ISO 13485:2016 Medical Devices Training Handbook

Transcription

1 ISO 13485:2016 Medical Devices Training Handbook Presented By Maria Mylonas Page 1 of 16 pages

2 How to use this handbook The handbook is organized to focus on particular skills and revisions. These lessons allow you to learn and practice the skills used throughout the course. The following icons are used in this handbook. Activity Revision exercise or written task Important Important points to remember for the assessment Quick Link or Tip A shortcut, tip, or favourite link Discussion Group discussion activity This intellectual property remains the property of PharmOut Pty Ltd. It is intended for training purposes and its format and contents are copy written by PharmOut For further information go to Page 2 of 16 pages

3 Table of Contents How to use this handbook Terms and definitions Activity 1: Select the Medical Device Activity 2: ISO 13485: Section 4 s Annex A review Activity 3: ISO 13485: Section 5 & 6 s Annex A review Activity 4: Customer Requirements Activity 5: Process validation Activity 6: ISO 13485: Section 7 s Annex A review Activity 7: Corrective and Preventive Actions (CAPA) Activity 8: ISO 13485: Section 8 s Annex A review Activity 9: ISO 13485:2016 considerations for transition Page 3 of 16 pages

4 1. Terms and definitions Source ISO 13485:2016 Term Advisory notice Authorized representative Clinical evaluation Complaint Distributor Implantable medical device Importer Labelling Life-cycle Manufacturer Definition Notice issued by the organization, subsequent to delivery of the medical device, to provide supplementary information or to advise on action to be taken in the: use of a medical device, modification of a medical device, return of the medical device to the organization that supplied it, or destruction of a medical device Natural or legal person established within a country or jurisdiction who has received a written mandate from the manufacturer to act on his behalf for specified tasks with regard to the latter s obligations under that country or jurisdiction s legislation [source: ghtf/sg1/n055:2009, 5.2] Assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer [source: ghtf/sg5/n4:2010, clause 4] Written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety or performance of a medical device that has been released from the organization s control or related to a service that affects the performance of such medical devices Note 1 to entry: This definition of complaint differs from the definition given in ISO 9000:2015. Natural or legal person in the supply chain who, on his own behalf, furthers the availability of a medical device to the end user [source: ghtf/sg1/n055:2009, 5.3] Medical device which can only be removed by medical or surgical intervention and which is intended to: be totally or partially introduced into the human body or a natural orifice, or replace an epithelial surface or the surface of the eye, and remain after the procedure for at least 30 days Natural or legal person in the supply chain who is the first in a supply chain to make a medical device, manufactured in another country or jurisdiction, available in the country or jurisdiction where it is to be marketed [source: ghtf/sg1/n055:2009, 5.4] Label, instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device, but excluding shipping documents [source: ghtf/sg1/n70:2011, clause 4] All phases in the life of a medical device, from the initial conception to final decommissioning and disposal [source: ISO 14971:2007, 2.7] Natural or legal person with responsibility for design and/or manufacture of a medical device with the intention of making the medical device available for use, under his name; whether or not such a medical device is designed and/or manufactured by that person himself or on his behalf by another person(s) [source: ghtf/sg1/n055:2009, 5.1] Page 4 of 16 pages

5 Medical device Medical device family Performance evaluation Post-market surveillance Product Purchased product Risk Risk management Sterile barrier system Sterile medical device Instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of: diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury; investigation, replacement, modification, or support of the anatomy or of a physiological process; supporting or sustaining life; control of conception; disinfection of medical devices; providing information by means of in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means [source: ghtf/sg1/n071:2012, 5.1] Group of medical devices manufactured by or for the same organization and having the same basic design and performance characteristics related to safety, intended use and function Assessment and analysis of data to establish or verify the ability of an in vitro diagnostic medical device to achieve its intended use Systematic process to collect and analyse experience gained from medical devices that have been placed on the market Result of a process [source: ISO 9000:20052), 3.4.2, modified] Product provided by a party outside the organization s quality management system Combination of the probability of occurrence of harm and the severity of that harm [source: ISO 14971:2007, 2.16] Systematic application of management policies, procedures and practices to the tasks of analysing, evaluating, controlling and monitoring risk [source: ISO 14971:2007, 2.22] Minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at the point of use [source: ISO :2006, 3.22] Medical device intended to meet the requirements for sterility Page 5 of 16 pages

6 2. Activity 1: Select the Medical Device Based on Module 1 Introduction Read the following background information: What is a Medical Device? According to ARGMD (V1.1 May 2011) a medical device is... a. any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following: i. diagnosis, prevention, monitoring, treatment or alleviation of disease; ii. diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability; iii. investigation, replacement or modification of the anatomy or of a physiological process; iv. control of conception; v. and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means; or aa. any instrument, apparatus, appliance, material or other article specified under subsection (2A); or ab. any instrument, apparatus, appliance, material or other article that is included in a class of instruments, apparatus, appliances, materials or other articles specified under subsection (2B); or b. an accessory to such an instrument, apparatus, appliance, material or other article covered by paragraph (a), (aa) or (ab). Page 6 of 16 pages

7 1. Select one of the devices below and assess if it is a medical device or not. 2. Refer to any part of the definition provided above. Work in groups (or by table depending on the number of participants). Discuss for minutes, nominate one person to present to the group. Use the space below to record your answers. Select the Medical Device and why? Device 1. Contact Lens 2. Crutch 3. Pacemaker 4. Pacemaker battery 5. Stethoscope 6. Stent 7. Examination bed 8. X-ray machine 9. Barium dye 10. Dentist s examination mirror 11. Replacement hip joint 12. Blood pressure monitors 13. Arm sling 14. Custom-made orthotics Medical Device? Y / N Definition section Page 7 of 16 pages

8 3. Activity 2: ISO 13485: Section 4 s Annex A review Notes: Page 8 of 16 pages

9 4. Activity 3: ISO 13485: Section 5 & 6 s Annex A review Notes: Page 9 of 16 pages

10 5. Activity 4: Customer Requirements Based on Module 4 Product Realisation 1. Select a device from the list in Activity 1 Select the Medical Device. 2. Identify requirements that may be specified by the customer. 3. Identify requirements that may not be specified by the customer. Work in groups (or by table depending on the number of participants). Discuss for minutes, nominate one person to present to the group Use the space below to write down what aspects that you would concentrate on: 1. Medical Device: 2. Requirements specified by the customer: Page 10 of 16 pages

11 3. Requirements NOT specified by the customer: Page 11 of 16 pages

12 6. Activity 5: Process validation Your company manufactures Intravenous (IV) solutions bags. During the QA release process it was noticed that some of the bags had leaked. In groups, review the Diagram 1 complete Section A, B and C. Diagram 1: Process map for manufacturing an IV bag (simplified) Blow fill seal Surface treat Seal and cut Label Finished product Section A: Identify the process step and CQA most likely the source of the faulty bag. Process Step CQA Section B: For the identified CQA list as many CPPs Section C: Select one CPP identified and decide on an acceptance criteria for testing in the PV. Section D: Where in the product lifecycle should these requirements be defined as part of a control strategy? Page 12 of 16 pages

13 7. Activity 6: ISO 13485: Section 7 s Annex A review Notes: Page 13 of 16 pages

14 8. Activity 7: Corrective and Preventive Actions (CAPA) Review the following scenario and answer the questions below. Scenario: An Intravenous (IV) solutions bag manufacturer has a batch of released product returned with visible particulates in the bag. As a part of the risk assessment team you are tasked by the QA manager to determine the root cause of the failure and determine the appropriate Corrective and Preventive actions (CAPAs) to implement. 1. Complete the fish-bone diagram below to determine the root cause of the quality failure. Cause People Method Measurement Effect (describe the problem statement below) Visual particulates observed in bags from released Batch ABC of product IV bags Machine Environment Materials 2. List two Corrective Actions that should be implemented to correct the problem. 3. List two Preventive Actions that should be implemented to avoid the failure in the future. Page 14 of 16 pages

15 9. Activity 8: ISO 13485: Section 8 s Annex A review Notes: Page 15 of 16 pages

16 10. Activity 9: ISO 13485:2016 considerations for transition In groups brainstorm as many ISO 13485:2016 transition considerations you can think of. Document End Page 16 of 16 pages