Central sterile supply department

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Surgical instruments after sterilization

The central sterile supply department ( CSSD ), also central sterilization or processing unit for medical products (AEMP) , is an internal or external service provider for one or more hospitals. Your task is the cleaning, disinfection , care, sorting, sterilization and provision of medical products such as surgical instruments .

A CSSD has an unclean and a clean area, which are hygienically separated from each other. This prevents germs from spreading to instruments that have already been cleaned.

History

Fumigating, fuming and incense - the use of smoke in diseases is the first clue to people's realization that there could be something in the air and on surfaces (e.g. of surgical instruments) that hinders the healing process without it there used to be knowledge of microorganisms. For this, the microscope had to be invented, under which the smallest particles suddenly “came to life” ( Antoni van Leeuwenhoek ).

The beginnings of sterilization for medicine can be traced back to the founder of microbiology , Louis Pasteur , who discovered in the 19th century that heating kills microorganisms ( pasteurization ). The next step in technology was to carry out the heating with saturated steam , which allowed lower temperatures, since the hot steam was placed in all accessible areas of the goods and thus ensured the killing of microorganisms. This principle led to today's steam sterilizers , which are the standard device for sterilization in the CSSD.

Instead of the name ZSVA, the abbreviation AEMP (processing unit for medical products) has recently been used. This is based on the Medical Devices Act , the Medical Device Operator Ordinance and the relevant European directives (e.g. 93/42 / EEC). The term “sterile goods” has grown over the years and can also be found in the sterile goods unit (STE). This volume measure of 54 liters describes the volume to be sterilized, but in which a different number of medical products can be stored. Therefore it is only suitable to a limited extent as a performance measure for the scope of the sterilization of medical products.

staff

Until the 1980s, the tasks of the sterilization department in the hospital were mainly assigned to the nursing staff , who took care of them on the side. The sterilization department was not seen as an independent department. It was customary to refer to them incompletely and pejoratively as steri . In the case of larger numbers, untrained workers could also be employed, as the work involved was only incompletely described, handled quite individually and did not seem to make any great demands.

The GDR had a sterilization law, while in the Federal Republic only ordinances and guidelines regulated this area. To date there is no clear training structure. As before, it is a training activity, which brings problems with the quality and reproducibility of the work and leads to questions of insurance law.

After the fall of the Berlin Wall , the first specialist courses were introduced across Germany from Potsdam. Today, sterile supplies are responsible for maintaining the value of the medical product as an investment and for hygienic reprocessing in terms of safe use on patients.

The increasingly complicated regulations for the reprocessing of medical devices, such as the guidelines of the Robert Koch Institute , the DIN and ISO standards, the manufacturer's information on reprocessing and the increasing complexity of medical devices, demand more and more knowledge, which is achieved through three specialist courses (FK I -III) is conveyed. There are efforts to turn the specialist courses into a training occupation. As a rule, the managerial staff has acquired hospital or surgical experience and additional specialist knowledge. The aim is for the simple employee to successfully take part in specialist knowledge I. For the shift management and deputy, you want specialist knowledge II and for the management of the CSSD specialist knowledge III, from January 2019 management course AEMP. These specialist courses (short FK I-III) are offered by the German Society for Sterile Supply (short: DGSV®) and the educational institutions that act accordingly. Since 2016 there has also been the professional profile "Specialist for medical device processing - FMA - DGSV®".

The staff can be employed by the hospital or a dental practice or belong to an external service provider. This can use the hospital's premises and equipment or maintain its own location.

In Switzerland , there has been a newly created, three-year professional training program to become a medical device technologist since summer 2018.

tasks

The core task is usually to supply the operating theaters with reprocessed equipment. In addition, the CSSD can also supply the functional departments and medical wards of a hospital. The logistical effort varies depending on the situation. As a rule, the entire production process for reprocessing medical devices is carried out in the CSSD. Today, medical devices are becoming uncritical, semi-critical, critical with regard to the reprocessing requirements; with or without increased demands on the processing. It is important that the highest possible documentation density is achieved in order to have the respective good under control at all times, which not only serves to protect against complaints, but also to ensure patient safety .

Instrument circuit

Packaging with color indicator to check the success of the sterilization

Provision of the sets

Surgical instruments are prepared in sets that can be packed in various forms (soft or hard packaging). The imprecise, rather historical term sieve is also used . Most often, sterile goods containers in all variations and sizes can be found below a sterile goods unit , which are increasingly being replaced by baskets packed in non-woven fabric .

The sets are kept in a sterile goods store and stored until they are used. They are given an expiry date . It is important to regularly check, supplement and update the inventory in order not to store dead capital in the closet.

cleaning

After an operation, the used surgical instruments are taken to the unclean area of ​​the CSSD, where they are dismantled as much as possible according to the manufacturer's instructions, unless they have already been done in the operating room. Areas that are difficult to access are pre-cleaned using plastic brushes, steam jets or ultrasound if necessary . Further cleaning takes place in the cleaning and disinfection device. Even cleaning can only be achieved through automated cleaning processes. Viewed worldwide, however, the instruments are mostly cleaned manually.

disinfection

The goods are now placed in a cleaning and disinfection device (WD or cleaning and disinfection machine). This works in a similar way to a dishwasher, but in contrast to this, it has special washing programs with other cleaning agents. The goods are cleaned in it, then thermally disinfected and finally dried. The aim is to minimize pre-cleaning as much as possible, on the one hand to achieve consistent results over and over again and on the other hand to save time. Time, rinsing mechanics, cleaning chemistry and temperature are the effective parameters in the sense of Sinner's circle that determine the success of cleaning.

Control, care and packing

The cleaning and disinfection devices are emptied on the clean side of the CSSD. They should be designed in such a way that, as pass-through machines, they separate the unclean from the clean area. The goods are now checked for cleaning success and functionality, sorted and, where necessary, treated with a special, water-vapor-permeable instrument care spray to prevent wear. Packing lists, ideally recorded in a computer system, indicate how the finished set is to be packed. They consist of an inventory list and a topographical assignment so that the instruments are always positioned in the same way in the container.

sterilization

The packed set is now sterilized according to the manufacturer's instructions . As a rule, about 90% of the cases, the steam sterilization process is used, one speaks of autoclaving . Gas sterilization with ethylene oxide , formaldehyde vapor and so-called plasma sterilization are also used in the CSSD . The advantage here is that the goods can be sterilized at lower temperatures, which is indicated for thermally unstable materials. The aim is to kill all microorganisms . After sterilization, the sterile goods must be released, which means that an employee with at least specialist knowledge I checks the goods or the packaging for any damage and then documents an approval. Expertise I can now be acquired from many training providers. The Fachkunde I is the minimum entry qualification in this professional area. Many hospitals, processing units, such as CSSD, doctor and dental practices and external service providers employ employees who have completed specialist knowledge I.

Web links

Individual evidence

  1. Thomas W. Fengler: Quality of instruments for laparoscopic surgery . ISBN 3-8265-1168-9 , pp. 2-10
  2. Recommendation for monitoring the reprocessing of medical devices (RKI Medical Devices Working Group). (PDF; 115 kB) (No longer available online.) Archived from the original on November 22, 2010 ; Retrieved May 17, 2011 .
  3. Appointed - find job information easily. Retrieved October 31, 2017 .
  4. New from summer 2018: Medical device technologist EFZ. (PDF) Retrieved August 21, 2019 .
  5. RKI guideline Federal Health Gazette Health Research and Health Protection 2001-44: 1115-1126