In order to eliminate gaps in supply chains for hand sanitizers and surface disinfectants, the Federal Institute for Occupational Safety and Health (BAuA) issued a general decree which has been updated several times. This authorizes pharmacies and companies in the pharmaceutical and chemical industry to manufacture biocide products that can be used as hand sanitizers and surface disinfectants. Specialist for hygiene and environmental medicine, Prof. Dr. Günter Kampf, explains what healthcare facilities should keep in mind.
What exactly is the reasoning for the general decrees issued by the Federal Institute for Occupational Safety and Health (BAuA) for the approval of biocidal products for hand sanitizers and surface disinfectants?
Prof. Dr. Günter Kampf: As the competent authority for biocidal products, the BAuA issued a general decree on March 4th 2020 regarding the approval of biocidal products for hygienic hand disinfection, which has been updated three times since it was first issued. The latest version is dated April 9th 2020. Additionally, a general decree on the approval of certain biocidal products for surface disinfection was issued on April 2nd 2020. These general decrees significantly expand the circle of manufacturers of disinfectants for hand sanitizers and surface disinfectants. These products may only be placed on the market for a maximum of 180 days as the biocidal products do not fulfill the conditions laid down in Regulation 528/2012 for granting an approval in the typical way.
Is this also the reason why you recommend that healthcare facilities use approved products from the well-known disinfectant manufacturers wherever possible?
Yes, because the antimicrobial effectiveness of approved, commercially available products for hand sanitizers and surface disinfectants has been extensively tested. Many of these products have been certified by the VAH and the skin compatibility or material compatibility is usually well documented.
How do we know how effective these products are against SARS-CoV-2?
Hand sanitizers and surface disinfectants that have a proven efficacy against enveloped viruses and therefore fulfill the “limited virucidal” efficacy spectrum are to be regarded as generally effective against coronaviruses including SARS-CoV-2.
Recipes for hygienic hand disinfection approved according to the BAuA are also effective against coronaviruses. And yet despite this, you critically evaluate these biocide products for healthcare facilities, why?
For the majority of biocidal products for hygienic hand disinfection mentioned in the general decree, there is no or only a small amount public evidence of efficacy in the form of expert opinions, even if the active substances themselves are mostly well investigated by the manufacturers or in the scientific literature. Based on published data, half of the 8 biocidal products for hygienic hand disinfection from the general decree issued by the Federal Institute for Occupational Safety and Health do not have sufficiently strong bactericidal and levurocidal efficacy within 30 seconds. Three of the formulations must even be applied with 2 x 3 ml over 2 x 30 seconds, which is twice the application time and twice the application volume if you compare it to the majority of commercially available products. On top of this, four of the alcohol-water mixtures from the general decree do not include skin care substances.
What consequences do these shortcomings in the formulations have for the practice with regards to the care of patients?
If these alcohol-water mixtures are frequently used, it is to be expected that employees will suffer from skin irritation. If their skin is irritated, it is less likely that employees will continue to comply with hand hygiene recommendations. This will then increase the patient’s risk of nosocomial infection. Clinics continue to treat critically ill patients whose greatest risk of infection is still bacteria and yeast fungi, and increasingly also multi-resistant bacteria. To prevent the transmission of these germs, employees sanitize their hands up to 60 times per shift. For hand sanitizers to provide reliable antimicrobial effectiveness within 30 seconds as well as having good skin compatibility are of the utmost importance for patient care. In the latest version of the general decree, the biocidal products described above with a lower efficacy within 30 s are therefore only recommended for use outside patient care.
According to the general decree from the Federal Institute for Occupational Safety and Health, four biocidal products should also be considered for hand disinfection in the care of patients in the event of a shortage?
These are two alcohol-water mixtures as well as the modified WHO formulations originally developed by the World Health Organization for countries with limited economic resources to locally manufacture products for the care of patients.
What do you think about biocidal products that are manufactured in accordance with the general decrees from the Federal Institute for Occupational Safety and Health (BAuA) for approval as surface disinfectants?
Biocide products that are temporarily approved by the Federal Institute for Occupational Safety and Health for surface disinfection are based on 80% v/v ethanol, 0.5% w/w sodium hypochlorite or 2.5% w/w chloramine T.
According to the general decree, ethanol can only be used on areas of up to 2 m2 and should be effective over a period of 15 minutes. Therefore, this biocidal product is only suitable for small areas. The manufacturer must also ensure that the ethanol does not contain hazardous impurities. Sodium hypochlorite should only be used against enveloped viruses and should only be applied to non-polluted dry surfaces for 30 minutes.
Aqueous chloramine T solution must also not contain any hazardous impurities and should be effective for over 2 hours. This all means that the practicability and application safety of these three temporarily approved biocidal products must still be critically questioned for routine use on surfaces in the care of patients.
Prof. Dr. Kampf, thank you for speaking with us.
With this decision, the 72nd World Health Assembly simultaneously celebrates the 200th birthday of Florence Nightingale. The British nurse reformed nursing care and was among the first to recognize that nurses could harm patients by spreading infections.
• Nurses: “Clean and safe care starts with you.”
• Midwives “Your hands make all the difference for mothers and babies.”
• Policy makers: “Increase nurse staffing levels to prevent infections and improve quality of care. Create the means to empower nurses and midwives in their tasks”.
• Managers for hygiene and infection control: “Support nurses and midwives in providing hygienic care.”
• Patients and families: “Safer care for you, with you.”
In order for nurses to be able to perform as well as possible in their important role in infection control, they must be protected themselves. Studies show the stresses to which nurses are exposed:
• Contradictory or inconsistent work instructions instead of targeted interprofessional cooperation
• Postponement of tasks: mainly taking over non-nursing activities
• Interprofessional tensions
• Lack of social support from colleagues and superiors (often in large institutions)
• Confronting death, illness and suffering
• Working extremely long hours
• Emotional and psychological strain and stress
On the other hand, the increase in personnel capacities and a more diverse mix of personnel and qualifications, also known as skill-mix teams, has a positive effect.
This means that there is an increase in:
• The quality of care
• Job satisfaction
The following is reduced:
Gill CJ, Gill G. Nightingale in Scutari: her legacy reexamined. Clin Infect Dis. 2005; 40:1799-805 Allegranzi B et al. Infection prevention: laying an essential foundation for quality universal health coverage. Lancet Global Health 2019. 7(6):e698–e700. doi:10.1016/S2214-109X(19)30174-3
Klaus Jacobs / Adelheid Kuhlmey / Stefan Greß / Jürgen Klauber / Antje Schwinger (Hrsg.) Pflege-Report 2016 „Die Pflegenden im Fokus“. Schattauer (Stuttgart) 2016