PORTSMOUTH HOSPITALS NHS TRUST CLINICAL POLICIES Section 3.40 Policy for the management of infusions with pumps Title Manager /committee responsible CLINICAL LEAD IV THERAPY TEAM SENIOR MEDICAL DEVICE TRAINER GOVERNANCE COMMITTEE Date issued 19.07.2005V2 Issue number 3.40 Review date Author Ratified by JULY 2006 ROBERT KIGHTLEY - SENIOR MEDICAL DEVICE TRAINER BARRY BUCHANAN - CLINICAL LEAD IV THERAPY TEAM PROFESSIONAL ADVISORY COMMITTEE – 01.07.2005 Amendments: April 2010. Section 11. References and Associated Documentation. By Trust Policy Officer. CONTENTS: 1. Item 2. Status 3. Policy Statement 4. Scope 5. Definitions 6. Responsibilities 7. Procedures 7.1 Procedures for the Purchase and Management of the Pumps 7.2 General Procedures for the Administration of Infusions with a pump 7.2.1 Training 7.2.2 Preparation 7.2.3 Set up 7.2.4 Record keeping 7.2.5 Safety 7.3 Procedures for Specialist Infusions 8. Forums for Discussion 9. Training 10. Audit 11. References and Associated Documentation APPENDICES: Appendix 1 Forms to record infusion pump settings PHTMangementofInfusionswithpumps. Issue 1. 19.07.2005V2 Page 1 of 13 Control date: 09/03/16 PORTSMOUTH HOSPITALS NHS TRUST CLINICAL POLICIES Section 3.40 1. Item Policy for the management of infusions with pumps. (“Pumps” includes volumetric pumps, syringe pumps and syringe drivers.) 2. Status This is a Clinical Policy 3. Policy Statement The aim of this policy is two fold: firstly to ensure that any infusion is given correctly and safely by the most appropriate method and secondly to ensure that the pumps and their associated consumable items are managed to ensure their optimum performance. It will ensure the following points: 3.1 The correct pumps are purchased 3.2 The pumps are ready for use at the correct place and at the correct time, are maintained correctly, are stored correctly and are in the best working order 3.3 All staff (including clinical and technical) that have contact with the pumps have the appropriate training, competence and confidence to perform their duties correctly and demonstrable competencies are recorded with the Trust 3.4 The pumps are checked and prepared correctly immediately prior to their use 3.5 The fluids and medication are correctly attached to the pump 3.6 The infusion is given at the correct rate and dose 3.7 The administration is recorded correctly 3.8 Any adverse incidents are correctly managed and recorded 3.9 That any problems with the infusion, pumps or disposables are reported in the correct manner to the correct authority 3.10 The infusion is terminated correctly and safely 3.11 The equipment is correctly and appropriately decontaminated or disposed of after use 3.12 The equipment is correctly stored ready for the next use 4. Scope The scope of this policy relates to all people who use or manage infusion devices; including but not exclusively doctors, nurses, midwives, operating department practitioners, clinical engineering technicians and specialist medical technicians. This policy covers the correct delivery, use and management of infusions when given with a pump and the correct use and management of the pumps and associated hardware, consumables and systems. The policy does not cover any medication; where mentioned it is assumed that the writing and checking of the prescription, dispensing, preparation and checking of the medicine has been performed correctly and to the appropriate policies. The policy does not cover the insertion, siting or management of cannulae for which a separate policy exists. This policy does not cover infusions not given by a pump, including gravity IV infusions, IV, IM, subcutaneous and similar injections or enteral feeds given via a pump. This policy should be read in conjunction with the Portsmouth Hospitals NHS Trust policies and guidelines detailed in section 11. 5. Definitions 5.1 An infusion system – As defined in DB2003(02). See Ref. 4 “An infusion system is the process by which an infusion device and any associated disposables are used to deliver fluids or drugs in solution to the patient by the intravenous, subcutaneous, epidural, parenteral or enteral route. PHTMangementofInfusionswithpumps. Issue 1. 19.07.2005V2 Page 2 of 13 Control date: 09/03/16 PORTSMOUTH HOSPITALS NHS TRUST CLINICAL POLICIES Section 3.40 The process comprises: prescription of the fluid or drug; preparation of the infusion solution; selection of the appropriate infusion device; calculation and setting of the rate of infusion; administration of the fluid to the patient; monitoring and recording of the actual delivery, disposal. The simplest devices, gravity controllers, employ a clamping action to vary the flow of liquid under the force of gravity. More complex systems use a positive pumping action for infusion. Infusion pumps are powered items of equipment, which, together with an appropriate administration set, provide an accurate flow of fluids over a prescribed period. Volumetric pumps may employ a linear peristaltic pumping mechanism or use a special cassette. Syringe pumps work by pushing the plunger of a disposable syringe along at a predetermined rate. The type of pump used will depend on the required volume and speed of infusion.” MDA publication DB2003(02) gives more detailed descriptions of the different types of pumps. 5.2 Parenteral route - Entering the body not by the alimentary tract but rather by another means (such as the subcutaneous or the intravenous route). 5.3 User – The person performing the procedure or action including: the setting up of an infusion, the altering of an infusion and the monitoring of an infusion Note: Different people will have different roles in the whole process; any mention of a “user” does not necessarily apply to all members of the above group. 5.4 Technical support - The management, provision and maintenance of the equipment needed to give an infusion. 5.5 Clinical practitioners – a generic term for all registered clinical staff including but not exclusively registered nurses, midwives, operating department practitioners and medical practitioners. It is assumed that under their respective professional registrations theses staff groups are qualified to give or operate infusions. Some staff groups, e.g. radiographers, may be able to give infusions in limited clinical situations 5.6 Clinical line managers – Staff who manage more junior staff and who take responsibility for the actions of non-registered staff. 5.7 Senior clinical practitioners – Staff who have had in-depth training and are experienced in their particular field. 5.8 Administration set – the part of the infusion system, usually disposable, that contains the fluid and the lines that connect it to the patient. This can be either a bag or syringe of fluid depending on the type of pump and lines that are generic or dedicated to one model of pump. 5.9 Therapy group classification for pumps – Infusion pumps have been divided in to three therapy groups by the MHRA. In general the group A pumps are of a higher specification and should be used for critical infusions, for drugs with a short half-life and for neonates. The specification decreases through group B which can be used for general use infusions and group C which are for non-critical, low risk infusions. The manufacturers or suppliers declare which group their pump falls in to. Details of these groups can be found in Appendix 1 of DB2003(02). See Ref. 4. 5.10 Extravasation - Extravasation occurs when fluid that should be delivered intravenously is inadvertently delivered into a tissue space. It can be caused by misplaced cannulae. The cannulae can migrate and puncture the vessel wall or thrombosed veins. 5.11 Infiltration – The unintended infusion of fluid in to tissue instead of a vein by an intravenous infusion. 5.12 Specialist Infusion – An infusion that is delivered via a route other than subcutaneous or intravenous or one that delivers a drug that is not encountered in general practice e.g. anaesthetic drugs or X-ray contrast media PHTMangementofInfusionswithpumps. Issue 1. 19.07.2005V2 Page 3 of 13 Control date: 09/03/16 PORTSMOUTH HOSPITALS NHS TRUST CLINICAL POLICIES Section 3.40 6. Duties and Responsibilities 6.1 It is the responsibility of all clinical practitioners to ensure the correct and safe administration of an infusion by being competent and confident in the use of the equipment and in the procedure. 6.2 It is the responsibility of clinical line managers and senior clinical practitioners to monitor the work of junior or non-registered staff and to ensure that measurable competency has been observed prior to autonomous practice. 6.3 It is the responsibility of the user to make sure that they have had adequate training in the procedure that they are performing. 6.4 It is the responsibility of the Trust and its managers to provide the appropriate training and to allow access to this training. 6.5 It is the duty of the Trust to provide all the necessary equipment required to set up an infusion safely and correctly. 7. Procedures 7.1 Procedures for the Purchase and Management of the Pumps Action The purchasing of infusion pumps must be managed so as to minimise the number of different models in the Trust. (The medical device management policy will give guidance on the correct methods for assessing equipment for purchase.) Infusion pumps with features that meet only the current and any probable future requirements of clinical users should be purchased. Infusion pumps should generally be managed as part of a centralised equipment library system. Specialist pumps will be managed in their own areas. Rationale Fewer models of pumps leads to less user errors. Evidence 1, 2, 3, 4 Additional unused features add to the expense of the pump and the likelihood of user error. 1, 4, 5, 11 Correct storage and management leads to fewer damaged pumps, increased reliability, increased availability and reduces the overall number of pumps required by the Trust. Hence reducing the purchase and maintenance costs. The pumps must perform safely, correctly, accurately and reliably. 1, 2, 3, 4 Infusion pumps must receive regular planned safety and performance tests in line with manufacturer’s recommendations. Staff maintaining pumps must be The maintenance is performed competent and confident to perform the correctly. tasks required of them. PHTMangementofInfusionswithpumps. Issue 1. 19.07.2005V2 3, 5, 6, 11 6, 11 Page 4 of 13 Control date: 09/03/16 PORTSMOUTH HOSPITALS NHS TRUST CLINICAL POLICIES Section 3.40 7.2 General Procedures for the Administration of Infusions with a pump 7.2.1 Training Action Rationale Any person operating a pump or Staff must not put patients at risk by managing an infusion must be familiar performing actions that could be with the process, be proved competent unsafe. and be confident to perform the task safely and correctly. The Trust must make device training Staff require training to perform actions and competency checks available for safely and correctly. all device users. The equipment instructions and any Staff may need to refresh their user guides must be readily available. knowledge prior to performing an action. When staff teach patients or their The pump is operated in a correct and carers about the use of patient safe manner when it is not under the operated infusion devices they must direct supervision of a member of staff. ensure that the person has fully understood the function and operation of the device, the consequences of incorrect use or misuse and any checks that need to be done to ensure that the device is operating correctly. The staff member giving this teaching To confirm that the correct information must record all the teaching and advice has been imparted. given to patients or carers. 7.2.2 Preparation Action The infusion pump must be of the correct type for the infusion route and application. The infusion pump must be of the correct type for the fluid volume and rate being infused. A pump of an appropriate therapy category must be used for the infusion. Rationale Different pumps are designed and optimised for different uses. Different pumps are designed and optimised for different types of infusions. Pumps of lower therapy categories do not have sufficient features or alarms to ensure a safe infusion. The pump must be physically inspected The equipment is safe to use and will for lack of damage and a valid service operate correctly and accurately, and is date prior to use. unlikely to fail in use. Only giving sets and syringes that are The pump will only operate correctly appropriate and approved use with for and safely with the correct the specific pump must be used. administration set and/or syringe. The giving sets and syringe must be The drugs and solutions reach the checked for compatibility with the drugs patient unaltered and at the correct and solutions being infused. dose. PHTMangementofInfusionswithpumps. Issue 1. 19.07.2005V2 Evidence 1, 5, 7, 8, 9, 10, 11, 27 5, 7, 8, 9, 11, 27 5, 7, 8, 9, 11, 27 4, 5 4, 13 Evidence 1, 4 1, 4 1, 4 1, 4 4 Manufacturers instructions Page 5 of 13 Control date: 09/03/16 PORTSMOUTH HOSPITALS NHS TRUST CLINICAL POLICIES Section 3.40 7.2.3 Set up Action The giving set or syringe must be correctly attached to the pump. Rationale If not the pump might operate incorrectly causing an incorrect infusion. The settings for rate, volumes, The pump must be set correctly for the pressures and alarms must be correctly infusion to be delivered correctly and set taking in to account the safely without nuisance alarms. prescription, drug, patient and cannula type, site and size as well as other physical factors. Only syringes with a Luer lock The risk of disconnection is reduced. connectors must be used with syringe pumps and drivers. Blood must only be given through The blood is not damaged by the pumps that have been approved for the pumping action of approved pumps. delivery of blood. Blood must only be given through The giving set material does not alter giving sets specially designated for the blood. blood delivery Drugs that are photosensitive must be These giving sets prevent light from given through opaque or appropriately reaching the fluid, preventing its coloured giving sets. chemical breakdown. The pump function and settings must To ensure the pump is functional and be checked immediately prior to the settings are correct and that the commencing the infusion and infusion is given as prescribed. immediately after any alteration to settings that might affect the delivery of the infusion. 7.2.4 Record keeping Action The asset number of the infusion pump as well as any settings and the drug or fluid being infused must be recorded in the patient record. Any alteration to these settings, including the completion of an infusion, must be recorded when made. See appendix 1. If an adverse incident involving an infusion occurs it must be reported following Trust procedures. All equipment associated with the pump, including disposables, must remain with the pump when they are detached from the patient. Rationale Should an adverse incident occur the pump can be identified for subsequent electronic interrogation to compare the actual settings and actions against the intended ones. The disposables form part of the whole infusion system and might be the part that is at fault. PHTMangementofInfusionswithpumps. Issue 1. 19.07.2005V2 Evidence 10, 12 12 1, 4, 22, 23 4, 19 4, 19 Manufacturers instructions 1, 4, 6 Local specialist policies may also apply Evidence 13 14, 15 Page 6 of 13 Control date: 09/03/16 PORTSMOUTH HOSPITALS NHS TRUST CLINICAL POLICIES Section 3.40 7.2.5 Safety Action If possible the pump operation must be locked if the environment in which the pump is being used might mean it could be altered by unauthorised people, e.g. by children or confused people. (If the pump does not have the facility to be electronically locked, a physical method of preventing access to the controls such as a locked box must be used) Only registered clinical practitioners can stop or temporarily halt an infusion, alter its settings or adjust the administration set or syringe once a pump has been started. The settings of the pump must be regularly and frequently checked. See appendix 1. The settings of any alarms must be regularly and frequently checked and altered if necessary. Rationale To prevent tampering which might cause the infusion to be given incorrectly. Evidence 1, 7, Manufacturers instructions This prevents the accidental alteration of the settings by a non-registered practitioner and ensures a continuous delivery of the infusion. 8 To ensure the settings remain correct and the infusion continues to be delivered as prescribed. An alteration in the patient’s condition or position might mean that a previous alarm setting needs to be altered to ensure continued safety without causing nuisance alarms. On completion of the infusion the single Drugs and clinical waste must be use items must be disposed of in the disposed of correctly to ensure the correct manner. safety of patients, staff, the public and the environment. The pump must be decontaminated as Prevention of cross infection. per the decontamination policy before storage. 7, Manufacturers instructions 16, 17, 18 16, 18, Manufacturers instructions 16, 18, Draft medical device decontamination policy All pumps that record and retain The next user only records the volumes Manufacturers volume totals and similar readings must of the current infusion. (In an instructions have these reset to zero or default emergency situation there may not be values prior to storage. time to clear totals prior to use.) The pump must be stored on The pump is in its optimum condition 1, 2, 3, 4 designated shelving in an approved for the next user. area so that it is unlikely to be There is no unnecessary damage, physically damaged and the battery, if adding to the cost of ownership. fitted, can be charged. The line to the patient must be It is possible to accidentally infuse 1, 4, manually clamped when the pump is excessive fluid in to the patient or to Manufacturers not infusing or when alterations are cause siphoning to or from the patient if instructions being made to the location of the giving they are connected directly to the fluid set. source without a clamped line. PHTMangementofInfusionswithpumps. Issue 1. 19.07.2005V2 Page 7 of 13 Control date: 09/03/16 PORTSMOUTH HOSPITALS NHS TRUST CLINICAL POLICIES 7.2.5 Safety continued Infusion sites must be regularly inspected for signs of cannula extravasation and fluid infiltration. If a boost or bolus may be required, only pumps that record the number of boluses given and limit the total volume that is given must be used. The rate setting of pumps needs to be carried out with extreme care. Some pumps do not have a syringe size detection mechanism, these must be used with extreme care and the dose rate carefully calculated taking in to account the size of the syringe in use. Section 3.40 The pressure of an infusion can decrease with extravasation so pressure alarms may not detect this situation. Harm may occur to the patient if repeated boosts or boluses of the drug are given. This may be through excessive drug delivery or local fluid overload. The units of rate with some pumps can be different from those normally encountered. (mm/hr or mm/day instead of ml/hr) The volume rate of infusion varies with syringe size and will not be automatically calculated by the pump. 4, 20, 21 4 4, Manufacturers instructions 4, Manufacturers instructions 7.3 Procedures for Specialist Infusions and Situations Action Specialist infusions such as intrathecal or epidural infusions must only be set up by staff who have received additional specific, specialist training and have shown themselves competent to do so. Intravenous anaesthesia infusions must be managed only by suitably qualified and competent anaesthetists Staff caring for patients with patient controlled analgesia and epidural anaesthesia infusions must ensure that the patient has been taught how to operate them correctly, and that the infusions are operating correctly and effectively. Highly specialist infusions, such as Xray contrast injectors, must follow local policies and guidelines and only be used by people who have received specialist training in that area. Rationale Patient safety can be compromised by inexperienced staff performing actions that they are not trained or competent to do. Evidence 8, 22, 24, 25, 28 Patient safety is not compromised. 26 The pain relief is effectively delivered to 27, 28 the patient. The patient may not know what to expect from the infusion so would not know if it were not operating correctly. Detailed, specialist, specific, knowledge 22 is needed to operate this equipment safely, along with knowledge of any associated equipment. PHTMangementofInfusionswithpumps. Issue 1. 19.07.2005V2 Page 8 of 13 Control date: 09/03/16 PORTSMOUTH HOSPITALS NHS TRUST CLINICAL POLICIES Section 3.40 8. Forums for Discussion The following have been involved in the formation of this policy: Clinical lead IV therapy team Head of clinical engineering Medical device training team Representatives of senior nurses (Nursing and Midwifery CASE group) The revision of this policy should be co-ordinated by the clinical lead of the IV therapy team and senior medical device trainer. They should involve those who assisted in its initial drafting along with any specialist or general users of infusion pumps especially representatives of nurses and midwives who are the largest user group. 9. Training All registered clinical practitioners will have received some education on infusions as part of their training. They are required to undertake specific study programmes as part of their post registration training prior to administering or managing IV therapy. Only practitioners who have undergone this additional training should manage infusions with pumps. Registered clinical practitioners who have not undergone this training should be supervised whilst managing infusions, as should all non-registered staff. All staff should receive training on the operation of the specific models of pumps that are used in this Trust even if they have received detailed training on infusions in a previous employment. All staff should receive specific training on the operation of any new models of pumps when they are introduced. 10. Audit Supervisors of clinical practice will be responsible for monitoring compliance with the guidelines on an ongoing basis. The medical device training team and IV therapy team will audit compliance as part of the medical device training and clinical practice audit process. A snapshot audit to monitor clinical practice during cannulation, infusion set up, and pump set up and operation will be undertaken by the IV therapy team as part of its total IV therapy audit. This data will be presented as part of the over all monitoring process of infusions to the governance leads of each division. The relevant data will be passed to the medical device training team to help identify any required amendment of the training programme. 11. References and Associated Documentation External 1. Safer practice notice 01 Improving infusion device safety, NPSA, May 2004 2. Standardising and centralising infusion devices – A project to develop safety solutions for NHS trusts, NPSA, May 2004 3. The Management of medical equipment in NHS acute trusts in England. National Audit Office, June 1999 4. Device Bulletin DB2003(02): Infusion systems, Medical Devices Agency, March 2003 5. Device Bulletin DB9801: Medical device and equipment management for hospital and community-based organisations, Medical Devices Agency, January 1998 (and subsequent supplements). 6. Equipped to care – The safe use of medical devices in 21st century, Medical Devices Agency, 2000 7. Guidelines for the Administration of Medicines. United Kingdom Central Council for Nursing, Midwifery & Health Visiting. Reprinted by Nursing and Midwifery Council, 2002 8. Reducing the risk of user error with infusion pumps, Professional Nurse Vol.15 No.6, March 2000 9. DB2005(02) Adverse incident reports 2004, Medicines and Healthcare products Regulatory Agency, March 2005 PHTMangementofInfusionswithpumps. Issue 1. 19.07.2005V2 Page 9 of 13 Control date: 09/03/16 PORTSMOUTH HOSPITALS NHS TRUST CLINICAL POLICIES Section 3.40 10. Devices in practice – a guide for health and social care professionals, Medical Devices Agency, 2001 11. Pickstone, Dr Martin, A pocketbook for safer IV therapy (Drugs, giving sets and infusion pumps), Scitech Educational, Margate, 1999 12. DB2005(01) Reporting adverse incidents and disseminating medical device alerts, Medicines and Healthcare products Regulatory Agency, January 2005 13. Smith J, Building a safer NHS for patients – Improving medication safety. Department of Health. London, 2004 14. Mallett J and Dougherty L (eds.). Royal Marsden Hospital 2003 Manual of Clinical Nursing Procedures. 5th edition. Blackwell. Oxford 15. Miller, D R, Intravenous infusion anaesthesia and delivery devices. Canadian Journal of Anaesthesia 2004; 41:639-51 PHT documentation Policy and protocol for the management of medical devices Policy and associated protocols for the completion and management of health care records at ward / departmental level Management of Adverse Events and Near Misses Policy Trust policy and protocol for the safe handling and disposal of sharps Policy for the prevention, control and management of infection Blood Transfusion Policy Intravenous Cannulation & Infusion Therapy Medicines Policy Trust policy for intrathecal chemotherapy oncology / haematology departments Management of continuous epidural infusions PHTMangementofInfusionswithpumps. Issue 1. 19.07.2005V2 Page 10 of 13 Control date: 09/03/16 PORTSMOUTH HOSPITALS NHS TRUST CLINICAL POLICIES Section 3.40 Appendix 1: Forms to record infusion pump settings In order that any change of setting of an infusion device can be readily identified the pump must be regularly inspected and the settings recorded and compared with previous settings. This task must be performed by or under the direct supervision of a registered practitioner. To facilitate this, a record form has been devised. Below are two forms that should be used to monitor infusions when delivered by a pump and record settings and readings. These forms should be used if no other similar record of infusions is made. The first is a form specific to the Graseby MS26 syringe driver. This is set up and used in a way that is different to other infusion pumps. The second form can be used for most other infusions whether given by other syringe pumps or volumetric pumps. Dependent on the model of pump or the way in which it is being used some of the readings might not be available. (Infusion pumps do not normally display the measured infusion pressure only the pressure alarm limit.) In this case a note should initially be made in the appropriate column to record this fact. For volumetric pumps drawing from a bag of fluid an estimation of the volume remaining in the bag should be made. If a setting has been changed the person altering the pump must record the fact by entering the new settings in the appropriate column and initialling the record. If a setting is different from a previous one or if excessive fluid is missing from the syringe or infusion bag, the staff discovering this should try to ascertain if a person has altered the settings and not recorded it or if excessive fluid has been lost through over bolusing. If these investigations do not provide a suitable answer an adverse clinical incident must be raised and medical assistance sort to investigate any possible side effects of any drug misadministration. PHTMangementofInfusionswithpumps. Issue 1. 19.07.2005V2 Page 11 of 13 Control date: 09/03/16 PORTSMOUTH HOSPITALS NHS TRUST CLINICAL POLICIES Section 3.40 GRASEBY MS26 SYRINGE DRIVER MONITORING This chart MUST be completed hourly for all patients receiving medication via a syringe driver and when complete filed in their records. Any change in settings must be initialled next to the recorded value. Pump Asset Number: (Medical Equipment Number) Patient Identification label: Date &Time commenced: Medication & Dosage: Commenced by: Total Volume (ml): Time Volume Remaining (mls) Pain Score Site Checked Site Changed Indicator flashing Y/N Rate (mm/hr): Vital Signs if indicated Signature 00: 01: 02: 03: 04: 05: 06: 07: 08: 09: 10: 11: 12: 13: 14: 15: 16: 17: 18: 19: 20: 21: 22: 23: PHTMangementofInfusionswithpumps. Issue 1. 19.07.2005V2 Page 12 of 13 Control date: 09/03/16 PORTSMOUTH HOSPITALS NHS TRUST CLINICAL POLICIES Section 3.40 INFUSION PUMP MONITORING This chart MUST be completed hourly for all patients receiving medication via a syringe driver and when complete filed in their records. Any change in settings must be initialled next to the recorded value. Pump Asset Number: (Medical Equipment Number) Patient Identification label: Date &Time commenced: Medication & Dosage: Commenced by: Total Volume(ml): Time Volume Remaining (ml) Set Rate Measured Infusion Pressure Pressure Alarm Setting Total Volume Infused Rate (ml/hr): Infusion Site Inspected Signature 00: 01: 02: 03: 04: 05: 06: 07: 08: 09: 10: 11: 12: 13: 14: 15: 16: 17: 18: 19: 20: 21: 22: 23: PHTMangementofInfusionswithpumps. Issue 1. 19.07.2005V2 Page 13 of 13 Control date: 09/03/16