Test report concerning disinfection of medical devices : Concept OXY PHARM : NOCOSPRAY/NOCOLYSE

Transcription

1 Test report concerning disinfection of medical devices : Concept OXY PHARM : NOCOSPRAY/NOCOLYSE 1. TABLE OF CONTENTS 1 CONTENTS 2 2 PURPOSE OF TESTS Problems, test context Criteria for choosing the solution Selecting the device 4 3 DEFINED WORK PROGRAMME Objective Test conditions Test devices Materials and methods Protocol tested Germs tested Sites and methods of sampling before and after protocol Samples on the DIDO Samples on the INOGEN ONE G Samples on the INOGEN ONE G1 8 4 IMPLEMENTING THE PROTOCOLS For the concentrators For the DIDO RESULTS DIDO Inogen One G Inogen G1 n Inogen G1 n Inogen G1 n Page 1 / 14

2 2. PURPOSE OF THE TESTS 2.1 Issues, test context: SCALEO Medical manufactures and distributes medical devices, particularly those designed for oxygen therapy. For this purpose, SCALEO Medical must ensure or assign a service internally, for its demonstration products and relative to its customers, to guarantee the health and safety aspects of the devices sold. Since the devices are often used by several patients, an effective disinfection solution is essential. For INOGEN concentrators, the protocol proposed by the manufacturer in its technical documentation is inappropriate for use by multiple patients: cleaning the surface and changing filters does not limit the risk of cross-infection between two patients. French regulations and the recommendations of the AFSSAPS (French health products safety agency) require compliance with standard NFT version Criteria for choosing the solution: The SCALEO Medical quality department has therefore been looking for a technical solution for disinfecting oxygen therapy devices in particular, and possibly other medical devices also. The technical solution must meet the following criteria: 1. provides external disinfection in compliance with regulatory requirements: standard NF T version achieves the disinfection of exposed internal components (fluid flow) in compliance with regulatory requirements: standard NF T version provides disinfection without dismantling the devices, and, if possible, disinfects a product during operation (concentrators) 4. does not carry a risk of damaging the device's internal and external components: electronic, plastic, seals, even in the event of repeated use. 5. be tried and tested: a large store of devices must be available, if possible in close or identical fields (oxygen therapy) 6. be easy to implement 7. once defined, the protocol must be easily reproducible without particular know-how and be automatic, if possible. 8. provides residue-free, odourless disinfection 9. be economically viable for SCALEO Medical and its customers Page 2 / 14

3 Disinfection solutions using wipes, directed dispersal or immersion were rejected because they did not meet all the selection criteria. Wipes, because the process does not meet criteria 2 and 6. Products by directed dispersal did not respect criterion 2. Products by immersion did not meet criteria 3 and 4. This research was supported by information from the AFSSAPS website on the subject listing products on the market when standard NFT72281 version 2009 was implemented. 2.3 Selecting the device: Three solutions from reputable manufacturers were studied, all three providing proof of compliance with standard NF T version 2009: - ASEPTANIOS AD: automatic disinfection device using a stabilised solution of peracetic diacid (+/ ppm) and hydrogen peroxide as disinfectant. - CONFORMAT DSVA Fogcleaner: DSVA using hydrogen peroxide as disinfectant. - OXYPHARM NOCOSPRAY using a dry hydrogen peroxide fog as disinfectant. The ANIOS solution was rejected because peracetic acid has two major disadvantages: - high risk of deterioration of certain materials and the internal electronics of the devices. No proof of harmlessness relative to the equipment was provided. - after use, presence of residues and an unpleasant odour (vinegar) incompatible with the patients targeted to use this equipment (respiratory system deficiencies) The CONFORMAT solution was rejected because: - the fog obtained is in the form of droplets so that internal disinfection is not guaranteed - the presence of residues is likely - the solution is too heavy and expensive relative to the need. The solution selected for testing is the OXYPHARM solution which, in view of the documentation provided, meets all the criteria for the defined choice: 1. provides external disinfection in compliance with regulatory requirements: standard NF T version Test report from an independent laboratory provided. 2. achieves the disinfection of exposed internal components (fluid flow) in compliance with regulatory requirements: standard NF T version Internal disinfection guaranteed because the dry fog saturates the atmosphere of the disinfection room 3. provides disinfection without dismantling the devices, and, if possible, disinfects a product during operation (concentrators) The devices can be disinfected while in operation. Solution already used on respirators. Page 3 / 14

4 4. does not carry a risk of damaging the device's internal and external components: electronic, plastic, seals, even in the event of repeated use. Proof of harmlessness with respect to electronic circuits and sealing materials was provided. be tried and tested: a large store of devices must be available, if possible in close or identical fields (oxygen therapy) a customer base, including institutions and services in the field of oxygen therapy is available and a list was provided. 6. be easy to implement the device proposed is very easy to use and does not require any particular installation. 7. once defined, the protocol must be easily reproducible without particular know-how and be automatic, if possible. the device has only one adjustment and does not require maintenance or calibration. 8. provides residue-free, odourless disinfection disinfection with hydrogen peroxide is odourless. Using a dry fog means there is no residue. 9. be economically viable for SCALEO Medical and its customers the cost of the equipment is modest (# 2000 ) and the disinfectant product is economical (1000 ml recharges) It was therefore decide to proceed with an implementation test on the SCALEO Medical premises under real conditions of use, on devices which had previously been used by patients. Mr JOUBERT and Mr SANNA during the sampling Page 4 / 14

5 3. DEFINED WORK PROGRAMME A work schedule was defined in association with Mr BON, pharmacist and hygienist, specialist in the field of oxygen therapy. The initial work schedule was amended for implementation on the site. 3.1 Objective: Evaluate the NOCOSPRAY/NOCOLYSE + system for disinfecting INOGEN concentrators versions G1 and G2, as well as the device for monitoring compliance with oxygen therapy (DIDO2), made by SCALEO Medical. 3.2 Test conditions: This programme was carried out on 13 April 2012 at SCALEO Medical premises, 107 rue Dassin, Montpellier by Mr JOUBERT, France Sales Manager for OXYPHARM and Mr SANNA, Quality Manager for SCALEO Medical. 3.3 Test devices: An INOGEN ONE G2 concentrator, number from the SCALEO Medical demonstration stock which had been used for 387 hours This concentrator was tested without prior cleaning. An INOGEN ONE G1 concentrator, number from the SCALEO Medical stock which had been used for 43 hours An INOGEN ONE G1 concentrator, number from the SCALEO Medical stock which had been used for 1293 hours An INOGEN ONE G1 concentrator, number from the SCALEO Medical stock which had been used for 43 hours These concentrators had first been subjected to the manufacturer's protocol: change of filters and manual disinfection of the surface with an ARGOS BACTYNYL spray. A DIDO 2 number DID , tested without prior cleaning. 3.4 Materials and methods: A disinfection system using hydrogen peroxide, NOCOSPRAY/ NOCOLYSE + in an appropriate room. The room chosen is the one used to degas oxygen therapy accessories with a volume of # 10 m3. The NOCOSPRAY system used was Mr JOUBERT's demonstration model. The dosage must be 3ml/m3 to obtain the required concentration. The NOCOSPRAY must therefore be set to the volume of the room x 3 to obtain the required concentration, i.e. 30m3. The room used had the advantage of being small (# 10m3), relatively well sealed to ensure the concentration of disinfectant throughout the disinfection operation, and equipped with an aspiration system to evacuate all gaseous residues in just a few seconds. Page 5 / 14

6 3.5 Protocol tested: A single protocol was tested: protocol 1 x 3ml/m3 / 2h of contact time after treatment. The 1ml/m3 protocol initially planned was not tested because the dosage of 1 ml/m3 did not match the dosage required to comply with the requirements of standard NF T version Germs tested: The prior efficacy study was initially intended to evaluate microbial reduction on surfaces so there was no identification of germs detected. 3.7 Sites and methods of sampling before and after protocol: For the concentrators: near the input and output filters. These two locations are the most likely to show an accumulation of dust and residues, and thus germs. The output filter is the part of the device closest to the patient, via the oxygen therapy glasses. For the DIDO2, the "front" and "above" surfaces (closest to the output nozzle) were chosen. Samples were taken using OXYPHARM NOCOBOX contact agar. The contact agars were sealed after sampling. The samples were stored at ambient temperature (# 23 C) for 72 hours before reading Samples on DIDO2 DIDO2 - sample on the front DIDO2 - sample on the top Samples on INOGEN ONE G2 INOGEN ONE G2 - sample near opening INOGEN ONE G2 - sample near exit Page 6 / 14

7 3.7.3 Samples on INOGEN ONE G1 INOGEN ONE G1 - sample near exit INOGEN ONE G1 - sample near opening The samples were identified for later reading: DIDO2 INOGEN ONE G2 INOGEN ONE G1 n INOGEN ONE G1 n INOGEN ONE G1 n Page 7 / 14

8 4 IMPLEMENTING THE PROTOCOLS The following protocols were defined. They will become the disinfection procedures if the process is validated For the concentrators 1. Prior cleaning 2. Unpacking 3. Remove the output nozzles 4. Remove the input and output filters.(inogen ONE G1),the output filter only (INOGEN ONE G2) 5. Reinsert the nozzle 6. Place the concentrators in the disinfection room 7. Set the NOCOSPRAY to 30 m3 8. Switch on the concentrators (mains or battery) at maximum setting: number 5 9. Switch on the disinfection device 10. Close the door 11. Wait an hour 12. Run the aspiration device for 1/4 hour. 13. Insert new input and output filters.(inogen ONE G1),the output filter only (INOGEN ONE G2) For the DIDO2 1. Prior cleaning 2. Place in the disinfection room 3. Set the NOCOSPRAY to 30 ml 4. Switch on the disinfection device 5. Close the door 6. Wait an hour 7. Run the aspiration device for 1/4 hour Page 8 / 14

9 Place devices in the disinfection room Setting of the Nocospray on 30m 3 Page 9 / 14

10 5. RESULTS 5.1 DIDO2 Before disinfection After disinfection Page 10 / 14

11 5.2 Inogen One G2 Before disinfection After disinfection Page 11 / 14

12 5.3 Inogen G1 n Before disinfection After disinfection Page 12 / 14

13 5.4 Inogen G1 n Before disinfection After disinfection Page 13 / 14

14 5.5 Inogen G1 n Before disinfection After disinfection Page 14 / 14