Journal of Perioperative Practice PROCUREMENT GUIDE March 2013 by Open Box Media & Communications

Journal of Perioperative Practice

PROCUREMENT GUIDE March 2013 Volume 02 Issue 01 www.afpp.org.uk

01423 881300 www.afpp.org.uk

Journal of Perioperative Practice PROCUREMENT GUIDE March 2013 Volume 02 Issue 01 www.afpp.org.uk

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Journal of Perioperative Practice PROCUREMENT GUIDE March 2013 Volume 02 Issue 01 www.afpp.org.uk

Contents

Welcome to your March 2013 Guide 04

Education and medical device usage in collaboration

A practical approach to OR efficiency

A critical guideline appraisal overview: CPFF 01-01 Part A

News

Product News

Journal of Perioperative Practice Procurement Guide information In print within the AfPP Journal of Perioperative Practice covering national AfPP members, but also with a dedicated print and e-distribution to supplies and purchasing managers. Key Sectors: NHS Supply Chain, Independent Hospitals, Higher Education. Medical Device Companies. Published 6 times a year we will focus on procurement issues in every edition as well as specialist subjects which for the following year include:

May 2013 Laparoscopic surgery July/August 2013 Infection prevention September 2013 Airway management November 2013 Safety January 2014 Recovery

Contact Information: Advertising, Sponsorship & Partner Packages. Frances Murphy Account Manager Open Box M&C T: 0121 200 7820 E: francesmurphy60@yahoo.com Editorial Chris Wiles Head of Publishing / Editorial AfPP T: 01423 882950 E: chris.wiles@afpp.org.uk

PR & press material. All press releases welcome and we will feature as many as we can in each issue, all press releases need to be submitted to: Frances Murphy Account Manager Open Box M&C T: 0121 200 7820 E: francesmurphy60@yahoo.com

Journal of Perioperative Practice PROCUREMENT GUIDE March 2013 Volume 02 Issue 01 www.afpp.org.uk

Education and medical device usage in collaboration A fleeting glance around an operating theatre, anaesthetic room or indeed any clinical environment will quickly highlight the importance and often, reliance on medical devices within healthcare. Not only do they assist in ensuring that the patient experience is as safe as possible, for many nurses and operating department practitioners (ODPs), they also make the stresses of each day that much easier by contributing to the overall quality of care delivered to patients.

Medical Devices For any medical device to be used safely, appropriate education and training must be provided, and practitioners have a duty within their professional codes of practice to ensure that their knowledge is developed and maintained as appropriate to the role they are undertaking. Late 2012 saw the publication of ‘Compassion in Practice’ (DH 2012), which is set to have a huge impact around how care is delivered. Although many will argue that this document will affect frontline areas, such as wards, assessment units and accident and emergency departments more, perioperative environments will also be encompassed within the vision set out.

The right skills

Action area five speaks of the importance of “ensuring we have the right staff, with the right skills, in the right place” and as such, mandatory training will assist in driving forward a workforce that has the skills required to deliver the care required within each care environment.

In many trusts, medical device teaching forms part of the mandatory training package as devices such as infusion and syringe pumps are widely used, with the potential to cause significant harm to a patient if used incorrectly or inappropriately. The way in which such education is delivered also varies greatly, with sessions being delivered in a clinical setting, classroom environment and also via e-learning, which is becoming an increasingly viable option, particularly if staffing numbers make leaving the operating theatre department difficult. As a former Medical Device Educator, my personal feeling is that there is no substitution for medical device education via a ‘hands-on’ approach. Experiential learning enables the student to practice in a safe, controlled environment, ask questions and ensure that they have the confidence to use the device in the clinical area. E-learning packages, whilst they certainly have their place within the sphere of education, are not best suited to practical subject areas.

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Patient Warming

Journal of Perioperative Practice PROCUREMENT GUIDE March 2013 Volume 02 Issue 01 www.afpp.org.uk

Product manufacturers can, and will often provide a valuable source of education and training. Education packages are often negotiated at the outset when a new infusion device is being sourced, and this is especially useful if a large number of staff require training in a short timeframe. Clinical support staff are also widely employed and are available to provide advice and guidance to perioperative teams within the local area. With a vast range of devices in use, an approach that is being adopted by many areas is to have ‘super-users’. These staff are trained to a higher level than other colleagues on a particular piece of equipment and act as both the local trainer as well as the ‘trouble shooter’. These practitioners are then able to keep themselves fully up to date around the equipment

Medical Devices Experiential learning enables the student to practice in a safe, controlled environment, ask questions and ensure that they have the confidence to use the device in the clinical area. E-learning packages, whilst having their place within the sphere of education, are not best suited to practical subject areas.

they are responsible for, and also liaise with the manufacturer and electrical and biomedical engineering (EBME) department around any technical difficulty or specification requirements. New or updated information around such equipment can then be cascaded locally or widely using opportunities such as clinical audit sessions.

Funding for training will no doubt continue to be a contentious issue, however the importance of delivering high quality standards of care to our patients will remain a constant – patient safety is a mainstay of healthcare in the modern day and as such, we all have a responsibility to maintain our knowledge and skills to the highest standard possible.

The importance of medical device education is supported by various professional bodies and regulatory agencies. In 2010 the NHS Litigation Authority (NHSLA 2010) reported that between 1995 and 2010, a total of 5489 claims were made in relation to medical devices, with costs to the NHS of £76.9 million. Whilst not all relating to the operating theatre environment the number of claims is staggering and easily reduced with a programme of robust training.

Darren Brand Medical Devices Educator/ Part-time Specialist Theatre Practitioner, St Leonards on Sea

In times of staff shortages or financial difficulty, training is frequently the victim of short term restrictions or cuts, yet in the long term, this is a backward step. By having a workforce that is highly trained, the standard of care by definition will be of a greater quality and assist in ensuring that feedback provided by the patient is positive – something that will be of particular importance with the imminent arrival of the mandatory ‘Friends and Family Test’ (DH 2012). Practice educators have a huge role to play in ensuring that the staff they are responsible for are trained to the standard required to undertake their job both safely and effectively. In areas where a post is not funded, the responsibility for education and training specific to role sits jointly between employee and line manager.

References: Commissioning Board Chief Nursing Officer and DH Chief Nursing Adviser 2012 Compassion in Practice [Online] www.commissioningboard.nhs. uk/files/2012/12/compassion-inpractice.pdf [Accessed January 2013] Department of Health 2012 The NHS Friends and Family Test Available from https://www. wp.dh.gov.uk/publications/ files/2012/10/NHS-Friends-andFamily-Test-ImplementationGuidance-v2.pdf [Accessed January 2013] NHS Litigation Authority 2010 Claims related to medical devices and equipment Available from www.nhsla.com/NR/ rdonlyres/709B7CAF-3D6A425D-BEEB-7557425C60CE/0/ ClaimsRelatedtoMedicalDevices andEquipment.pdf [Accessed January 2013]

Journal of Perioperative Practice PROCUREMENT GUIDE March 2013 Volume 02 Issue 01 www.afpp.org.uk

Patient Warming

Journal of Perioperative Practice PROCUREMENT GUIDE March 2013 Volume 02 Issue 01 www.afpp.org.uk

Recovery

Journal of Perioperative Practice PROCUREMENT GUIDE March 2013 Volume 02 Issue 01 www.afpp.org.uk

Procedure Trays

A practical approach to OR efficiency Switching to customised procedure trays in Ramsay Health Care Hospitals

With the current climate in healthcare demanding a difficult juggling act between the apparently opposing forces of financial restriction and wider provision of superior care, efficiency is the buzzword. Given that operating rooms account for as much as 40% of hospital costs (Greiling 2011) it’s no surprise that operating room (OR) efficiency has come under the spotlight, but whilst the need for OR efficiency is clear, how does it work in practice? Ramsay Health Care’s patient focused approach is built on a culture of continued improvement; in the operating room, any savings that can be made in time or costs allow procedures to be completed more efficiently and in greater numbers. In 2011, after feedback from clinical staff highlighted issues with the generic surgical trays being used, Ramsay Health Care began to assess the cost and efficiency savings that could be achieved through the use of procedure and site specific surgical trays. Despite initial resistance over apparent higher costs of the procedure specific trays, the project has yielded impressive results. Surgical procedures in Ramsay Health Care hospitals were originally performed using a combination of surgeon specific trays and individually packaged components, but with so many procedures being performed, set-up and re-stocking required a significant investment of time by clinical staff and presented

an ideal opportunity to improve efficiency. Early measures to ensure OR efficiency saw the adoption of generic trays nationwide, but it was soon recognized that they were unsuitable for all hospitals. The generic trays solved issues surrounding set-up time and stock availability, but created new inefficiencies around component wastage and requirements for additional components: some items in the trays were unused and additional missing components were added. The group’s hospitals started to examine alternatives to the generic trays and while procedure specific trays were initially dismissed on the grounds of increased cost, the need for more tailored trays was recognised by procurement.

A case study on the adoption of procedure specific trays at the NHS Royal Liverpool and Broadgreen University hospitals (NHS Sustainable Development Unit 2012) highlighted the benefits and provided the catalyst for change. With requests from clinical staff backed up by the promise of time and component wastage savings that would translate to real cost savings, Ramsay Health Care’s procurement department took a closer look at procedure specific trays from M lnlycke Health Care (ProcedurePak® customised procedure trays). The companies worked together to measure and analyze surgical procedures at eight of Ramsay’s hospitals. They recorded the components added to existing trays by surgical teams and those components left unused and discarded. This allowed the true cost of the existing generic trays to be calculated, the amount of component wastage to be quantified and ensured that the customised procedure trays to be supplied by M lnlycke Health Care would meet the clinical requirements of the surgical teams and deliver the cost savings expected by procurement. With promising results from the research phase, ProcedurePak® customised procedure trays were introduced in the eight pilot hospitals and reaction

from a clinical perspective was entirely positive. “We welcomed the introduction of the customised procedure trays. Using these trays has allowed us to save time during set-up, spend more time with the patient in the operating room and ultimately to complete more procedures. Before a typical joint replacement procedure we used to spend up to 30 minutes unwrapping and checking all of the individually packaged components. With ProcedurePak® customised trays this is reduced to about 10 minutes. We have seen a dramatic reduction in component wastage. We would discard as many as 20 items for each procedure when using generic trays, along with a considerable amount of packaging waste from the additional individually packaged items we added. Working with M lnlycke Health Care to tailor the contents, we now have single packs with the components we really need.” Pat Flood, Orthopaedic Sister, Rivers Hospital. Alongside support to the clinical staff, M lnlycke Health Care worked with Ramsay and their distributor to ensure full utilisation of trays and provide assistance to hospitals with forecasting and ordering. Forecasting monthly tray stock requirements is a more complicated process with

Journal of Perioperative Practice PROCUREMENT GUIDE March 2013 Volume 02 Issue 01 www.afpp.org.uk

customised trays than with generic, and M lnlycke Health Care have been working more closely with individual sites to ensure continued supply and appropriate orders. This supply chain optimization now includes the adoption of lean management processes and reduced inventories, and this start-tofinish approach allows efficiency to be maximised throughout. The project can already be considered a highly successful collaboration and a fine example of operating room efficiency. Cost savings from component wastage reduction alone at the eight Ramsay Health Care hospitals are estimated to be approximately £47,000. Though undoubtedly impressive, cost savings are not the only benefit of wastage reduction and it’s unsurprising to find that a wider commitment to waste reduction and

Procedure Trays sustainability is demonstrated by both Ramsay Health Care (one of the top 100 most sustainable global corporations) and M lnlycke Health Care in all areas of their businesses. “The range of benefits from the switch to procedure specific trays in addition to the commercial gains already identified includes, reduced set up time for surgery, reduced time for surgical roster completion, improved inventory management, lean supply and logistics solutions and improved staff morale. While time savings from the adoption of procedure specific trays have yet to be calculated, if they match those seen elsewhere (Greiling 2010), the benefits to both staff workload and surgery throughput will continue to add up to even greater OR efficiency.” Lucy Sweeney MCIPS Category Lead - Core Consumables & Implants, Ramsay Health Care.

The success of the switch to procedure specific trays in the first wave of Ramsay Health Care’s hospitals is such that it was extended to a further nine of the group’s hospitals in the second half of 2012. The project has touched all stakeholders in and around the operating room from patients through clinical staff to hospital managers and procurement teams; all have benefited from a straightforward change to working practice. From this successful start, Ramsay and M lnlycke Health Care are continuing to work together to identify other areas in which practical changes can be implemented to maximise OR efficiency. For further information please contact: Andreas Normén Global Marketing Manager Trays andreas.normen@molnlycke.com (+ 46 31 722 3428)

Angela Evans Head of Public Affairs and Media angela.evans1@ramsayhealth.co.uk (0207 847 2877) References Greiling M 2010 A multinational case study to evaluate and quantify time-saving by using custom procedure trays for operating room efficiency Data presented at European Association of Hospital Managers (poster) Greiling M 2011 More than Time and Money; Defining Operating Room Efficiency EHospital 5:20-21 NHS Sustainable Development Unit 2012 Waste Case Study: Royal Liverpool & Broadgreen University Hospitals Available from: www.sdu.nhs.uk/ documents/case_study/ Royal_Liverpool_Broadgreen.pdf [Accessed September 2012]

Journal of Perioperative Practice PROCUREMENT GUIDE March 2013 Volume 02 Issue 01 www.afpp.org.uk

Patient Warming

Journal of Perioperative Practice PROCUREMENT GUIDE March 2013 Volume 02 Issue 01 www.afpp.org.uk

Recovery

Journal of Perioperative Practice PROCUREMENT GUIDE March 2013 Volume 02 Issue 01 www.afpp.org.uk

CFPP 01-01

A critical guideline appraisal overview Choice Framework for local Policy and Procedures (CFPP) 0101: Management and decontamination of surgical instruments (medical devices) used in acute care. Part A: The formulation of local policy and choices manual Version 1.0: England Efficient decontamination of reusable invasive surgical instruments (medical devices) endeavours to eliminate inadvertent transmission of disease by infectious agents and human prions. Although there are several pertinent regulatory British, European and international decontamination standards to adhere to, the Department of Health (DH) is now emphasising the need for individual departments to be proactive in the local decisionmaking processes, with the aim of improving patient experience in line with health policy direction and support. The following aims to address some of the questions that many nursing and allied health professionals may want to be answered in relation to Part A of this series. What does the CFPP series relate to? There are five documents in total: Part A covers a local policy and management approach, and discusses the choices available in support of local policy development. Part B covers common elements of reprocessing i.e. test equipment and materials, design and pre-purchasing, validation and verification. Part C covers steam sterilisation standards and guidance. Part D covers washer-disinfectors standards and guidance. Part E covers low temperature (non-steam) sterilisation standards and guidance. Where is the CFPP series available from? The five guidelines are readily

In particular: • Health and Social Care Act 2008 (DH 2008) • Health and Social Care Act 2012 (DH 2012b) • NICE IPG 196 2006 (NICE 2006) • Various studies that relate to: moist environment for surgical instruments; inactivation of human prions disease transmission and detection; instrument segregation; single instruments and instrument tray tracking and tracing; dropped instruments or compromised sterility of instruments during operative procedures; loan sets and repairs, and staffing roles. Does the guideline link to the underlying evidence outlined in each recommendation? Yes. It refers to several key documents within the body of the text, particularly: • Health and Social Care Act 2008 (DH 2008) • Care Quality Commission (CQC 2010, p42) • Health and Social Care Act 2012 (DH 2012)

available in full text and are free to NHS employees via ‘spaceforhealth.com’. However, consideration needs to be given to printing these documents, as they are each around 100 pages long. Please note, there are separate sections for Scotland, Wales, Northern Ireland and England. What is the purpose of the guideline? The purpose of the guideline is to provide: • best practice guidance on the management and decontamination of

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surgical instruments used in acute care precautionary policy on human prion disease transmission advice on surgical instrument management in relation to surgical care efficiencies and contingency against perioperative non-availability of instruments.

Does the guideline provide a summary of recommendations? Throughout document A there are overviews, summaries of current reports and studies for commissioners and regulators.

What does the document actually refer to? In no particular order, the document particularly refers to: • Essential Quality Requirements (EQR) – defined as best practice guidance that is inclusive of statutory and regulatory requirements i.e. MDD, applicable standards and approved codes of practice. • Best Practice (BP) which is additional to EQR. This covers guidance on nonmandatory policies and procedures with the intention of reducing risk to patients and staff, resulting in the best possible outcome. This is based on localised and appropriate departments. In order to access BP, a local risk assessment group may be set up. BP should be considered and applied to developing local policy to promote innovation and choice, cost effectiveness, improved instrument management and clinical outcomes throughout the

Journal of Perioperative Practice PROCUREMENT GUIDE March 2013 Volume 02 Issue 01 www.afpp.org.uk

Best Practice (BP) covers guidance on nonmandatory policies and procedures with the intention of reducing risk to patients and staff, resulting in the best possible outcome. This is based on localised and appropriate departments. In order to access BP, a local risk assessment group may be set up. BP should be considered and applied to developing local policy to promote innovation and choice, cost effectiveness, improved instrument management and clinical outcomes throughout the whole decontamination cycle.

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whole decontamination cycle. BP should be measured and awarded to encourage innovation. Encouraging continuous local improvements Promoting patient and staff safety Ensuring clinical effectiveness Improving patient experience Supporting and encouraging local decision-making Effective management of surgical instruments during life cycle reprocessing Responding to patient and service users issues (CQC 2012) local and national service users. Healthwatch is an independent body working with care providers, commissioners and quality regulators, see: www.cqc.org.uk/public/ about-us/partnershipsotherorganisations/ healthwatch Control and prevention of transmission of all human prion disease, i.e. variant CJD, TSE Implementation of effective risk management (NICE 2006) Complying with risk control of surgical instruments – tracking and traceability , loan instruments and repairs Control and management of surgical instruments, i.e. availability, sustainability, quality and instrument integrity Separation of instruments used on high risk tissues of patients born after January 1997 High quality engineering (European Norms (EN), quality and standards) High quality decontamination environment, equipment, facilities Guidance of instrument auditing and tracking – inclusive of single instrument Contingency plan for dropped instruments, or those sets whose sterility has been compromised Keeping instruments in a moist environment between use and reprocessing Efficient human protein removal techniques Support and direction for poor performing hospitals Best practice rewarded to

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encourage innovation High standard of staff training throughout the decontamination life cycle

Who has ultimate responsibilities for coordinating activity between the operating theatre and the decontamination services team? • A designated ‘instrument manger/coordinator will assume responsibility to manage RIMD supply and purchase • This may be a co-managed role between theatres and sterile services References Care Quality Commission 2010 Guidance about compliance. Essential standards of quality and safety [online] Available from: www.cqc.org.uk/sites/ default/files/media/documents/ essential_standards_of_quality_ and_safety_march_2010_final_0. pdf [Accessed January 2013]

Department of Health 2008 Health and Social Care Act 2008 Available from: www.legislation. gov.uk/uksi/2009/660/contents/ made [Accessed January 2013] Department of Health 2012 Health and Social Care Act 2012 Available from: www.legislation. gov.uk/ukpga/2012/7/contents/ enacted [Accessed January 2013] National Institute for Health and Clinical Excellence 2006 Patient safety and reduction of risk of transmission of Creutzfeldt-Jakob disease (CJD) via interventional procedures: IPG 196 Available from: www. nice.org.uk/guidance/IPG196 [Accessed January 2013] A longer version of this article by Angela Cobbold and Sue Lord can be found in Journal of Perioperative Practice, Volume 22, Issue 12, 376 to 379.

Readers’ Letters My colleagues and I are experiencing increased difficulty in opening certain types of packages or products for use in the clinical setting. This is not just an age issue but something that manufacturers have not given adequate consideration. In particular saline or water bottles (we now have to ask a male colleague for help); IV bags, where it is impossible to push the giving set or pulse lavage into (yet another job for our men and they struggle) and plastic wrapping on certain orthopaedic implants. At a time when we are meant to be more productive, and with an ageing workforce, this subject needs to be discussed. There is an infection control issue where certain products can easily become contaminated when staff are struggling to open products safely. Finally there is an occupational health issue. This may seem a trivial matter to some but I can assure you it is becoming a real problem in my place of work. Thank you for giving this your time. Tracey Brown Deputy Lead Orthopaedic and Trauma Conquest Hospital, East Sussex NHS Trust

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Recovery

Journal of Perioperative Practice PROCUREMENT GUIDE March 2013 Volume 02 Issue 01 www.afpp.org.uk

MHRA

Guidance on EU Commission Regulation 207/2012 on electronic labelling of medical devices

News

The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. The MHRA is an executive agency of the Department of Health. The MHRA is the competent authority (CA) for the UK and on behalf of the Secretary of State for Health, they administer and ensure compliance with medical device legislation in England, Northern Ireland, Scotland and Wales. The MHRA meets its CA functions in the following ways: • Enforces the regulations by: o investigating allegations received about possible non-compliance with the regulations o operating a proactive inspection programme where manufacturers are randomly selected for inspection by MHRA’s own staff • Designates UK notified bodies and audits them

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Investigates post-market surveillance reports received from medical device manufacturers and users Maintains a register of certain types of manufacturers

The MHRA website holds extensive information for the device industry on a number of topics which includes: • Legislation • Surveillance and enforcement • Compliance with device regulations • Vigilance and adverse event reporting • Guidance and policy www.mhra.gov.uk/Devicesindustry/ index.htm

One Liners issue 96 - January 2013 All medical devices can fail but an increasing number of incidents that result in significant morbidity or mortality arise out of user error or because of poor practices. This edition highlights common issues that have been encountered and provides guidance on preventing problems in the future. Available from: www.mhra.gov.uk/Publications/ Safetyguidance/OneLiners/CON222589

This Regulation which comes into force on 1 March 2013 allows manufacturers of certain types of medical devices and accessories to provide electronic instructions for use if they wish and lays down requirements that have to be met in order for this to fulfil the requirements of the Medical Devices Directive. EU Regulations are directly applicable in UK law and do not therefore need to be transposed into domestic medical devices regulations to take effect. The provision of instructions for use in an electronic form can be beneficial for certain professional users and the purpose of the Regulation is to reduce the environmental burden and improve competitiveness by reducing costs whilst at the same time maintaining safety.

There is even a suggestion that electronic instructions for use could improve levels of safety, given that electronic storage of information is less susceptible to loss, providing that sufficient safeguards are used. For further information go to: www.mhra.gov.uk/Publications/ CON224439

Journal of Perioperative Practice PROCUREMENT GUIDE March 2013 Volume 02 Issue 01 www.afpp.org.uk

News

FDA approved portering chair

aluminum with a powder coated finish, wipe clean welded seam vinyl upholstery. The folding portering chair has been independently weight tested by FIRA International Ltd. It can safely transport patients up to 200Kg (440Lbs) and when not in use it neatly folds away to a width of 405mm (16”).

Wardray Premise Ltd is pleased to announce that the USA, Food & Drug Administration (FDA) have approved their 510K application for the MR4500 folding portering chair. In the United States medical devices are subject to the general controls of the Federal Food Drug & Cosmetic Act. These controls apply to all medical devices necessary for marketing, proper labeling and monitoring of its performance once the device is on the market.

The FDA have approved Wardray’s folding portering chair as MR conditional for use up to and including 7.0T. Wardray believe that this is the first such device to be approved in this way by the FDA. Although the 510K application process

Call for innovative health technologies for low-resource settings Do you have a new technology solution to a well-known health problem? Do you have a technology solution to a health problem not yet addressed? The Medical Devices and eHealth units of WHO invite you to submit your solution to the call for innovative medical devices and eHealth solutions for low-resource settings. Selected submissions will be published in the WHO Compendium of innovative health technologies 2013.

The deadline for submissions is 15th of March 2013. Please feel free to pass the word to your colleagues and all interested parties. For more information go to: www.who.int/medical_devices/ compendium_2013/en/index.html

was somewhat laborious Wardray felt that this globally recognized standard supported their ethos of Quality without Compromise, as well as making the USA market accessible through FDA approval. The MR4500 folding portering chair is constructed from

The MR4500 folding portering chair is designed and manufactured in the UK by Wardray Premise Ltd. They have an excellent range of equipment for the MR environment; further details are available at www. wardray-premise.com. Alternatively for further information and enquiries contact the Company’s Head Office: Tel: 020 8398 9911; Fax: 0208398 8032 and e-mail: sales@wardray-premise.com

Journal of Perioperative Practice PROCUREMENT GUIDE March 2013 Volume 02 Issue 01 www.afpp.org.uk

Product News

Improving patient outcomes through perioperative warming Almost any patient undergoing anaesthesia is susceptible to inadvertent perioperative hypothermia. Inadvertent perioperative hypothermia has been called a frequent, preventable complication of surgery (Kurz 2008). Many publications have documented the adverse effects on patient outcomes, which include an increase in wound infections (Barie 2002), increased length of stay (Kurz et al 1996) and higher mortality rates (Tryba et al 1996). Some estimates say that more than 50% of all surgical patients are hypothermic on arrival to the recovery room (Young & Watson 2006). Research has shown that patients can lose up to 1.6°C during the first 60 minutes of anaesthesia (Sessler 1997), due to anaesthesia induced vasodilatation. Under normal conditions the temperature gradient between the body’s core and periphery is approximately 2 to 4°C and is very tightly controlled. Anaesthesia induced vasodilatation allows the warmer blood in the core, to flow freely around the cooler periphery. As the blood circulates throughout the periphery, it cools before returning back to the heart, where it causes a drop in core body temperature. This process of reducing core body temperature is known as redistribution temperature drop (RTD) and is responsible for 81% of the heat loss during the first hour of anaesthesia (Sessler 2000). After the first hour of anaesthesia, the body continues to lose heat, but at a slower rate, with RTD contributing to only 43% of this further reduction (Sessler 2000). Therefore during the first hour of anaesthesia the main cause of hypothermia, is core-to-periphery redistribution. One of the most important factors controlling the extent redistribution hypothermia affects the patient’s temperature is their initial body heat content (Sessler 2000). Core body temperature remains relatively constant, even in warm environments. However as the

peripheral tissues warm, the body heat content increases reducing the core-to-periphery gradient. As heat requires a gradient to flow, the extent to which redistribution hypothermia affects body temperature decreases as body heat content increases.

of hypothermia. The Bair Paws system uses forced-air warming technology to provide both preoperative warming, that will contribute to increasing body heat content, as well as perioperative clinical warming for many surgical procedures.

Actively warming patients before induction of anaesthesia (prewarming) is an effective way to increase body heat content and help prevent perioperative hypothermia in many surgical procedures. Cotton blankets, especially warmed ones may be comforting, but these passive insulators do not provide any active warming. In fact heat from cotton blankets dissipates into the environment (Sessler et al 1993).

There are two parts to the Bair Paws system: the warming gown and the warming unit. The Bair Paws gown is worn like a traditional gown, however, unlike a traditional gown, it has its own special features. Inside the front of the gown is a Bair Hugger blanket, that has two independent air channels for delivering forced-air warming

Prewarming patients before surgery have been shown to reduce the effect of RTD, maintain normothermia (Just et al 1993), reduce postoperative shivering (Just et al 1993) and aid in the reduction of postoperative wound infection (Melling et al 2001). Prewarming has also been shown to reduce length of stay in the recovery room and reduce the cost of anaesthesia (Bock et al 1998). The 3MTM Bair PawsTM Patient Warming System offers a way of reducing anaesthesia induced RTD and improving patient outcomes, through a reduction in the adverse effects

pre, intra and postoperatively. The Bair Paws warming unit is attached to the gown to circulate warm air around the patient via the gown. The temperature of the air flowing through the gown can be controlled by the patient, by the use of a handheld controller. This ensures the patient remains comfortable during the preoperative warming period. For a number of surgical procedures, the Bair Paws gown can be used to deliver intraoperative clinical warming, by connecting the Bair Paws gown to a Bair Hugger warming unit in the theatre

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With only a minimum of 10 to 20 minutes of prewarming required (Horn et al 2012), the Bair Paws system offers an easy method of ensuring you provide patients with a high standard of care and assist in reducing the adverse effects of inadvertent perioperative hypothermia. For further information visit www.bairpaws.co.uk and www. bairhugger.co.uk 3M is a trademark of 3M Company. Bair Paws & Bair Hugger are trademarks of Arizant Healthcare Inc., a 3M Company. References Barie PS 2002 Surgical site infections: epidemiology and

Product News prevention Surgical Infections 3: 9-21, Supplement Bock M, Müller J, Bach A et al 1998 Effects of preinduction and intraoperative warming during major laparotomy British Journal of Anaesthesia 80 (2) 159-163 Horn EP, Bein B, Böhm R et al 2012 The effect of short time periods of pre-operative warming in the prevention of peri-operative hypothermia Anaesthesia 67 (6) 612-617 Just B, Trévien V, Delva E, Lienhart A 1993 Prevention of intraoperative hypothermia by preoperative skin-surface warming Anesthesiology 79: 214-218 Kurz A 2008 Thermal care in

the perioperative period. Best Practice & Research Clinical Anaesthesiology 22 (1) 39-62 Kurz A, Sessler DI, Lenhardt R 1996 Perioperative normothermia to reduce the incidence of surgical-wound infection and shorten hospitalization. Study of Wound Infection and Temperature Group New England Journal of Medicine 334 (19) 1209-15 Melling AC, Ali B, Scott EM, Leaper DJ 2001 Effects of preoperative warming on the incidence of wound infection after clean surgery: a randomised controlled trial The Lancet 358: 876-880 Sessler DI 1997 Current concepts: mild perioperative hypothermia New England

Journal of Medicine 336: 1730-1737 Sessler DI 2000 Perioperative heat balance Anesthesiology 92: 578-596 Sessler DI, Schroeder M 1993 Heat loss in humans covered with cotton hospital blankets Anesthesia & Analgesia 77 (1) 73-77 Tryba et al 1996 Does active warming of severely injured trauma patients influence perioperative morbidity? Anesthesiology 85: A283 Young VL, Watson ME 2006 Prevention of perioperative hypothermia in plastic surgery Aesthetic Surgery Journal 26 (5) 551-571

Protection from Surgical Smoke Awareness of the health risks arising from exposure to surgical smoke is growing although the only guidance for infection control staff comes from the MHRA (Device Bulletin, 2008) and British Occupational Hygiene Society (2006) where some form of smoke removal system is recommended. Electro and laser surgery produce particulates ranging in size from 0.07 micron. Particles from ultrasonic devices, high speed saws and drills are from 0.35 micron but because of their biological make-up – tissue, blood and blood by-products - pose a greater risk of cross-infection to surgical staff. Particulates of these sizes can easily penetrate deep into the lung and several studies reported on the presence of viral DNA, such as human papillomavirus (HPV), and HPV lesions in surgical staff. In Laparoscopy patients risk carbon monoxide build-up in the abdomen which can be absorbed through the peritoneal membrane causing a reduction in the capacity of red blood cells to carry oxygen resulting in a falsely elevated pulse oximeter reading potentially leading to unrecognised patient hypoxia.

Frequent removal of smoke during laparoscopy reduces the risk to patients and improves visibility for surgical staff. However, whether released during or at the end of surgery the ultra-fine particles can travel up to 3 metres away from the site posing a risk to both scrubbed and unscrubbed staff. Removal of contaminant as close to the source of its generation is the rule of thumb when developing air filtration devices. Air Safety’s Laparo Clear Smoke Filtration Kits consisting of ULPA and activated carbon media meet this requirement along with a capability to remove particles down to 0.027 micron. E: info@airsafetymedical.gvs.com T: 01524 388696

The Association for Perioperative Practice is a registered charity (number 1118444) and a company limited by guarantee, registered in England (number 6035633). AfPP Ltd is its wholly owned subsidiary company, registered in England (number 3102102). The registered office for both companies is Daisy Ayris House, 42 Freemans Way, Harrogate, HG3 1DH.

Journal of Perioperative Practice PROCUREMENT GUIDE March 2013 Volume 02 Issue 01 www.afpp.org.uk

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