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Inspection, Servicing and Management of equipment: are you following the Guidelines.

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Presentation on theme: "Inspection, Servicing and Management of equipment: are you following the Guidelines."— Presentation transcript:

1 Inspection, Servicing and Management of equipment: are you following the Guidelines

2 Learning Outcomes 2 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. LO1 To have a working knowledge of the MHRA Guidelines Managing Medical Devices DB2006(05) as they relate to the Inspection, Servicing and Management of postural support furniture that falls under the Medical Devices Directive. LO2 To have a basic understanding of the types of processes and procedures that individual therapy departments can introduce to help them to comply with the Guidelines and to improve product provision, carer and user training and product maintenance. LO3 To understand how product inspection, service and management improves overall safety, appropriate procurement and efficient use of medical devices. LO4 To understand the need to record and monitor devices and to document their service history, whereabouts and current condition.

3 What Guidelines? MHRA Device Bulletin: DB2006(05) November 2006 Managing Medical Devices Guidance for healthcare and social services organisations 3 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines.

4 The original Medical Devices Directive has been updated and is currently: Medical Devices Regulations 2002. These regulations came into force on June 16th 2002. 4 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines.

5 The MHRA Medical Devices Guidelines were drawn from the Directive. http://www.legislation.gov.uk/uksi/2002/618/pdfs/uksi_20020618_en.pdf 5 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines.

6 These Guidelines grew up from the British response to the Medical Devices Directive. Each country covered by the Medical Devices Directive has an official body that interprets the Directive and issues Guidance for their country to follow. In the UK the official body is the MHRA. 6 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines.

7 Who is the MHRA? The Medicines and Healthcare Regulatory Authority Formed in 2003 from the merger of the Medical Devices Agency (MDA) and the Medicines Control Agency (MCA) 7 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines.

8 What is their role? To protect and promote public health and patient safety by ensuring that the manufacture and use of medicines and medical devices meet appropriate standards of safety, quality, performance and effectiveness. To minimise the risk of new adverse incidents involving medical devices and reduce the risk of those that have already occurred from happening again. 8 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines.

9 Why have Guidelines? To regulate the design, manufacture, acquisition, use, maintenance and destruction of Medical Devices. 9 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. MHRA Device Bulletin: DB2006(05) November 2006

10 In order to know if you are following the guidelines, you need to know what they say about Inspection, Servicing and Management of Medical Devices. 10 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines.

11 11 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. MHRA Device Bulletin: DB2006(05) November 2006 The main reasons that the MHRA believes incidents occur with medical devices are listed in the Guidelines as; Inappropriate management procedures inadequate instructions for use inadequate servicing or maintenance shortcomings in design or manufacture lack of policies for disposal or replacement inappropriate use (including incompatible devices) inadequate training (staff and users/carers) incompatible ancillary equipment inadequate documentation, such as missing service history or instructions for use

12 Unless medical devices are managed proactively, the same type of adverse incidents happen repeatedly. Good medical device management will greatly assist in reducing their potential for harm. 12 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. MHRA Device Bulletin: DB2006(05) November 2006

13 The Guidelines themselves are written for Authorities to help them to set up appropriate procedures to manage medical devices and these include guidance for: 13 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. Acquisition (including prescription) Training Use Maintenance Destruction/disposal of medical devices So what do you need to do to follow the Guidelines?

14 Read a copy! 14 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines.

15 Make sure that Devices that you use have been properly prescribed, set up, used, maintained and disposed of. 15 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. How do you do this?

16 Make sure that your service has a procedure for dealing with all aspects of medical device management. This is not as difficult as it might look. 16 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines.

17 A system will need to cover : 17 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. Who is responsible for: - procurement – who decides what medical devices are bought what criteria do they use to ensure that the correct things are chosen? As a physiotherapist, you will often be the person who prescribes a medical device for a child. You should know how to assess whether a product suits their needs and be able to set that product up for them and adjust it as their needs change.

18 Once a product has been bought or supplied from stores, the round of Inspection, Service and Management becomes vital. 18 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines.

19 Practical things YOU may need to do. 19 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. Decide on what equipment to purchase Decide who services/inspects/maintains what and how often Decides when products are disposed of and how Decide how members of staff are trained in the use of products, including understanding the dangers of using incompatible ancillary equipment Decides how to keep service records up to date and what to enter in to them. Have a process, a Management Procedure written down for how you will do the following:

20 Unless medical devices are managed proactively, the same type of adverse incidents happen repeatedly. Good medical device management will greatly assist in reducing their potential for harm. 20 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. MHRA Device Bulletin: DB2006(05) November 2006 Proactive management will result in fewer incidents.

21 Safety is planned. 21 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. Safety doesnt just happen.

22 Best practice expects that all aspects of equipment provision are properly planned and recorded. 22 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines.

23 The following suggestions will help you to make sure that Inspection, Servicing and Management of Devices is controlled and effective. 23 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines.

24 (1) Procurement and (2) Deployment 24 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. Assessment of a childs needs comes first. This will lead you to a list of criteria for equipment for this child. Assessment of the possible equipment options may be done with different companies or with equipment you already have in stores.

25 (1) Procurement and (2) Deployment 25 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. Delivery Checks The first inspection will be delivery checks.. Pages 20ff of the guidelines explain procedures for safe acceptance of new products including: - Checking that the correct product, complete with usage and maintenance information and any relevant accessories, has been supplied - ensuring that devices have been delivered in good condition and, where relevant, in good working order. You may well be the person who is responsible for these checks. Someone should be doing this and if the product is for your child, you should know that these checks have been completed and are retained.

26 (1) Procurement and (2) Deployment 26 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. Delivery Checks Make sure that you have a robust policy in your service for the local Stores to inform the person who ordered a piece of equipment to be told exactly when it will be delivered to the child. You can then arrange to go and check the product and set it up for the child.

27 (1) Procurement and (2) Deployment 27 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. Delivery Checks Delivery checks are just as important for new equipment as for equipment that is re-issued.

28 (1) Procurement and (2) Deployment 28 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. Delivery Checks Products that arrive at a childs home and are not set up on that day may well be used by the family in an unsafe way. You should aim to be there the day that a product arrives or ensure that the family/school knows to contact you as soon as the product arrives and knows not to use it until you have set it up.

29 (1) Procurement and (2) Deployment 29 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. Delivery Checks Why cant the rep just set up the equipment? Reps get to know a great deal about getting a good position for a child in their companys equipment but they dont know the child. You do. If you are the prescriber of the equipment then you are responsible for how it is used.

30 (1) Procurement and (2) Deployment 30 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. Delivery Checks Asking the rep to set up the equipment in your absence is like the joiner who has come to fit your new windows asking the rep from the tool company to fit the window. You are the one who knows how you want the equipment to be used so you need to make sure that it is used in the way you prescribe.

31 (1) Procurement and (2) Deployment 31 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. Delivery Checks Safe practice requires planning and process. The Guidelines suggest that the prescribing organisation may need to augment the Instructions for Use for particular families and train the families thoroughly before leaving a product with them.

32 (1) Procurement and (2) Deployment 32 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. Delivery Checks Pages 20-25 cover Delivery of a new piece of equipment.

33 (1) Procurement and (2) Deployment 33 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. Delivery Checks Once you have completed your delivery checks and are happy that the correct product, to the correct specification has been supplied, you should record your findings and ask carers to sign to say that they understand how to use the equipment and how to get hold of a competent person should they need to..

34 (3) Maintenance and Repair 34 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. Your service should have a policy for maintenance and repair of all Medical Devices. This should cover: How each device is to be maintained and repaired, and by whom. arrangements for maintenance and repair to be included as part of the assessment process arrangements for the most suitable persons/providers to carry out the work the timescale for planned maintenance the timescale for repairs to be completed

35 (3) Maintenance and Repair 35 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. You need to know what the process is in your service for maintenance and repair. You may be the person who alerts the repair provider to the need to repair a particular product. You may be required to write up a planned maintenance plan for equipment that you provide.

36 (3) Maintenance and Repair 36 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. Planned maintenance will help to prevent accidents. Many products require little beyond cleaning, a visual inspection and replacement or tightening of moving parts.

37 (3) Maintenance and Repair 37 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. Some elements of products require more careful inspection because their failure is more likely to result in an accident. Castors: if these fail, a child could fall out of a product or their product fall over and trap them underneath. Check castors regularly to make sure that they work properly and are not loose.

38 (3) Maintenance and Repair 38 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. Some elements of products require more careful inspection because their failure is more likely to result in an accident. Webbing and Buckles If a buckle breaks or a webbing strap is frayed, the strap will not hold a child in place and they could fall and be injured. Check all straps and buckles daily before a child uses the product. Check there are no frayed ends or broken buckles.

39 (3) Maintenance and Repair 39 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. Some elements of products require more careful inspection because their failure is more likely to result in an accident. Webbing and Buckles

40 (3) Maintenance and Repair 40 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. Some elements of products require more careful inspection because their failure is more likely to result in an accident. Webbing and Buckles Never use a buckle if one of the prongs is missing. It will not hold a child securely.

41 (3) Maintenance and Repair 41 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. Some elements of products require more careful inspection because their failure is more likely to result in an accident. Webbing and Buckles Always replace both parts of a broken buckle as the replacement buckle may be a slightly different design to the one you already have and may not hold securely. This may mean that you need to buy a whole new strap.

42 (3) Maintenance and Repair 42 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. Some elements of products require more careful inspection because their failure is more likely to result in an accident. Missing or broken parts You should never use a product that has missing or broken parts. It will not be safe.

43 (3) Maintenance and Repair 43 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. Some elements of products require more careful inspection because their failure is more likely to result in an accident. Gas springs, hydraulic units and electrical power units. Any malfunction or deterioration in the function of any of these should be checked out by whomever you use in your service to do this. Electrical units should have a written, planned maintenance schedule that is followed and recorded. This is required by law.

44 (3) Maintenance and Repair 44 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. Legal Requirements The legislation of specific relevance to electrical maintenance is the Health & Safety at Work Act 1974, the Management of Health & Safety at Work Regulations 1999, the Electricity at Work Regulations 1989, the Workplace (Health, Safety and Welfare) Regulations 1992 and the Provision and Use of Work Equipment Regulations 1998.

45 (4) Disposal 45 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. It is important that once a product has finished its useful life, it is disposed of in an environmentally safe manner. It is important that products considered to be at the end of their useful life are labelled as such and removed from circulation immediately to prevent them being re-issued to another child.

46 (4) Disposal 46 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. You should have a process that records all the products that you have along with their individual identity number, batch number or serial number. Each product should have a service record and also a record of where it is currently being used and by whom. Each product that is de-commissioned should then be identified as such and the date of destruction recorded.

47 So what makes for safer practice? 47 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. Good record keeping Good training Good maintenance Recorded de-commissioning And planning, planning, planning.

48 48 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. The MHRA Guidelines also cover other aspects of safe Medical Device use. Bulletins on many aspects of product use, warnings about problems and guidance on bed rails, decontamination and adverse incident reporting are also available from the MHRA website.

49 49 Catherine Jenkins APCP 2011 Inspection, Servicing and Management of equipment: are you following the Guidelines. Let nothing happen by accident and dont let accidents happen!


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