The treatment (cleaning, disinfection, sterilization) of medical devices (MD) must be extremely rigorous in order to ensure patient safety, avoid healthcare-associated infections (HAIs) and guarantee quality of care. From the definition of disinfectants used in the medical sector to a review of current French and European standards and regulations, this article provides an overview and a better understanding of the positioning of the SANIVAP device and the Nocotech solution developed by Oxy’Pharm.
Defining disinfectants: Medical device or biocide?
WHAT IS A MEDICAL DEVICE?
According to article L.5211-1 of the French Public Health Code and article 2 of Regulation (EU) 2017/745 passed by the European Parliament and the European Council on April 5, 2017, medical device means any instrument, apparatus, equipment, software, implant, reagent, material or other article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the medical purposes mentioned below and whose principal intended action in or on the human body is not obtained by pharmacological, immunological, or metabolic means, but which may be assisted in its function by such means:
- Diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease.
- Diagnosis, control, treatment, alleviation of, or compensation for injury or disability.
- Investigation, replacement, or modification of the anatomy or of a physiological or pathological process or state.
- Providing information by means of in vitro examination of specimens derived from the human body, including organ, blood, and tissue donations.
The article also specifies that medical devices are those known to be:
- Devices for the control or support of conception
- Products specifically intended for the cleaning, disinfection or sterilization of medical devices, their accessories and non-medical product groups listed in Annex XVI to Regulation (EU) 2017/745.
Therefore, to be considered a medical device, a disinfectant product must be specifically intended for the disinfection of medical devices which, in order to be used, must be disinfected in line with their instructions for use.
Medical devices are classified according to the level of risk associated with their use (duration of use, part of the body exposed, inside or outside the body) and the potential risks associated with their use for public health (class I, IIa, IIb, and III, in line with increasing risk of use).
WHAT IS A BIOCIDE?
The French Ministry for the Ecological Transition and Territorial Cohesion defines biocidal products as a set of products intended to destroy, repel, or render harmless otherwise harmful organisms, to prevent their action or to combat them, by chemical or biological means.When asked about the definition of disinfectant products used in the medical sector, the French national drug regulator, the ANSM, specifies that:
- Medical device disinfectants designed to control microbiological risks related to the environment are biocidal products.
- A disinfectant cannot be considered an accessory to a medical device, and therefore cannot have the status of a medical device.
SANIVAP: The only solution on the market with medical device status
The SANIVAP device is a steam bio-cleaning system. High-temperature steam with detergent properties eliminates dirt and biofilms (while leaving no residual trace of chemicals).
To date, the SANIVAP device is the only one of its kind with medical device status, meaning that it can be used to disinfect medical devices in hospitals (such as surgical tables and incubators). SANIVAP devices are Class IIa medical devices – Notified Body GMED 0459.
Nocotech: A full-spectrum biocide
The Nocotech automated airborne surface disinfection solution is based on the combined action of a Nocospray device and a disinfectant from the Nocolyse range.
The Nocotech solution has biocide status, and is recognized for its broad spectrum of application and effectiveness: bactericidal, fungicidal, sporicidal, and virucidal (EN 17272).
Manufactured in France, the SANIVAP MD and the Nocotech system have also been awarded ISO 13485 certification, proving Oxy’Pharm’s commitment to product quality and safety.
MDs and biocides: The current regulatory and standards framework
REGULATIONS
Disinfectants used in the medical sector are subject to different regulations depending on whether or not they are intended for disinfecting medical devices. In this case, they fall under:
- Medical device status under European Regulation 2017/745 on medical devices (applicable since May 26, 2021); or,
- Biocide status under European Regulation 528/2012 on biocidal products, passed on May 22, 2012.
Rule 16 of Annex VIII of the Medical Devices Regulations stipulates that a disinfectant used specifically for disinfecting a medical device is indeed a Class IIa medical device: All devices specifically intended for use in disinfecting or sterilizing medical devices are Class IIa, unless they are disinfectant solutions or washer-disinfectors specifically intended for use in disinfecting invasive devices at the end of the procedure, in which case they are Class IIb. A manufacturer can therefore claim that its disinfectants comply with either one of these regulations.
STANDARDS
The CE medical device marking certificate, affixed by the manufacturer, guarantees that medical devices available on the European market have undergone the conformity assessment procedure as defined by the directives to guarantee their safety and reliability. Be careful not to confuse CE electrical marking, which indicates safety compliance, with the CE medical device marking, which displays the number of the certifying body.
ISO 13485 is a voluntary quality certification standard developed for the medical device sector. Its full title, “Medical devices – Quality management systems – Requirements for regulatory purposes,” indicates that it is intended to demonstrate regulatory conformity, and is recognized by the industry internationally. This standard validates a quality management system, but does not itself provide medical device status.
To find out more, please contact your regional representative for a demonstration.
Sources
Article L5211-1 – French Public Health Code. Version in force since July 31, 2022
https://www.legifrance.gouv.fr/codes/article_lc/LEGIARTI000046126069
Official journal of the European Union
https://eur-lex.europa.eu/legal-content/FR/TXT/PDF/?uri=CELEX:32017R0745
French Ministry of the Economy, Finance, and Industrial and Digital Sovereignty. Medical devices and in vitro diagnostic medical devices. Updated on April 10, 2024..
ANSM. Medical devices
French Ministry for the Ecological Transition and Territorial Cohesion. Biocidal products.
https://www.ecologie.gouv.fr/produits-biocides
ANSM. Status of disinfectants used in the medical sector (TP2 biocide / Medical device). Updated on March 31, 2021
MD Guide: Guide to best practices in the use and treatment of reusable medical devices.November 2022
https://www.sf2h.net/k-stock/data/uploads/2022/11/Guide_DM_22_SF2H.pdf