Experts in customised contract testing.Supporting your antimicrobial, biofilm, viral and fungal research.

BIOMED

n Bactericidal agents;

n Sporicidal agents; and

n Fungicidal agents.

5) Contact lenses:

n Antimicrobial polymers;

n Coated contact lenses;

n Duration of antimicrobial activity; and

n Lens cleansers.

6) Non sterile manufacturing:

n Assessment of manufacturing plants;

n Biofilm build up in pipe work; and

n Produce sterility testing.

Historical origin of planktonic testingIn 1884 Robert Koch and Frederich Loeffler described four causativeagents of infectious diseases such as tuberculosis:

1) The pathogen must be present in all cases of the disease;

2) The pathogen can be isolated from the diseased host and grown inpure culture;

3) The pathogen must cause the disease when inoculated into a healthy,susceptible individual; and

4) It must be possible to re-isolate the pathogen from the new host andthe pathogen must be demonstrably the same as the original pathogen.

Although number 1 was abandoned relatively quickly when non-symptomatic disease carriers were discovered, the three remainingpoints persist in microbiological understanding to date. Along withBradford Hill criteria (1965), many of these principles form the basis ofour internationally recognised microbiological test methodologies.

Whilst being designed to represent specific scenarios, and be bothstatistically sound and repeatable in test laboratories around the world,these test methods do not always accurately mimic the intricacies of areal-world scenario, for example, the mixed communities and structuresof micro-organisms that can persist within a chronic wound, a foleycatheter or a swimming pool. The published test methods to date focuson free floating planktonic bacteria whilst science over the last 30 years,largely promoted by Bill Costerton, has progressed to recognise thatpersistent microbial infections are more commonly the result of biofilminfections than planktonic infections.

Focus on providing real-world data to advancecommercial research and developmentWhilst standard test methods have a critical role to play in the approvalof products for consumer and medical use, a deeper understanding of

P erfectus Biomed Limited aims to support companies who produceantimicrobial agents, by producing in vitro data that closely mimicsreal-world scenarios. Our mission is ‘To improve quality of life

through the provision of exceptional customised microbiological services’.Perfectus Biomed supports six key sectors with customised test methodsand specialises in biofilm testing. Our laboratories have ISO 9001 andUKAS 17025 accreditation specifically relating to our biofilm methods,making us the only test house to offer UKAS accredited biofilms methods.Our PhD level researchers design and run studies in six key sectors andhave extensive experience working with a range of product types:1) Wound care:

n Wound dressings;

n Topical antimicrobials;

n Wound irrigation solutions;

n Debridement tools; and

n Negative pressure wound therapy (NPWT).

2) Medical devices:

n Foley catheters;

n Intravenous catheters;

n Inner lumen and outer lumen studies;

n Endoscopes;

n Implantable devices;

n Ventilation devices;

n Plasma devices; and

n Fogging systems.

3) Dentistry:

n Oral care

n Toothpaste;

n Mouthwash;

n Dental floss;

n Dental units

n Dental water lines;

n Probes; and

n Dental equipment.

4) Household care and surface antimicrobials:

n Liquid, mouse and foam formulations for bathroom and kitchen cleaning;

n Liquid, mouse and foam for bathroom and kitchen disinfection;

n Specialised agents for hospital disinfection;

n Antimicrobial wipes;

2

Scientists specialise in modellingreal world scenarios in vitro

perfectusbiomed.com

significance of the biofilm phenotype for a testing laboratory is thatplanktonic-based test methods can considerably over-estimate theefficacy of antimicrobial products. A single bacterial species can berendered 1,000 times less susceptible to an antimicrobial treatment ina biofilm state compared to its planktonic counterparts.

Proven track record of supporting SMEs and blue chipsPerfectus works with a range of microbial companies from SMEs to bluechips with a consistent focus on delivering a tailored service to eachclient. Data generated by Perfectus is used to support research anddevelopment of new products and to support clients in their decisionsregarding formulation differentiation. Support is also provided forregulatory submissions, competitor testing and for product marketing.In order to support the utilisation of this data by companies Perfectusproduces posters, journal articles and present, as an independent bodyat company symposiums.

High quality research environment enables highlyranked researchPerfectus Biomed is located at Cheshire’s prestigious SciTech DaresburyFacility, UK, and, through the Science and Technology Facilities Council(STFC), has world-class technology.

The site team strategically engages with the management team ofbusinesses that move on to site. They utilise their broad network andstrategic partnerships to facilitate connections that maximise potentialbusiness-to-business and business-to-academia collaborations bothwithin the UK, Europe and further afield.

Just 20 minutes’ drive from two international airports with connectionsto over 250 destinations worldwide, including a widespread networkacross Europe and direct connections to the US, the site is ideally located.In addition, it is close to local rail networks and motorways, makingjourneys to and from local cities and London especially easy.

The futureIn order to continually improve the applicability of in vitro testing to thereal world, Perfectus Biomed is developing and validating novel internalmethods and is also expanding to include viral and cell based studies aspart of their unique tailored microbiological services.

our antimicrobial products and medical devices is sought by companiesand consumers alike. Perfectus Biomed specialises in designing,developing, executing and reporting on in vitro studies that more closelymimic real world scenarios than standard planktonic tests. The assayswe perform include single and mixed species biofilm models.

Understanding biofilmsBiofilms are described as a cluster of micro-organisms (single or multispecies) that irreversibly attach to a surface and produce an exopolymericlayer which they live within and beneath. The five key phases of biofilmformation are described below and shown in Fig. 1.

1) Planktonic bacteria receive a trigger, such as a depletion of availablenutrients, and attach to a surface. This initial attachment is reversible;

2) Attachment becomes irreversible. The measure of irreversiblyattached bacteria is regularly used in vitro as an indication of biofilmencased bacteria;

3) An exopolysaccharide (EPS) matrix is produced by the bacteria. Thismatrix contains peptides, polypeptides, sugars and matrixmetalloproteases amongst others. The exact consistency of the matrixis species specific and can be further altered by the microbialpopulation and the environmental conditions;

4) The biofilm matures as further production of the EPS occurs andchannels are developed within the matrix. These channels arethought to transport nutrients to the depths of the biofilm, wasteproducts out of the biofilm and quorum sensing molecules aroundthe biofilm. Within a mature biofilm micro-organisms can undergoa phenotypic change that results in a reduction in metabolic activitywhich renders the organisms less susceptible to an immuneresponse and antimicrobial treatments. In addition there is thepotential for inter- and intra- species transfer of genetic elementswithin the biofilm; and

5) When bacteria within the biofilm become nutrient deficient, thedispersion stage is triggered. Bacteria, that may maintain their biofilmphenotype, are sloughed away from the core biofilm and attachelsewhere to produce a new biofilm matrix.

Living within a biofilm affords bacteria with extra protection from thehost’s immune system and from antimicrobial agents making biofilmencased bacteria less susceptible to antimicrobial treatments. The

3perfectusbiomed.com

Fig. 1 Five stages of biofilm formation

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of wounds that require special treatment. Preventing SSIs requires arange of preventive measures before, during and after surgery. However,these measures vary significantly across the world and it remains achallenge to implement best practice.

One of the simpler preventive measures is the proper and thorough handwashing carried out by healthcare professionals in connection with theexamination and management of a post-operative wound patient. Whilestrict hygienic procedures during surgery are often applied (butunfortunately still regularly shown to be inadequate), the procedures aftersurgery are often not applied according to best practice, thus causing arisk for the patient to develop SSI. According to a WHO report based ona range of SSI rates in low-, middle- and high-income countries, up to31% of patients who undergo surgery will get an SSI.

The WHO campaign poster ‘My 5 Moments for Hand Hygiene – Focuson caring for a patient with a post-operative wound’ advises healthcareprofessionals to wash their hands: 1) Before touching the patient;

2) Before cleaning/aseptic procedure;

3) After body fluid exposure risk;

4) After touching the patient; and

5) After touching patient surroundings.

The ICN-EWMA campaign material included a spin-off posterhighlighting the recommendations for hand washing in connection withthe management of wounds in general, including acute as well as non-healing wounds such as pressure ulcers, diabetic foot ulcers andvenous leg ulcers.

In many healthcare settings with scarce staff resources, or limitedresources in general, as well as many different tasks, it remains achallenge to implement these recommendations for systematic handwashing. According to WHO, 61% of healthcare staff members do notwash their hands at the right times. Even though healthcare staff knowand respect the guidelines, they may neglect to follow these due to theworkload and the number of procedures to be followed. However, currentcampaigns support the need for a common understanding, within ahealthcare setting, of the well-proven fact that respecting therecommendations will in the end reduce the number of adverse eventsand ultimately save patient lives.

A key recommendation in implementation research is the need formanagement support. However, a bottom-up approach to changing

Due to the complex aetiology of most non-healing wounds andthe various medical problems of individuals suffering fromthem, efficient management of these wounds remains a

challenge. In recent years, the over-use of antibiotics and antimicrobialsin the management of acute and non-healing wounds represents anotherchallenge that demands action and clear guidelines for healthcareprofessionals as well as patients and private carers. In 2013 theEuropean Wound Management Association (EWMA) initiated anAntimicrobial Stewardship Programme, aiming to address the problemsrelated specifically to wounds and support the general need for theprevention of infections and the reduced use of antibiotics. Within theframework of this programme EWMA decided to join the World HealthOrganization’s ‘SAVE LIVES: Clean Your Hands’ campaign with a jointprogramme developed together with the International Council of Nurses(ICN) in May 2017. Hand hygiene is a key component of infectionprevention and this includes preventing wound infection.

Campaigning for improved hand hygiene in wound managementAs a strategic approach to supporting the objectives of the association,EWMA continuously evaluates opportunities to engage in collaborationwith societies or individuals that may provide valuable expertise ornetworks to shared causes. One such collaboration is with the ICN on ajoint programme in support of the annual WHO Hand Hygiene Campaign.With this annual campaign, WHO highlights the importance of handhygiene in healthcare, as well as the risks related to insufficient handhygiene. Within wound management, focus is on the prevention of woundinfections in acute wounds and non-healing wounds, as well as the needfor clear guidance on when antibiotic treatment is really needed.

The ICN-EWMA campaign programme included a hand hygieneinformation point and a workshop on hand hygiene held during theEWMA Conference in Amsterdam, the Netherlands, and the ICNConference in Barcelona, Spain, both held in May 2017. While EWMAprovided a campaign focus on the importance of hand hygiene andcorrect use of antibiotics in wound management, ICN emphasised therole of nurses in infection prevention and control. For EWMA, ICNrepresents a very important collaboration partner, due to the largenetwork of nurses and international information sharing systems.

Hand hygiene when dealing with a post-operativewound patientA patient going through surgery is exposed to multiple factorscontributing to the risk of surgical site infection (SSI). As an infectedwound does not heal normally, the surgical site infections fall withinEWMA’s area of interest. EWMA focuses on the more complicated types

6

The EWMA approach

The current and immediate past presidents of the European Wound ManagementAssociation reflect on how best to implement effective wound management

Pan European Networks: H e a l t h 0 2 www.paneuropeannetworks.com/pen-health

activities address the challenges related to the education of wound carespecialists. These include the development of educational curricula inwound management for doctors and nurses to support commoneducational standards in Europe. In this process, the collaboration withorganisations like ICN and the European Union of Medical Specialists(UEMS) is crucial for an efficient implementation. The EWMA Curriculumfor Physicians has already been approved by the UEMS and a recentlyestablished UEMS Federation on Wound Healing is currently working toimplement the curriculum across Europe.

In future years, EWMA hopes to be able to continue the collaborationwith other organisations to increase the quality and impact of theactivities and projects initiated.

cultures within a healthcare setting can also be effective. Nurses play akey role in this as they provide daily care for hospitalised patients as wellas patients cared for in homecare or community care settings. Withinthe joint ICN-EWMA campaign this call for action targeting the nurseswas one of the key messages taken forward by ICN.

Fighting antibiotic resistance – the woundmanagement perspectiveNurses also play a key role in fighting antibiotic resistance, especially withinwound care, as nurses are often responsible for dressing choices and forthe overall wound management. In other countries physicians areresponsible for the treatment choices, while nurses carry out the dailymanagement. The key message aiming to reduce the use of antibiotics inwound management is that this should be avoided as a preventionmeasure. As it is stated in a recent joint position paper by the British Societyfor Antimicrobial Chemotherapy (BSAC) and EWMA, ‘All open wounds willbe colonized with bacteria, but antibiotic therapy is only required for thosethat are clinically infected.’ The paper also recommends that the chosentherapy must always be based on the results of appropriately collectedspecimens for culture, and should always be as narrowly focused, andadministered for the shortest duration, as possible.

As within wound management, the need for interdisciplinary AMS teamsshould be highlighted. These should ideally include specialists in infectionand pharmacy, with input from administrative personnel, the treatingclinicians and their patients.

Supporting cost-effective wound managementCampaigning for the implementation of improved hand hygiene is partof a larger objective to create efficient healthcare systems with a highdegree of patient safety. Within wound care, the efforts to reducehealthcare sector costs have resulted in a transfer of wound care patientsfrom the hospitals to community-based care. This has further stressedthe need to establish clear treatment pathways for wound patients, asnon-healing wounds need a careful diagnostic evaluation, which oftenrequires input from different specialties. Their treatment addresses avariety of underlying factors and usually involves different medicalprofessionals (such as physicians, nurses and physiotherapists). Thebenefit of multidisciplinary interventions for many chronic diseases,including wound care, is well proven. However, actually achieving theestablishment of an interdisciplinary team approach to wound care withinall relevant clinical settings remains a challenge across Europe.

Furthermore, difficulties related to implementing appropriate referralroutes also present an obstacle, as do variations in the level of educationwithin the domain of wound care. This is partly due to the fact that woundmanagement is not defined as an independent speciality for physiciansor nurses. This situation also constitutes a challenge in wound-relatedinfection prevention and control, as the type of healthcare professionalswho are responsible for treatment and management varies significantlyacross the world.

EWMA has addressed some of these challenges in recent publicationsproviding recommendations for establishing interdisciplinary teams inwound management and how to address the challenges related toproviding wound care in a homecare environment. Current EWMA

7www.paneuropeannetworks.com/pen-health Pan European Networks: H e a l t h 0 2

AS A PART OF A NATURAL PROCESS AND WHEN ANTIBIOTICS ARE NOT MANAGED PROPERLY MICROBES DEVELOP RESISTANCE

RESISTANT MICROBES CAN THEN BE SPREAD IF HAND HYGIENE IS NEGLECTED AGAIN

FIGHT ANTIBIOTIC RESISTANCE

IT’S IN YOUR HANDS

INFECTIONS INFECTIONS ARE OFTEN(SOMETIMES UNNECESSARILY)

TREATED WITH ANTIBIOTICS

DID YOU KNOW THAT WASHING

YOUR HANDS IS KEY TO PREVENTING

ANTIBIOTIC RESISTANCE?

NOT WASHING YOUR HANDS COULD LEAD TO:

www.icn.ch www.ewma.org

Based on the ”Fight Antibiotic Resistance – It’s in your hands poster” © World Health Organization 2017

Sue Bale, Dr, FRCN, PhD, BA, RGN, NDN, RHV, PG Dip, Dip NursingPresidentSeverin Läuchli, Priv.-Doz., Dr MedImmediate Past President European Wound Management Association

http://ewma.org/

Reproduced by kind permission of Pan European Networks Ltd, www.paneuropeannetworks.com © Pan European Networks 2017

Perfectus Biomed

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+44(0) 192 586 4838