Improve quality, minimize risks, optimize processes

A seamless sterile supply workflow is a fundamental component of efficient and successful OR performance. The prerequisites for safe patient treatment using properly hygienic surgical instruments are created in the reprocessing unit for medical devices (RUMED/CSSD).

Vitruvia advises hospitals on how to ensure and maintain a strong culture of compliance with the stringent legislative and normative framework for the reprocessing of medical devices, while driving operational efficiency to deliver cost-effective and quality-assured services and care.

Training Institute

Are you interested in developing your staff’s knowledge and skills?
Our course offering

Process management

We analyze and evaluate the whole process chain of medical device reprocessing, with particular focus on its interfaces, including OR unit, hygiene, building services, and procurement. Based on our comprehensive review, we identify potential for improvement and recommend an appropriate course of action for your specific hospital to help optimize your processes for a more efficient and effective workflow in compliance with the relevant legal and quality requirements.

Focal points:

  • Development of an organizational and operational structure tailored to the requirements of your RUMED/CSSD
  • Systematization and standardization of the RUMED/CSSD workflows
  • Organization chart incl. duties and responsibilities
  • Personnel situation incl. qualification requirements
  • Processes and workflows in the reprocessing of medical devices
  • Medical/technical equipment and its sizing
  • Space requirements
  • Process documentation
  • Cooperation with the interfaces, particularly the OR unit

Quality management

Our audit and analysis of your quality management system provides you with the professional support and guidance you need to implement or maintain a compliant quality management system in your RUMED/CSSD. Our certified auditors conduct internal audits in preparation of external auditing by a notified body according to DIN EN ISO 13485.

Our services include:

  • Compliance with applicable laws and quality standards
  • Implementation of the RKI/BfArM requirements
  • Guidance/support or preparation of a QM manual
  • Guidance/support or preparation of process and work instructions
  • Implementation of a quality management system in line with ISO 13485:2016
  • Internal auditing of the RUMED/CSSD
  • Guidance/support through to certification of the RUMED/CSSD

Our primary objective in all our audits is to ensure compliance with the German Medical Devices Operator Ordinance (MPBetreibV) in conjunction with the recommendation of the Commission for Hospital Hygiene and Infection Prevention (KRINKO) at the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices (BfArM).

Conceptual design of medical device reprocessing facilities

The reprocessing of medical devices ties up a large number of cost-intensive resources, especially when spread across several locations. Our conceptual design of medical device reprocessing facilities provides you with a data- and knowledge-based analysis of different site models based on compliance, efficiency and quality aspects. This enables you to make informed decisions about the future concept of your medical device reprocessing facility.

We support you with:

  • Carrying out location analyses
  • Development of different location concepts
  • Data-based evaluation of location concepts according to investment costs, operating costs, logistics costs
  • Knowledge-based evaluation of location concepts according to process-related advantages and risks
  • Development of recommendations for action

Focus is given to efficiency, supply security and the organization of processes. Using appropriate calculation models, we highlight synergy effects and offer specific examples of the effect of operating times, medical/technical equipment and necessary transportation logistics on investment and operating costs.

Instrument management

Medical instruments are a critical resource in every hospital. High rates of availability and cost efficiency are imperative. Despite the fact that the cost of procuring surgical instruments can quickly run into several hundreds of thousands of euros, potential economic efficiency gains often are not realized.

In many cases, this is due to a lack of dovetailing between the various departments involved in the process. The consequences become apparent only much later, when supply shortages in the OR result in sub-optimal performance due to incomplete or missing surgical trays and substandard instrumentation.

This is where our consulting services come in. We optimize surgical instruments from any manufacturer and help you establish standardized instrument management processes. This includes all sub-processes and involves a direct dialog at your facility with all relevant professional categories and departments.

Inventory analyses

  • Recording of the quantity of surgical tray instruments and replenishment reserves
  • Evaluation of the quality of recorded instruments
  • Evaluation of the product spectrum
  • Evaluation of the composition of replenishment stocks
  • Evaluation of manufacturers’ and repair service spectrum
  • Evaluation of repair quality

Tray usage analyses

  • Analysis of the usage pattern of surgical trays
  • Analysis of the usage pattern of surgical tray contents
  • Development of recommendations for optimization of surgical trays and tray contents in direct dialog with users and RUMED/CSSD

Interface analyses

  • Procurement management
  • Change management of surgical tray contents
  • Repair management

Our OR-versed team also supports you in the organizational and operational execution of our recommendations and the implementation of an effective instrument controlling system to ensure sustained efficiency and quality in instrument management.