4 What is Medical Device? A medical device - instrument - apparatus - appliances - material - Software - -used alone or in combination -prevent, -Diagnose -treat -disease -any type of injury -modify anatomic function of the body
5 MDAs AIM: Take all reasonable steps To protect: -the public health -safeguard Ensuring medical devices and equipment meet: -appropriate standards -Safety -Quality -performance In European Union.
6 List of Medical Devices: Anaesthetic machines and monitorsApnoea monitors Artificial limbsArtificial eyes Blood transfusion and filtration devicesBreast implants Cardiac monitorsCardiopulmonary bypass devices Clinical thermometersCondoms Contact lenses and prescribable spectacles CT scanners DefibrillatorsDental equipment and dentures Dental material and restorativesDiagnostic X-ray equipment DialysersDressing and wound healing devices Electrosurgery devicesEndoscopes Enteral and parenteral feeding systemsEquipment for disabled people Examination glovesFetal monitors
7 Hearing aids and insertsHeart valves Hospital bedsHydrocephalus shunt Incontinence padsInfant incubators and warmers Infusion pumps and controllersIntra-uterine devices Intravascular catheters and cannulaeLaboratory equipment covered by IVD directive LithotriptersMedical textiles, hosiery and surgical supports Medical lasersOperating tables Orthopaedic implantsOstomy and incontinence appliances PacemakersPhysiotherapy equipment Prescribable footwearPressure sore relief devices Radiotherapy machinesResuscitators
8 ScalpelsSpecial support seating SphygmomanometersSuction devices Surgical instruments and glovesSutures, clips and staples Syringes and needlesUltrasound imagers Urinary catheters, vaginal speculae and drainage bags Ventilators Walking aidsWheelchairs
9 Which are not medical devices? TOILETRY AND COSMETICS PRODUCTS PERSONAL PROTECTIVE EQUIPMENT OTHER EQUIPMENT
10 Facts about MDA…. Headed by Chief Executive, appointed by the Secretary of State for Health Established as a part of NHS in 1948 Change to Agency status in 1994 The majority of MDA's 140 staff are specialists: Medical and nursing staff, professionally qualified technologists and scientists
11 Activity Areas: Clinical (Medical and Nursing) Device Technology and Safety Device Evaluation Service European and Regulatory Affairs (ERA) The Agency - through ERA - represents the UK on all regulatory matters affecting medical devices
12 European and Regulatory Affairs (ERA): Negotiating within the European Union creating three Medical Directives to set and check Safety and performance requirements for medical devices and procedures
13 The Three Directive: 1. ACTIVE IMPLANTABLE MEDICAL DEVICES DIRECTIVE 90/385/EEC: Covers all power medical devices implanted and left in the human body E.g. pacemakers implantable defibrillators, implantable infusion pumps 2. MEDICAL DEVICES DIRECTIVES 93/42/EEC: Covers most other medical devices E.g. simple bandages orthopedic implants high-technology radiology equipment.
14 3. IN VITRO DIAGNOSTIC MEDICAL DEVICES DIRECTIVES 98/79/EEC: Covers any medical device Reagent/kit Instrument Apparatus, etc. used in-vitro for the examination of substances e.g blood grouping reagents pregnancy testing Hepatitis B test kits
15 These Directives… Ensured: 1.A device does not compromise the clinical condition or safety of the patient 2.A device achieves its intended purpose 3.Benefits overweighs minor risks Introduced controls for: 1.Manufacturing 2. Labelling 3. Packaging of devices 4. Preclinical and clinical assessments Specified action to be taken if any adverse incident releated to device
16/45 ADVERSE INCIDENTS: ROLE OF MHRA (DEVICES)
17 What is an Adverse Incident (AIs)? Event causing, or has potential to unexpected unwanted effects Affecting The safety of patients, users or other persons. For example: injury treatment interrupted medical device failure or its misuse misdiagnosis
18 Causes of AIs: shortcomings in the design or manufacture of the device itself inadequate instructions for use inadequate servicing and maintenance locally initiated modifications or adjustments inappropriate user practices (which may in turn result from inadequate training) inappropriate management procedures the environment in which a device is used or stored selection of the incorrect device for the purpose.
19 Events in AIs Reporting: Database Records Referral to another agency Recording as information only Linking to existing investigations Investigations Death and serious deterioration in health (or potential for such) – Section investigations Minor injury or no injury (with low potential for more serious injury) – standard investigations Review of investigations MHRAs safety warnings
20 The Biological Safety Assessment: Necessary for the assurance of biological safety Carried out before any clinical investigation is commenced The manufacturer of a device is responsible for documenting the results of the biological safety analysis
21 Application made to the Competent Authority 60 days before the investigation begins no objection raised by the UK Condition: Competent Authority within the 60 day time constraint. Ethics Committee opinion required for each participating centre, soughed by the investigator. Compliance demonstration requires clinical data Clinical Investigations:
22 When is Clinical Investigation required? Introduction of completely new concept of device into clinical practice where components, features and/or methods of action, are previously unknown Existing device is modified affecting the clinical performance and/or safety of the device Device incorporates materials previously untested in humans, where existing materials are applied to a new location in the human body
23 Device proposed for a new purpose of function In vitro and/or animal testing of the device Who do not mimic the clinical situation New manufacturer of a high risk device In Special circumstances like: 1.Change in the intended use/performance claims of a device 2. Comparative studies 3. Prototype devices
24 Documents Required for clinical investigation: GENERAL INFORMATION DETAILS ALLOWING DEVICE TO BE IDENTIFIED OTHER DEVICE DETAILS GENERAL INFORMATION CLINICAL INVESTIGATION PLAN DATA COLLECTION / ANALYSIS / STATISTICS
25 Appeal Procedure: MHRA developed an appeals system for manufacturers who wish to challenge regulatory decision not already covered by a legislative right of appeal. WHO MAY APPEAL? Any manufacturer, an authorized representative, a supplier or Notified body subject to the regulations.
26 Appealing for? –clinical investigation notification –notified body designation –applications for exceptional use of non- complying device –restriction notice –suspension notice –prohibition notice –notice to warn No administrative complaint is dealt with. The handling of such complaints is described in the MHRA Code of Practice copies.
27 How to appeal? Within three month regulatory decision from Secretary of State Chief Executive (CE) consider the basis upon which the regulatory decision was made within four weeks of receiving the appeal notice if CE thinks further investigation required then matter referred to IA (Independent Assessor) otherwise not
28 CLASS I DEVICES: Administration Dental Diagnostic Dressings Equipment and furnishings Ophthalmic Orthoses and prostheses Surgical Walking aids and wheelchairs Waste collection
29 Requirements to manufacture Class I devices: Confirm whether their products fall within Class I Check whether devices meet the Essential Requirements Prepare relevant technical documentation Draw up the EC Declaration of Conformity before applying the CE marking to the devices Implement and maintain corrective actions and vigilance procedure Obtain notified body approval for sterility or metrology aspects of their devices, where applicable Present relevant documentation on request for inspection by the Competent Authority Notify the Competent Authority, in advance, of any proposals to carry out a clinical investigation
30 Custom made devices: Devices are manufactured in accordance with a professionals written prescription for the sole use of a particular patient and are not adapted from mass produced items K 1 Dental Appliances/Prostheses K 2 Hearing Aid Inserts K 3 Prescribed Orthopaedic Footwear K 4 Artificial Eyes K 5 Orthoses And Prostheses - External (Made Direct From Casts/Prescriptions) K 6 Orthopaedic Implants K 7 Maxillo-Facial Devices K 8 Standing And Walking Frames K 9 Ligament And Tendon Repair Implants K 10 Spectacle Frames
31 Requirements to mfg. Custom made devices (a)Chemical, physical and biological properties of the device (B) Infection and microbial contamination (c) Construction and environmental properties (d) Protection against radiation (e) Requirements for medical devices connected to or equipped with an energy source (f)Information supplied by the manufacturer, including labels. As a minimum requirement the labels on a custom-made device must include : The name or trade name and address of the manufacturer, for devices imported into the European economic area (EEA), The name and address of a representative based there Directions Contents of the packaging The words custom-made device.
32 Need for a recall: The hazard arising from the device shortcoming Risk overweighs benefits of the device Recall does not arise when a manufacturer is exchanging of upgrading device in the absence of a safety risk related to a deficiency in the device.
33 Recall Procedure: The return of a medical device to the supplier Device modification by the supplier at the site of installation Device exchange Device destruction Retrofit by purchaser of manufacturers modification or design change
34 What triggers recall? Information depicting unacceptable increase in risk posed by a medical device post-marketing surveillance
35 Notification of Recall: The manufacturer or authorized representative has to notify the CA of each EC member State in which the recall is being conducted For Class I, II, III and IVDs listed in Annex II or those for self testing, manufacturer should notify additionally the CA of the country where their authorized representative reside Notification should be made before and when the recall letter is being issued Where practical MDA should be advised of the recall prior to its initiation
36 Information MDA needs from Manufacturer: Details of the problem Details of the factors giving rise to the recall, including summary of relevant adverse incidents Technical details of the device shortcoming if known Potential hazard presented by use of the device Circumstances under which the device is used and when the hazard may occur Indication of likelihood of hazard occurring Conclusions of tests and other investigations on suspect or other samples if available (draft) recall letter
37 Details of the product whether device is CE-marked and device classification/category; device model name/number and description; batch or serial number(s) of affected devices; manufacturers contact details if reported by distributor; when affected products were distributed; UK customers of affected product; names of other EEA countries affected by the recall the identity of the relevant Notified Body where applicable
38 Implementation of the recall: Manufacturers responsibility for implemention To enable an effective recall manufacturers have a responsibility to: (a) implement an effective post-market surveillance (b) maintain product records (c) establish a recall procedure
39 Decontamination of Medical Devices: The MAC (Microbiology Advisory Committee) Manual addresses aspects of the decontamination This manual is in 3 parts: Part 1- general principles of decontamination, illustrated by some examples of basic decontamination equipment Part 2 - protocols and usage of particular instruments and materials Part 3 - procedures decontamination of different types of medical equipment
40 General principles: The choice of decontamination method may be related to the infection risk associated with the intended use of the equipment The choice of decontamination method will also depend on many other factors including the nature of the contamination, the time required for processing, the heat, pressure moisture and chemical tolerance of the object, the availability of the processing equipment and the quality and risks associated with the decontamination method
41 Protocols: describes an overall system for the decontamination of medical devices and equipment for reuse or prior to inspection, repair or investigation
43 Procedure: Cleaning instructions covers: Instructions - how to dismantle (and subsequently reassemble) the device Generic and brand name of cleaning agents Any accessories which may assist the cleaning process, such as automatic washers, ultrasonic cleaners or brushes
44 Disinfection instructions should cover: Generic or brand-named disinfectants known to be effective and compatible with the device Method(s) of sterilization should cover: The name of the process (e.g. steam sterilization) The type of cycle (e.g. pre-vacuum/porous load) Any relevant cycle parameters (e.g.134-137°C for a minimum holding time of 3 minutes).