BED RAILS: MANAGEMENT AND SAFE USE POLICY MAY This policy supersedes all previous policies relating Bed Rails

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1 BED RAILS: MANAGEMENT AND SAFE USE POLICY MAY 2016 This policy supersedes all previous policies relating Bed Rails 1

2 Policy title Policy reference Policy category Relevant to Bed Rails: management and safe use policy CL67 Clinical Date published May 2016 Implementation date Date last reviewed Next review date Policy lead Contact details Accountable director Approved by (Group): Approved by (Committee): Document history Membership of the policy development/ review team Consultation Nursing, Medical and Clinical Support Staff May 2016 May 2016 May 2019 Kevin Cann, Medical Devices and Resuscitation Lead Sarah Papworth-Heidel, Matron for Falls Prevention and Training Claire Johnston, Director of Nursing and People Medical Devices and Procurement Group May 2016 Quality Committee 17 May 2016 Telephone: Date Version Summary of amendments Sept New Policy May Clear guidance on assessing risk and follow-up actions and meeting the requirements of MHRA Caroline Harris-Birtles, Deputy Director of Nursing Kevin Cann, Medical Devices and Resuscitation Lead Sarah Papworth-Heidel, Matron for Falls Prevention and Training Medical Devices and Procurement Group Deputy Director of Nursing, Deputy Director of Nursing and Research, Consultants, Members of the Medical Devices and Procurement Group, Falls Champions, Senior Service Managers, Professional Leads, Clinical Practitioners and Support Workers DO NOT AMEND THIS DOCUMENT Further copies of this document can be found on the Foundation Trust intranet. 2

3 Contents 1 Trust values 4 2 Policy and governance 4 3 Policy statement 5 4 Executive summary 6 5 Duties and responsibilities 7 6 Definitions 8 7 Risk Assessment 8 8 Assessment of the bed rail 9 9 The Mental Capacity Act and the use of bed rails Incidents, Reporting and Investigation Maintaining and Servicing Medical Devices Training Requirements Dissemination and implementation arrangements Monitoring and audit arrangements Review of the policy References Associated documents Appendices 15 Appendix 1: Equality Impact Assessment Tool Appendix 2: FallStop Review (Bed Safety Rail Trigger for Assessment) Appendix 3: FallStop Bed Safety Rail Assessment Appendix 4: Flow chart for assessing risk of falls from bed 3

4 1. Trust values Camden and Islington NHS Foundation Trust developed its set of six values with more than 500 service users and members of staff. Our values are important to us. They are our promise to patients as well as to each other that we will behave in a certain way, no matter what our job title is or how under pressure we feel. Our commitment to our values makes us who we are. It gives our service users confidence that they will be treated in the most compassionate way possible as they go through their journey to recovery. It also gives us pride in the knowledge we are providing the best care. Our values show that we are welcoming, respectful and kind. Professional in our approach. Positive in our outlook. Working as a team, we are your partner in care and improvement. These values are part of a wider campaign, Changing Lives which is helping to drive up the standards of care across the Trust. In simple terms our values assure our service users that: They will receive a warm welcome throughout the journey to recovery. They, their dignity and their privacy will always be respected. Their care will be founded on compassion and kindness. They will receive high quality, safe care from a highly trained team of Professionals. We work together as a team to ensure they feel involved and offer solutions and choices no decision about you, without you. We are positive so they can feel hopeful and begin their journey of recovery knowing we will do our very best. 2. Policy and governance A policy is an organisational statement of rules and standards which govern performance and actions required to be followed by those in employment by the Trust. A policy provides a framework for the Trust to work within and should specify actions which are required. A policy may include detailed procedures which supply standardized methods of performing clinical or non-clinical tasks by providing a series of actions to be conducted in a certain order to achieve a safe and effective outcome in a consistent method by all concerned. Policies should take account of existing good quality evidence. The Whittington Health Library provides a library service to the Foundation Trust and can assist with literature searches and finding evidence to inform policy and practice. For more information please contact: 4

5 Richard Peacock Librarian Whittington Health Library Good governance lies at the heart of all successful organizations. Good governance helps protect the Trust, its staff and service users from poor decisions and exposure to risks. All Trust policies must be compliant with the relevant statutory legislation, e.g.: the Mental Health Act 1983 (which was amended in 2007) and national expectations, e.g.: the NHS Litigation Authority Risk Management Standards A policy which has not been scrutinized and approved by the appropriate Trust committee but is being used by staff could lead to poor practice being delivered which could potentially harm service users and have consequences for staff. It is therefore essential that in either developing or revising a policy, managers ensure that the proper governance procedures have been followed. By following the correct governance procedures, we all help to reduce risk and assure safe and effective care is delivered to service users. 3. Policy statement This policy has been developed to meet the guidance set out by the Medicines and Health Care Regulatory Agency (MHRA)(2013) Safe use of Bed Rails. This guidance is in place in order to minimise the risk of entrapment in a bed rail as set out by the Department of Health (DoH)(2015) Never Events Policy Framework. There have been serious incidents reported to MHRA. The majority of these involved third party bed rails used on domestic, divan and metal framed beds that have led to injury and death by asphyxiation after entrapment of the head, neck or chest. This policy will describe the following areas around bed rails: What is a bed rail When should a bed rail be used Risks associated with bed rail use including entrapment and falling over the bed rail Risk Assessment around bed rail use Assessment of a bed rail and if it is fit for use Capacity to consent to bed rail use and the use of bed rails under best interest and the Mental Capacity Act (2005) Procurement of beds with integral bed rails, matrasses and bumper rails This policy related to the following Trust Values 5

6 Trust value They will receive a warm welcome throughout the journey to recovery They, their dignity and their privacy will always be respected; Their care will be founded on compassion and kindness They will receive high quality, safe care from a highly trained team of professionals We work together as a team to ensure they feel involved and offer solutions and choices no decision about you, without you We are positive so they can feel hopeful and begin their journey of recovery knowing we will do our very best. Yes/ Yes Yes Yes Yes Yes Yes 4. Executive summary This policy applies to all wards, teams and departments that use bed rails on and off the Trust s premises. This includes bed rails supplied to service users as part of their care in the home. Camden and Islington NHS Foundation Trust requires that all ward and team managers for inpatient and community services take responsibility for the bed rails in their area. Correct management of bed rails and assignment of responsibilities plays an essential part in fulfilling our obligations under the Health and Safety at Work Act (1974), the Provision and Use of Work Equipment Regulations (1998) and The Health and Social Care Act (Regulated Activities) Regulations 2014 (Part 3) (2008). This policy has been reviewed to reflect and meet all recommendations set out by the Medicines and Healthcare Products Regulatory Agency (2013) and the Department of Health (DoH) (2015) Never Events Policy Framework. This policy sets out the systems for managing the use of bed rails in directly managed Trust services within the operational Directorates. The standards set out in this policy should be incorporated into all subcontracts for the provision of services by other organisations. Although not directly applicable to independent contractors and their staff, the standards set out in this policy should be regarded as good practice for these services. Services provided for users of the Trust by other NHS Trusts should follow their own Trust s policy relating to bed rails. Integrated services providing social services equipment should follow social services policies in managing this equipment. This policy aims to: Minimise the risk of a service user falling from the bed 6

7 Eliminate the risk of a service user becoming entrapped in a bed rail Support staff to comprehensively assess risk associated with falls from the bed and risks associated with the use of bed rails To support and ensure that service users are involved in the decision making process of using bed rails if they are able to do so Ensuring that staff are aware that the use of bed rails is a restrictive intervention and that provided the patient has capacity can make the choice on if they should be used Ensuring that for patients that lack capacity around this decision are assessed in accordance with the Mental Capacity Act (2005) Ensure compliance with the MHRA (2013) 5. Duties and responsibilities The Chief Executive has ultimate responsibility for ensuring that mechanisms are in place for the overall implementation, monitoring and revision of policy. The Associate Director, Governance and Quality Assurance, via the Clinical and Corporate Policy Manager, is responsible for ensuring: In conjunction with the Policy Lead identifies resource implications to facilitate implementation and compliance. Training and monitoring systems are in place. Regular review of the policy takes place. Associate Divisional Directors are responsible for implementation of the policy within their own spheres of management and must ensure that: All new and existing staff have access to and are informed of the policy Ensure that local written procedures support and comply with the policy Ensure the policy is reviewed regularly Staff training needs are identified and met to enable implementation of the policy. All Trust staff are responsible for ensuring that they: Are familiar with the content of the relevant policy and follow its requirements Work within, and do not exceed, their own sphere of competence. Medical Devices Lead is responsible for: Reviewing all incidents that occur regarding the failure or harm to a service user that involves the use of a bed rail 7

8 Providing advice around the procurement and servicing of bed rails 6. Definitions For the purpose of this document the term bed rail will be adopted, although other names are often used, such as: bed safety rails, bed side rails, side rails, cot-sides, and safety sides. In general, manufacturers intend their bed rails to be used to prevent bed occupants from falling and sustaining injury. They are not designed or intended to limit the freedom of people by preventing them from intentionally leaving their beds; nor are they intended to restrain people whose condition disposes them to erratic, repetitive or violent movement MHRA (2013) p.5 Rigid bed rails can be classified into two basic types: Integral types that are incorporated into the bed design and supplied with it, or are offered as an optional accessory by the bed manufacturer, to be fitted later Third party types that is not specific to any particular bed model. They may be intended to fit a wide range of domestic, divan or metal framed beds from different suppliers. This type of bed rail should not be used within Camden and Islington NHS Foundation Trust. If you are currently using Third party bed rails contact the Medical Devices Lead to have them changed. 7. Risk Identification 7.1 Identification of Service Users who may require bed rails in the inpatient wards, Stacey Street Nursing Home and the Residential Services Camden Road, Hanley Gardens, Caledonian Road, Highview and Aberdeen Park All service users must undergo a FallStop Review on admission in compliance with the Trust s Assessment and Prevention of Falls Policy The FallStop Review includes the Bed Safety Rail Trigger for Assessment (Appendix 2), this appendix is not the whole FallStop Review just the section mentioned above. This identifies if a FallStop Bed Safety Rail Assessment is required. 8

9 A FallStop Assessment must be completed on admission and reviewed regularly for all service users who are identified as being at risk of falls, in accordance with the recommendations in the Trust s Assessment and Prevention of Falls Policy. The FallStop Assessment also identifies whether a FallStop Bed Safety Rail Assessment is required and the frequency of regular reviews needed. 7.2 Identification of Service Users who may require bed rails in Community Services including Crisis Houses All service users must undergo a Community Services FallStop Review in compliance with the Trust s Assessment and Prevention of Falls Policy If the review identifies a service user has fallen from their bed or may be at risk of falling out of bed, a FallStop Bed Safety Rail Assessment must be completed. If a falls risk is identified, including a fall from the bed, then all appropriate action should be taken to minimise this risk as advised by this policy. 8. Assessment of bed rails Bed rails come with significant risk and the potential gains from using bed rails should be carefully weighed against the risks associated with their use. All service users who are identified as at risk of falling from bed must have a FallStop Bed Safety Rails Assessment completed (Appendix 3). This assessment must be repeated monthly or if there is a significant change in the service users presentation, e.g. significant weight changes, regaining capacity, regains the ability to climb out of bed. All assessment documentation must be scanned and uploaded on to the service user s electronic patient record (EPR) as soon as possible with a clear heading Bed Rails Risk Assessment. A new FallStop Bed Safety Rail Assessment should be completed every time a service user is assessed or reassessed. If the FallStop Bed Safety Rails Assessment indicates not to use the specific bed rails you currently have available, contact the Medical Devices Lead to discuss available options. 9

10 9. The Mental Capacity Act and the use of bed rails The use of bed rails is considered a restriction of movement that cannot be used under the provision of the Mental Health Act (2007). If there is any doubt around the service user s ability to make a capacitated choice regarding the use of bed rails then a Deprivation of Liberty Order needs to be considered. Relatives or carers cannot make decisions for adult patients (except in certain circumstances where they hold a Lasting Power of Attorney extending to healthcare decisions under the Mental Capacity Act 2005). If a service user has capacity to make a choice regarding the use of bed rails this must be followed in accordance with the Trust s Mental Capacity Act 2005 (incorporating the deprivation of liberty safeguards) policy. For full details of this process then please refer to the Trust s Mental Capacity Act 2005 (incorporating the deprivation of liberty safeguards) Policy or contact the Trust s Mental Capacity Act Lead. 10. Incidents, Reporting and Investigation It is recommended that all bed rail incidents are reported on Datix, any incident resulting in moderate harm will have a 72 hour review completed (and if appropriate, a level 1 investigation instigated). All bed rail incidents resulting in severe harm or death will have both a 72 hour review and a level 1 investigation, or level 2 investigation if appropriate, instigated. Serious Incidents relating to falls incidents are reported and investigated in line with the Trust s Incident Reporting Policy and Management of Serious Incidents Policy. All serious incidents must be reported to the service manager and Associate Divisional Director within the division as soon as possible after the incident. During out of office hours, the senior manager on call and on call Director must be made aware of the incident. An online Datix form must be completed and submitted, and should contain as much detail about the incident as is known at the time of reporting. Teams must not delay reporting an incident on Datix even if the details of the incident are not fully known. The Risk and Patient Safety Manager must also be notified of a serious incident as soon as possible after the incident and always within one working day of the incident occurring. 10

11 This section must be read in conjunction with the Trust s Incident Reporting Policy and Serious Incidents Policy 11 Maintaining and Servicing of Medical Devices in clinical areas Medicines and Healthcare Products Regulatory Agency (2013) defines a bed safety rail as a medical device and as such is subject to the same servicing and maintenance schedules. All bed safety rails should be checked for functionality prior to use as described in Appendix 3. All bed safety rails should be added to the teams Medical Devices Inventory and serviced on an annual basis in accordance with the Medical Devices Policy. When the bed safety rails have been serviced a clear identifiable label must be placed on the device to show that the servicing is within date. If any fault is detected with the bed safety rail this should be reported to the Team Leader, Medical Devices Lead and whoever is responsible for servicing the medical device. 12. Training requirements All staff using bed rails should be assessed as competent to do so in accordance with the Trust Medical Devices Competency Assessment. All wards and teams must meet all of the training requirements set out in the Trust s Assessment and Prevention of Falls Policy. 13. Dissemination and implementation arrangements This Policy will be published on the Trust Intranet/Website This policy will be disseminated through the Associate Divisional Directors and Divisional Clinical Directors for each service to the Wards / Team Managers who are responsible for the dissemination and implementation of this policy in their team. 11

12 14. Monitoring and audit arrangements Elements to be monitored Lead How Trust will monitor compliance Frequency Reporting Acting on recommendations and Lead(s) Change in practice and lessons to be shared Requirement to provide a safe environment in relation to provision, maintainance and use of bed rails Ward Manager All bed rails to be included in the medical devices inventory and serviced on an annual basis. They should have a clear and visible servicing sticker on the device that states the last date of service Training L&D Falls audit (part of the Trust s audit linked to the Falls Prevention Policy) 6 Monthly Medical Devices and Procurement Group Quarterly Falls Management Group Required actions will be identified and completed in a specified timeframe Required actions will be identified and completed in a specified timeframe Issues resolved or lessons learnt from issues relating to provision, maintenance and use of bed rails will be shared with the Medical Devices Lead A lead member of the clinical team will be identified to take each change forward where appropriate. Lessons will be shared with all the relevant stakeholders 12

13 15. Review of the policy This policy will be reviewed in April 2018 or following a serious incident recommendation, change in legislation or best practice advice. 16. References Care Quality Commission (2015) Guidance for Providers on Meeting the Regulations. London Houses of Parliament (2002) Medical Device Regulations, London. Houses of Parliament (2008) Health and Social Care Act (Regulated Activities) Regulations 2014 (Part 3), : London. The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 Houses of Parliament (2005) Mental Capacity Act (Chapter 9), London. Medicines and Healthcare Products Regulatory Agency (2013) Safe use of bed rails. London. Medicines and Healthcare Products Regulatory Agency (2015) Managing Medical Devices: Guidance for healthcare and social services organisations. London. NHS England Patient Safety Domain (2015) Revised Never Events Policy and Framework. London. Nursing and Midwifery Council (2015) The Code: Professional standards of practice and behaviour for nurses and midwives. London. 13

14 17. Associated documents Trust Assessment and Prevention of Falls Policy Trust Mental Capacity Act 2005 (incorporating the Deprivation of Liberty Safeguards) Policy Trust Medical Devices Policy Trust Incident Reporting Policy Trust Management of Serious Incidents Policy Trust Clinical Risk Assessment and Management Policy 14

15 Appendix 1 Equality Impact Assessment Tool Yes/ Comments 1. Does the policy/guidance affect one group less or more favourably than another on the basis of: Race Ethnic origins (including gypsies and travellers) Nationality Gender Culture Religion or belief Sexual orientation including lesbian, gay and bisexual people Age Disability - learning disabilities, physical disability, sensory impairment and mental health problems 2. Is there any evidence that some groups are affected differently? 3. If you have identified potential discrimination, are any exceptions valid, legal and/or justifiable? 4. Is the impact of the policy/guidance likely to be negative? 5. If so can the impact be avoided? 6. What alternatives are there to achieving the policy/guidance without the impact? 7. Can we reduce the impact by taking different action? Yes N/A N/A N/A N/A This policy aims to address in particular patients aged over 65 and those under 65 who are considered to be at risk of a falling from their bed due to an underlying condition 15

16 Appendix 2 FallStop Review (Bed Safety Rail Trigger for Assessment) Bed Safety Rail Trigger for Assessment Are their bed safety rails on the patient s bed? Yes If YES complete the Bed Safety Rail Risk Assessment Would the patient potentially benefit from using bed safety rails? Yes If YES complete the Bed Safety Rail Risk Assessment 16

17 ; MENTAL STATE Appendix 3 BED RAILS: MANAGEMENT AND SAFE USE POLICY_CL67_MAY 2016 Family Name: Forename(s): NHS : DOB: / / FallStop Bed Safety Rail Assessment Complete when indicated on the FALLSTOP Review, FALLSTOP Assessment or if bed rails are requested by the patient, relative or carer Bed safety rails should ONLY be used when their benefit outweighs the risk to the service user The service user should decide whether or not to have bedrails if they have capacity Relatives or carers cannot make decisions for adult patients (except in certain circumstances where they hold a Lasting Power of Attorney extending to healthcare decisions under the Mental Capacity Act 2005) If a service user lacks capacity, staff have a duty of care and must decide if bedrails are in the patients best interests SECTION A: Bed Safety Rail Risk Trigger Identify which physical risk and mental state factor describes your patient. Use the grid below to identify the risk of bed rail use, then date the box indicated and follow the instructions to complete assessment. PHYSICAL RISK FACTORS INDEPENDENT PATIENT REQUIRES ASSISTANCE PATIENT IS FULLY DEPENDENT (manages own needs (needs aids to mobilise (requires assistance with all independently) and / or transfer) activities of daily living) CONFUSED AND DISORIENTATED DO NOT USE bedrails DO NOT USE bedrails Use bedrails WITH CARE DROWSY DO NOT USE bedrails Use bedrails WITH CARE Bedrails CAN BE USED ALERT AND ORIENTATED DO NOT USE bedrails Bedrails CAN BE USED Bedrails CAN BE USED UNCONSCIOUS t applicable Bedrails CAN BE USED Bed safety rail trigger category DO NOT USE USE WITH CARE CAN BE USE (delete as appropriate) Directions for further assessment RED CATEGORY DO NOT USE bed safety rails and complete section E ONLY RED CATEGORY and the patient, relative or carer request Bed Safety Rails - continue from section B AMBER CARE CATEGORY and rails are to be raised continue from section B AMBER CATEGORY and bed rails are not used complete section E ONLY GREEN CATEGORY and bed rails are to be raised - continue from section B SECTION B: Benefits versus risk analysis Ensure the benefits of safety rails outweigh the risk and complete the following risk assessment The risk of NOT using Bed Safety Rails The risks of using Bed Safety Rails? Is the patient likely to fall out of bed? Y N Will bedrails affect the patient s independence? Patients may be more likely to slip, roll, slide or fall out of Bedrails can be a barrier to Y N independence bed if they have mobility or eyesight problems or are for patients who otherwise could leave their bed safely confused or drowsy. without help. Is the patient likely to be injured in a fall from Is it possible the patient may climb over the bed the bed? Y N This may be more likely and more serious for older patients, or those who are very ill, or have osteoporosis or take anti-coagulant drugs Will the patient become anxious if bed safety rails are not used? Y N Some patients may be afraid of falling out of bed even though their actual risk is low. 17 safety rails? The severity of injury is increased if the patient climbs over a bedrail and falls from a greater height. Y N Could the patient injure, trap or suffocate if the bed safety rails are raised? Y N Bedrails can cause injury if the patient knocks themselves on them or trap their legs or arms between

18 . BED RAILS: MANAGEMENT AND SAFE USE POLICY_CL67_MAY 2016 BED SAFETY RAIL USE IS RECOMMENDED IF THE RISKS ABOVE ARE GREATER THAN THE RISKS ON THE RIGHT them. There is also a very rare risk of suffocation. Could the bed safety rails cause the patient distress? Y N Rails may distress some patients who feel trapped by them. BED SAFETY RAIL USE IS NOT RECOMMENDED IF THE RISKS ABOVE ARE GREATER THAN THE RISKS ON LEFT If considering using bed safety rails continue from Section C. If bed safety rails are not recommended, DO NOT USE and complete Section E. Family Name: Forename(s): NHS : DOB: / / SECTION C: Is it safe to raise the bed safety rails? Is it Safe? YES NO Do you consider the patient to be a typical sized adult? If a pressure relieving mattress is required, are the bed rails high enough to prevent the patient from rolling out of bed? Has the bed rail been inspected and maintained in the past year and is a sticker present to indicate this? Is the service users weight below the maximum weight capacity of the bed and mattress supplied? Typically kg Are the bed, bed rails and mattress in good working order? Is the bed rail suitable for the intended bed, according to the supplier s instructions? Do the fittings or mattress allow the bed rail to be fitted to the bed securely, so that there is no excessive movement? YES to ALL Bed Safety Rails can be raised One NO or more DO NOT USE BED SAFETY RAILS, consider alternative strategies If bed rails are not in good working order or have not been serviced in the last year, alert team manager Is there an Entrapment Risk? YES NO When the mattress is compressed is the gap between the lower bed rail and the mattress large enough to trap a limb? (the gap should not exceed 120 mm) Is the gap between the bed safety rail and side of the mattress large enough to possibly trap the patients head? (the gap should not exceed 120 mm) Is the gap between the bars of the bed safety rail large enough to possibly trap the patients head? (gaps between bars should not exceed 120 mm) Is the gap between the headboard and the bed safety rail large enough to possibly trap the patients head? (the gap should not exceed 60 mm) If a pressure relieving mattress is required, do the bed rails cause an increased entrapment risk when extra compression is applied to the mattress edge? Rail bumpers reduce the risk of entrapment, BUT if they move the risk is increased. Can the bed safety rail bumpers move easily once fitted? One YES or more DO NOT USE BED SAFETY RAILS, consider alternative strategies NO to ALL Bed Safety Rails can be raised If gaps are present that are larger than specified, please contact the Medical Devices Lead 18

19 SECTION D: Consent & Capacity Does the patient have the ability to understand and weigh up the risks and benefits of bedrails once these have been explained to them Y N If a service user lacks capacity, staff have a duty of care and must decide if bedrails are in the patients best interests and need to consider completing a Deprivation of Liberty Order Discuss the use of bed safety rails with the patient, relative or carer Informed consent gained from the patient for the use of bed safety rails SECTION E: Assessment Outcome tick when completed Y N Decision BED RAILS RAISED BED RAILS LOWERED (delete as appropriate) Assessment completed by (print, signature & designation) If bed rails are in use: Assessment date and time: Provide the patient with the Falls Prevention in an inpatient environment leaflet which includes The correct use of bed safety rails Complete a Bed Safety Rail Care Plan on Carenotes Reassess monthly or if clinical condition changes, complete a new FallStop Bed Safety Rail Assessment Date of next review: Possible alternative strategies: bed alert alarms or increased observations 19

20 Appendix 4 Flow chart for assessing risk of falls from bed Complete FallStop Review upon Admission Is a risk of falls indicated? Y e s N O Complete FallStop Bed Safety Rail Assessment further Action Required Is the use of Bed Safety Rails Indicated? Y E S Does the FallStop Bed Safety Rails Assessment indicate yes or no to Bed Safety Rail use? Y E S N O Use Bed Safety Rails repeat assessment every 30 Days Discuss with Manager around management of Falls Risk without Bed Safety Rails 20

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