Establishment of procedures
1. Prior to starting the reprocessing, reprocessors shall perform a visual check of the single-use devices for damages. They shall test whether movable parts can be correctly moved. If maintenance or adjustment is needed for the single-use device to perform as specified in the instruction for use, the maintenance shall be performed according to the established procedure. The reprocessors shall dispose of damaged or dysfunctional single-use devices.
2. The reprocessor shall establish a validated decontamination procedure adapted to the properties and characteristics of the single-use device and the risks linked with its use.
3. Preparation for reprocessing shall not compromise the hygienic state and the functionality of the decontaminated device. If there is a delay exceeding an established time limit in the procedure before cleaning and disinfection or sterilization of single-use device, it shall be adequately pre-cleaned and put in intermediate storage. The single-use devices shall be transported to the reprocessing premises in closed identified and dedicated containers under the conditions set out in a procedure.
4. The necessary requirements in terms of microbiological and chemical properties of water, chemicals, and other products used in the reprocessing shall be set out in the procedures for each specific cycle.
5. When choosing cleaning, disinfection and sterilization procedures, priority shall be given to validated automated procedures that ensure their reproducibility. The disinfection shall ensure appropriate bactericidal (including mycobacteria), fungicidal, and virucidal effects, and the effectiveness of the disinfection shall be verified regularly on samples.
6. Cleaning and disinfectant solutions, and the sterilizing agent if applicable, shall be removed by a validated method described in a procedure.
7. The sterilization with moist heat (steam sterilization) shall be used where such use is appropriate. However, other validated methods may be chosen according to the properties and characteristics of the single-use device to be reprocessed.
8. Monitoring of sterilization cycles and release of sterilized single-use devices shall be based on attaining the sterilization parameters within the established and validated tolerances described in a procedure. If not all relevant sterilization parameters can be measured, those physical measurements shall be supplemented by using qualified biological indicators to provide additional assurance that no undetected deviations from the validated cycle occurred.
9. The packaging system shall be suitable for the content, validated according to relevant standards and the sterilization method used if applicable, for the properties of the reprocessed single-use device and for the intended storage and transportation. The packaging shall enable sterilization and guarantee sterility during the stated shelf life and until use, under proper storage and transportation conditions. If during the reprocessing a problem concerning the functionality, performance, or safety of the single-use device is detected, the problem shall be addressed and the single-use device shall be repaired, if possible, or disposed of if repair is not possible. The cause of the problem shall be investigated in order to verify the continued efficacy of the cycle. If the process is no longer achieving its objective, the cycle shall be modified or reprocessing shall be stopped for that specific single-use device. If any of the steps of the reprocessing fails to meet the requirements laid down in the procedures for that single-use device, it shall not be released for reuse.
Steps of the reprocessing cycle
The reprocessing cycle shall cover the following steps, if applicable to the device concerned:
(a)
pre-treatment at the point of use;
(b)
transportation, including procedures for safe transportation of hazardous materials;
(c)
preparation before cleaning;
(d)
cleaning;
(e)
thermal disinfection or chemical disinfection;
(f)
drying;
(g)
inspection, maintenance, repair and functionality testing;
(h)
packaging;
(i)
labelling and provision of instructions for use;
(j)
sterilization;
(k)
storage.
Pre-treatment at the point of use and transportation
Procedures for pre-treatment at the point of use and transportation prior to reprocessing referred to in points (a) and (b) of Article 11 shall cover the following, if applicable:
(a)
description of the pre-treatment techniques;
(b)
any checks that need to be undertaken;
(c)
definition of the maximum period of time that may elapse between use and cleaning;
(d)
description of the support systems and containers for transportation;
(e)
requirements for transportation.
Preparation before cleaning
Procedures for preparation before cleaning referred to in point (c) of Article 11 shall cover the following, if applicable:
(a)
requirements for disassembly of the single-use device;
(b)
capping or opening of ports;
(c)
leak testing;
(d)
special soaking or brushing techniques and ultrasonic treatment of the single-use device.
Cleaning
Procedures for cleaning referred to in point (d) of Article 11 shall cover the following, if applicable:
(a)
techniques to be used, including rinsing;
(b)
description of the accessories required for cleaning process;
(c)
identification and concentration of chemicals required for cleaning;
(d)
identification of water quality to be used;
(e)
limits and monitoring of chemical residues remaining on the single-use device;
(f)
limits on process parameters, including temperature, concentration of solution(s) and exposure time to be used.
Thermal disinfection
Procedures for thermal disinfection referred to in point (e) of Article 11 shall cover the following, if applicable:
(a)
limits on process parameters, including temperature and exposure time;
(b)
description of the accessories required for the disinfection process;
(c)
identification of water quality required;
(d)
techniques to be used including rinsing volume and time with criteria or requirements for approval or rejection.
Chemical disinfection
Procedures for chemical disinfection referred to in point (e) of Article 11 shall cover the following, if applicable:
(a)
identification and concentration of chemicals required for the disinfection process;
(b)
contact time of the disinfectant;
(c)
temperature(s) to be used;
(d)
limits on temperature, concentration of solution(s), exposure time;
(e)
description of the accessories required for the disinfection process;
(f)
identification of water quality required;
(g)
techniques to be used including rinsing volume and time;
(h)
limits and monitoring of chemical residues remaining on the single-use device after disinfection;
(i)
limits and monitoring of chemical residues remaining on the single-use device from cleaning agents to ensure these residues do not interact adversely with the disinfectant;
(j)
criteria and/or requirements for approval or rejection.
Drying
Procedures for drying referred to in point (f) of Article 11 shall cover the following, if applicable:
(a)
criteria and/or requirements for the maximum temperature and exposure time;
(b)
specification of the drying agent.
Inspection, maintenance, repair and functionality testing
Procedures for inspection, maintenance, repair and functionality testing referred to in point (g) of Article 11 shall cover the following, if applicable:
(a)
method(s) and performance criteria for inspection;
(b)
method(s) to be used for adjustment, reparation and/or calibration;
(c)
type, amount and method of application of lubricant;
(d)
re-assembly of the single-use device;
(e)
specification of parts that might need to be replaced;
(f)
functionality testing and parameters to be considered for acceptance or rejection.
Packaging
1. Procedures for packaging referred to in point (h) of Article 11 shall cover the following, if applicable:
(a)
material specification;
(b)
compliance with the specific sterilization or disinfection method;
(c)
limits on packaging process parameters, including sealing temperature;
(d)
criteria for acceptance or rejection.
2. The packaging and the instructions for use of the reprocessed single-use device shall not bear the CE mark.
Labelling and provision of instructions for use
1. Reprocessed single-use devices shall bear the word ‘reprocessed’ on their label, as well as the status of the single-use device: ‘disinfected’ or ‘sterilized’, followed by the sterilization method or disinfection method, and shelf life.
2. The name and address of the health institution, and the external reprocessor if applicable, shall be clearly indicated on the label and in the instructions for use of the single-use device.
3. The maximum number of reprocessing cycles allowed and the number of reprocessing cycles performed shall clearly appear on the label.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
