Residual risk of processing "practice" ?
(article / June 2012)
What can be described, what must be described? File folders full of paper as a consequence of the validation process are a heavy (!) burden on sterile supply departments all over and hinder their productive work.
We speak here as experienced validators with hundreds of process-validations about the common practice of documentation ("30 years ..."). Volume 15 of our international series "Medical Devices & Processes" with the topic "Residual Risk Processing?" will draw attention to all that is being filed. And we will demand sound judgement in regard to the required "formal" services, hampering the productive processing work. How successfull can efforts towards qualitative enhancements in the quality cycle of processing really be, if they consist primarily of filling paper? What kind of security do we gain here? Improvement requires creativity, not administration.
It is in the true sense of the word, a "growing" problem. Take, for example, the case of an employee of ours, reporting on his return from a process validation. Among other things, the Annex to the german ‘packaging guidelines’ were used. Puzzled, he noted that the downloaded and printed out pdf-file had to be hand-edited - as in the 20th century - with Tippex (in order to clear the entry fields of the pre-filled examples) before any data can be filled in. Or they have to be handcopied and tables with diagrams be crafted into them, using scissors and glue. Just look for example Annex B7 in the 'packaging guideline'.
Technical annexes must be provided to the user as fillable documents!
This applies to other areas of process validation, too. Why are the relevant documents not accessible online, already pre-formulated where possible and fillable where necessary? Or even: Why not a complete validation protocol? That should not be "superior knowledge", but consensus among experts.
Without going into the details of the contents, we would also like to indicate the non-editable "Recommendation for the Validation and Routine Control of Sterilization Processes with Saturated Steam for Medical Devices" (DGHK - July 2009): Appendix 3 Part 1 has 14 pages with tables, for example, Part 2 at least 9 pages, part 3 another 11.
For several questions, clarifications on the expected answer would be welcome: do we, for instance, fill in the supplier or the manufacturer (who is not always known) under “put in circulation by …”?
A remedy is demanded here, even in the standardization work.
Finally, if a facility takes care of process validation responsibly, this must be achievable in an appropriate manner without file folders being filled by the meter - which is happening, unfortunately! Think of the bulky maintenance reports for each machine: an average hospital with 600 beds produces at least 10 full file folders per year, only for validations… which they would certainly prefer not to have to store for 30 years…
Would it not make sense to start a new process validation with an inventory sheet, where the results of previous validations are filled in, rendering the old shets redundant? The old results remain "noted", but just as with the BD test, the measurement and other protocols can go to the waste bin, the CD in the yellow bin. Mind you, in case of previous findings, these would have to be described.
You have your own views on the subject or further suggestions for ‘waste reduction’? Then please get in
Thomas W. Fengler.