In accordance with the provisions of Royal Decree 773/1997, the equipment must be certified on the basis of Regulation (EU) 2016/425 on personal protective equipment, which is evidenced by the CE conformity marking. In the case of equipment such as gloves or masks, for example, which are intended for medical use as a preventive measure for the patient, they must be certified as a medical device (MP) in accordance with the provisions of Royal Decree 1591/2009, which regulates them. The same product, used for a dual purpose, must simultaneously comply with both legislations (dual-use gloves or masks). In any case, the general recommendation is to use disposable PPE, or PPE that can be disinfected after each use, as indicated in each case by the manufacturer. PPE must be selected in such a way as to guarantee maximum protection while seeking the minimum discomfort for the user, and it is necessary to choose the size, design or size that adequately adapts to the user. In order to avoid possible routes of entry of the biological agent, it is essential to place them correctly, following the manufacturer's instructions. As important as it is to know the correct placement, it is equally important to know the most appropriate way to remove PPE in order to avoid contact with contaminated areas and/or dispersion of the infectious agent. The following is a description of the PPE indicated in the case of personnel exposed to or in contact with persons with symptoms of the condition, as well as the characteristics or aspects of the same that may be relevant in the work environment in question. The evaluation of the risk of exposure will make it possible to determine the need for the most appropriate type of protection. In order to avoid contagion, any confirmed case and/or case under investigation should wear a surgical mask. In the case of wearing a self-filtering mask, this should not include an exhalation valve since in this case the air would be exhaled directly from the environment without any type of retention, thus favoring the spread of the virus. In the case of surgical masks, these must comply with UNE-EN 14683:2019+AC:2019). The placement of a surgical mask on a person with respiratory symptoms is the first measure of protection for the worker. The respiratory protection generally recommended for healthcare personnel who may be in contact within 2 meters with cases under investigation or confirmed cases is a self-filtering mask type FFP2 or a half-mask with a P2 particulate filter. Self-filtering masks (which must comply with UNE-EN 149:2001 +A1:2009) or, if applicable, the filters used (which must comply with UNE-EN 143:2001) must be discarded after use and must not be reused. Half masks (which must comply with UNE-EN 140:1999) shall be disinfected and cleaned after each use following the recommendations and products indicated by the manufacturer. If after the risk assessment it is found that in the development of the activity, assistance procedures are performed in which bioaerosols can be generated in high concentrations, the use of self-filtering masks against FFP3 particles or half masks provided with a filter against P3 particles is recommended for health personnel. The masks, i.e. respiratory protection equipment, will be removed last, after the removal of other protections such as gloves, gowns, etc. Protective gloves must comply with UNE-EN ISO 374.5:2016. In patient care and laboratory activities, the gloves used are disposable, since the associated tasks require dexterity and do not admit any other type of thicker glove. In cases where less dexterity is required (cleaning tasks, for example), thicker, tear-resistant gloves may be used. Regarding clothing, it is important and necessary to protect the work uniform from possible splashes of biological fluids or secretions from infected patients. To avoid this, the necessary PPE must comply with the UNE-EN 14126:2004 standard, which includes specific tests for resistance to the penetration of microorganisms. Thus, PPE can offer different levels of hermeticity both in their material and in their design, partially covering the body such as gowns, aprons, sleeves, leggings, etc., or the whole body. The designation includes the Type and the letter B (for Biological). In case additional protection is needed in some area, such as some impermeability, chemical protection aprons complying with UNE-UNE-EN 14605:2009 can be used, called Types PB [3] and PB [4] (PB stands for "Partial Body") which, although not specifically for biological protection, may be suitable for the use of splash protection mentioned or to complement a gown that is not a PPE. It is recommended that all protective equipment be disposable, since this way it can be easily disposed of, thus avoiding possible sources of contagion that could arise in the event that the equipment is not correctly disinfected. As mentioned above, PPE must be selected in such a way as to ensure that adequate protection is provided according to the form and level of exposure and that this protection is maintained during the work activity. This is especially important in cases where different PPE must be worn at the same time, as they should not interfere with each other in the individual protective functions of each piece of equipment. For this purpose, the manufacturers' instructions shall be respected both when putting on and removing PPE. In the latter case, it should be taken into account that these protections are probably contaminated and are a source of risk, so that an inadequate removal procedure would cause user exposure. To avoid this, a protocol should be implemented for their placement and removal, which will be controlled by an external user. Personal protective equipment should be put on before starting any activity likely to cause exposure and should be removed only after being out of the exposure area. These PPE, once removed, shall not be deposited on any surface, but shall be disposed of in a container provided for this purpose. WHO information on PPE donning and removal Once the protections have been removed, they should be disposed of in suitable containers or bags and subsequently managed as class III biohazardous waste. In the case of reusable PPE, they must be decontaminated following the method indicated by the manufacturer, this method being validated as effective against the virus and being compatible with the materials of the PPE, so that it is guaranteed not to be damaged and therefore its effectiveness and protection is not compromised. . The main objective is to establish effective systems to ensure proper cleaning and disinfection. Certain bacteria, including some pathogens, can adapt to adverse conditions when they form a biofilm, which are not effectively removed by normal cleaning procedures with neutral soap and water. They become a thousand (1000) times more resistant to common disinfectants compared to those found in a free state. A systematic cleaning routine should be followed for their removal. Cleaning can be accomplished with the individual or combined use of physical methods (such as heat, scrubbing, turbulent flow, vacuum cleaning or other methods that avoid the use of water) and chemical methods using alkaline or acidic detergents. Brushes or disposable wipes - physical methods of removing dirt - can be very effective if properly chosen. If it is necessary to apply more pressure to remove stubborn dirt, the bristles of the brushes may bend, significantly reducing efficiency. In such cases, brushes with stiffer bristles should be used. The same brushes, brooms or sponges should not be used in unprocessed product areas and ready-to-eat product processing areas. Disposable wipes, brushes and brooms should be made of non-absorbent material and used only for the tasks for which they were designed. In this way, cleaning efficiency is optimized, reducing the risk of cross-contamination. Detergents do not act immediately, but need a certain amount of time to penetrate the dirt and loosen it from the surface. One way to simplify this process is to leave the utensils and equipment immersed in suitable containers (tanks or basins). This procedure often significantly reduces the need for manual scrubbing. Obviously, major pieces of equipment and permanent fixtures cannot remain in detergent or bleach solutions. An effective method to increase the contact time on these surfaces is to apply the detergent in foam or gel form or to nebulize it into the environment. All cleaning methods, including foams and soaking tanks, require sufficient contact time to loosen and fully suspend the dirt. The pre-rinse uses water to remove small particles that were not removed in the dry cleaning stage, and wets the surfaces for the application of sodium hypochlorite (bleach). Detergents help loosen dirt and bacterial films and keep them in solution or suspension. During the subsequent rinsing, water is used to remove the cleaning agent and loosen the dirt from the contact surfaces. This process prepares the cleaned surfaces for disinfection. Any cleaning agent must be removed for the disinfecting agent to be effective. Once cleaned, food contact surfaces should be sanitized to eliminate, or at least reduce, pathogenic bacteria. Cleaning and disinfection programs should be continuously and effectively monitored for adequacy and efficiency. They should be documented specifying: Where appropriate, programs should be developed in consultation with specialized advisors. Cleaning and disinfection methods are classified according to the design of the equipment. Those with troughs or pipes are cleaned without disassembling the sections. This process is known as "clean-in-place" or CIP. Closed processing systems are cleaned and sanitized by pumping one or more detergent or sanitizer solutions through the lines and other connected equipment (such as heat exchangers or valves) at set intervals. The dairy industry uses this system to clean and sanitize milk circulation lines. Low foaming detergents are specially prepared and required for CIP applications. When equipment needs to be disassembled for cleaning, it is referred to as a "clean-out-of-place technique", or COP. The operator should have a written cleaning and disinfection program that specifies the areas to be cleaned, the cleaning methods, the person responsible and the frequency of the activity. The document should indicate the procedures required during processing. Detergents help to remove particles and reduce cleaning time and water consumption. In the use of detergents, their instructions should be followed. Many household cleaning products, and others made for intensive hand contact, are indicated for general use and are recommended for painted surfaces. Chlorinated products are usually more aggressive, allowing protein-based or more adherent soiling to be loosened. Especially detergents and substances based on sodium hypochlorite, the main component of common bleach, are recommended for this infection. Chlorinated substances are also alkaline and, because they are corrosive, should not be used on easily corrosive materials (such as aluminum). Although they help in the chemical breakdown of dirt, chlorinated substances are detergents and not disinfectants. In cases where exposure to excessively alkaline or acidic conditions becomes problematic, enzymatic detergents may be an acceptable alternative. Since enzymes are specific for certain types of soiling, these detergents are not as effective as other general purpose detergents. Enzymatic detergents are suitable for soils composed of proteins, fats or carbohydrates. Chlorine and chlorine-based products make up the largest group of sanitizing agents used in food processing establishments, and are also the most common group. Chlorine-based sanitizers are effective against many types of bacteria and fungi, act well at room temperature, tolerate chalky water, and are relatively inexpensive. Household bleach is a solution of sodium hypochlorite, a common form of chlorine. Label instructions should be observed, as not all chlorinated products are acceptable for use in food processing establishments. It is advisable not to mix chlorine bleach and detergent, as this can be hazardous. Other disinfecting agents include ozone, ultraviolet light and hot water. Ozone is an unstable oxidizing gas that must be produced on site where it will be applied. Its cost is relatively high. It is a more aggressive disinfectant than chlorine and requires more careful control to prevent it from releasing excessive levels of toxic gas. Ozone, like chlorine, disappears when it comes into contact with organic materials. It can be injected into water systems as an alternative to chlorine gas. Ultraviolet (UV) irradiation is sometimes used for treatment of water, air or surfaces exposed to UV generating lamps. UV light does not penetrate turbid liquids or beneath film or solid surfaces. It has no residual activity and cannot be applied or pumped into equipment like most chemical disinfectants. If waste is not collected, stored and disposed of properly, it can be a new and dangerous source of infection for others. Avoid cross-contamination as much as possible and minimize the potential for contagion. Waste storage areas require as much attention as process areas in terms of cleaning and disinfection. Containers, tubs and utensils used for garbage collection, waste handling and storage require adequate cleaning and disinfection to avoid possible contagion. The cleaning and sanitizing system should be monitored periodically to verify its efficiency, by means of previous inspections or microbiological analysis of the environment and food contact surfaces. Against Microorganisms: Safety and Protection
Approved protective equipment against infection:
PERSONAL PROTECTIVE EQUIPMENT (PPE):
1. Respiratory protection:
Protective gloves and clothing
2.1 Protective gloves:
2.2 Protective clothing:
Eye and face protection.
Masks:
Placement and removal of PPE.
Waste and decontamination.
Storage and maintenance.
PPE must be stored properly, following the instructions given by the manufacturer, in order to avoid accidental damage or contact with a source of infection. Procedures: Virus cleaning and disinfection
Against infection - Good disinfection practices:
1- Cleaning and disinfection:
a) Cleaning Methods and Procedures
When cleaning and disinfection are required, this generally includes:
b) Cleaning and disinfection programs:
c) Equipment Cleaning and Disinfection
d) Site Cleaning and Disinfection
e) Detergent Substances: Sodium Hypochlorite
For any type of detergent and dirt, cleaning efficiency depends on several basic factors:
f) Disinfecting Agents
e) Waste management
2- Efficiency control
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