Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - CLEANI-Rad (Effective and Resource efficient cleaning system for X-Ray Personal Protective Equipment (PPE))

Teaser

The volume of conducted surgical procedures has been increasing steadily over the years. Laparoscopic is a major surgical innovation that has seen widespread application in many areas of surgery. Currently, 90% applications are based on this minimally invasive surgery. This...

Summary

The volume of conducted surgical procedures has been increasing steadily over the years. Laparoscopic is a major surgical innovation that has seen widespread application in many areas of surgery. Currently, 90% applications are based on this minimally invasive surgery. This type of surgery utilises X-rays, which have been classified as harmful carcinogens by the World Health Organisation (WHO). The use of X-rays is strictly governed by radiation protection laws. One of the protective requirements for persons in surgeries involving X-rays, is the use of a lead apron which work as a radiation shield to reduce exposure of the patients or the surgeons to X-rays. During surgery there is often patients’ blood and other fluids contaminated with microorganisms which come into contact with the scrubs, and inevitably, the aprons underneath them. These aprons then need to be washed in order to prevent the occurrence of healthcare associated infections.
The current method of washing these aprons is by hand. This poses a risk of infection as the person that is cleaning them as comes into direct contact with the aprons and its contaminants. There is also no guarantee of total disinfection of the aprons using this method. Inadequate washing of the apron results in a risk being presented to the patient, compromising the sterility of the operating room infections. Healthcare associated infections result in an increase in the patients’ length of hospital stay by an average of 9.7 days, which is very costly. In Europe, it has been shown that the cost of treating an infected person is three times as much as it would be to treat any other patient.
These aprons are also very fragile and if they are not handled properly the lead lining inside it could be damaged. This means the apron will no longer be able to serve its purpose. These aprons will then need to be disposed of, releasing lead into the environment. The dangers of exposure to this element in adults include cardiovascular conditions, increased blood pressure, hypertension, decreased kidney function and reproductive problems, in both men and women In children even low levels of lead in the blood of children can result in behaviour and learning problems, lower IQ, slowed growth, hearing and anaemia .
The objective of the overall project is to industrialise this automatic washing and drying machine for lead aprons and bring it to commercial stage, penetrating the hospital market worldwide.

Work performed

The work performed from the beginning of the project to the end of the Phase 1 is summarised below:
- Identification of customer needs (evaluation of current solutions to wash and dry lead aprons in hospitals).
- Defining the know-how of our product (how to develop a suitable machine to wash this kind of aprons and a identifying a suitable system to facilitate the control and maintenance of the aprons).
- Analytical studies to physically validate the analytical predictions of separate elements of the CleaniRad technology.
- Definition of technical requirements for the pilot development and design of the pilot equipment.
- Design of the CleaniRad prototype.
- Patenting of CleaniRad’s concept in Italy.
- Installation of first three prototypes in Finland and Italy.
- Analysis of customer feedback
- Analysis by by 4HYGIENE s.r.l. and CEPRA to check the effectivity and safety of our system.
As for the Phase 1 completion, we have carried out the following activities:
- Analysis of all technical aspects that needed to be developed and implemented for the full industrialisation of CleaniRad.
- Deep analysis of the feedback received from the hospitals which are currently testing our first prototypes.
- Establish a protocol for the necessary tests to develop the scientific study with ANIPIO in order to quantify results of microbiological tests on the washed aprons.
All the indicators found during the realization of the Feasibility Study, prove the viability of the project and subsequently green-light carrying on with Phase 2.

Final results

There is no evidence of other processes able to automatically wash and dry lead aprons without damaging them. Methods such as using hospital industrial washing machines are not an option as the high mechanical energy during the centrifugation process causes folds, creases, bends, and kinks which result in the formation of cracks or other irregularities in the lead-lining. The high temperatures used in autoclaves would destroy the X-Ray film, making the aprons lose their shielding properties. CLEANI-Rad is an innovative system that will have no problem to differentiate itself from its competitors that are currently just products to clean the lead aprons by hand.

Hospitals that will implement the CLEANI-RAD system will reduce the risk of infections in the operating room considerably. The expenditure of the extended patients’ stay supposes a cost of €6.5 billion annually. The use of CLEANI-RAD will result in the reduction of the investment required for new lead apron purchases as our solution avoids damage to the aprons and enables better maintenance. Their lifetime will be increased and approximately, in a conventional hospital of about 150 lead aprons, €12,000 will be saved per year.