise certain areas are quickly forgotten, which can quickly cloud the positive overall impression of the auditor. Many regional dental associations offer free templates for preparing a practical checklist. To provide employees with initial orientation and sensitisation as to which areas are particularly in the focus of a thorough hygiene management, I find the following mnemonic quite useful: "The main thing is, that nobody intentionally ignores important guidelines!" The initial letters of the individual words stand for a central topic complex:
- Antibiotics & Prophylaxis
- Water & Disposal
At the same time, the sentence reminds all stakeholders that hygiene management should be a conscious process. Clean work is everybody's business!
In your opinion, what are the most common mistakes that can easily be avoided?
The ultimate insider tip in terms of cleanliness does not really exist. Anyone who follows the basic hygiene requirements of the Robert Koch Institute for the reprocessing of dental tools and aids and has grasped the basics of wearing gloves and facemasks has already gained a lot. It is important to keep a watchful eye beyond the hygiene plan and to always consciously analyse one's own actions. Especially the famous " well-meant " measures can quickly backfire: of course, tilted windows provide fresh air, but at the same time the pollen burden rises during the hay fever season and nobody really wants to have airborne grass spores in a fresh wound.
At COLTENE we have also been thinking and experimenting for years on how to elegantly handle problems in dental practice and to develop effective solutions for the small and big pitfalls of everyday routine. Maybe this has something to do with the typical Swabian tinkering mentality as well as Swiss accuracy, which inspire our research departments in Langenau and Altstätten...
...in other words, call COLTENE straight away if you have specific questions about applications or hygiene issues?
Definitely! Our Customer Service is well versed and answers the most important questions regarding the reprocessing of Concorde suction cannulas and NiTi files or the individual programming of our intelligent BioSonic UC 150 ultrasonic unit every day. And for those who are not fond of studying instructions for use, it is better to be on the safe side in case of doubt before the implementation of legal regulations fails due to incorrect operation of the cleaning and disinfection equipment.
By the way, we are also very familiar with hygiene plans: our hygiene plan for our production regulates where which clean room class applies, which protective clothing is to be worn there, which disinfection solutions are to be used, how the machines are to be cleaned and by whom, and so on. And this quickly sums up to a documentation of over 30 pages! From this perspective, dentists and dental companies are clearly acting in concert.
Will we ever have a uniform industry standard?
Fortunately, a lot has already happened in our industry. The testing requirements are clearly increasing and are being enforced more and more rigorously - they represent an additional challenge to our speed of innovation. However, it would certainly be desirable if products that claim to be sterile according to their EC label would in fact truly be sterile, after all, hygiene is one of the cornerstones of patient protection. There are differences in quality in every industry, therefore it is worthwhile for the dentist to take a closer look when purchasing and follow the pioneers in this area. If one always orders the same solutions out of habit, one may miss out on promising new approaches.
The topic of hygiene management will, by the way, continue to accompany us in the long term despite all the ingenious possibilities which self-regulating substances and bioactive dental materials already promise us today. The use of a bioactive 3-in-1 obturation material such as GuttaFlow bioseal in root canal treatment does not make clean working superfluous, quite the contrary. Where bone material is to be reproduced, bacteria hinder regeneration and prevent the smooth flow of the triggered natural processes. From this perspective, aseptic and hygienic working even immensely increases the chances of success of smart, futuristic-looking dental materials. In view of the worldwide advance of dangerous infectious diseases such as hepatitis or tuberculosis, the topic of cleanliness will not fade out of fashion quickly anyway.
Final question: who actually looks after cleanliness in your home?
(laughs) Too much hygiene is also not healthy, after all, the immune system needs to be kept busy! Clean yes, but not sterile, so I can occasionally turn a blind eye to the general level of cleanliness of the rooms after work...