JoPP PG November 2014 (Vol:3 Issue:5)

Journal of Perioperative Practice

PROCUREMENT GUIDE November 2014 01423 881300

Volume 03 Issue 05 www.afpp.org.uk

01423 881300 www.afpp.org.uk

Journal of Perioperative Practice PROCUREMENT GUIDE November 2014 Volume 03 Issue 05 www.afpp.org.uk

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Contents 03

Journal of Perioperative Practice PROCUREMENT GUIDE November 2014 Volume 03 Issue 05 www.afpp.org.uk

Welcome to your November 2014 Guide 04 A promise to learn:

patient safety in the operating theatre

06 Best practice for safe

handling of surgical sharps

08 Product news:

Are you putting your patients at risk?

10 Pre-warming 11 News: Statement from ABHI

12 Product news: Eco EZ

Cleanse, The Valvesafe, The OxyShield

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:

January 2015 Recovery/Patient Warming March 2015 Medical Devices/Instruments May 2015 Infection Prevention/Control July 2015 Consumables/Innovation September 2015 Airway Management/Anaesthesia

Contact Information: Advertising, Sponsorship & Partner Packages.

Frances Murphy Account Manager Open Box M&C T: 0121 200 7820 E: frances.murphy@ob-mc.co.uk 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: frances.murphy@ob-mc.co.uk

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Journal of Perioperative Practice PROCUREMENT GUIDE November 2014 Volume 03 Issue 05 www.afpp.org.uk

A promise to learn: patient safety in the operating theatre In a letter sent to all ministers, senior executives, and all NHS staff the first of four guiding principles outlined by Don Berwick for us to adhere to was:

“Place the quality and safety of patient care above all other aims for the NHS. (This, by the way, is your safest and best route to lower cost.)” (DH 2013) Reducing the risk of an infection following a surgical procedure or medical intervention is an important outcome for patients and the NHS. The National Institute for Health and Care Excellence published its guideline (CG74) on the prevention and treatment of surgical site infection in 2008 (NICE 2008). NICE, more recently, published a set of NICE Quality Standards (QS49) describing high-priority areas for quality improvement (NICE 2013).

Quality statement 4 describes intraoperative staff practices that would help to minimise the risk of microbial contamination of the surgical site from the theatre environment.

All patients will receive treatment of the proposed surgical site, prior to the first incision. This is an essential part of the standard procedures within a theatre.

Many theatres will have agreed guidelines that determine which products to be used in which situation and protocols that describe how they are going to be applied. However, in my experience, not all surgeons, nurses and managers are aware of the regulatory status of the products that they use and the implications behind their selection.

Many theatres will have agreed guidelines that determine which products to be used in which situation and protocols that describe how they are going to be applied.

However, in my experience, not all surgeons, nurses and managers are aware of the regulatory status of the products that they use and the implications behind their selection.

The preparation of the skin with an antiseptic, prior to an intervention such as surgery, in order to reduce the risk of infection is a ‘medicinal purpose’. The product selected for this medicinal purpose should be a medicinal product authorised and regulated by the Medicines and Healthcare Products Regulatory Agency (MHRA 2009). Naturally a clinician can decide to use a licensed medicine ‘off-label’ (in a manner not described within the marketing authorisation or in line with the recommendations in the label) or in exceptional circumstances a product that is not licenced at all.

There are guidelines from the MHRA (2014) on the supply of unlicensed medicinal products (specials) and from professional bodies to support the decision making process and the implementation of such decisions. Box 1 offers some suggestions as to the variety of situations that can be found around the use of unlicensed products or products used off-label and gives some examples in the infection prevention field.

Box 1: Examples of off-label or unlicensed use The product may have marketing authorisation as a medicinal product and is indicated for the purpose, but it is used in a manner that is not described within that authorisation.

• For example Hydrex Pink when it is mixed with a skin delineation dye before application The product may have a marketing authorisation or a CE mark, but it is not indicated for the purpose.

• For example some medicated wipes are licensed as medical devices and may be indicated for the disinfection of medical devices, but not for the disinfection of skin prior to the insertion of medical devices The product does not have marketing authorisation and is introduced as a biocide • For example Chlorhexidine 2% in 70% IPA (Ecolab), although this product is clearly labelled as a biocide and not for therapeutic application (for example pre-operative skin preparation)

Naturally the MHRA and the healthcare professional bodies such as GMC (2013), NMC (2007), RPS (2012) recommend that, in general, healthcare professionals should use a licensed medicinal product when one is available and it should be used in the manner described within the marketing authorisation and the label.

Where an unlicensed product is to be supplied, everyone involved within the process should be aware of a ‘special need’ relating to the clinical needs of the patient that cannot be met by a licensed product and this does not include reasons of cost, convenience or operational needs as described within MHRA guidance note 14 (MHRA 2014).

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It is only the clinician that can assess whether a patient has a special clinical need that can only be fulfilled by an unlicensed product or a licenced product used off-label. The hospital then has a duty to consider this proposed use and complete a risk assessment that should be recorded within the risk register. The hospital should start with two questions: • What is the defined special need (clinical needs of individual patients) for the use of an unlicensed product or a licenced product used offlabel (The special need does not include reasons of cost, convenience or operational needs).

• Is there a licenced medicinal product available that can be used in this situation?

If the hospital considers that a special need has been defined and there is no licenced medicinal product available, then the hospital should conduct a risk assessment using the questions in Box 2 and should they consider the risk acceptable consider the questions within Box 3 as to whether a robust implementation process can be achieved.

Box 2: Risk assessment and implementation questions • Is there a published evidence base supporting the use of the product for that indication or in that manner?

• What is the clinical, legal and financial risks to the hospital of this practice (see NPSA risk matrix for risk managers)

Box 3: Implementation questions • Has the ‘specific need’ been documented within the medical notes • Is there a patient specific direction signed by the responsible clinician • Are all members of the surgical team aware of the use of unlicensed products and licenced products used off-label and are aware of the rational and the evidence base • Has the patient been fully informed that an unlicensed product or a licenced product used off-label is proposed for use and has consent been documented in the medical records • Is the administration of the product clearly documented and signed • Are there appropriate adverse reporting mechanisms in place for an unlicensed product • Is implementation in line with the advice of the professional bodies

Openness and transparency in decision making is crucial.

Patients should be fully informed when a clinician has identified a special need and proposes to use an unlicensed product or a licensed product off-label.

Informed consent should always be documented.

The hospital may have to consider the pharmacovigilance and adverse reaction reporting of unlicensed products that are not covered by the MHRA yellow card scheme.

Summary Healthcare professionals should always read the label of the product that they propose to prescribe and/or administer to a patient. Wherever possible an appropriately licenced product (medicine or device) should be used and in the manner described within the marketing authorisation and label. When the responsible clinician identifies a ‘special need’ that cannot be met by a licenced product or within the label of a licensed product, the clinical team in association with the hospital should assess the clinical, legal and financial risk of this practice and ensure that use is compatible with current the law, MHRA guidelines and professional guidance and standards.

Returning to Don Berwick’s recommendations post the Francis report always “place the quality and safety of patient care above all other aims”.

Mark Robinson BPharm, MSc, MRPharmS, GPhC Pharmacist, the Medicines Management Partnership & Medicines, Pharmacy and Medicines Optimisation Advisor NHS Alliance

References and further reading Department of Health 2013 A promise to learn - a commitment to act: improving the safety of patients in England [online] Available from: https://www.gov. uk/government/publications/ berwick-review-into-patient-safety [Accessed October 2014] General Medical Council 2013 Good practice in prescribing and managing medicines and devices - prescribing unlicensed medicines (para 6770) [online] Available from http:// www.gmc-uk.org/Prescribing_ guidance.pdf_56002831.pdf [Accessed October 2014] Medicines and Healthcare products Regulatory Agency 2009 Medicinal devices and medicinal products Bulletin No 17 London, MHRA Medicines and Healthcare products Regulatory Agency 2014 Guidance Note 14 on the supply of unlicensed medicinal products (‘specials’) updated [online] Available from: http:// www.mhra.gov.uk/home/groups/ is-lic/documents/publication/ con413520.pdf [Accessed October 2014] National Institute for Health and Care Excellence 2008 Clinical Guideline (C74) Prevention and treatment of surgical site infection [online] Available from: https://www.nice.org. uk/guidance/cg74 [Accessed October 2014] National Institute for Health and Care Excellence 2013 Quality Standards (QS49) Surgical site infection [online] Available from: https://www.nice.org. uk/guidance/qs49 [Accessed October 2014] Nursing and Midwifery Council 2007 Standards for medicines management [online] Available from: http:// www.nmc-uk.org/Documents/ NMC-Publications/238747_ NMC_Standards_for_medicines_ management.pdf [Accessed October 2014] Royal Pharmaceutical Society 2014 Professional standards for hospital pharmacy services [online] Available from: http:// www.rpharms.com/support-pdfs/ rps---professional-standards-forhospital-pharmacy.pdf [Accessed October 2014]

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Best practice for safe handling of surgical sharps

With over 400,000 occupational injuries reported each year, aspects of the EU Sharps Directive 2010/32/EU were implemented from the 11th May 2013 under the Health and Safety (Sharps Instruments in Healthcare) Regulations 2013, which aim to achieve the safest possible environment for healthcare workers through the prevention of sharps related injuries.

The objectives of the EU Legislation can be summarised as: 1) To achieve the safest possible working environment.

2) To prevent workers injuries caused by medical sharps.

3) To protect workers at risk.

4) To set up an integrated approach establishing policies in risk assessment, risk prevention, training, information awareness raising and monitoring.

5) To put in place response and follow up procedures.

The prevention of injuries caused by all medical sharps is the overriding objective of the Directive and this is hoped to be

achieved by applying a number of control measures within the working environment. These would be: 1) Elimination of unnecessary use of sharps through changes in working practice identified during risk assessment.

2) Safe procedures to be clearly specified and implemented for the use and disposal of sharp medical instruments and contaminated waste.

3) Engineering Controls enabling the provision of medical devices incorporating safety mechanisms and protection.

4) PPE - the use of personal protective equipment such as gloves, gowns and masks.

Sharps A policy for the disposal of sharps is recommended.

The way in which a surgical blade is handled prior to use can determine how effectively it performs during use.

Needles, blades and other sharps should be collected and contained safely during surgical procedures. Needles should not be re-sheathed.

Special care should be taken when disposing of needles used to ‘draw up’ solutions for injections. Used needles and syringes should not be parted but placed as a whole in a yellow sharps bin or other recommended container in accordance with national/local guidelines.

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Journal of Perioperative Practice PROCUREMENT GUIDE November 2014 Volume 03 Issue 05 www.afpp.org.uk

In addition: • Sharps bins should be available at all times and located at the most suitable place.

• Sharps containers must conform to the British Standard BS EN ISO 23907-2012 which specifies that they must: o be leak-proof o have a handle which does not interfere with the disposal process o have a suitable aperture o be able to be sealed o have a line showing when the container is three quarters full o be able to be incinerated o be yellow and clearly marked ‘Danger, contaminated sharps only, destroy by incineration’.

• Sharps bins are to be sealed and sent for incineration when they are three quarters full.

All staff should be made aware of the protocols to be followed in the event of a sharps injury. The number, frequency and types of sharps injuries should be reviewed periodically.

Safe handling of surgical blades The way in which a surgical blade is handled prior to use can determine how effectively it performs during use. There are a number of ways that the cutting edge of a blade can become damaged once removed from its protective foil packet.

When removing a blade from the protective packet make sure it is not dropped into a metal bowl or container as this can reduce

the initial keenness of the cutting edge even before it is fitted to the handle. If you have to use forceps or needle holders to remove the blade from its protective packet ensure that you do not grip the blade across the cutting edge.

A blade remover allows for safe and easy removal of all sizes of scalpel blade from both No 3 and No 4 handles assisting in the reduction of accidental sharps injuries amongst nursing staff and the associated risks of cross infection and exposure to blood borne pathogens.

Further information can be found on AfPP’s poster ‘Sharps’.

Downloadable from: www. http://www.afpp.org.uk/careers/ Standards-Guidance

When removing a blade from the protective packet make sure it is not dropped into a metal bowl or container as this can reduce the initial keenness of the cutting edge even before it is fitted to the handle.

Product News 08

Journal of Perioperative Practice PROCUREMENT GUIDE November 2014 Volume 03 Issue 05 www.afpp.org.uk

Are you putting your patients at risk?

Even mild hypothermia (when the patient’s core temperature drops below 36°C) can increase postanaesthesia recovery time, blood loss and morbid cardiac outcomes and lengthen hospital stays (AORN 2007).

Not knowing the exact temperature of the irrigation fluid at point of use can jeopardise patient safety.

Maintaining normothermia should include the use of warm irrigation fluid for surgical procedures as part of the holistic approach to keeping the patient warm throughout the procedure.

NICE guidelines state that fluids should be warmed to 37°C and that all irrigation fluids used intraoperatively should be warmed in a thermostatically controlled cabinet to a temperature of 38–40°C (NICE 2008). However, how many operating teams check the temperature of the fluid leaving the warming cabinet and can be sure of the exact temperature of the fluid being used to irrigate the patient?

How confident are you that the fluid is the same as the temperature reading on the warming cabinet?

A recent survey carried out by Ecolab Healthcare at the AfPP conference in York, identified that out of 28 participants, only 12 % were able to correctly

“guess” the temperature of the warmed irrigation fluid, when using the traditional “finger dip” test. The tried and tested method of adding some warm or cold water to get to the correct temperature before being used does raise questions. Not knowing the exact temperature of the irrigation fluid at point of use can jeopardise patient safety.

Irrigation with hot solutions has resulted in patient injuries (AORN 2012) and we know that fluid temperature drops by 1°C per minute after removal from a warming cabinet.

Do you know the exact temperature of the irrigation fluid that you are using?

The new Intratemp Fluid Warming System from Ecolab prevents this risk by taking out the guesswork of irrigation fluid temperatures.

For further details contact Alison on 0113 232 2480

References Association of periOperative Registered Nurses Recommended Practices Committee. Recommended practices for the prevention of unplanned perioperative hypothermia AORN Journal 85 (5) 972-988 Association of periOperative Registered Nurses 2012 Perioperative Standards and Recommended Practices: For Inpatient and Ambulatory Settings Denver, AORN (p371) National Institute for Health and Care Excellence 2008 Inadvertent Perioperative Hypothermia Clinical Guideline 65 London, NICE (p12)

Journal of Perioperative Practice PROCUREMENT GUIDE November 2014 Volume 03 Issue 05 www.afpp.org.uk

Product News 09

AfPP’s Theatre access course Who’s it for?

This course has been tailored specifically for medical device representatives but may also be suitable for students wanting to get a ‘taste’ of theatres.

Where is it held?

Either at AfPP HQ in Harrogate or onsite at your offices (a minimum of 10 delegates are required for onsite courses).

What do you get out of it?

- An understanding of theatre etiquette, correct protocol and the roles and responsibilities of those within theatres.

What does it cost?

- £250+VAT for medical device representatives - £150+VAT for students

- A certificate and theatre access course ID pass card.

How long does it last?

The course is valid for two years, after which you will be required to complete a refresher module.

The course can also be ‘tailor made’ to your specifications.

To book your place or for further information, please call Pauline Thompson on 01423 882969 or visit www.afpp.org.uk/events/theatreaccess

Product News 10

Journal of Perioperative Practice PROCUREMENT GUIDE November 2014 Volume 03 Issue 05 www.afpp.org.uk

Pre-warming

References

Research shows that patients can lose up to 1.6°C during the first 60 minutes of anaesthesia (Sessler 1997), due to anaesthesia induced vasodilatation.

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.

Actively pre-warming patients before surgery has been shown to reduce the effect of redistribution temperature drop, maintain normothermia (Just et al 1993) and improve patient outcomes by reducing postoperative shivering (Just et al 1993) and aid in the reduction of postoperative wound infection Melling et al 2001).

Pre-warming 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 System uses Bair HuggerTM therapy to provide both preoperative warming, that will contribute to increasing body heat content, as well as perioperative clinical warming for many surgical procedures.

With only a minimum of 10 to 20 minutes of pre-warming required (Horn et al 2012). The Bair Paws system offers an easy method of ensuring you can provide your patients with a high standard of care and assist in reducing the adverse effects of inadvertent perioperative hypothermia.

Bock et al 1998 Effects of preinduction and intraoperative warming during major laparotomy British Journal of Anaesthesia 80 (2) 159-163 Horn 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 et al 1993 Prevention of Intraoperative Hypothermia

by Preoperative Skin-Surface Warming Anesthesiology 79 (2) 214-218 Melling et al 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

News 11

Journal of Perioperative Practice PROCUREMENT GUIDE November 2014 Volume 03 Issue 05 www.afpp.org.uk

Statement from ABHI Statement from ABHI concerning press coverage of the Institute of Mechanical Engineers Report ‘Biomedical Engineering: Advancing UK Healthcare’ ABHI broadly support the report from the institute and the desire to increase the biomedical engineering resource within NHS Acute Trusts. They are however disappointed in the sensationalist use of the press release which they feel undermines the balanced nature of the report and its aims.

Medical interventions are never entirely risk free and any death caused by either equipment or personnel fault is of course very

regrettable, this is why there are stringent processes in place for defect prevention, calibration, maintenance and repair of medical equipment.

Where appropriate the device manufacturers will have a planned maintenance regime as required under the Medical Device Regulations.

All adverse incidents resulting in death or serious injury are investigated by MHRA enabling

trends to be identified and corrective action established.

As part of this important feedback loop medical device manufacturers are constantly monitoring any product issues to minimize any adverse patient impact. We also strongly support the recent requirement

by MHRA of Medical Device Safety Officers in clinical establishments to support learning and best practice and call for sufficient resourcing against this initiative.

As healthcare becomes increasingly dependent on technology there is an increased need for competent engineering support, with the technology becoming more complex and diverse it is also vital that required specialist knowledge and personnel are available to the NHS. Medical device manufacturers, working in partnership with biomedical departments, have a vital role to play in ensuring that equipment is working reliably, safely and effectively to deliver vital, sometimes life-saving care, to patients. The ABHI support the principle of ensuring that only suitably qualified personnel maintain equipment.

Journal of Perioperative Practice PROCUREMENT GUIDE November 2014 Volume 03 Issue 05 www.afpp.org.uk

Product News 12

Eco EZ Cleanse™

The Valvesafe™

Eco EZ Cleanse™ is an all-in-one Channel Cleanser and scope sponge designed for the initial flush and wipe of an endoscope immediately postprocedure. It consists of a unique two-tiered pot, a universal sponge and a sachet of detergent concentrate.

All you need to do is just add water!

The Valvesafe™ is a single-use endoscope valve cage for the safe handling of endoscope valves during the cleaning, disinfection and storage process. Valvesafe™ ensures that the valves and other detachable parts to be reused remain as a unique set with the parent endoscope.

The OxyShield™

The OxyShield™ is an endoscopic bite block which provides a simple, safe, and highly effective method of quickly delivering oxygen to the patient. It prevents the occasional episodes of hypoxia and hypoxic cardiac arrests as it ensures adequate oxygenation during endoscopic procedures.

For free samples for evaluation, please contact our office. For information on special offers and how we can help save you money on your bedside cleaning, please contact Matthew. Email: support@peskettsolutions.com Peskett Solutions Ltd, Unit 4-5 Brampton Business Park, 55 Brampton Road, Eastbourne, BN22 9AF. Tel: 01323 511038 Fax: 01323 503 247 Web: www.ruhof.co.uk

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.