That highlighted once again to just what an extent reprocessing was a production process aimed at automating similar sequences such that they would assure an equally good outcome. That endeavour helped to improve reproducibility, from cleaning to packing, while taking account of the different transportation steps. Various examples were presented but financial issues, i.e. balancing the personnel costs against the investment costs in (more or less) long-term investment goods, continued to be unresolved. In his laboratory-based study, B. Keevil (UK) described the feasibility of using cold plasma to clean the outer and inner surfaces of flexible endoscopes; how to clean these semi-critical medical devices continued to be a controversial topic.
C. Conneely (Ireland) presented a learning tool for analysing reprocessing sequences. By training all members of the decontamination team together, the Quality Improvement Division was able to ensure that employees with different levels of training were able to learn from other colleagues. That proved to be at least as important as the training on prevention (hygiene) and improvement of decontamination /reprocessing performance. An interesting aspect was that the success of the training measures was evaluated on the basis of indicators (performance with regard to cleaning flexible endoscopes, damaged packaging, overstocking of instruments) H. Ney (Switzerland) dealt with the performance of low-temperature sterilizers, citing by way of example his own workplace where performance indicators were defined in a multifactorial matrix which facilitated decision-making.
The 5th session on the morning of the second conference day focused on the issue of reprocessing medical devices declared for single use on a patient. F. Tessarolo (Italy reported on the new Medical Devices Regulation (MDR) of the European Union which imposed national demands. In such scenarios liability was transferred from the manufacturer to the reprocessor. The national regulations had to, in particular, make provision for risk management and validated reprocessing. These requirements had to then be met by the respective institution, hospital or service provider. In principle that applied only to medical devices invoking EU conformity on the basis of their affixed CE marking.
D. E. Montero Velázquez analysed the legal obligations applicable in Mexico and examined the international standards in that light. E. Mendoza Carrera explained the bioethical principles that should determine decision-making regarding the reuse of single-used devices.
C. Rivara (Italy) reported on a national procedure for reprocessing heat-sensitive (flexible) endoscopes which still had to be brought into line with the international recommendations of the specialist organizations. Of paramount importance in that regard was ensuring that endoscopes were properly dried before storage.
D. Percin (Turkey) dealt with the hitherto underestimated topic of semi-critical medical devices. Based on the example of laryngeal masks, she demonstrated that even after cleaning and (high level) disinfection, and depending on the process used, it was possible to analyse DNA residues but their infectiousness could not be demonstrated in that experiment. In comparative tests it was also demonstrated that thermal reprocessing of single-use masks was not possible (deformation).
The session was brought to a very lively close with a talk by S. Holmes (Scotland). First the speaker created a stir in the large audience and also made an apparent impact with her well-humoured interposed questions. At issue was how to deal with challenging medical devices whose successful reprocessing / reprocessability should be demonstrated before being subjected to routine reprocessing. Often, the use of test soils in a laboratory did not suffice; rather spot checks in a clinical setting were needed. Lesson learned was the provocative question.
J.-M. Legentil (Canada) tried to dispel the fears the Profesionalistas had regarding formalised risk management. The speaker defined risk management, while citing the main risks and proposing strategies aimed at finding solutions for risk minimization and elimination. All that was aimed at assuring an outcome whereby as (hopefully) when visiting the dentist, much feared situations such as dental drilling procedures went unnoticed…
Lean production meets hygienics – a re we safe or efficient or can we be both? G. Kirmse (Germany) reported on the range of facilities currently available for verifying process steps, citing several instances where lean production could be meaningfully balanced against risk minimization.
Risk minimization – safe but also efficient.
JPCM van Doornmalen Gomez Hoyos (Netherlands) had something very different in mind on presenting an approach aimed at verification of steam sterilization processes. While validation was fine, before conducting spot checks of certain physical parameters a routine test could be run to measure the steam for every steam sterilization process in an around 40 cm long metal pipe (with two wavelengths). That was then calibrated together with the parameters for performance qualification of the medium “saturated steam” for process evaluation. The Bowie and Dick test was becoming gradually obsolete after 50 years of use and more important than strict adherence to a temperature of 134 degrees (or for some Americans only 132) was the presence of the “correct” steam. A new trend for evaluation of the most important sterilization process was now being observed. Pressure was not by the way a necessary sterilization parameter, but humidity definitely was – but maybe that was merely a question of viewpoint? However, there was no question that the load and the materials of which it consisted often resulted in deviation at the site of actual use from these theoretically uniform conditions throughout the pressurized chamber. And suddenly one was faced with wet instruments…
The third congress day was opened with the 10th session .Which packaging should be used, hard or soft, single-use versus reusable packaging materials: “either or” or “both“? S. Riveros (Chile) described the approach undertaken in her department , while concentrating on the test methods used for the seals of pouches and reels.
The next, detailed and interesting, presentation by Yang Hai-yi (China) on identifying the worst position within mixed clinical loads of an 18-load sterilizer with a full or partial load. Numerous measurements had revealed surprising results which now had to be applied to other chamber models of different sizes. These showed that there were various good positions, the process would have to be configured for this worst process “filling” and process challenge devices (PCDs) (Bowie and Dick test, data loggers) placed accordingly.