Topics. CDRH Total Product Lifecycle (TPLC) Transformation. Andrew Steen; Lauren Giles, RAC: Regulatory Insights from FDA 5/30/2018

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1 Regulatory June 1, 2018 Andrew Steen Lauren Giles, RAC FDA/CDRH/ODE/DAGRID/DEDB Topics Highlight of TPLC Transformation Reprocessing of Dental Operative Units and Dental Handpieces 2 CDRH Total Product Lifecycle (TPLC) Transformation Conference 1

2 TPLC Reorganization Goals Create an agile infrastructure that can adapt to future organizational, regulatory, and scientific needs. Facilitate information sharing to help make better informed decisions. Facilitate professional development for all employees by increasing opportunities for cross skills development and creating multifunctional positions. 4 TPLC Reorganization Goals Ensure process and policy consistency. Minimize organizational layers of review and facilitate employee professional development, to achieve more efficient work processes and allow employees to leverage their knowledge of pre and post market information to optimize decision making. Allow the increases in efficiency and organizational flexibility to translate into reasonable employee workloads, so that managers and staff can have healthy work life balances. 5 Value Added for You Improving our internal processes, coordination and communication more straightforward & streamlined interactions with CDRH Consolidating our structure provides you with one stop shopping in many cases Creating a more agile organization better response to changing regulatory needs and new technologies 6 Conference 2

3 Value Added for You Ensuring more consistent policy application across the Office easier for you to know what to expect Streamlining decision making more informed interactions with CDRH staff Creating a better work life balance for our employees increased longevity of your points of contact within the organization due to reduced staff turn over 7 New Design Features Working in teams Team management approach Teams within and across divisions Common management chain for compliance, premarket and surveillance programs Division is the lowest organizational structure Empowering staff by driving decision making to lowest appropriate level Emphasis on professional development & work life balance 8 What Will Change CDRH Office of the Director Office of Communication and Education Office of Compliance Office of Device Evaluation Office of In Vitro Diagnostics and Radiological Health Office of Management Office of Science and Engineering Laboratories Office of Surveillance and Biometrics 9 Conference 3

4 Proposed Structure Office of Product Evaluation and Quality Office of Regulatory Programs Office of Clinical Evidence and Analysis Office of Health Technology (OHT) 1 OHT 3 OHT 2 OHT 4 OHT 5 OHT 6 OIR 10 FUTURE DESIGN: OFFICE OF HEALTH TECHNOLOGY 1 OPHTHALMIC, ANESTHESIA, RESPIRATORY, ENT & DENTAL DEVICES Office Director Malvina B. Eydelman, M.D. Office Staff: Sharene Brash, Damia Jackson, Anahit Khshtoyan, Marisol Lendor, Donna Morgan, Eva Sheridan Deputy Director Kesia Alexander Deputy Director Keisha Thomas Chief Medical Officer Eric Mann Associate Director Denise Hampton Associate Director for Operations Maritze Ortega Associate Director for Professional Development Vacant Assistant Director for Professional Development Shanika Booth Division I: Ophthalmic Devices Director: Vacant Assistant Director: Bradley Cunningham Assistant Director: Tieuvi Nguyen Assistant Director: Vacant Assistant Director: Vacant Division II: Dental Devices Director: Susan Runner Assistant Director: Vacant Assistant Director: Vacant Division III: Anesthesia, Respiratory and ENT Devices Director: Michael Ryan Assistant Director: Todd Courtney Assistant Director: James Lee Assistant Director: Srinivas Nandkumar Assistant Director: Vacant IOL and Accessory Devices Implantable Devices Anesthesia Devices Contact Lenses and Dry Eye Devices Restorative and Surgical Devices ENT Devices Diagnostic and Retinal Devices Glaucoma, Cornea, and Surgical Devices Respiratory Devices Sleep Disorder Breathing Devices 11 Timing Package is being reviewed by DHHS Congress will need to approve We expect clearance to take at least 6 months 12 Conference 4

5 Reprocessing of Dental Handpieces and Dental Operative Units Lauren Giles, RAC Dental Handpiece Regulation Identification Regulation: 21 CFR A dental handpiece and accessories is an AC powered, water powered, air powered, or belt driven, hand held device that may include a foot controller for regulation of speed and direction of rotation or a contra angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth. Consensus Standards ISO Dentistry Handpieces and motors Guidance Document: Guidance for Industry and FDA Staff: Dental Handpieces Premarket Notification [510(k)] Submissions dated May 2, Dental Operative Unit Regulation Identification Regulation: 21 CFR A dental operative unit and accessories is an AC powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair. Consensus Standards ISO Second edition Dentistry Dental units Part 1: General requirements and test methods ISO Second edition Dentistry Dental units Part 2: Air, water, suction and waste water system 15 Conference 5

6 Recent Reported Infections Nontuberulosis mycobacterium (NTM) outbreaks in Georgia (2015) 1 and California (2016) 2 pediatric dental clinics. Pediatric patients who received pulpotomy procedures developed a Mycobacterium abcessus infection. These infections required medical intervention. An investigation determined that this outbreak was caused by contaminated water supplied from the dental unit waterline used during the pulpotomies Non Sterilizable Handpieces CDC Statement on Reprocessing Dental Handpieces issued on April 11, 2018 CDC guidelines for infection prevention and control state that, between patients, dental health care personnel (DHCP) should clean and heat sterilize handpieces and other intraoral instruments that can be removed from the air and waterlines of dental units For non sterilizable handpieces the DHCP should use FDA cleared devices and follow the validated manufacturer s instructions for use for reprocessing (cleaning, lubricating, and/or sterilizing) these devices on reprocessing dental handpieces.htm 17 Reprocessing Concerns Dental Handpieces Cleaning and Sterilization Validation Complex design for cleaning of internal parts Disassembly of handpiece components Detailed description of reprocessing of each component/accessory Sterilizable Manual/Automatic Cleaning Process Dental Operative Units Selection of bacterial challenge for validation Use of disinfection solutions/products (e.g. filters, EPA disinfectants) Duration and frequency of disinfection process Maintenance and use life of dental unit waterline tubing Monitoring of water quality 18 Conference 6

7 Devices Prior to 2015 Reprocessing Guidance Instructions for older, legally marketed, reusable devices may not be consistent with state of the art science Labeling may not ensure device is clean, disinfected or sterile Device may be adulterated; Purity or quality of the device falls below that which it purports or is represented to possess Device may be misbranded; Labeling does not bear adequate directions for use and the device is dangerous to health 19 FDA Reprocessing Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff issued on March 17, egulationandguidance/guidancedocuments/ucm pdf 20 FDA Reprocessing Guidance Labeling VI. FDA s Six Criteria for Reprocessing Instructions Criterion 1.Labeling should reflect the intended use of the device Criterion 2. Reprocessing instructions for reusable devices should advise users to thoroughly clean the device Criterion 3. Reprocessing instructions should indicate the appropriate microbicidal process for the device Criterion 4. Reprocessing instructions should be technically feasible and include only devices and accessories that are legally marketed Criterion 5. Reprocessing instructions should be comprehensive Criterion 6. Reprocessing instructions should be understandable 21 Conference 7

Criterion 5 Reprocessing Instructions should be Comprehensive Special Accessories Point of Use

Visual Inspection Method of Disinfection or Sterilization Reduction of Sterilant Residuals Drying

Accessory Labeling Manufacturer s Contact Information 22 Point of Processing Instructions for

prior to cleaning may be appropriate, as this will facilitate subsequent cleaning steps.

The method may be manual or mechanical (e.g.

8 Criterion 5 Reprocessing Instructions should be Comprehensive Special Accessories Point of Use Processing Disassembly and Reassembly Method of Cleaning Cleaning Agents Rinsing Lubricating Agents Visual Inspection Method of Disinfection or Sterilization Reduction of Sterilant Residuals Drying Reuse Life Additional Labeling Recommendations Patient or Lay Use Reference to Guidelines or Accessory Labeling Manufacturer s Contact Information 22 Point of Processing Instructions for prompt, initial cleaning steps and/or measures to prevent the drying of soil on the device surface prior to cleaning may be appropriate, as this will facilitate subsequent cleaning steps. 23 Method of Cleaning The labeling should provide a detailed, validated method of cleaning. The method may be manual or mechanical (e.g., washer, washer/disinfector, ultrasonic washer) or may combine the two. Cleaning instructions should include a list of the appropriate parameters for each recommended method. 24 Conference 8

Visual Inspection All routine cleaning instructions should include instructions for visual inspection, which may

The instructions should advise the user that if the device is determined not to be visually clean at the end of

9 Visual Inspection All routine cleaning instructions should include instructions for visual inspection, which may include use of magnification and adequate lighting. The instructions should advise the user that if the device is determined not to be visually clean at the end of the cleaning step, the user should either repeat the relevant previous cleaning steps or safely dispose of the device. Additionally, the visual inspection instructions should identify acceptance or failure criteria related to device performance (e.g., unacceptable deterioration such as corrosion, discoloration, pitting, cracked seals), as well as instructions to properly dispose of devices that fail. 25 Method of Sterilization or Disinfection For reusable devices intended to be disinfected or sterilized, reprocessing instructions should specify at least one validated microbicidal method for disinfection or sterilization. 26 Reuse Life The labeling should either 1) inform the user how many times the device can be reused, based on testing; or 2) provide the user with a mechanism or method to ascertain whether the device has exceeded its use life. 27 Conference 9

10 Reprocessing Instructions Examples Contra Angle Handpiece Instructions Prior Frequency Sterilize after each patient Cleaning Rinse the handpiece in water to remove an debris Wipe down external surface of the handpiece with the damp cloth. Lubricate the internal surface of the device Sterilization Put the sterilization bag in the sterilizer and sterilize for 4 minutes at 132 C, and let it dry for 30 minutes. 29 Contra Angle Handpiece Instructions After Frequency Clean and sterilize the handpiece prior to first use and immediately after each subsequent use to prevent drying of contaminates Cleaning Rotate the head in a tap water (<38 C) about 10 seconds with maximum speed to remove the remains(blood physiologic saline solution, etc.) and rinse. Remove contaminants using a nylon brush after soaking for 20 minutes in Enzymatic Detergent. Rinse using the tap water for 3 minutes to remove Enzymatic Detergent of product. Wipe using dust absorbent after the product soaked in alcohol(70%) for disinfection 30 seconds. Use PANA SPRAY Plus to lubricate the internal surface of the device for 2 seconds Sterilization The product is to be wrapped in an FDA cleared sterilization bag prior to sterilization. Put the sterilization bag in the sterilizer and pre vacuum sterilize for 4 minutes at 132 C, and let it dry for 30 minutes. 30 Conference 10

11 Dental Unit Waterlines Instructions Prior Frequency of Cleaning: Occasional Cleaning Disinfection Procedures: 10 parts water and 1 part mouthwash or follow instructions provided for the disinfectant If using distilled water, some type of antimicrobial agent, approved for dental procedures can be added to prevent potential bacterial growth Recommended Disinfectant: Bleach, water, mouthwash (SCOPE), or other 31 microbial agent Dental Unit Waterlines Instructions After Frequency of Cleaning: At the beginning of each day and purge lines after each patient Disinfection Procedures Remove any surface contamination using a disposable cloth/paper towel. Manually disinfect surfaces with disinfectant wipes. Fill the water bottle with fresh water and perform a flush sequence Mix approximately 10% bleach with 90% water Perform a flush sequence and keep bleach mixture in system for minutes than remove then repeat with water Perform a visual inspection to check for damage and wear and tear. Recommended Disinfectant: Warm Water (30 C ±5 C), Mild detergents and 5.25% bleach solution CaviCide/CaviWipes 32 Conference 11

Scope This policy applies to all personnel and departments that clean, prepare and/or sterilize items intended for patient care use.

Scope This policy applies to all personnel and departments that clean, prepare and/or sterilize items intended for patient care use. Dental Sterilization Procedures Policy Number VIM4(4)-10 Purpose The purpose of this policy is to ensure patient and employee safety when using instruments with potential for exposure to bloodborne pathogens