Healthcare dispenser regulations around the world

Hospital-acquired infections will remain a challenge for healthcare systems, and healthcare dispensers must be ready to tackle these challenges.

Hand hygiene is the most critical component of preventing infections, and a core component of hand hygiene programs are dispensers, in their limitless iterations. National institutions, such as the Robert Koch Institute (RKI) in Germany, the World Health Organization (WHO), and the Centre for Disease Control (CDC) in the United States, work hard to produce guidelines for hand hygiene and the products affiliated with hand hygiene programs. These guidelines can vary greatly, but share the common goal of reducing infections, and saving lives.

The latest figures on the frequency of nosocomial infections in Germany show that an estimated 500,000 people are infected with a pathogen every year during a hospital stay [1]. The latest data collected by the Robert Koch Institute (RKI) in cooperation with researchers from Berlin and Stockholm, showed that hospital-acquired infections cost Germans 240,000 years in time spent being ill annually. This stunning report ended with a reminder that an improved framework of rules for hand hygiene must be a top priority.

WHO says what?

In the 250-page WHO Guidelines on Hand Hygiene in Health Care, there are four subchapters that focus on dispensers. Due to its global approach, however, the WHO does not commit itself to specifically endorsing one type of system over another. Dispensers more suited for developing nations are still regarded as acceptable. Since the guideline is now more than ten years old, some of its views are considered outdated. This pertains in particular to the subcategory concerning touch free dispensers, where the WHO describes them as “aesthetically appealing” and originating from non-medical settings. It goes on to bemoan their maintenance issues, lack of standardized, open-formats, and the lack of evidence supporting their use. These issues have all been addressed in the last 10 years, and do not represent the current state of hygiene recommendations.

The WHO also mentions clip-on dispensers, table-top dispensers, and wall-mounted dispensers. For wall-mounted dispensers the WHO recommends Euro Bottle systems in order to ensure independence from manufacturers, drip trays to prevent injury, elbow-operation, and mounting solutions at the point of care.

Electronic hand hygiene monitoring systems are briefly mentioned. Though in 2009 the WHO did not have enough evidence to understand how impactful these tools were, the organization already foresaw the potential to improve hygiene behavior with data.

Germany – The Origin of the Euro Bottle

The procedures which hospitals and clinics in Germany should follow in order to avoid nosocomial infections is legally regulated by the Infection Protection Act (IfSG). [2] According to the IfSG, medical institutions are required to fight infections and pathogens using state-of-the-art methods accepted in medical science. The IfSG then goes on to crown the Commission for Hospital Hygiene and Infection Prevention at the RKI (KRINKO), as the organization that defines what state-of-the-art means.

With the increasing evidence that hand hygiene is the most important method of infection prevention, the KRINKO decided to significantly expanded its recommendations on hand hygiene in 2016. The guideline grew from 4 pages in 2000 to 32 pages, and is one of the Commission’s most comprehensive recommendations. [3]

While the earlier version of KRINKO recommendations had no category dedicated to dispensers, the latest version dedicates an entire chapter – 7 — to delivering a detailed description of the requirements that a healthcare dispenser must be able to fulfill.

Like the WHO, KRINKO offers strong support for dispensers that use a standardized bottle system like the Euro Bottle, which is not tied to specific manufacturers of soaps and sanitizers. The KRINKO outlines that this mitigates the threat of supply shortages during pandemics, and offers significant economic advantages to healthcare facilities. When discussing standardized, open-source dispensers, the KRINKO also clarifies that refillable dispensers are not an acceptable solution in healthcare settings. A new bottle is to be inserted each time a dispenser is emptied.

The KRINKO differs greatly from the WHO when it comes to the touchless vs. manual dispenser debate. The RKI clearly positions itself as a staunch supporter of automatic dispenser systems. It argues that no touch dispensers reduce cross-contamination, and they demonstrably improve hand hygiene compliance.

In Chapter 7, the KRINKO also defines the need for reprocessing (medical cleaning) of dispensers. Here it says that soap dispensers are more critical than disinfectant dispensers, but both must be cleaned in regular intervals. Due to the high cost of regular reprocessing of dispensers, the KRINKO also recommends the use of disposable pumps as an inexpensive alternative. 

Finally, the KRINKO also takes a favarouable stance, on electronic hand hygiene monitoring systems, stating that they can be used to increase hand hygiene compliance.

DGKH

The German Society for Hospital Hygiene (DGKH), is another medical society dedicated to the prevention and control of infectious diseases. (DGKH) regularly publishes standard operating procedures, recommendations and statements on issues relating to hospital hygiene. The DGKH published a recommendation for dispensing requirements in 2011, which closely mirrors that of the KRINKO [5] Here, Euro Bottle systems are promoted, refillable systems are discouraged, and electronic hand hygiene monitoring systems are considered a best-in-class solution. Where the DGKH differs, is in stronger wording for supporting the use of single-use pumps to prevent contamination in dispensers. Here, little differentiation is made between soap and disinfectant dispensers.

Hopping over the boarder

Though Germany’s hygiene regulations for healthcare could be viewed as the most comprehensive in the world, other European nations are developing their own guidelines. In the Netherlands the National Health Institution (RVIM) has created a working group for infection prevention that publishes regular recommendations. Most recently, the group stated that dispensers should be operated with the elbow to avoid cross-contamination.

In France, the Recommendations pour l’hygiène des mains supports medical institutions with questions concerning hospital hygiene. Other countries in Europe do not have their own regulatory hygiene in healthcare body, and have simply opted to use a translated version of the WHO recommendations from 2009. This is done in the Czech Republic and Poland, for example.

Across the Pond

Finally, we look at the world’s largest healthcare system. About 1.7 million people suffer hospital-acquired infections every year in the United States. Many of these can be prevented with better hand hygiene programs. In 2002, the Centers for Disease Control and Prevention (CDC) published a comprehensive guideline entitled, The Guideline for Hand Hygiene in Health-Care Settings. [9] This document describes two essential hygiene aspects of choosing a dispensing system. Firstly, the CDC recommends that users take the time to carefully evaluate several soap or hand disinfectant dispensers before purchasing. Needs can vary based on the type of facility. Secondly, the CDC advises against the use of refillable soap dispensers. Specifically the practice of “topping off” should be prevented. The CDC points out that this practice can lead to contamination of the contents in the dispenser, and eventually become a source of infection.  

The Public Health Agency of Canada (PHAC), also publishes guidelines on best hand hygiene practices. [10] The guidelines show eight points that should be taken into account when selecting and using a dispenser – many of which mirror the points above. The guidelines also point out that the dispensers should be placed in the immediate vicinity of the patient – as close as possible to the point of care. This has been proven to have a positive effect on hand hygiene compliance. The potential to lock dispensers in order to prevent illicit consumption of alcohol-based disinfectants is also encouraged.

Conclusion

Though many countries differ in how they approach infections in healthcare, the trend is clear, that guidelines will only become stricter in the coming years. No matter if the recommendations you follow are based on the WHO, KRINKO or the CDC, OPHARDT Hygiene has professional hygiene solutions that will help you Break the Chain of Infection. Learn more at www.ophardt.com.

Sources:

[1] Zacher, Benedikt, et al. “Application of a new methodology and R package reveals a high burden of healthcare-associated infections (HAI) in Germany compared to the average in the European Union/European Economic Area, 2011 to 2012.” Eurosurveillance 24.46 (2019): 1900135.

[2] Gesetz zur Verhütung und Bekämpfung von Infektionskrankheiten. “Infektionsschutzgesetz (IfSG).” Bundesgestzblatt 2000 (2000): 1045-1077.

[3] Kommission für Krankenhaushygiene und Infektionsprävention beim Robert Koch-Insitut “Händehygiene in Einrichtungen des Gesundheitswesens.” Bundesgesundheitsblatt-Gesundheitsforschung-Gesundheitsschutz 9 (2016): 1189.

[4] AWMF Händedesinfektion und Händehygiene. “Empfehlung des Arbeitskreises „Krankenhaus-und Praxishygiene “der AWMF für Einrichtungen des Gesundheitswesens zur Formulierung von Regeln zur Händehygiene–AWMF-Register-Nr. 029/027. Hyg Med. 2008; 33 (7/8): 300-13.”

[5] Assadian, Ojan, et al. “Empfehlung zu Anforderungen an Seifen-und Händedesinfektionsmittelspender in Einrichtungen des Gesundheitswesens.” Hygiene und Medizin 36.10 (2011): 407.

[6] Infectiepreventie, Werkgroep. “Handhygiëne medewerkers ziekenhuizen.” (2007).

[7] Societe Francaise d’Hygiene Hospitalière “Recommandations pour l’hygiène des mains.” (2002).

[8] World Health Organization. “WHO guidelines on hand hygiene in health care.” http://whqlibdoc. who. int/publications/2009/9789241597906_eng. pdf (2009).

[9] Boyce, John M., and Didier Pittet. “Guideline for hand hygiene in health-care settings: recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force.” Infection Control & Hospital Epidemiology 23.S12 (2002): S3-S40.

[10] Canada.Public Health Agency of Canada. Infectious Disease and Emergency Preparedness Branch “Hand hygiene practices in healthcare settings”