Performance Qualification Autoclaves Hospital
The advent of new regulations on the production of sterile products, the ever-increasing demand for controls and certifications, aimed at guaranteeing the health of the patient, increasing the quality of the service offered and, last but not least, protecting the users of sterilizers in the event of disputes, have led to the creation of a division specialized in the validation activity.
Since the beginning of the 1990s, CEN (European Committee for Standardisation) has issued standards aimed at establishing the construction requirements for sterilising machines for medical devices (European Standard) EN 285.
Consequently, the standard that regulates the systematic control and validation of the sterilization process: EN 554.
There is also the UNI EN 13060 (2006) standard that regulates the production and controls of small autoclaves (< 54 litres). We then come to January 2007 to find the EN554 replaced by the new UNI EN 17665-1 that defines the requirements for the development, validation and routine control for steam sterilization of medical devices. In 2009, EN 17665-1 was implemented by the 2 part. At the same time, both EN 285 and EN 13060 are renewed in the 2009 and 2016 versions. Over the years, the machines have been continuously renewed in search of the best performance, compliance with increasingly stringent standards, and obtaining competitive prices to maintain a significant presence in the sterilization market. The guidelines provided by ISPESL (Italian “safety “ authority) in 2010 were also certainly useful: "GUIDELINES ON STERILIZATION ACTIVITIES AS A COLLECTIVE PROTECTION BY ORGANIC AGENTS FOR THE OPERATOR IN THE HEALTH STRUCTURES" which contributed significantly to clarifying the roles of the persons involved and the operating procedures themselves. The evolution of recent years has meant that virtually all European health care facilities proceed to carry out checks on their sterilization process through the service of Performance Qualification (namely Validation).
With the development of the latest generation of machines, the accompanying documentation is now more complete and officially required by norm: IQ (Installation Qualification) OQ (Operational Qualification) and PQ (Performance Qualification) are composing the “validation”. The three phases have now to be executed both by the manufacturer (or its authorized) and a third party (regarding the PQ) with no involvement with any the previous as a guarantee of his independence.
Our service focuses – as an independent entity – mainly on the execution of this last phase.
In the field of sterilization in general, the market for medical practices (dentists, surgeons, private clinics…) still needs to be homogeneously integrated. Unlike the provisions of laws, regulations and guidelines, for reasons not understood and completely arbitrary, in some European countries (like Italy for example) they still feel excluded from the application of procedures to verify and harmonize their internal sterilization processes. The same (geographic) regions that in some cases have issued precise local regulations, do not then provide for the verification of the application of these procedures or what is worse are struggling to free themselves, through regional “recommendations”, some categories (…dentists, for example) even by the application of European regulations on the need for an unspecified “simplification” in practice leading to the acceptance of an acquired sterilization “A” division (hospital) and a lower division (“B”) dedicated to the use and consumption of the above categories, …. but there are no division “A” and division “B” infections!