The latest release of the Manual on Boderline and Classification in the Community Regulatory Framework for Medical Devices Version 1.9 was updated March of 2011.
There are 4 new areas that have been incorporated into this version (1.9) of the manual.
They include: 1) Bio functional clothes or “therapeutic clothes” in section 1.7 of the manual, 2) System for the determination of bacterial contamination in blood products in section 1.8 of the manual, 3) Independent in-vivo dosimeters in section 1.9 of the manual, and 4) Eye drops regulated as medical devices in section 8.19 of the manual
Below is an excerpt of each of the four sections of its’ background to give you an idea of what each item is covering.
1.7 Bio functional clothes
Bio functional clothes or “therapeutic clothes” consist of clothes (e.g. socks, leggings, pyjamas, undershirts…) impregnated with silver and brown algae extract. These clothes are presented as having anti-bacterial, anti-microbial, breathable, thermal regulating and anti-odour properties. According to the manufacturer, the silver ions (positively charged) integrated into the fiber reduce the microbial growth in the fabric and inhibit microbial growth on the skin, and the brown algae extract protects against rash act by neutralization of neuromediators and vasodilatator agents responsible for flushing. The intended use of these clothes is to prevent inflammatory crisis of atopic dermatitis.
The main mode of action described by the manufacturer is the creation of a physical barrier that prevents the contact of sensitive skin with the outside and other tissues potentially sensitizing, creating an environment helping to the attenuation of skin conditions. The actions of silver and algae extract were presented as an ancillary action. The product was presented as a Class I medical device.
1.8 System for the determination of bacterial contamination in blood products
The bacterial contamination of blood components represents a high infectious risk in blood transfusion, particularly for platelets concentrate. In order to estimate the bacterial contamination, manufacturers have developed some bacterial detection systems near the time of blood collection. A new system has been developed based on the detection and identification of a wide spectrum of common pathogenic bacteria. Following the identification, a direct count is obtained by cytometry.
1.9 Independent in-vivo dosimeters
In vivo dosimetry systems are used in radiotherapy to monitor the radiation dose received by the patient during a radiotherapy treatment. The device consists in a semi-conductor detector placed on the patient’s skin and an electrometer placed in the control room where the physicians control the radiotherapy equipment. When performed early in treatment as an additional measure, the in vivo measurements of the radiation dose are an additional safeguard against setup, calculation or transcription errors. If the dose delivered to the patient is higher than the calculated dose, the system, independently of the radiotherapy equipment, can alert the physician, allowing him to act on the treatment.
8.19 Eye drops regulated as medical devices
The ocular surface is a physiological complex fundamental in the maintenance of a good visual function, so its integrity must be properly safeguarded irrespective of the use of contact lenses. The use of substances that increase the retention time of the lubricants, tend to increase the contact time between the lubricant and the ocular surface.
According to point 3.1.2.2 of MEDDEV 2.4/1 rev.9 on the Concept of continuous use, if it cannot be demonstrated that components of the device are totally eliminated in the interval between uses, this is also considered as an immediate replacement.
The continued use in situations where there is no lasting relief of symptoms as well as the continuation of aggressive conditions (environmental or not / or due to a number of medical conditions) can lead to the permanent and / or high frequency use (with products whose rate of elimination is unknown), setting the conditions for the continued use of these lubricants. Considering eye lubricants as examples of medical devices (in which there is no demonstration of their total elimination between applications) destined for continuous use.