Central Service - Issue 2/2013
- What's New in Standardisation: Information on reprocessing
- World conference on sterilization, 21 - 24 November 2012, Osaka, Japan
- Utilisation of low-temperature sterilization in compliance with the amended RKI/BfArM Recommendation (H.-W. Röhlig)
FROM THE FIELD
Problems associated with reprocessing of reusable implants
Reprocessing of reusable implants gives rise to manifold problems. Often, the implementation of the applicable guidelines (e. g. the recommendation jointly compiled by the Robert Koch Institute [RKI] and the Federal Institute for Drugs and Medical Devices [BfArM], the Medical Devices Directive [MDD] and the Medical Devices Operator Ordinance [MPBetreibV]) causes difficulties in the overall reprocessing process employed for reusable implants, and can detract from the high quality of the results aspired to. Unfortunately, not all manufacturers' instructions yet meet the current guidelines and recommendations, thus hampering reprocessing of implants.
The situation is further compounded by the reprocessing problems arising in the washer-disinfectors (WDs), in particular with regard to perforated implants or implants with blind-end bores. Here the manufacturers of washer-disinfectors equipped with such loading trolleys are also called upon to assure validated reprocessing based on a quality management system. This they can do, for example, by fitting WDs with nozzles that, in terms of flexibility and density, are tailored to today's increasingly more complex implants.
The manifold nature of implants calls for a large body of expertise, something that can only be assured through personnel training. Besides, there is the issue of keeping a record of the number of reprocessing cycles or of whether it is more advisable to switch over one's system, if feasible, to single-use devices. However, since in our institution we continue to use reusable implants, getting to grips with these processes continues to be a challenge for all staff members.
If one wants to opt instead for the alternative solution of single-use implants, that choice is partially restricted since not all implants are available in sterile form. That decision also has implications for the logistics as a whole, e. g. greater storage space is required. There is also the issue of how to deal with resterilizable implants whose packaging has been inadvertently opened. Since there is no guarantee that both systems will not get mixed up with each other (i. e. reusable and single-use implants), the various procedural steps and instructions must be set out in the quality management system.
Such decisions have vast implications for the Central Sterile Supply Department (CSSD) ranging from how to design the CSSD through choosing implant manufacturers, and their reprocessing instructions, to storage and ordering logistics. This article now describes the problems encountered in everyday practice and how to overcome them.
implant reprocessing manufacturer's instructions quality management
20 YEARS OF CENTRAL SERVICE
The legal framework for medical device reprocessing: past - present - future
The 20th year jubilee of Central Service is an opportune moment to look back on the evolution of legal regulations for medical device reprocessing. Without any claim to completeness of minor details, the author endeavours in this article to describe developments taking place in medical device legislation during that period and to highlight a number of interesting key points, including future developments.
Qualitätsmanagement in der Medizin- produkte-Aufbereitung - mit Rückblick nach vorn
Against a background of radical changes in the healthcare service, relentless developments in medicine, changes to care procedures and more exacting demands on the service providers, the need for documented and reproducible standards in routine hospital and office-based medical practices is accentuated. Patients are now more wont to query medial services and treatment results, to enable them to engage in the decision-making process too.
Hospitals, external service providers as well as contract physicians are expected to provide the same standard of, or even better, services despite cost cutting, streamlining and competition. The tool to be deployed here is Quality Management (QM)
LTSF sterilization; Class 6 indicators; Development of cleaning
Recommendations by the «Quality Task Group»: Management of Loan Instruments (Part 1)