BodyGuard T Syringe Pump Protocol

All hospital, acute and community, and individual units should develop and maintain comprehensive device registers and resource information. These registers will provide up-to-date information on the availability of devices and on important practical aspects of the infusion system particularly those related to patient safety.

Healthcare professionals caring for patients requiring continuous subcutaneous infusion of medication via the BodyGuard T syringe pump must ensure that they:

1. Are competent in the operation of the BodyGuard T syringe pump and its use for the administration of subcutaneous infusions.
2. Have up-to-date knowledge of this protocol and The Lothian and Borders Palliative Guidelines.
3. Seek support from their line manager to achieve, maintain competence and complete training sessions in accordance with personal development training.
4. Keep a record of training activities completed as part of the Personal Development Planning and Review process
5. Access NHS Borders Palliative Care Guidelines and other sources of help and These include pharmacy and specialist palliative care services that can provide appropriate information relating to symptom management and the compatibility of medication combinations for delivery via a continuous subcutaneous infusion. All staff setting up and monitoring infusions must ensure that they have up-to-date knowledge of the medications prescribed and that the prescription is appropriate to the patient and their care needs.

Registered Nurses are professionally accountable for ensuring their practice is evidence-based and for taking appropriate action to ensure competency is achieved and maintained, in accordance with the Nursing and Midwifery Council (2015) Professional Standards and Behaviour for Nurses and Midwives. This includes seeking support from their line manager and completing relevant education, training activity and supervised practice.

Within NHS Borders a registered nurse may set up and manage the BodyGuard T Pump providing the following conditions have been met:

The nurse must:

1. Be a Registered General Nurse
2. Have the relevant knowledge of the drugs, therapeutic dose, its contra- indications, method, route and timing of action
3. Have undertaken appropriate level of BodyGuard T Pump training:
   • BodyGuard T Train the trainer – mandatory for all cascade trainers- 2 hours, training and competency assessment
   • BodyGuard T User training – mandatory for all users- 1 hour theory and practical skills followed by competency All users must be signed off as competent at level 2 by the trainer and themselves.
   • All infusion trainers and users must undertake formal training and competency update every 2 years which will be captured in the Competency Assessment and Recording System (CARS) on LearnPro.
4. Registered nurses using the BodyGuard T syringe pump must review their competency and on-going training needs with their line manager through annual personal development If additional training is needed the nurse should inform their line manager to request supervised practice if necessary.

Assistant Practitioners

Trained and competent Assistant Practitioners may check and monitor the BodyGuard T syringe pump. This specifically includes:

1. 2^nd check only where a registered nurse is making up and commencing the infusion
2. This excludes "high dose" controlled drugs (as labelled by pharmacy)
3. 2^ndcheck of drug, volume, diluent, route, dose and prescription
4. 2^nd check of patient
5. 2^nd check of rate and calculation
6. Medicines that are being mixed under prescription must conform to those identified in The Lothian and Borders Palliative Care Guidelines (accessed via the NHS Borders Palliative Care intranet micro-site) Medicines not listed in this document cannot be 2^nd checked by the assistant practitioner

They must undertake formal training, competency assessment and update every 2 years.

All incidents and near misses involving syringe pumps which may compromise patient safety or comfort should be reported to the senior nurse on duty or on call and medical staff immediately. The local reporting system for medication/ medical device incidents must be followed using the NHS Borders Datix reporting systems as appropriate. Examples include:

• Administration of incorrect medication or diluent
• Delay in administration
• Device not alarming
• Infusion completed ahead of, or beyond the intended time of completion

Any device and/ or equipment involved in an adverse incident must be quarantined and labelled “Do not use”. When controlled drugs are still in the syringe this should be removed with the giving set, retained in the CD cupboard and CD officer informed. The syringe driver should then be returned to Medical Electronics department with the incident report number stated on the Medical Equipment Maintenance Request Form. The battery should be removed, but kept with the pump, to prevent in advertent operation of the pump during transport.

• A record of the incident/fault should accompany the syringe pump to the Medical Electronics department, including the asset number: 
• A different BodyGuard T Infusion pump should be obtained and used.

To access or return syringe pumps in the BGH bleep 1412.

Hazard warning notification

All NHS boards operate a cascade system for hazard warning notification. Managers of areas where the BodyGuard T is used are responsible for ensuring that relevant notices area acted and reported on.

All BodyGuard T Syringe Pumps must be properly maintained. Users should routinely visually inspect the pump and lock-box for damage. Routine maintenance is undertaken by the Medical Electronics Department only at the Borders General Hospital and all pumps have a small label attached to indicate when maintenance has been performed. The Medical Electronics Dept (01896 826390) maintain a register and will inform personnel when a pump requires servicing.

All syringe pumps are required to have activity and locality recorded on their local register by the users.

All pumps must be returned to Medical Electronics department for annual servicing whether used or not, to ensure continued safe functional performance. If a pump has been dropped, submerged in water or there is any doubt as to its functional integrity, it must be labelled “Do not use” and returned to the Medical Electronics department as soon as possible.

When pumps are returned to Medical Electronics department, the Medical Equipment Service Request Form should be completed (Available on the Intranet) as fully as possible, describing the suspected fault and completing the decontamination section.

The syringe pump and box should be cleaned with general purpose detergent wipes and dried thoroughly. If MRSA is suspected refer to the Infection Prevention and Control Manual on the intranet.

The syringe pump must not get wet. If it does, it must be withdrawn from use immediately and returned to Medical Electronics department.

If additional cleaning is required (e.g. after contamination with body fluids) or if when cleaning the threads of the screws the actuator moves along, contact Medical Electronics for advice. Do not use chemicals such as xylene, acetone, similar solvents as this will damage components and labels.

Scientific and technical support for the use of and care for the BodyGuard T syringe pumps in circulation will be provided by the NHS Borders Department of Medical Electronics, which will

1. Maintain asset and maintenance registers of the BodyGuard T syringe pumps.
   
   
2. The pumps have been configured with safety in They are Lock– on, which means that they are set to run for 24 hours and this cannot be changed by anyone other than the Medical Electronics Dept.
   
   
3. Provide and organize the scheduled inspection and breakdown maintenance of the BodyGuard T syringe pumps in NHS Borders
4. Support the overall management of the BodyGuard T syringe pumps and the accessories used with the pumps
   
   
5. Support and arrange for the purchase of additional pumps that are required to deliver palliative care and patients requiring subcutaneous medication in NHS Borders, supporting the development of business plans for submission to the Medical Equipment Committee

The BodyGuard T is used to deliver one, two or three medicine combinations via the subcutaneous (SC) route over a 24-hour period. This avoids the administration of regular multiple injections when the patient cannot swallow or absorb oral medications, e.g. due to persistent nausea or vomiting, gastro-intestinal obstruction or impaired consciousness.

The BodyGuard T is pre-set for a 24 hour delivery period and is calibrated in milliliters per hour (ml/hr).

Careful selection of patients who may benefit from continuous subcutaneous infusion of drugs must be undertaken and the use of the BodyGuard T Syringe Pumps should not be viewed as a convenient alternative to rectal medication. It should be used only if clinically indicated, e.g.

• haemochromatosis
• persistent nausea and vomiting
• severe dysphagia
• intractable pain not controlled by oral medication
• gastrointestinal obstruction abnormal-absorption
• profound weakness resulting in the inability to take oral medication
• reduced conscious level or coma

Equipment required:

• BodyGuard T and plastic box
  
  
• 9 V alkaline battery for immediate use (and a spare battery must also be available). Do not use rechargeable batteries
  
  
• BD Plastipak Luer-Lok syringe: 20ml or 30ml (see choice of syringe below)
  
  
• Becton Dickinson (BD) Saf-T-Intima 24 gauge single port cannula
  
  
• CME100cm infusion line with anti-syphon valve, syringes and safety needles/devices to prepare medication
  
  
• Prescribed medicines including correct diluent
  
  
• Syringe pump additive label
  
  
• 2% chlorhexidine in 70% alcohol wipe for skin cleansing
  
  
• Transparent dressing
  
  
• McKinley T34/ BodyGuard T subcutaneous infusion set-up and monitoring chart

Choice of Syringe

Only BD Plastipak Luer-lok syringes should be used and water is recommended as a diluting agent unless otherwise stipulated by the drug manufacturers. Within NHS Borders and Lothian the BodyGuard T are calibrated to BD Plastipak Luer– Lok syringes.

Note that syringe brands from other manufacturers may hold different volumes of medication and should not be used, as the flow rate determined by the BodyGuard T will be inaccurate. Other health boards may calibrate their BodyGuard T syringe pumps to use different syringe brands, and therefore staff must be aware of this when setting up an infusion. The Luer-Lok is important to avoid leakage or accidental disconnection.

Size of Syringe

The dosage of prescribed drugs is calculated and diluted to the maximum volume as per Lothian and Borders Palliative Care Guidelines (www.palliativecareguidelines.scot.nhs.uk) e.g. 17mls in a 20ml syringe and 22mls in a 30ml. The NHS Education for Scotland (www.nes.scot.nhs.uk) recommends the use of 20ml and 30ml syringes only to allow greater dilution of medications, to reduce interactions and incompatibility and also to accommodate larger doses.

10ml syringes should not be used. The preferred syringe to use is the 20ml syringe. However the 30mls syringe may be used if the greater volume is required.

If a combination of more than 3 drugs is required, or if the volume required is greater than 22ml, practitioners should seek guidance from the Specialist Palliative Care Team in the Margaret Kerr Unit, and Pharmacy. Consideration should be given to the use of 2 syringe drivers in these situations to reduce the risk of incompatibility.

Accessories include a rigid lock box for syringes up to 30ml. There are 2 keys provided with each box although any lock box key will open any other box.

The key is usually held by the nurse in charge of designated wards in acute, and community hospitals. In community care environments the key must always stay with the pump to ensure that Community and Out of Hours teams including Marie Curie can access the syringe pumps. A carrying pouch is available to protect the pump and/or lockbox. Both of these accessories help to protect the syringe pump, syringe and contents from damage and tampering. 

Drugs are prescribed on the patient’s prescription chart and documented on the syringe pump record form when the drug is administered.

Controlled drugs are recorded in the controlled drug register/book in acute and community hospitals, and in the patient held documentation in community care.

The prescription should state:

• Patient identification – name and CHI number
• Date of prescription
• The generic name of the medications for infusion
• Dose
• Route and duration of infusion g. continuous subcutaneous infusion over 24hours
• Prescribers name and signature

In addition to the medications prescribed for continuous infusion by syringe pump, medications should be prescribed for use as required, to control any breakthrough symptoms. Refer to the Lothian and Borders Palliative Guidelines.

Staff should follow the NHS Borders Policy for the management of Controlled drugs in Secondary Care (2015). In Community Care environments the nurse and the family should record any drugs that are left over in line with the Management of Controlled Drugs Disposal guidance (NHS Borders 2015).

NHS staff should follow the NHS Borders Infection Control manual regarding standard precautions, aseptic techniques, hand decontamination and the disposal of sharps and waste.

Step 1

1. Explain the use of the syringe pump and medications to the patient and family and gain consent.
   
   
2. Verify the patient’s details with the prescription and
   
   
3. Check the compatibility of the prescribed medication(s) and
   
   
4. Check the BodyGuard T is intact, with no parts damaged or missing and has been serviced within the last

Step 2: Prepare the syringe and infusion line

Draw up the prescribed medication(s) and compatible diluent in the syringe as per prescription and NHS Borders Code of Practice for the Control of Medicines (2013). Syringes should be made up immediately prior to administration. The medications listed within the Lothian and Borders Palliative Care Guidelines compatibility tables are stable for 24hours.

Invert the syringe gently several times to mix the solution thoroughly. Observe for cloudiness, discoloration or precipitation. Discard if this occurs and seek advice. Expel any air from the syringe.

Fully complete the additive label which must include:

• Patient’s name CHI number or date of birth
• Drug contents and dose
• Diluting agent
• Date and time of preparation
• Name and Signature(s) of nurse(s)

Ensure that the label does not obscure visual inspection of the syringe for monitoring purposes or interfere with the mechanism of the device i.e. contact with the barrel clamp arm.

Aseptically connect the syringe to the infusion set/cannula and manually prime the line.

Device Features

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Only designated staff with the authority and relevant access codes can change pump default settings and configuration via the pump and/or BodyComm communications software. Access code protected areas are available in the pump, though no code is required to turn the pump on and run an infusion. The pump can be configured for adult or paediatric use, for specific drug delivery route and for any of three modes of operation depending on the drugs being delivered. Safety features include secure user access codes, lockbox, keypad lock, alarms, pre-set maximum rate limit and administration set, colour-coding (optional).

The mode of operation your pump is configured to is Lock On: the pump will deliver the syringe volume confirmed, over the fixed (locked) duration. Once a syringe is detected and confirmed, the pump calculates the ml/hr Infusion rate:

      Syringe volume
                                    = ml/hour infusion rate
      Fixed duration                                 

The pump calculating the hourly infusion rate prevents programming errors and makes setting up an infusion very simple as the user is not required to enter data/numerals during infusion set up/programming, however the user must check, change and/or confirming information and programming screens. This includes checking that the programme summary screen (showing duration, syringe volume and the calculated rate) matches the prescription before starting the infusion.

Start up Sequence : Prime and Load or Load and Prime ?

Step 3

Check the pump to ensure that the device is clean, visually intact and appropriate for the intended use

Step 4

Check the battery and placement.

Always use a 9 volt alkaline battery. Battery supplied By BGH is an Energiser Industrial. Although Duracell is recommended in FSN the batteries are manufactured to the same dimensional specification so Energiser Battery is Okay to use. There is some variation in size between different brands of batteries.

Please Never try to force a battery into the battery compartment as this may damage the battery contacts.

To insert the battery into the pump:

Push the battery into the compartment taking care to ensure that the battery + / - contacts are aligned on the label inside the compartment.

Remember the BGT syringe pump requires annual maintenance and calibration and needs to be returned to Medical Electronics Department when requested

Before loading the syringe check the battery power. If the battery is less than 40%-50% (In patient areas), choose a new battery: and then press YES/START to confirm.

a) press the INFO key to display the info menu inert pic

In the community, discard the battery if less than 50% remains to ensure the infusion will continue for 24 hours.

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Press and hold down the (ON/OFF) KEY.

The pump’s identity and palliative care 24 hour appear on the LCD display screen, followed by PRE-LOADING during which the actuator will start to move.

Whilst the actuator is moving, the self-test screen above is briefly displayed. This shows the pumps configuration. During pre-loading the actuator always returns to the position of the last infusion programmed. Wait until the actuator stops moving and load syringe appears.

Use the Forward /back keys (see below) to move the actuator to the position required for loading the syringe.

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It is important to correctly position the actuator at this point to enable the syringe to be loaded correctly later.

For safety reasons, the forward movement of the actuator is limited to short steps: thus repeated depressions of the FF key may be required to move the actuator forward. Backwards movement is not restricted. The barrel clamp has to be down for actuator movement.

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Use the FF/BACK keys to move the actuator into the correct position).

Load and confirm the correct syringe

Ensure the syringe is not connected to the patient at this point. The pump should recognize the brand and size of syringe.

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Uncontrolled flow of medication may occur if the syringe is not correctly or securely fitted to the syringe pump.

Correct placement reduces the start up time when a new infusion is started.

To avoid inadvertent administration of a bolus dose the syringe must be attached to the pump before being connected to the patient.

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The infusion should be checked 15 minutes after set up to ensure that the infusion is progressing. All monitoring of the infusion site and syringe pump should be recorded on the appropriate patient documentation in each healthcare setting. In hospital, hospice/care home 4 hourly &community on each visit. More frequent monitoring is necessary where problems have occurred or are specifically anticipated during the infusion. /where problems are identified, prompt action must be taken.

Step 1: The patient

Are the symptoms controlled?

Is breakthrough medication required?

Is the patient experiencing any side effects from the medication?

Step 2: The cannula site

The subcutaneous infusion site is inspected for the following complications which could affect the absorption of medication and increase the risk of infection

1. bleeding
2. leakage
3. blanching
4. erythema
5. pain
6. bruising
7. hard subcutaneous swelling

If any of the above are detected, the subcutaneous administration set should be removed and the inflamed site treated. A record of observations and interventions should be made in the syringe pump recording sheet. The syringe pump is re-sited and closely monitored.

Infusion site reactions

This may be due to the type of subcutaneous administration set used or it may be due to the combination of drugs in the syringe pump. Drugs such as Cyclizine (Valoid) and Levomepromazine (Nozinan) are some of the more common drugs which can cause site reaction.

Once these causes have been considered the following interventions may be tried: Try an alternative subcutaneous administration set.

Further dilute the drug concentration as is practically possible.

Prescribe 0.5mg-1mg Dexamethasone to the syringe pump contents over 24hours (ensure the Dexamethasone is added last) as recommended by pharmacy.

Divide the drug dose into two syringes and dilute the syringe contents to the maximum volume, then use two syringe pumps to administer the prescribed drug over a 24 hour period.

NB No more than 3 drugs should be used in one syringe pump at any time unless the patient is in a Specialist Inpatient facility i.e. Palliative Care, BGH Margaret Kerr Unit or a hospice setting. Any unusual or extra drug combinations should be discussed with NHS Borders Pharmacy Dept and the Specialist Palliative Care Team in the BGH Margaret Kerr Unit.

If the patient is experiencing break through symptoms a stat, or break through, dose of appropriate drugs can be given because the syringe pump medication will take 4 to 6 hours to reach its optimum plasma level.

It remains the responsibility of each individual practitioner to ensure that the drugs prescribed are suitable for continuous subcutaneous infusion and are stable under these conditions.

The use of medicines outside of the manufacturer’s license (off-label use) is common practice in palliative care (e.g. administration by the subcutaneous route) but carries additional responsibilities for prescribers, pharmacists and nurses. If using off- label medications that have not been specifically indicated for individual drugs, the practitioners should take further advice from pharmacists or Specialist Palliative Care Team. Remember that package inserts included with medicines only refer to the licensed indications, routes and doses.

Single drug infusions–instability is not common however the drug must be:

• Available in injection
• Suitable for subcutaneous
• Stable in the diluting agent for the duration of

Drug combinations–instability and incompatibility may arise when combinations of two or more drugs are used and the following criteria must be met:

• the drugs must be
• the diluting agents must be
• the diluting agents and the drugs must be compatible (see NHS Lothian and Borders Palliative Care Guidelines).

Step 3: The syringe

 Check that the syringe is securely placed in the syringe pump The syringe is inspected for:

• precipitation (separation of a substance forming a solution and a solid).
• crystallisation (solid form e. snowflakes).
• discolouration (cloudiness, opaque or any alteration in colour).

If any of the above are detected, the syringe pump is immediately discontinued and the contents are reviewed by medical staff before the syringe is reconstituted, and re-sited.

Step 4: The Infusion line

 Check for security, kinking and

• Check if the patient has been lying on the

 Step 5: The syringe pump

 Check for physical signs of damage to the pump and/or

• Check the time remaining and the flow rate displayed on the screen is

Record the volume infused and the volume remaining to assess the syringe pump is running on time. Confirm this by visual inspection of the syringe.

In Acute Care and Community hospitals battery checking at each monitoring is not routinely to be done as the battery level is checked and recorded at each infusion set up. In the Community, battery checking must always be undertaken as part of routine monitoring as the patient may not receive another visit for 24 hours or more. If the battery is less than 50% use a new battery.

Press INFO key twice

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The screen should display the battery power level remaining.

Step 6 –Documentation

Record the checks on the Palliative Care (Purple) monitoring chart. Any incidents must also be fully documented in the patient’s notes. If any checks are not carried out (e.g not checking the cannula site as to avoid disturbing the patient’s sleep record this on the monitoring chart.

It is the responsibility of all staff giving direct care, whether a registered practitioner or someone in a support role, to make a note of all encounters and interventions relating to the patient in the appropriate section of the patient’s health record.

( NHS Borders Completion of the Health Records Policy).

The BD Saf -T-Intima single port cannula can remain in situ for up to seven days if the site is intact with no leakage, hardness, inflammation, swelling or discomfort.

When re-sited the new cannula should be placed at least 3cm from previous sites. The used cannula should be disposed of in a sharps container.   A new infusion line should also be used when the cannula is changed.

The infusion line and cannula should be changed when the prescribed medications are changed, to avoid the risk of incompatibility between current and new prescriptions.

If there is only an increase or decrease in the dose of the current medications, then the cannula can remain insitu and only the infusion line changed.

Refer to local policy for the specific brand of administration set and cannula to use with the pump. CME Medical administration sets incorporate the following features:

• Latex-free
• Micro bore anti-kink tubing to prevent occlusion
• Colour-coded to aid identification of administration route 0.5ml priming volume
• Check valve at the distal end of the set to enhance pump functioning by preventing
  • Free-flow in event the set is detached from the pump
  • Free-flow in the event of a mechanical malfunction

The check valve also prevents back flow reflux if several infusion pumps are connected to the patient

When an alarm is activated, an audible alarm sound will sound. The LED light turns red and the screen displays a message and instructions to help identify and resolve problems. Before trouble shooting press YES/START to acknowledge and silence alarm.

Alarm

Trouble Shooting

NHS Borders McKinley T34 Syringe Pump Protocol (2011).

This document is based on evidence from the NHS Borders McKinley T34 Syringe Pump Protocol (2011) which was produced by the following authors:

Judith Smith, Nurse Consultant Cancer and Palliative Care Billy Hogg, Medical Electronics

Samantha Dunlop, Lead Palliative Care Clinical Nurse Specialist

All graphics in the McKinley T34 Syringe Pump Protocol (NHS Borders 2015) have been reproduced with kind permissions from CME Medical and NHS Lothian.

CME Medical T34 Ambulatory Syringe Pump Advanced User Workshop, Device Use and Training Resources (July 2011 v2)

NHS Lothian (2010) Subcutaneous Infusion by McKinley T34 Syringe Pump For Symptom Control in Palliative Care (Adults)

Michelle Scott: Nurse Consultant Palliative Care

Stuart Douglas: Manager – Medical Electronics Department Eileen Nichol: Clinical Pharmacist

Christine Irving: Clinical Practice Lead Jan Turnbull: Clinical Practice Facilitator

Kathy Stewart: Community Nurse Manager Andrea Johnstone: Community Nurse Manager Clare Middlemiss: District Nurse Manager Rhona Morrison: Senior Charge Nurse

Julia Hume: Practice Education Facilitator

Acknowledgements for their contributions.

Please note there are no differences in preparing the different version of T34 Pumps