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MHRA Guidelines. Understanding how to improve practice/safety

MHRA Guidelines. Understanding how to improve practice/safety. Catherine Jenkins MCSP, SRP, FRSA Director of Jenx Limited. 30 years experience in manufacturing.

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MHRA Guidelines. Understanding how to improve practice/safety

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  1. MHRA Guidelines. Understanding how to improve practice/safety

  2. Catherine Jenkins MCSP, SRP, FRSADirector of Jenx Limited Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  3. 30 years experience in manufacturing Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  4. Jenx Limited was first recognised as a Quality Process Company under the BS 5750 system and has had continuous recognition since 1987 Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  5. The original Medical Devices Directive has been updated and is currently:Medical Devices Regulations 2002.These regulations came into force on June 16th 2002 Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  6. The MHRA Medical Devices Guidelines were drawn from the Directive. What Guidelines?MHRA Device Bulletin:DB2006(05)November 2006“Managing Medical Devices”Guidance for healthcare and social services organisations Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  7. 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. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  8. Who is the MHRA?The Medicines and Healthcare Regulatory AuthorityFormed in 2003 from the merger of the Medical Devices Agency (MDA) and the Medicines Control Agency (MCA) Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  9. 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. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  10. Why have Guidelines?To regulate the design, manufacture, acquisition, use, maintenance and destruction of Medical Devices. MHRA Device Bulletin: DB2006(05) November 2006 Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  11. 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. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  12. 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 MHRA Device Bulletin: DB2006(05) November 2006 Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  13. “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.” MHRA Device Bulletin: DB2006(05) November 2006 Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  14. The Guidelines themselves are written for Authorities to help them to set up appropriate procedures for acquisition (including prescription), training, use, maintenance and destruction/disposal of medical devices.So what do you need to do to follow the Guidelines? Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  15. Read a copy! Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  16. Make sure that Devices that you use have been properly prescribed, set up, used, maintained and disposed of.How do you do this? Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  17. 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. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  18. Your system will need to cover who is responsible for: - procurement (1) – who decides what medical devices are prescribed and how they will be bought or retrieved from stores. - what criteria do they use to ensure that the correct things are chosen? This will often be you. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  19. Your system will need to cover who is responsible for: - deployment (2) - who makes sure that the correct product, in good working order is delivered to the child and set up properly for them. This will often be you. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  20. Your system will need to cover who is responsible for: - maintenance and repair (3) - who undertakes the regular safety checks and initiates repair when necessary? This may be you or you may need train the school staff or carers to do this. It is essential that all checks, inspections and repairs are fully documented. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  21. Your system will need to cover who is responsible for: - disposal (4) - who decides when a product is beyond economical repair? - who disposes of the product and keeps the records that the product has been disposed of and in what way? Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  22. Starting to get it right. If you have policies that cover the issues above, you will be going in the right direction to improve safety in the procurement, deployment, maintenance and disposal of Medical Devices. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  23. So what is a Medical Device? • “medical device” means an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which – • Is intended by the manufacturer to be used for human beings for the purpose of – • diagnosis, prevention, monitoring, treatment, • alleviation of or compensation for an injury • or handicap. http://www.legislation.gov.uk/uksi/2002/618/pdfs/uksi_20020618_en.pdf (Interpretation: page 5) Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  24. As an Occupational Therapist , 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. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  25. Practical things YOU can do to improve practice and safety. Management Procedures Have a process, written down for how your service does the following: • Decides what equipment to purchase • Services/inspects/maintains what and how often • Decides when products are disposed of and how • Decides how 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. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  26. “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.” Proactive management will result in fewer incidents. MHRA Device Bulletin: DB2006(05) November 2006 Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  27. Safety is planned. Safety doesn’t just happen. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  28. Best practice expects that all aspects of equipment provision are properly planned and recorded. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  29. The following suggestions will help you to improve practice and safety in your provision of equipment to children.You and your service need to address safety in device provision to meet your local needs. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  30. (1) Procurement and (2) Deployment Assessment of a child’s 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. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  31. (1) Procurement and (2) Deployment Delivery Checks The first step in real safety provision comes in the 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, youshould know that these checks have been completed and are retained. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  32. (1) Procurement and (2) Deployment 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. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  33. (1) Procurement and (2) Deployment Delivery Checks Delivery checks are just as important for new equipment as for equipment that is re-issued. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  34. (1) Procurement and (2) Deployment Delivery Checks Products that arrive at a child’s 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. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  35. (1) Procurement and (2) Deployment Delivery Checks Why can’t the rep just set up the equipment? Reps get to know a great deal about getting a good position for a child in their company’s equipment but they don’t know the child. You do. If you are the prescriber of the equipment then you are responsible for how it is used. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  36. (1) Procurement and (2) Deployment 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. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  37. (1) Procurement and (2) Deployment 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. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  38. (1) Procurement and (2) Deployment Delivery Checks Pages 20-25 cover Delivery of a new piece of equipment. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  39. (3) Maintenance and Repair • 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 Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  40. (3) Maintenance and Repair 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. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  41. (3) Maintenance and Repair Planned maintenance will help to prevent accidents. Many products require little beyond cleaning, a visual inspection and replacement or tightening of moving parts. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  42. (3) Maintenance and Repair 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. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  43. (3) Maintenance and Repair 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. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  44. (3) Maintenance and Repair Some elements of products require more careful inspection because their failure is more likely to result in an accident. Webbing and Buckles Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  45. (3) Maintenance and Repair 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. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  46. (3) Maintenance and Repair 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. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  47. (3) Maintenance and Repair 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. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  48. (3) Maintenance and Repair 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. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  49. (3) Maintenance and Repair 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. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

  50. (4) Disposal 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. Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

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