What exactly is the hospital supposed to do under this new regulation (MDD)?
The hospital is requested to verify that barrier products used in the operating room carry the CE mark,
or, if they are re-processed, verify that they have definitely been reprocessed to ensure ensure compliance with EN 13795 every time they are used.
What departments will be affected by EN 13795?
The principle functions in the hospital affected by EN 13795 are the operating department, the Central Sterile Services Department (CSSD), hospital administration, infection control and the purchasing department.
Is cotton linen definitely forbidden under the MDD and the Standard EN 13795?
Will it be possible to get a medical device made of cotton linen CE-marked?
No, cotton linen is neither forbidden by the MDD nor by the Standard EN 13795.
The MDD and the Standard EN 13795 only define properties and not materials as such.

However, cotton linen does not have the necessary properties to comply with the following test methods in the EN 13795:
  • Wet bacterial penetration
  • Linting/particulate matter
  • Resistance to liquid penetration ¹ ²
It is therefore not possible to CE-mark plain cotton linen products as Medical Devices.

¹
Woodhead K, et al. 2002: Behaviours and rituals in the operating theatre, A Report from the Hospital Infection Society Working Party on Infection Control in Operating Theatres, Journal of Hospital Infection (51) 241-255
²
Abreu MJ, Silva ME, Schacher L, Adoplhe D 2003: Designing surgical clothing and drapes according to the new technical standards, International Journal of Clothing Science and Technology (15) 69-74
Is it permissible to use cotton linen products until they are "worn out" even after the EN 13795 has come into force if reprocessing in-house?
EN 13795 supports the safety legislation for medical devices which regulates the products that manufacturers may place on the European market. Users may in theory use whatever products they see it for the purpose. If, however, a patient is injured due to the use of devices not complying with the 'harmonised European Standard' then the hospital carries the full legal responsibility, and an action may be brought against it in court.
Will it be possible for an external laundry to supply a hospital with traditional cotton linen textiles?
No, it is not possible if the products are intended for use as medical devices as anyone placing products on the European market has to state the intended use of their products. An external laundry places products on the market and those products must comply with European legislation, which is specified in EN 13795.

This means that a hospital using sub-standard products, apart from being open to litigation, will not be able to replenish its stock with the same products again, and will therefore have to change to products ensuring a higher level of patient safety.
Who is responsible for the guarantee that a device is not used more often than it is supposed to be, in order to be safe to use?
The person carrying out the reprocessing will be held responsible, which could be the reprocessor, external laundry or hospital.
How can a hospital enforce observation of EN 13795 requirements by a supplier?
If a hospital discovers that products do not comply with EN 13795 a contact with the Competent Authority in that country should be the first step. The second step should be to find a manufacturer who has products which do comply, in order to ensure safety for the hospital's own patients and staff.
Who is the Competent Authority?
The Competent Authorities are the national government bodies. They are the ones implementing the EC directives locally. In each country the Competent Authority authorises certain organisations to evaluate each manufacturer's compliance with a directive. These organisations are known as Notified Bodies, and they permit a manufacturer to add the CE-mark to a product after a successful evaluation.