Journal of Perioperative Practice
PROCUREMENT GUIDE March 2015 Volume 04 Issue 01 01423 881300 www.afpp.org.uk
01423 881300 www.afpp.org.uk
Journal of Perioperative Practice PROCUREMENT GUIDE March 2015 Volume 04 Issue 01 www.afpp.org.uk
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Contents 03
Journal of Perioperative Practice PROCUREMENT GUIDE March 2015 Volume 04 Issue 01 www.afpp.org.uk
Welcome to your March 2015 Guide 05 A medical device
training programme
07 Armamentarium 08 10 things you may not
know about the medical device industry
10 Product news: Halyard
Health sterilisation wrap, Wardray Premise M3
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 2015 Infection Prevention/Control July 2015 Consumables/Innovation September 2015 Airway Management/Anaesthesia November 2015 Safety/Sharps January 2016 Recovery/Patient Warming
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
Journal of Perioperative Practice PROCUREMENT GUIDE March 2015 Volume 04 Issue 01 www.afpp.org.uk
Product News 04
Medical Devices 05
Journal of Perioperative Practice PROCUREMENT GUIDE March 2015 Volume 04 Issue 01 www.afpp.org.uk
A medical device training programme As a responsible employer the National Health Service (NHS) has a legal obligation to provide ongoing training and education for all it staff. Medical device training is a requirement of the National Health Service Litigation Authority (NHSLA standard 5.5, April 2012). To ensure full compliance with NHSLA standards, individual trusts must have a medical device training policy but also demonstrate that they have comprehensive medical device training processes in place.
As registered practitioners, in order to maintain our registration with our professional regulatory bodies, we must ensure that we maintain and update our knowledge and skills by undertaking on-going training and education (HCPC 2008, NMC 2008). The importance of staff education in the use of medical devices and the relative costs to the NHS was highlighted by Brand (2012). He identified that between 1995 and 2010 the cost to the NHS of claims from litigation relating to medical devices was in excess of £76.9 million pounds. This does not take into account the human cost due to injury either to staff or patients. My own Trust undertakes a regular review of the medical device training programme to ensure that the processes remain fit for purpose. The most recent review identified that some of these processes had become unnecessarily complex and protracted.
Through active management of the equipment register the CME in the last financial year has saved our department an estimated £50,000. Obsolete equipment has been removed not only from the register but also physically from the department where it was taking up valuable and limited storage space.
The specific areas of concern identified in the review were: • How the medical device competency documents are initially written and ratified. • How these documents are reviewed. • How the risk scoring has been applied to medical devices at departmental level. • The structure of departmental medical device training needs analysis documents. • The frequency of re-assessment of medical devices competencies. • The recording process for medical device competency assessments. • How medical device training/ competency assessment is reported and monitored. • The procurement arrangement for new medical devices. • The use of different manufacturers for the same device. To address these issues my own Trust has developed an innovative solution within theatres. They explored the possibility of creating a new
role within the theatre team with specific responsibility for medical devices; the Clinical Equipment Manager (CEM). The aim of this new role is to provide clinical expertise to ensure the safe and effective management of all medical equipment within the theatre department. Within one year the role has proven itself to be cost effective. Through active management of the equipment register the CME in the last financial year has saved our department an estimated £50,000. Obsolete equipment has been removed not only from the register but also physically from the department where it was taking up valuable and limited storage space. Additional cost savings have been identified by the CME by ensuring that all our key equipment is covered by routine maintenance contracts thus avoiding costly repair bills. The CME has also identified future saving through renegotiating the existing service contracts with our medical equipment suppliers. The role has grown and developed and within the past year the CME has developed a good working relationship with the Trust’s procurement team. He is now involved as the acknowledged clinical expert in advising on the purchase of new equipment for theatres as well as arranging for the clinical trials. One of the main functions of the role is to coordinate and oversee the safe delivery of >>
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Journal of Perioperative Practice PROCUREMENT GUIDE March 2015 Volume 04 Issue 01 www.afpp.org.uk
>> medical devices training. In the last year the CME has reviewed the way risk scoring is applied to medical devices in theatres and he has updated the way in which we record our initial and ongoing medical device training. While the theatre training team provides initial training on a range of core medical devices such as the pat slide and diathermy during the induction period for all new staff, more work needs to be done to support ongoing training and the reassessment of staff competency. As the role of the CME continues to develop and evolve the CME is working closely with the theatre training team to ensure that we have robust processes going forward for our ongoing medical device training and education. Sandra Phillips Training & Development Coordinator Main theatres, Lancashire Teaching Hospitals NHS Foundation Trust
References Brand D 2012 Just a piece of equipment? The importance of medical device educations Journal of Perioperative Practice 22 (12) 380-382 Health and Care Professions Council 2008 Standards of Proficiency – Operating Department Practitioners London, HCPC Nursing and Midwifery Council 2008 The code: Standards of conduct, performance and ethics for nurses and midwives London, NMC National Health Service Litigation Authority 2012 Standard 5.5. In NHSLA Risk Management Standards 2012-13 London, NHSLA Available online: http:// www.nhsla.com/safety/ Documents/NHSLA%20 Risk%20Management%20 Standards%202012-2013.pdf
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Journal of Perioperative Practice PROCUREMENT GUIDE March 2015 Volume 04 Issue 01 www.afpp.org.uk
Armamentarium The Daily Mail, 6 January 2015, published a story ‘The secret scandal of faulty NHS equipment that kills hundreds of patients a year’ (Gornall 2015). What a frightening prospect for the man or woman who might read this as they prepare for their surgical experience. Just another fear element to be added to the emotional pot for potential patients who are coming to our operating theatres all over the UK!
The incident that appears to have spurned this article related to a 46 year old policeman, Mike Cawson, who died on his way to hospital as a result of equipment failure. Mr Cawson who suffered from a heart condition was relying on a specialist portable intra-aortic balloon pump to sustain cardiac activity. The battery in this case was discovered to be faulty and although fully charged leaving one hospital, it lost its power during a 40 mile transfer to another hospital. The inquest into his death heard from a consultant cardiologist that it was “highly unlikely” that the pump failure had contributed to his death. However, the pump that was meant to sustain him in whatever capacity did fail and thus he did not have the opportunity to have his planned surgery. The article states that 13,600 reports of failed devices were made to the Medicine and Healthcare products Regulatory Agency (MHRA) in 2013 and of these 5,000 were linked to serious injuries and a further 309 deaths. Every year we see hundreds of ‘field safety notices’ and ‘medical device alerts’ issued from some of the biggest and most well-known device manufacturers alerting to problems within their products. You only have to visit the MHRA website to evidence these.
Over the last decade there have been almost 100,000 reports of failed devices to the MHRA involving 2,300 deaths and 22,000 injuries. This is likely to be a substantial underestimate – based on knowledge of general incident under reporting. “These official figures could be just a fraction of the true human cost of unreliable medical equipment.” In a stunning admission to ‘Good Health’, the MHRA says it fears the true total could be more than five times as bad”. Following the MHRA experts revelations to the magazine they now say that their investigations have “whittled down the number of deaths associated with device failures in its most recent official report from 309 to just 86”, which is described in the article as “an extraordinary turn on its own published official figures”. Peter Walsh, the Chief Executive of the patients’ charity Action Against Medical Accidents (AAMA), is quoted as stating: “two things are certain, far too many people are needlessly dying or being harmed as a result of faulty devices or poor use of devices, and the reported incidents are still an underestimate of how big the problem is”. Are we aware as perioperative professionals, of the responsibility we have in relation to the
Over the last decade there have been almost 100,000 reports of failed devices to the MHRA involving 2,300 deaths and 22,000 injuries. This is likely to be a substantial underestimate – based on knowledge of general incident under reporting.
competent use and maintenance of all medical devices? There are huge variations in terms of the items that constitute the title of ‘medical device’. We must ensure we treat these potential ‘time bombs’ with respect, applying full and comprehensive knowledge and expertise in the application and use of each one. There are people, often very sick people, relying on us to provide
the assurance and expertise they require and deserve in this complex area of working with multiple variations in equipment and medical devices. Twenty-first century innovation is truly wonderful and has changed the landscape in which we deliver care. We are constantly challenged to accept new equipment, some of which is life changing for the patients for whom it is provided. We need to work very closely with the medical device companies to ensure that we are best prepared to meet the requirements of our patients. In my own personal experience, the company representatives I have dealt with over many years have always been more than willing to share their vast experience and knowledge. Our mutual relationships are interdependent when serving the best interests of the patient. Mona Guckian Fisher (President AfPP)
References Armamentarium 1855-60; (Latin armoury) the array of devices or materials used or available for an undertaking. (arsenal,tools). The items that comprise the material and equipment used by a physician in his professional practice. Collins English DictionaryComplete and unabridged Harper Collins Publishers 2003. Gornall J 2015 The secret scandal of faulty NHS equipment that kills hundreds of patients a year, Daily Mail 5 January, Available from http:// www.dailymail.co.uk/health/ article-2897660/Secret-scandalfaulty-NHS-equipment-killshundreds-patients-year.html [Accessed February 2015]
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Journal of Perioperative Practice PROCUREMENT GUIDE March 2015 Volume 04 Issue 01 www.afpp.org.uk
10 things you may not know about the medical device industry 1. A medical device is an instrument, apparatus or implant or is a related object that is used to diagnose, prevent or treat disease or other condition. 2. Medical devices can vary greatly in complexity and application i.e. from the lowly tongue depressor through to medical implants or prosthesis. 3. The global medical device market in 2006 was worth in excess of $209 billion. 4. There are strict guidelines for importing and use of medical
devices across Europe and the core legal framework consists of three directives:
5. All current directives are in the process of being revised ... watch this space.
Directive 90/38/EEC regarding active implantable medical devices Directive 93/42/EED regarding medical devices Directive 98/79/ED regarding in vitro diagnostic medical devices
6. CE Marking on a device or its packaging means that the manufacturer is confirming that the produce conforms to the relevant essential requirements in the above directives.
The ‘New Approach’ rules relating to safety and performance, as defined in a European Council Resolution in May 1985 provides an innovative way of technical management.
7. A recent meeting of government officials has revealed that medical equipment can become vulnerable to malware infections which can clog patient-monitoring equipment, rendering the devices temporarily inoperable.
8. According to the Association of British Healthcare Industries (ABHI) the medical device industry employs in excess of 50,000 people and supports a further 250,000 indirectly. 9. There are 2,000 small to medium enterprises (SMEs) in the medical technology sector. 10. The single-use label may often be chosen by manufacturers for economic reasons, not patient safety reasons.
Journal of Perioperative Practice PROCUREMENT GUIDE March 2015 Volume 04 Issue 01 www.afpp.org.uk
Perioperative Audit Tool
£95.00 Members. £125.00 Non-members. ISBN: 978-1-904290-21-6 Buy online from the Associations for Perioperative Practice at www.afpp.org.uk or call 01423 881300
Medical Devices 09
Product News 10
Journal of Perioperative Practice PROCUREMENT GUIDE March 2015 Volume 04 Issue 01 www.afpp.org.uk
Halyard Health sterilisation wrap is now most validated on the market Halyard Health, formerly Kimberly-Clark Health Care, has announced that its sterilisation wrap portfolio has been validated by the US Food and Drug Administration (FDA) for use with all standard sterilisation systems.
As the first manufacturer to receive the 510 (k) clearance from the FDA, the validation covers the Halyard* sterilisation wrap with Kimguard* technology and Halyard QUICK CHECK* dual colour wrap. The following sterilisation modalities are covered by the validation:
Low Temperature STERRAD® Sterilisation Systems STERRAD® 100NX STERRAD® NX STERRAD® 100S STERRAD® 200 STARRAD® 50 STERIS® Sterilisation Systems STERIS® V-PRO 1 STERIS® V-PRO 1 Plus STERIS® V-PRO maX Pre-vacuum Steam Ethylene Oxide (EO) Gravity Steam
The M3 has been developed for patient monitoring during MRI examinations The unit is suitable for use with scanners up to and including 3T systems. It was developed in conjunction with clinical users and fulfils all the requirements of a modern patient monitor. The unit can be configured to meet customers’ needs and all components (eg capnography and automatic gas analysis) can be upgraded or added to at any time, helping customers manage and plan their financial commitments.
The M3 provides: • wireless ECG and pulse oximetry • 15” colour touch screen, capable of displaying up to 6 waveforms at one time • up to two channels each of IBP and temperature • automatic gas analysis • mains or battery operated From July 2014 the Restriction of Hazardous Substances (RoHS 2) encompasses the area
of medical devices. Wardray Premise is pleased that the M3 is fully compliant with this latest legislation. Full details of Wardray’s products and services are available at www.wardraypremise.com call: 020 8398 9911 or e-mail: sales@wardraypremise.com
“Providing innovation in sterilisation technology was a priority at KimberlyClark Health Care and we will continue to invest in innovation as Halyard Health,” said Karina Engels, Product Manager for Sterilisation & InteguSeal for Halyard Health in Europe, Middle East and Africa (EMEA). “Securing FDA clearance for use of our market-leading sterilisation wrap with each and every sterilisation modality supports our ongoing mission to help clinicians prevent infections and protect patients.” For more information visit www.halyardhealth.co.uk
Journal of Perioperative Practice PROCUREMENT GUIDE March 2015 Volume 04 Issue 01 www.afpp.org.uk
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Journal of Perioperative Practice PROCUREMENT GUIDE March 2015 Volume 04 Issue 01 www.afpp.org.uk
News 12