Re-assurance over the safety of the new

Transcription

1 Issue 03 October 2011 News on the implementation of devices with safer Design for patient safety There have been fatal cases where intravenous medicines have been administered by the spinal (intrathecal) route and epidural medicines have been administered by the intravenous route. There is also the potential for medicines intended for regional anaesthesia to be administered by the intravenous route, with fatal outcomes. These wrong route errors will always be possible as long as medical devices with standard (Luer) are used. The introduction and use of medical devices which do not physically connect with intravenous equipment will further reduce the risk of wrong route errors. NPSA response to the Joint Statement Introduction In the August 11 th 2011 Anaesthetic Association Newsletter there was a Joint Statement from Anaesthetic Organisations Presidents that raised a number of issues concerning the implementation of neuraxial devices with safer. This has caused some confusion with practitioners and Trusts in England on how to proceed with their implementation. The need for one connector design The joint statement expressed a view that a single dedicated new connector is required to maximize efficiency and safety. The NPSA agrees that this is the long term goal. However, there is no international standard for a neuraxial connector and the development of such a standard is likely to take many more years. This had influenced the guidance in the Patient Safety Alert issued in From the outset the NPSA was of the opinion that without an international standard in place the medical devices industry required a two step process to achieve the long term goal of a single connector design. First, a move to the introduction of several safer connector designs for neuraxial devices that will prevent wrong route errors. Second, an international agreement on a single standardised non-luer connector design for all neuraxial devices. Neuraxial Update It is too soon to decide on a single connector design for the NHS in England due to its complexity and size. Making a decision on a single design at this stage increases the risk of selecting the wrong connector design. A single device assessment, like any single clinical trial cannot replicate all clinical requirements. A device or medicine that passes only one assessment or trial may have to be substituted for another in practice, once broader clinical experience is gained. There are also risks to the device market and supply chain, that manufacturers will withdraw satisfactory new devices on the basis of just one assessment used to a select a single design for both Wales and England. It is our view that the risks associated with the use of two or more connector designs in England can be managed effectively for an interim period. It is only by using a two step process will the long term goal of a standardised design be achieved. Re-assurance over the safety of the new The joint statement also notes that a full process of bench-top and clinical evaluation is planned in Wales organized by Mr Peter Phillips of the Surgical Materials Testing Laboratory, Bridgend We anticipate that many anaesthetists or hospitals will decide to await the outcome of the Welsh testing It should be noted that several manufactures of neuraxial devices with safer may not, for a variety of reasons, be taking part in the Welsh testing process. Hence, there will be no data available at all from that source for those manufacturers devices. In addition, due to the phased evaluation process being used in Wales, devices may be eliminated from the process at various stages, and therefore a complete set of data may not be available for all the products which start the process. Moreover, the complete set of clinical user evaluations will not be available until late summer 2012, whereas the target date for implementation for non-luer is 1st April Page 1 of 7 In this issue Response to Joint Statement The first incident with new devices Lumbar puncture and CNS infections A safer design infusion spike Independent testing information Frequently asked questions In the last Neuraxial Update Newsletter we clearly indicated that the NPSA External Reference Group on Neuraxial Devices has advised that NHS clinicians and other healthcare staff wish to be well informed about new devices with safer coming onto the UK market. The group has recommended that suppliers should provide the NHS with independent technical and usability test results of new devices that will assist the procurement process. Details of the recommended test information were included in the newsletter. The Welsh testing process is only one source of independent technical and usability test information. We hope device manufacturers and larger assessments in some hospitals in England will provide test information in a more timely fashion, to assist the device procurement process in England. For all these reasons we do not support the use of the Welsh testing programme to select a single connector design for the NHS in England. We are concerned that the joint statement may cause clinicians and Trusts in England to disengage from the implementation process. Moreover, we do not support the use of the Trust risk register, if there has not been local assessment of any of the new neuraxial devices with safer. Even when independent test information is provided, in our view it is essential that local clinicians have an opportunity to assess first hand, neuraxial devices with safer and determine which of these devices most closely meets their local needs. The process for introducing other new CE marked devices into practice has always involved local assessment. Therefore we recommend that Trusts in England should continue with their plans to assess new neuraxial devices, to gain some familiarity with the functionality of these products. This, in conjunction with reviewing information from multiple independent assessments of the new devices, will enable Trusts to implement their purchasing for safety initiatives to meet the requirements of the Patient Safety Alert.

2 The First Patient Safety Incident Report Involving Spinal Devices With Safer Connectors Incident summary A patient was undergoing an elective caesarean section. After a spinal needle had been inserted, it was discovered that the needle was fitted with a safer connector. Only Luer syringes were available for use, and these would not connect to the spinal needle that had been used. The procedure was delayed for a short time until a spinal needle with a Luer connector was obtained. The procedure then went ahead without any further incident and no harm to the patient. On investigation it was discovered that a routine order for spinal needles (with Luer ) had been placed by the hospital with the usual medical device distributor. A box of spinal needles with safer, from the same manufacturer, had been supplied in error by the distributor. A hand written label with the code for spinal needles fitted with Luer had been applied to the box of spinal needles with safer, probably by the distributor and supplied to the hospital. The supply of the wrong spinal needles was not discovered by the hospital, until after the first needle had be used in a patient. The hospital policy is to use spinal devices with Luer until a decision on a planned change to spinal devices with safer is taken Causes of the incident Unclear design on the spinal needle device, labeling, packaging and shipping carton that did not clearly differentiate devices with Luer from similar devices with safer Insufficient differentiation of catalogue code numbers and descriptions to minimize possible mis-selection between similar devices with different Lack of awareness of staff, in the medical device distributor and in the hospital, that neuraxial devices with safer have recently been introduced onto the market, and additional safeguards are required to ensure that neuraxial devices with the required connector are ordered and supplied The application label with the wrong catalogue code number onto the shipping carton The need to prevent mismatching of devices with incompatible Neuraxial devices with safer are being placed on the market by industry in response to the NPSA Patient Safety Alert issued in Although the use of these devices will minimise the risks of wrong route errors, it is essential that effective controls are in place to minimise the risk of mis-selection and supply of devices with incompatible, that could cause delay in clinical procedures and harm patients. Based on learning from this incident the following recommendations are intended to promote actions to minimise the risk of another patient being treated with a neuraxial device with an incompatible connector in the future. Recommended safer practice For device manufacturers Improve the safe use of neuraxial devices fitted with either safer or Luer, by improving the design of labelling packaging and shipping cartons. This can be achieved by using colour, wording and symbols to clearly Indicate to individuals who handle these products, the type of connector used in the device. Device manufacturers and distributors Alert all staff involved in the neuraxial devices supply chain, of the risk of supplying devices with the wrong connector. Improve catalogue code numbers and written descriptions to minimize the risk of mis-selection and miscommunication. Introduce safe systems for processing orders to ensure that only devices with the specified connector are supplied. Confirm when a hospital orders neuraxial devices with safer, for the first time that the hospital intends to use devices with these Healthcare providers Alert healthcare staff who order, receive, transport, restock and clinically use neuraxial devices of the risk of mismatching Amend written distribution and clinical procedures and train staff to confirm the identity of the connector used in neuraxial devices Apply additional labels to clearly identify the connector design, to neuraxal devices, where the manufacturers labelling, packaging and shipping carton provides insufficient differentiation Require clinical staff to check that neuraxial devices required for a procedure are fitted with the same connector design before commencing the procedure. Check that current stocks of neuraxial devices are fitted with compatible. How to distinguish and check connector compatibility on neuraxial devices Checks should not solely rely on catalogue code numbers. The term Luer and where safer are fitted, the device trademark should be used identify different connector designs. Currently Correctinject, Hall Lock, Neurax, Surety, Univar are trademarks being used. Only devices with the same connector descriptors are compatible. Other design elements such as colour, wording and symbols should assist users identify the type of connector used in the device. Page 2 of 7

3 Lumbar Puncture, Diagnosing CNS Infections And Spinal Devices With Safer Connectors Problems with diagnostic lumbar puncture The NPSA external reference group had a presentation from Dr Benedict Michael NIHR Doctoral Research Fellow, Institute of Infection and Global Health, University of Liverpool concerning diagnostic lumber puncture at its April meeting. Bacteria meningitis and viral encephalitis are medical emergencies, the outcome of which is improved by prompt antibiotic treatment. For patients with suspected meningitis and no features of severe disease, such as clear meningococcal septicaemia or clinical contraindication, the British Infection Society (now the British Infection Association) and NICE both recommend immediate lumbar puncture (LP) before antibiotics, to maximise the chance of a accurate cerebrospinal fluid (CSF) results and establishment of an early diagnosis. In such patients, CT scanning before LP is not needed. Update lumbar puncture kits Dr Michael informed the external reference group that practice can be improved by including guidance concerning sampling and management in LP packs. There is an opportunity to update LP packs with spinal devices with safer, and information about sampling and management before the target implementation date for Part A guidance from the NPSA on 1 st April 2012 An extract from an example of information that could be included in LP packs is shown below: The problem Dr Michael described problems with diagnostic lumbar puncture due to: Sub-optimal clinical practice Delays in LP due to inappropriate CT Delay reduces chance of identifying the pathogen responsible and therefore guiding treatment Adequate tests often not requested He identified reasons why some clinicians don t perform a LP and obtain a diagnosis? Delay in clinical suspicion Think need a CT first Can t get kit Takes too long Get the next shift to do it Don t know what to send it for Frequently inadequate tests sent National Encephalitis Guideline A national group is developing guidelines for the management of acute encephalitis for both adults and children. The guidelines development group is composed of a national collaboration of leading neurologists, virologists, infectious diseases specialists, acute care physicians, paediatricians and patient support leaders and includes collaboration with a broad range of representative groups including the Association of British Neurologists, the British Infection Association and the Encephalitis Society. University of Liverpool For more information on research into improving management and outcomes in central nervous system infections Page 3 of 7

4 A safer design infusion spike Chapter has designed and developed a safer epidural connector infusion spike, which is protected under patent application and registered under the NonivLok trade mark. NonivLok is now in the final stages of development. It is anticipated that NonivLok will become available from the end of 2011 or early NonivLok is about to embark upon an independent testing program culminating in independent pilot studies conducted in clinical settings in December and January. NonivLok is presently compatible with semi-rigid polypropylene infusion bags, containers with 20mm DIN neck apertures and containers with 32mm DIN neck apertures. Consideration will be given to accommodating other specific container systems upon request. NonivLok will be made available to all manufacturers of finished products and giving sets. Chapter Unit 1 Cardinal Park Godmanchester Huntingdon Cambridgeshire PE29 2XN Contact name : Karol Pazik Telephone : chapter@bucksnet.co.uk Supplier contact details Aspen Medical Europe Limited Thornhill Road, Worcestershire B98 9NL Telephone: tom.moss@aspenmedicaleurope.com Web: B-Link (UK) Limited Cliffe House, Cragg Wood Drive, Rawdon, Leeds. West Yorkshire. LS19 6LG Telephone: info@neurax.co.uk Web: B.Braun Medical Limited Hospital Care, Thorncliffe Park, Sheffield. S35 2PW Telephone: Contact Nav Cameron safeconnect.bbmuk@bbraun.com Web: Becton Dickinson Medical The Danby Building, Edmund Halley Road, Oxford Science Park, Oxford. OX4 4DQ Telephone: rachael_harvey@europe.bd.com Website: Bluebox Medical Limited Unit 29, New Forest Enterprise Centre, Chapel Lane, Totton, Southampton, Hants, SO40 9LA Telephone: Marc Buckingham marc@blueboxmedical.co.uk Website: Flexicare Cynon Valley Business Park, Mountain Ash. Mid Glamorgan. CF45 4ER Telephone: hash.poormand@flexicare.com Website: InterVene Limited Waterloo Court, Markham Lane, Chesterfield. S44 5HN Telephone: mroot@ivltd.co.uk Web: CME McKinley UK Limited Kincraig Business Park, Kincraig Road, Blackpool. Lancashire. FY2 0PJ Telephone: neuraxial@cme-mckinley.co.uk Web: Pajunk UK Limited Swan Building, Prestwick Park, Prestwick, Northumberland. NE20 9SJ Telephone: Contact: stephen.brown@pajunk.co.uk Website: Rocket Medical plc Research & Development, Sedling Road, Washington, Tyne & Wear. NE38 9BZ Nick Tyrell; nick@rocketmedical.com Telephone: Web: Sarstedt Limited 68, Boston Road, Leicester. LE4 1AW Telephone: robert.heald@sarstedt.co.uk Website: Smith Medical International Limited 1500 Eureka Park, Lower Pemberton, Ashford, Kent. TN25 4BH Telephone: barbara.morin@smiths-medical.com Website: Vygon (UK) Limited Bridge Road, Cirencester, Gloucestershire. GL7 1PT Telephone: Contact: james.leek@vygon.co.uk Website: Page 4 of 7

5 New Product Assessment Checklist For Neuraxial Devices Technical and usability information to support purchasers select new devices The NPSA External Reference Group on Neuraxial Devices has advised that NHS clinicians and other healthcare staff wish to be well informed about new devices with safer coming onto the UK market. The group has recommended that suppliers should provide the NHS with independent technical and usability test results of new devices, that will assist the procurement process. Recommended devices and sizes of devices The NPSA has recommended a list of devices required for organisations to meet Part A requirements for spinal (intrathecal) and lumbar puncture use. Independent test information is required on the following: Technical laboratory testing results on: security of connection; ease and force of separation; leakage tests; ease of thread engagement; cross connectivity with Luer and other small bore ; microbiological integrity testing of prefilled syringes. Clinical simulation test results using an anatomically realistic spinal trainer manikin should include four simulated clinical settings: spinal anaesthesia; epidural analgesia and anaesthesia; intrathecal chemotherapy; lumbar puncture. Simulation results from the clinical settings above should include: The following range of devices with NPSA compliant is recommended: Spinal needles - Quincke and pencil point e.g. Sprotte, Whitacre; Lengths: mm; Gauges: 18, 19, 20, 22, 24, 25, 26, 27; Introducer. needles Syringes - both slip and lock ; sizes: 1, 3, 5, 10 and 20ml. Filters 5micron; Filter needles; Drawing up needle (sharp) 19G; Spinal manometer. Syringe cap; Fluid dispensing connector. clinical acceptability; user satisfaction; cross connectivity with Luer and other small bore. Three way tap. Winged needle and tube (butterfly device) for use with Omayer reservoirs Details of recommended methods for independent technical and usability testing are available from the NPSA. Page 5 of 7

6 Frequently asked questions 3.1 Are spinal catheters covered in part A or B of the NPSA Alert? All neuraxial infusion devices are covered by Part B guidance with an implementation date for the NHS of 1 st April Are winged needle infusion (Butterfly) devices with non-luer necessary to achieve compliance with the NPSA alert? Medicines are sometimes administered through the scalp and into an Ommaya reservoir using a winged needle infusion device, An Ommaya reservoir is an intraventricular catheter system that can be used for the aspiration of cerebrospinal fluid or for the delivery of medicines into the cerebral spinal fluid. It consists of a catheter in one lateral ventrical attached to a reservoir implanted under the scalp. Winged needle infusion devices are also used sometime in spinal bolus and infusion procedures. As this type of device contains tubing it is included in Part B Guidance. 3.3 In my orthopaedic practice, I use a spinal needle to aspirate the knee joint. What do I need to do in April 2012? Continue to use a long needle with a Luer connector. Organisation should identify those areas that will continue to require to use these needles and introduce control measures such as controlled storage and additional labelling to minimise the risk of these needles being used for neuraxial use. Manufacturers are being ask to remove the term spinal; from the catalogue descriptions, product labelling and packaging of these devices to reduce confusion. The new name for these needles should be long Luer needle. 3.4 Is local anaesthetic wound infusion devices covered by Part B, or is it outside the NPSA alert? Wound infusions using large volumes of local anaesthetics are included in the NPSA guidance under the heading regional anaesthesia Part B of the Patient Safety Alert with a target implementation date of 1 st April It is important to prevent these devices being administered by the intravenous route and Luer must be replaced in these devices. 3.5 Which suppliers are supplying short spinal needles with safer suitable for use with children? Becton Dickinson B-Link Blue Box Medical Sarstedt 3.6 Is there a requirement for tamper evident syringe caps to meet the NPSA Alert requirements? The use of tamper evident syringe caps is not required by the NPSA to meet Part A recommendations. It is routine practice in the NHS to place prefilled spinal syringes in tamper evident transport bags. Some NHS organisations currently use tamper evident Luer syringe caps and would like to continue to use tamper evident caps with safer. The NPSA would not support a decision not to implement the use of devices with safer, if a tamper evident syringe cap was not available. FAQ s that appeared in previous newletters Issue 2 February External-ventricular drains 2.2 Are Ommaya reservoirs 2.3 Neuro-endoscopes 2.4 Three-way taps 2.5 Sub-tenon anaesthesia 2.6 Epidural blood patch technique 2.7 Bier's Block s 2.8 Definitions for regional and local anaesthesia 2.9 The need to engineer out all possible cross connections? 2.10 Misconnection with needle free and bionnectors used in intravenous devices? 2.11 Devices to administer local anaesthetics into the skin prior to neuraxial procedures Issue 1 August who is responsible for managing the introduction of safer devices in NHS organisation? 1.2 How should the new devices be introduced into clinical practice 1.3 What degree of training is necessary before clinicians start using the Alert compliant Devices 1.4 Can t this work be undertaken nationally or regionally? 1.5 What is the status of combined and epidural kits (CSE)? Are they covered by NPSA Part A or Part B guidance? 1.6 What is the status of Loss of Resistance Syringes (LOR) are they covered by Part A or Part B guidance? 1.7 What if non-luer 10ml and 20ml syringes are not available by April 2011?. Page 6 of I understand that the International Standards Organisation (ISO) is developing an international standard for neuraxial, how will this affect the NPSA guidance?

7 Links Q: Where can I get more information on the implementation of new neuraxial devices in the future? and on the Patient Safety First website at: aspx?path=/interventions/relatedprogramme s/medicationsafety/safer-neuraxial-devices This site also has a neuraxial device forum to discuss and share experience of implementing devices with safer. Welsh Neuraxial Reference Group Neuraxial testing programme - Wales A: The NPSA plans to issue more editions of the Neuraxial Update in the future. In addition FAQs and information concerning new devices will be updated more frequently. The information will be available on the NPSA website at: tient safety topics/medicationsafety/?entryid45= neuraxial-non-luer.html Obstetric Anaesthetists Association Association of Anaesthetists Newsletter Page 7 of 7