nir-vana innovation network

The German company is a consultancy for medical surgeons and dentists with the core competence in hygiene management. Their main subject is the validated reconditioning of medical devices and instruments and training of the medical staff and dentists.

In May 2017 the Medical Device Regulation (EU) 2017/745 has come into force, which is valid within a transitional period of three years and has to be implemented directly in all European countries. It is the most important regulation instrument for the proof of the security and the medical and technical performance of medical devices. The reconditioning of medical devices has not been changed and remains consistant within the conformity assessment procedures in all European countries.
A validated reconditioning is the indispensable requirement for the protection of patients and staff against infections.

It legally provides a fully manageable risk. The risk of, e.g. technical or human failures, can be excluded, if the hygiene standards are complied with. However, in any case of noncompliance the medical practioner or responsible person of a surgery is liable for the consequences. In the case of a legal dispute it has to be proven that all hygiene standards had been fulfilled. This is only possible, when relevant procedures are documented appropriately.
Targeting the highest operational hygiene standards for the protection and benefit of patients, the company has developed an innovative hygiene management system that also aims to disburden medical staff in their duties to carry out, monitor and to document these procedures.

The innovation is that besides the instrumental steps, e.g. the cleaning, disinfection, sealing device etc., also the manual working steps are included and documented in the same way. By this, the whole process becomes independant of the day's form of the individual employees.
The offered hygiene management system is legally compliant and documents automatically all steps of a validated reconditioning of medical devices and instruments.

The company is already working together with partners in Germany, who are selling and implementing the system successfully. For opening international markets, the company needs local partners, who are capable to offer and implement the system in their clients' work spaces and to provide technical service.

The service package for the local business partner includes:

• Analysis and evaluation of the reconditioning processes

The company offers the complete analysis and evaluation of the reconditioning processes for medical devices currently used by the client, e.g. the clinic or surgery operator etc., and also provides all relevant documents, if requested by the local business partner.

• Individual Software and court-proof documentation

Based on the analysis and evaluation the company provides an individual software, which enables the clinic or surgery operator to establish a self-controlling, paperless and court proof documentation of a validated reconditioning process in the day-to-day operations. The software is provided on a firm server and can be downloaded by the business partner.

• Implementing and services

The system will be implemented in the clients’ work space in cooperation with the local business partner and supported by a remote control facility. All maintanance services will be also realised by remote control. The company provides additional hardware (PC, printer etc) upon request.

The company seeks distribution service agreements with local business partners. This can be distributors of medical equipment and hardware for medical surgeries, dentists, clinics, care organisations etc. The business partners should be interested in implementing the innovative hygiene management system into the technical instrumentation and in the day-to-day operations of their clients. The partner receives a license for using the software.

Advantages & innovations

Improvement of efficiency: • controlled hygiene recondition • permanent electronic data transfer • seamless self-control Legal compliance: • conformity with European and national directives • tamper-proof documentation • court-proof Portable Document Format Cost saving: • significant saving of working time • paperless documentation • protection against regress and compensation

Stage of development

Already on the market

Partner sought

Distributors of dental/medical equipment are sought. The ideal partner has a good position on the dental/medical market with a broad clientele as a supplier for dental or medical equipment, consultancy and technical servant for medical surgeries, dentists, clinics etc. The local business partner is the supplier of the hardware and will be responsible for the installation of the hygiene management system in cooperation with the German company. The partner can receive a license for the software.