The Società Italiana di Medicina Subacquea ed Iperbarica (SIMSI) is actively commiitted ed to promoting the spread of hyperbaric oxygen therapy (HBO2). In Italy HBO2 is included in the Essential Levels of Care – the benefits guaranteed by the state to all citizens – using code 93.95, which has a value of € 81-120 per treatment. This is is for a scheduled 90-minute treatment for a seated non-critical patient, including medical or nursing assistance. The Italian market is managed by 50 hyperbaric centers that produce 150,000 HBO2 treatments per year, for an estimated value of around €20 million. In Italy the 10 main private companies in health care have not yet invested in hyperbaric medicine, as they are likely unaware of the potential (i.e., pro table/positive gross contribution margin). A “technology push” marketing approach may help with awareness. Regarding technology, Italian legislation currently exists only for multiplace hyperbaric chambers. SIMSI, through the Institute of Clinical Physiology (IFC) of the National Council for Research (CNR), has created a web portal as a tool that aims to facilitate understanding among manufacturers, operators and users.
The Società Italiana di Medicina Subacquea ed Iperbarica (SIMSI) is actively committed to promoting the spread ofhyperbaric oxygen therapy (HBO). In Italy HBO, is included in the Essential Levels of Care - the benefits guaranteed by the state to all citizens - using code 93.95, which has a value of € 81-120 pe r treatment. This is fo r a scheduled 90-minute treatment for a seated non-critical patient, including medical or nursing assistance. The Italian market is managed by 50 hyperbaric centers that p induce 150,000 HBO, treatments per year, for an estimated value of around €20 million.
In Italy the 10 main private companies in health care have not yet invested in hyperbaric medicine, as they are likely unaware of the potential (i.e., profitable/positive gross contribution margin). A "technology push” marketing approach may help with awareness. Regarding technology, Italian legislation currently exists only for multiplace hyperbaric chambers. SIMSI, through the Institute of Clinical Physiology (IFC) of the National Council for Research (CNR), has created a web portal as a tool that aims to facilitate understanding among manufacturers, operators and users.
The portal is located at: https://hddb.area.pi.cnr.it/
The portal contains the datasheets of hyperbaric devices (the contents are controlled by a panel of experts), regulations and provide for operator training. The training platform is a three-dimensional reconstruction of a hyperbaric chamber, allowing maximum safety for the student. The system allows SIMSI to measure the learning curve of each student and catalog mistakes in older to adapt each student’s curriculum. For information on the portal email SIMSI Project Manager Eng. Remo Bedini at: ranci’ ai ini a l.c om
On November 25,2019, SIMSI and the Superior Health Institute organized the meeting "Analysis and Perspectives of Medical Devices Using Hyperbaric Atmosphere Therapy and Prevention." In 2020, upon the request of SIM SI, the Superior Health Institute of the National Health System activated a task force to develop recommendations on the different types ofhyperbaric medical devices. The first meeting was on February 24. The following classes were evaluated :
- multiplace chamber for clinical use (Decree 24.02.9? class lib: device with medium-high risk);
- monoplace chamber for clinical use;
- low-pressure hyperbaric cabins;
- hyperbaric chambers for veterinary use;
- hyperbaric plants for diving work;
- hyperbaric chambers for tunneling work;
- hyperbaric chambers for research (laboratory).
In Europe the most important guideline that clarifies and tightens the mandate on all medical devices is the 2017/745 regulation. This will be mandatory in Italy beginning 26 May-2020. All manufacturers and their clients are required to comply with the directive.
Article 61 and Ann ex XIV state that the actual clinical effectiveness of the device should be assessed by a team of experts. For monoplace hyperbaric chambers that are not currently covered by Italian law, risk analysis and mitigation measures are required. Additionally, the intended use of low-pressure hyperbaric cabins and risk analysis needs to be clarified.
Other current regulatory references for the use of hyperbaric devices in Europe and in Italy include:
- Legislative Decree 24 February 199?, No 46 has implementation of Directive 93/42/CEE, concerning medical devices. This isbasedon the concept of risk. The medical device has an "intended”use that is the one stated by the manufacturer. Risk analysis is essential. Certification procedures are indicated in attachments 1-4 to the Decree.
- EN 14971 “risk analysis and management.” Medical devices are attributed to risk classes for the human body. All medical devices fall into class Ila (low risk to humans). In some cases, such as the hyperbaric chamber, the devices are in class lib (medium-high risk).
- Accordance guidelines such as ISPESL of 25.10.1999 (medical devices for HBO, therapy) have been authorized.
- The code of practice for multiplace chambers (e.g., ISPESL 25-10.1999) provides detailed practical guidance and safety-standards on how to comply with legal obligations in Italy.
- UNI EN 16081:2012"Hyperbaricchambers-Specific requirements for fire extinguishing systems - Performance, installation and testing.” This European Standard is applicable to the p erformance and safety requirements of fire extinguishing systems and their associated test methods for multiplace chambers designed for pressures in excess of ambient atmospheric pressure and employed in medical installations for therapeutic purposes, in the following referred to as chambers
- The standard UNI 11366, produced by the Italian Standardization Authority (UNI), "Safety and health protection in working diving and hyperbaric activities in the service of industry: Operational Procedures" was recognized asNorm by the Legislative Decree24.01.2012 No.l "Utgent measures for competition, infrastructure development and competitiveness.”
- Regardless of the minimum operating pressure of 03 bar (13 AT A) contemplated by the so-called PED directive (Pressure devices directive, Legislative Decree n. 26/2016, which implemented Directive 2014/68/EU on pressure devices of the European Community), the Italian task force will provide a code of good practice fo r the hyperbaric cabins operating at a pressure of less than 1.7 bar (tentatively proposed as the threshold value to define *hyperbaric”therapy) to protect individuals subjected to pressure, as well as the operators and the environment where the devices are positioned. Results of the wide review will help to determine whether the administration of low-pressure oxygen could be truly effective.
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Reported by Pasquale Longobardi MD
President, SIMSI