Imagine yourself lying on the surgical table about to undergo a surgery in the hands of one of the finest professionals in medicine. Now think about invisible threats that may lie on the hands of the surgeon who is going to cure your ailments. Even the most skillful surgeons may carry bacteria on their hands which can lead to infection during the surgical procedures. Use of surgical hand disinfectants can prevent such infections but these disinfectants must be tested as per international standards for their effectiveness. Surgical hand disinfectants test conducted as per EN 12791 proves the efficacy of disinfectants for ensuring sterility of surgical hands. 

Let’s uncover the details of this important standard and why it is a cornerstone of modern medical hygiene.

Overview of EN 12791

EN 12791 is a European Standard that defines the requirements for testing the efficacy of surgical hand disinfectants meant to minimize microbial flora on the hands of healthcare workers. This would be helpful in avoiding the spread of infectious agents during surgical contacts. That is particularly important in hospitals, institutions for dental care, community healthcare and also non-medical areas like kitchens and laundries which do serve medical institutions.

EN 12791 specifies the requirements and test methods for evaluating the efficacy of surgical hand rubs and washes. This surgical hand disinfectants test is a Phase 2 Step 2 test method, which involves the simulation of practical conditions to ensure that disinfection products reduce both transient and resident microbial flora on the hands.

Test Methodology

The EN 12791 test method evaluates the effectiveness of surgical hand disinfection products. The main objective is to establish the reduction in the number of microorganisms from artificially contaminated hands immediately after the application of disinfectant and re-growth during a three-hour period. This is achieved by comparing the microbial counts before and after the application of the hand disinfectant.

Key Parameters

Several parameters are critical in the evaluation of a product under EN 12791, including:

• Test Organism: Volunteer hands’ natural microbial flora are used instead of using a specified test organism.

• Neutralizer: A validated neutralizer is applied to recover the test organisms after the handwash or handrub procedure thus ensuring that the activity of the disinfectant is suppressed.

• Contact Time: The contact time of the disinfectant should be 60 seconds to 5 minutes and preferably, as stipulated by the manufacturer. In the surgical hand disinfectants test, the reference product—a propan-1-ol —is tested for 3 minutes. 

• Temperature: The EN 12791 test for surgical hand disinfectants is performed under controlled conditions typically at 20°C to ensure consistency in results.

• Incubation: Samples taken from the volunteers’ hands are incubated after disinfection. The incubation allows bacteria that remain on hands to grow which can be counted.

Test Procedure

The procedure involves several steps to ensure accurate and reliable results:

• Preparatory Handwash: Volunteers first undergo a preparatory hand wash to remove most transient microorganisms and any foreign material that may affect the test results.

• Sampling of Resident Flora: Before applying the hand disinfectant the volunteers’ hands are sampled to determine the baseline number of microorganisms.

• Application of Hand Disinfectant: The disinfectant is then applied by the volunteers according to the instructions provided by the manufacturer so that they completely cover their hands with the product. This can be achieved by rubbing or washing for specific contact time as required by the surgical hand disinfectants test method.

• Post-Treatment Sampling: Following application of the disinfectant, volunteers’ hands are sampled immediately and again at three hours to determine the reduction in the microbial count.

Test Results and Acceptance Criteria

To be considered effective as per EN 12791 standard, the product must demonstrate an immediate reduction in microbial flora, followed by sustained efficacy three hours later. For a disinfectant to be considered effective, we should check:

• Immediate Effect: The product must achieve greater microbial reduction than the reference product (60% propan-1-ol), as per the surgical hand disinfectants test standards.

• Three-Hour Effect: The product tested using EN 12791 test methods must also demonstrate sustained effectiveness, with microbial reduction superior to the reference product three hours after application.

Products are considered suitable for surgical hand disinfection if they meet the criteria listed under standard EN 12791. Additionally, the methodology must be validated and results should be statistically significant.

Importance of EN 12791 in Healthcare

There is a critical contribution made by the EN 12791 standard to patient safety during surgical procedures. Proper hand disinfection of the surgeon will prevent health-associated infections (HAIs), potentially leading to serious complications and even death. EN 12791 provides guidelines for surgical hand disinfectants test procedures to ensure the effectiveness and safety of hand disinfectants used in healthcare, thereby reducing the risk of infection.

Apart from ensuring that the patients are safe, surgical hand disinfectants also contribute to supporting the integrity of the healthcare setting. By ensuring the efficacy of products used during surgical hand disinfection, the standard contributes to general infection control processes. It notably helps reduce the spread of pathogenic microorganisms inside hospitals and other healthcare settings.

Application Beyond Healthcare

Although the EN 12791 surgical hand disinfectants test is primarily applicable to products used in healthcare facilities, its procedures can also be used for products used in other industries where hygiene is a priority. Food processing industries, pharmaceutical production facilities and cosmetic laboratories can benefit from using surgical hand disinfectants tested under EN 12791. The industries can therefore mitigate contamination risks and guarantee their consumers’ safety by adopting such rigorous disinfection procedures.

EN 12791 is one of the most significant standards meant to ensure effective surgical hand disinfection. The standard provides detailed test procedures and requirements for testing the efficacy of disinfectants to ensure that both patients and healthcare professionals are protected from surgical infections. The surgical hand disinfectants meeting the requirements of the EN 12791 test standard, have proven efficacy for reducing microbial flora from the hands thus establishing a reliable solution to maintain hand hygiene in crucial environments.

For laboratories and healthcare institutions seeking to validate their hand disinfectant products Microbe Investigations Switzerland (MIS) offers comprehensive testing services. Partner with MIS to ensure your products meet the stringent criteria required to pass the EN 12791 surgical hand disinfectants test , contributing to safer healthcare environments. Contact us today to learn more about our testing and validation services.