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Medical device:
Medical thoracic drainage system ATMOS® S 201 Thorax with consumables production ATMOS Medizin Technik GmbH & Co.KG, Germany.
Compiled by:
Department of thoracic surgery Emergency State budget institution of Moscow "Scientific-Research Institute of Emergency Care named after Sklifosovsky Moscow Health Department "(GBUZ" SRI EC NV Sklifosovsky MHD ").
Actual address: 129090, Moscow, Bolshaya Sukharevskaya Square, 3
Tel .: (495) - 620 - 12 - 85; Fax: (495) - 680 - 85 - 63.
1. In the period from 01.10.2013 till 01.10.2014, the staff of the thoracic department evaluated the results of clinical trials of ATMOS® S 201 Thorax
in the form of tests involving human subjects and the assessment and analysis of clinical data in accordance with the regulatory, technical and operational documentation of the manufacturer.
2. For the conduct of clinical trials (CT) presented:
2.1. A letter from applicant
2.2. Registration Statement SPF number 2009/04117 with the application
2.3. Information about the medical device
2.4. Promotional materials
2.5. User manual
2.6. Technical testing protocol №128R 2009
2.7. Test report №DE042ME.02MD for compliance with GOST R 50267.0.2-2005
2.8. Report № 890.009 toxicological tests with the application of 17 February 2009 Research Laboratory Center FHM Roszdrav
2.9. Thoracic drainage system ATMOS Thorax S 201 – 5 pcs. with consumables
3. Department of thoracic surgery
conducted clinical trials of thoracic drainage system « ATMOS® S 201Thorax» with consumables, in accordance with the approved profile of clinical research.
3.1 Brief description of the subject product and its purpose, set by the manufacturer.
Medical thoracic drainage system ATMOS® S 201 Thorax designed for mobile chest drainage. It is used for short-term
treatment of people less than 30 days. It is a portable device which is independent of the power supply network. The device is equipped with an electronic control system with visual and acoustic mapping information. The device does not require sterile conditions for the application of the exception connected hoses that are disposable sterile product.
3.2 Type of a medical device in accordance with the nomenclature Classification of medical devices::
502.04.02.32
3.3 The class of potential risk of application of the medical device in accordance with the nomenclature Classification of medical devices::
2а (nomenclature of classification of medical devices by class, depending on the potential risks of their use, the Order of the Russian Ministry of Health of 06.06.2012 №4n).
3.4 Assessment of the documentation
Presented for clinical trials of medical products "ATMOS® S 201Thorax" documentation meets the requirements of the order of Ministry of Health of Russia from 09.01.2014 № 2N. "The procedure of conformity assessment of medical devices in the form of technical testing, toxicological studies, clinical trials for the purpose of state registration of medical devices.».
3.5 Characteristics of the object of research
During the clinical trial analyzed the treatment of 100 patients aged 16 to 77 years (51,07 ± 16,76 years). (56 were women and 44 men). Nosological range accounted cancer of the lungs, pleura and mediastinum - 61 patients, pneumothorax various genesis - 15, interstitial lung disease - 4, pleurisy - 5, malformations - 8 tuberculosis - 1, suppurative disease - 3, mediastinal lymphadenopathy - 3. Performed 100 operations, mostly lobectomy (32%) and sublobarnye atypical pulmonary resection (23%). In 17% of cases performed pleurodesis. Biopsy of the pleura, mediastinum, and lung tumors produced in 13%, removal of tumors of the chest wall and mediastinum in 12% of cases. In 3% of the intervention is limited thoracostomy. Each operation ended thoracostomy one or two drains, which are connected to the canisters of ATMOS® S 201 Thorax in a sterile environment. When you turn on instrument is tested for leaks, and then set the system pressure -20 mbar and perform key lock device.
Due to sterile closed system "pleural cavity, drainage, connecting tube-tank", as well as one-way traction pumping mechanism implemented prevention of ascending infection of the pleural cavity of the patient in the postoperative period.
Retrospective analysis of air flow was made by graph over the past 12 hours.
To make a decision about the removal of pleural drainage adhere to the following criteria:
1. Lack of blood supply, chyle, pus, pleural drains air for at least 12 hours.
2. The amount of serous, sero-hemorrhagic discharge by less than 200 ml drains per day.
3. Clinically and radiographically straightened lungs.
Activation of the physical activity of patients after the operation was performed on the background of the analgesic therapy with 1 postoperative day, with the movement in space did not require disconnecting from the vacuum aspiration device because the integrated battery.
3.6 The results of the clinical trials of a medical device
Analysis of the data showed that the length of the air intake of pleural drains in patients observed for 0-30 days and an average of 2.07 days. Prolonged air intake (more than 7 days) was observed in 8 patients.
Pleural drains removed up to 7 days of the postoperative period in 77% of cases, the average duration of drainage was 5,96 ± 5,65 days.
Duration of hospitalization after surgery was from 6 to 37 days, which averaged 13,03 ± 7,64 days.
Analysis showed the predominance complications wound infection (6%) patients in the study group. Limited
pneumothorax caused after the removal of pleural drainage was detected in 3 patients, but signs of infection detected in the pleural cavity and did not require additional drainage. Dynamic observation noted absorption of free air in the pleural cavity in all cases. Postoperative nosocomial pneumonia was detected in 1 case.
3.7 Comparison of the functional characteristics of medical devices used in the reference method (if available)
The reference method does not exist.
3.8 Functionality of medical products, the effectiveness of its application, indications and contraindications for its use
The study took into account the following indications for the use of medical products " Medical thoracic drainage system ATMOS® S 201 Thorax":
1. operations on the organs of the chest, made using Access: thoracotomy, minithoracotomy, Videoassisted minithoracotomy, videothoracoscopy;
2. The isolated or combined chest trauma complicated by pneumothorax and / or hemothorax;
3. thoracostomy about spontaneous pneumothorax;
4. thoracostomy about hydro (hemo or hilo-) thorax or empyema.
Exclusion criteria considered conducting additional surgery after surgery, by vacuum drainage of the pleural cavity, the need for constant aspiration-washing drainage of the pleural cavity, the presence or development of postoperative patient mental or psychosomatic disorders.
Contraindications to the use of medical products "Medical Vacuum Aspirator ATMOS® S 201 Thorax" in the course of the study have been identified.
3.9 Information discovered during the clinical trial design faults and quality of medical products (if exist), especially working with it during the operation.
As a result design weaknesses and quality of Medical thoracic drainage system ATMOS® S 201 Thorax production ATMOS Medizin Technik GmbH & Co.KG, Germany, especially working with it during the operation were not identified.
4. Summary of the test results.
During clinical trials, Medical thoracic drainage system ATMOS Thorax S 201 analyzed the clinical use of a medical device in 100 patients after surgery Thoracic profile.
Analysis of the data showed that the length of the air intake of pleural drains in patients observed for 0-30 days and an average of 2.07 days. Prolonged air intake (more than 7 days) was observed in 8 patients.
Pleural drains removed up to 7 days of the postoperative period in 77% of cases, the average duration of drainage was 5,96 ± 5,65 days.
Duration of hospitalization after surgery was from 6 to 37 days, which
averaged 13,03 ± 7,64 days.
Analysis showed the predominance complications wound infection (6%) patients in the study group. Limited pneumothorax caused after the removal of pleural drainage was detected in 3 patients, but signs of infection detected in the pleural cavity and did not require additional drainage. Dynamic observation noted absorption of free air in the pleural cavity in all cases. Postoperative nosocomial pneumonia was found in 1 patient.
5. Conclusions
5.1 Technical data of Medical thoracic drainage system ATMOS® S 201 Thorax with supplies matched instruction.
5.2 Connection features of the device and its operation with the creation of a sterile closed system "pleural cavity, drainage, connecting tube-capacity" avoid ascending infection of the pleural cavity of the patient and prevent infectious complications of the pleural cavity.
5.3 Duration of drainage after surgical operations on the thorax using an thoracic drainage system ATMOS® S 201 Thorax averaged 5,96 ± 5,65 days.
5.4 Early activation of patients in the postoperative period due to the autonomous operation of the aspirator ATMOS® S 201 Thorax allows you to minimize the frequency of complications associated with physical inactivity, which leads to a reduction in the duration of treatment, compared to the standard drainage systems.
5.5 Retrospective graphical monitoring air flow has priority when deciding about removing drainages compared to real-time monitoring, which reduces the risk of pneumothorax in the postoperative period compared with conventional drainage systems.
6. Evaluation of the results of clinical trials
The effectiveness of a Medical thoracic drainage system ATMOS® S 201 Thorax (ATMOS Medizin Technik GmbH & Co.KG, Germany) supported by the results of clinical trials said medical device, as well as the regulatory, technical and operational (Operating Instructions) documentation.
CONCLUSION
Medical device thoracic drainage system ATMOS® S 201 Thorax (ATMOS Medizin Technik GmbH & Co.KG, Германия) is a high-quality, effective and safe medical product when used according to the manufacturer's intended use.
Appendix:
1) Profile of clinical research “Evaluation of the clinical effectiveness and safety of mobile thoracic drainage systems ATMOS® S 201 Thorax”
2) The protocol of the clinical study "Evaluation of the clinical effectiveness and safety of mobile thoracic drainage systems ATMOS® S 201 Thorax”
3) Operating Instructions thoracic drainage systems ATMOS® S 201 Thorax Applications are an integral part of the Act..
The principal investigator,
Leading Researcher
Emergency department thoracoabdominal
Surgery, MD, Ph.D. Е.А. Tarabrin