Setting and Deactivating Alarm Parameters on Clinical Monitoring Devices Guidelines

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1 Setting and Deactivating Alarm Parameters on Clinical Monitoring Devices Guidelines This procedural document supersedes: CORP/RISK 7 v.2 Guidelines for Setting and Deactivating Alarm Parameters on Clinical Monitoring Devices. Did you print this document yourself? The Trust discourages the retention of hard copies of policies and can only guarantee that the policy on the Trust website is the most up-to-date version. If, for exceptional reasons, you need to print a policy off, it is only valid for 24 hours. Author/reviewer: (this version) Date revised: August 2012 Approved by (Committee/Group): Date of approval: 8 May 2013 Date issued: 12 June 2013 Next review date: August 2015 Target audience: Trust-wide Valerie Colquhoun Matron, Anaesthetics and Critical Care Andrew Leverton Medical Technical Services Manager Policy Approval and Compliance Group (on behalf of the Patient Safety Review Group) Page 1 of 8

2 Policy Amendment Form Please record brief details of the changes made alongside the next version number. If the policy has been reviewed without change, this information will still need to be recorded although the version number will remain the same. Version Date Brief Summary of Changes Author Version 3 12 June 2013 Title change Style and format updated in accordance with CORP/COMM 1 Included a contents page Included sections on: - Introduction - Duties and Responsibilities - Monitoring Compliance - Equality Impact Assessment - Associated Trust Procedural Documents Valerie Colquhoun Andrew Leverton Version 2 August 2007 Addition of policy amendment form page 2 MDA reference change page 3 and page 5 Valerie Colquhoun Andrew Leverton Page 2 of 8

3 Contents Section Page 1 Introduction 4 2 Purpose 4 3 Duties and Responsibilities 4 4 Recommended Procedure 4 5 Training 6 6 Faults 6 7 Monitoring Compliance 6 8 Definitions 7 9 Equality Impact Assessment 8 10 Associated Trust Procedural Documents 8 11 References 8 Page 3 of 8

4 1. INTRODUCTION This guideline is for all staff who are competent in the setting up, monitoring and use of medical devices in the Organisation. 2. PURPOSE This is a general principle that applies to all ward and departments who have access to monitoring devices for patients. To ensure safety mechanisms are in place when using clinical monitoring devices on wards and departments throughout the Trust. The following provides guidance in order to avoid adverse incidents involving alarms. 3. DUTIES AND RESPONSIBILITIES All departmental and ward managers are responsible for ensuring that staff are competent in the use of patient monitoring devices including the setting and deactivating of alarms. All staff are responsible for ensuring their own competence in the use of patient monitoring devices including the setting and deactivating of alarms. For further training see CORP/RISK 2 - Medical Equipment Training for Trust Staff. 4. RECOMMENDED PROCEDURE 4.1 All clinical monitoring devices should be used and discontinued according to medical advice and clinical guidelines as available. It is good practice to record its use in the nursing and midwifery care documentation/plan. 4.2 The use of any monitoring devices should only be undertaken by doctors, Allied Health Care professionals, technicians, nurses and midwives who have received appropriate training and are competent and confident in their use. 4.3 Each ward and department will identify which users are permitted to set, inactivate, deactivate or change alarm levels and under what circumstances 4.4 If required, alarm settings should be within agreed limits (agreed between medical/nursing and midwifery staff). Reasons for any deviation from Page 4 of 8

5 recommended parameters should be recorded in the nursing and midwifery care documentation / plan. 4.5 If the alarm sounds, the response must be immediate and the problem identified. The alarm should not be inactivated unless the problem has been identified. 4.6 Alarms on any piece of equipment may need to be deactivated or inactivated during an emergency, or when the patient is moved and during certain procedures, such as changing a tracheal tube or priming an infusion line. In all instances an appropriately trained doctor, nurse/midwife or technician must be with the patient for the time the alarms are deactivated. 4.7 On deactivating an alarm other than from the reasons in paragraph 4.6, a record must be made of this event, including time, duration, reason and signature of staff member, in the nursing and midwifery care plan, nursing and midwifery records, patient notes or on the observation chart as appropriate. However, most equipment has an internal log. 4.8 For general ward use where a device is being used for routine patient observations it is important to ensure that the alarm settings and safety checks are performed at least weekly. This should be documented in an appropriate record. Any faults or concerns should be reported immediately. For patients on frequent or continuous monitoring it is recommended that on each change of nursing and midwifery shifts the alarm settings and other safety checks must be performed by the trained person taking over the patient with the trained person going off duty. This should be documented in an appropriate record. The checking should specifically include: a) Monitoring equipment High / low alarm limits Alarm on/off b) Ventilators Check all ventilator settings compare with observation charts Asset number of ventilator in use-should be recorded on observation chart c) Infusion Devices (Refer to appendices in PAT/MM 1 A & B Policy for the Safe and Secure Handling of Medicines Controlled Drugs) Type of fluid/drug and dose against prescription chart Rate setting on infusion device against prescription chart Total volume infused 4.9 The operator of the device is the responsible person for recording/documenting relevant information. Page 5 of 8

6 5. TRAINING 5.1 All staff using medical equipment must have had the appropriate level of training to enable safe use of the device. Evidence should exist in the form of attendance lists, competency programs, certificates etc. to support the operator. This is should be recorded in the Gold standard folder or equivalent. 5.2 Training on new Medical Equipment should be in accordance with Policy CORP/RISK 2 - Medical Equipment Training for Trust Staff. 5.3 All staff must know where to locate the operators instructions for each piece of monitoring equipment they could be expected to use. The location of the manual is located in the gold standard operating manual on each area. 6. FAULTS 6.1 If practically possible, before reporting a fault check with the operator s manual and perform a system check (if available) or tests for readiness. Referring to the troubleshooting guide can also help solve common problems. 6.2 Verified faults should be recorded and reported in accordance with policy CORP/PROC 1 - Policy for the Use of Medical Equipment Used On-Trial/On Loan to the Service Centre 2828 at Bassetlaw and 3558 at Doncaster. 6.3 Any serious or disruptive faults should be reported using the Trust Adverse Incident procedure. As per policy CORP/RISK 15 Serious Incidents (SI) Policy. 6.4 In line with Infection Control procedure PAT/IC 24 Decontamination Policy, equipment should be cleaned prior to being sent for repair. 7. MONITORING COMPLIANCE What is being Monitored Who will carry out the Monitoring How often How Reviewed/ Where Reported to List of staff who have completed appropriate training Ward/departmental managers Internal Audit Medical technical services Nurse educators Annually Or as new devices are procured into service Supervision of clinical practice. Professional development reviews. Personal portfolios Gold Standard Folder Page 6 of 8

7 Midwives REF: CORP/RISK 7 v.3 Ward/departmental manager will address any shortfalls. Nursing and midwifery and medical documentation of devices recorded whilst in use Ward/departmental managers Internal Audit Medical technical services Nurse educators Matron In line with performance targets and/or as required in response to specific compliance Supervision of clinical practice. CSU Clinical Governance as appropriate via adverse incident reporting. CSU Clinical Governance CSU Audit lead Escalate as required. 8. DEFINITIONS Adverse Incident: An adverse incident is an event that causes, or has the potential to cause, unexpected or unwanted effects involving the safety of patients, device users or other persons. Causes may include: design; user instructions; training and practice; maintenance; storage and use conditions. (Medicines and Healthcare Products Regulatory Agency, DB2006(05) Managing Medical devices Clinical Monitoring Devices: For the purpose of these guidelines, clinical monitoring devices will include; cardiac monitors, pulseoximetry, blood pressure monitors, apnoea monitors, capnographs, electro-mechanical ventilators, infusion devices and other specialised equipment monitoring clinical parameters. Alarms: Different kinds of alarm features may be needed for different devices and purposes. These include warning about the state of the patient, warning about the state of the device, or warning about failures of functionality. There can be auditory alarms, some of which are volume controlled, and visual alarm display (text or flashing light). However, most devices feature both. Inactivation of Alarms: Most devices can have the alarm muted for a limited period of time (usually 1-2 minutes). For the purpose of these guidelines, this is referred to as inactivation of the alarm function. Page 7 of 8

8 Deactivation of Alarms: Some devices have the facility to switch off the alarm function for more than a specific period of time. For the purpose of these guidelines, this is referred to as deactivation of the alarm function. 9. EQUALITY IMPACT ASSESSMENT An Equality Impact Assessment (EIA) has been conducted on this procedural document in line with the principles of the Equality Analysis Policy (CORP/EMP 27) and the Fair Treatment For All Policy (CORP/EMP 4). The purpose of the EIA is to minimise and if possible remove any disproportionate impact on employees on the grounds of race, sex, disability, age, sexual orientation or religious belief. No detriment was identified. A copy of the EIA is available on request from the HR Department. 10. ASSOCIATED TRUST PROCEDURAL DOCUMENTS PAT/MM 1 A & B - Policy for the Safe and Secure Handling of Medicines CORP/RISK 2 - Medical Equipment Training for Trust Staff CORP/PROC 1 - Policy for the Use of Medical Equipment Used On-Trial/On Loan CORP/RISK 15 - Serious Incidents (SI) Policy PAT/IC 24 - Decontamination Policy 11. REFERENCES Reporting Adverse Incidents and Disseminating Medical Device Alerts: DB2006(05) Managing Medical devices Medicines and Healthcare Products Agency Report of the Expert working Group on alarms and clinical monitors (recommendations 11 of Clothier Report, 1995) Page 8 of 8

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