BIOFILMS 6: Biofilms in Medical Devices and Impact

In earlier discussions in this series, biofilms and how they come about were introduced. Overview of the risk and impact in food, restauration, human wellbeing as well as control measures were also provided 

In this part, we provide information on biofilms and potential threat to an important aspect of healthcare delivery, the use of medical devices to treat disease conditions and / or improve patient wellbeing as in daily diagnosis, cardiac malfunction, kidney conditions, etc.

What is a medical device?

• any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:  — diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, 
• diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
• investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, 
• providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. The following products shall also be deemed to be medical devices
•  devices for the control or support of conception,
• products specifically intended for the cleaning, disinfection or sterilisation of devices …

In daily healthcare experience in hospitals, health clinics, healthcare centres, at the dental centres and eye clinics, the variety available may range from relatively uncomplicated to the very complex ones, which may be seen without particular notice.

They include, among many, bandages for dressing wounds, stethoscopes, catheters, transfusion equipment, stethoscopes, injection needles, surgical aides and equipment, dentures, pacemakers, defibrillators, artificial body parts (limbs, bone parts, etc.) large and expensive healthcare equipment such as X-Ray machines and dialysis machines, etc. all of which could be contaminated by microbes and form potential growth sites for biofilms if adequate care is not in place.

Importantly, all medical devices directly or indirectly come in contact with patients to diagnose and treat a medical condition and improve wellbeing. It may contribute to the process and task of delivering better treatment and wellbeing such as an healthcare optimisation and delivery computer software.

Medical Devices

Electronic medical diagnostic stethoscope

St John Ambulance Dual Headed Stethoscope

Catheters are tunnelled under the skin with the opening being external. They can last and function for a long time provided the they are very well cared for on the external parts and the skin around them to avoid microbial contamination, potential development of infection including biofilms, which can be complicated in certain cases depending on location on the body, type of microbes and other factors.

Hip and / or groin and spinal replacement surgery is an area of particular attention and care to prevent infection

So also, is spinal cord treatment with external bodies or objects including metals and their alloys

A Haemodialysis machine: the complexity of the machine means that a robust contamination prevention practice must be in place to stop microbes taking hold and causing infections.

Microbes Identified from Different Types of Medical Devices

Pathogens Associated with Cardiac Implantable Electronic Devices (CIED) Infection (Saliba, E. et al. 2016).

The prevalence of in infection is very variable. Staphylococcus aureus and S. epidermidis infections were most prevalent particularly at the early stage. Methicillin Resistance Staphylococcus aureus (MRSA) infection occurs but rarely.

References

1. Ahsan, S. Y. Saberwal, B. Lambiase, P. D. et al. (2014) A simple infection-control protocol to reduce serious cardiac device infections. Europace. 2014;16(10):1482–1489
2. American Cancer Society – Catheters adapted from: https://www.cancer.org/treatment/treatments-and-side-effects/central-venous-catheters.html
3. Durante-Mangoni, E. Mattucci, I. Agrusta, F. Tripodi, M. F. Utili, R. (2013) Current trends in the management of cardiac implantable electronic device (CIED) infections. Intern Emerg Med. 2013;8(6): 465–476
4. Lekkerkerker, J. C. van Nieuwkoop, C. Trines, S. A. et al. (2009) Risk factors and time delay associated with cardiac device infections: Leiden device registry. Heart. 2009;95(9):715–720.
5. Medical Devices Regulation (MDR) 2017/745/EU amends Medical Devices Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
6. Padeletti, L. Mascioli, G. Perini, A. P. et al. (2011) Critical appraisal of cardiac implantable electronic devices: complications and management. Med Devices (Auckl). 2011; 4:157–167
7. Sandoe, J.A. Barlow, G. Chambers, J.B. et al. Guidelines for the diagnosis, prevention and management of implantable cardiac electronic device infection. Report of a joint Working Party project on behalf of the British Society for Antimicrobial Chemotherapy (BSAC, host organization), British Heart Rhythm Society (BHRS), British Cardiovascular Society (BCS), British Heart Valve Society (BHVS) and British Society for Echocardiography (BSE). J. Antimicrob Chemother. 2015;70(2):325–359
8. Sohail, M.R. Henrikson, C.A. Braid-Forbes, M.J. Forbes, K.F. Lerner, D.J. (2011) Mortality and cost associated with cardiovascular implantable electronic device infections. Arch Intern Med. 2011;171(20):1821–1828
9. Spinal cord adapted from Wikipedia: https://en.wikipedia.org/wiki/Spinal_cord#/media/File:Diagram_of_the_spinal_cord_CRUK_046.svg
10. Surrey Orthopaedic Clinic: Hip and groin adapted from http://www.surreyorthopaedicclinic.com/conditions?gclid=EAIaIQobChMIlY-rv9r63wIVxJTVCh19wARYEAAYAyAAEgL7t_D_BwE
11. Viola, G.M. Awan, and L. L. Darouiche, R. O. (2010) Nonstaphylococcal infections of cardiac implantable electronic devices. Circulation. 2010;121(19):2085–2091
12. Welch, M. Uslan, D.Z. Greenspon, A.J. et al. (2014) Variability in clinical features of early versus late cardiovascular implantable electronic device pocket infections. Pacing Clin Electrophysiol. 2014;37(8):955–962

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