Obtaining Manufacturer s IFU: Challenges and Barriers

Transcription

1 2011 AAMI/FDA Medical Device Reprocessing Summit 1 : Obtaining Manufacturer s IFU: Challenges and Barriers Rose Seavey RN, BS, MBA, CNOR, CRCST, CSPDT

2 ANSI/AAMI ST79:2010 & A1: Cleaning and other decontamination processes 7.1 General rationale The type of decontamination required for a particular contaminated device depends on the biohazard that the device presents. The cleaning and/or microbicidal process appropriate for a particular device depends on a) the device manufacturer s written instructions; b) the necessary level of microbial kill c) the design of the device 2 NOTE. Device manufacturers have the responsibility to provide complete and comprehensive written instructions for the decontamination of their products, as well as a summary and interpretation of test results verifying that their products can be safely and effectively decontaminated. See AAMI TIR12 and FDA (1996a).

3 ANSI/AAMI ST79:2010 & A1:20107 Cleaning and other decontamination processes Manufacturers instructions The written instructions of the device manufacturer should always be followed. The reusable medical device manufacturer is responsible for ensuring that the device can be effectively cleaned and sterilized The device labeling should identify specific methods of cleaning and sterilization that have been validated by the manufacturer. The manufacturer s written instructions should be kept on file and periodically reviewed for any updates. If there are no specific instructions in the labeling, then the manufacturer should be contacted directly to provide a documented method. See also Annex D, AAMI TIR12, and FDA (1996a). 3

4 ANSI/AAMI ST79:2010 & A1:20107 Annex D 4 User verification of cleaning processes The U.S. Food and Drug Administration (FDA) places the primary responsibility for developing and validating methods for effective reprocessing of a reusable medical device on the manufacturer of the device. The manufacturer is expected to validate that the device can be cleaned and disinfected or sterilized adequately to allow the device to be reused.

5 AAMI TIR12:2010 Designing, testing, and labeling reusable medical devices Manufacturers of reusable medical devices have the responsibility to support product label claims of reusability by providing complete and comprehensive written instructions for the handling, cleaning, disinfection, testing, packaging, sterilization, and, if applicable, aeration of their products. Manufacturers also have the responsibility to conduct and document any testing necessary to validate the suitability of these instructions. Manufacturers have these obligations under U.S. Food and Drug Administration (FDA) labeling regulations (21 CFR 801). Health care personnel have the responsibility to obtain and review manufacturers data and recommendations and to ensure that they have the necessary resources to follow manufacturers instructions thoroughly. 5

6 AAMI TIR 30:2003 A compendium of processes, materials, test methods, and acceptance criteria 1.2 Inclusions This TIR covers the validation of cleaning processes for medical devices that are intended and labeled by the manufacturer for reprocessing and reuse. 6 Manufacturers of reusable medical devices must provide validated cleaning instructions with their products in order to comply with U.S. Food and Drug Administration (FDA) regulations and, more importantly, to ensure that their products can be properly cleaned and sterilized in health care facilities Three types of risks are associated with the reuse of a medical device: (a) risk of disease transmission from one patient to another (b) risk of inadequate or unacceptable device performance; and (c) risk of occupational exposure to bloodborne pathogens

7 IFU Challenges and Barriers Frequently difficult to obtain Sometimes: Vendors are not always knowledgeable about current published standards regarding reprocessing, Provide inaccurate information or refuse to give IFU in writing Do not communicate updates or modifications to their IFU unless specifically asked and then sometimes only if you ask the right person Example one of the most difficult surgical items to clean 7

8 Flexible Intramedullary Reamers 8

9 Flexible Intramedullary Reamers 9

10 Flexible Intramedullary Reamers 10 Picture provided by Spectrum Surgical.

11 11 Tightly coiled metal harbor debris such as bone. Pictures provided by Spectrum Surgical.

12 12 Pictures provided by Spectrum Surgical.

13 Obtaining Flexible Reamers IFU for Cleaning March 3 rd (Wednesday) contacted ABC Company Orthopedic Quality Assurance Sterilization Sciences via phone and asked for cleaning and sterilization instructions Promised to send electronic copy March 5 th document (Friday) ed - but forgot to attach a copy of the I responded with a note - you forgot the attachment 13 March 8 th (Monday) attached a document however it a one page generic document - Recommendations of sterilization of the ABC Company Orthopedic Reusable Devices: All hip, spine, and trauma devices should be sterilized using these parameters Nothing about how to clean

14 Obtaining Flexible Reamers IFU for Cleaning March 9 th (Tuesday) Thank you for sending me the recommendations for sterilization for Orthopedics Reusable Devices. However, what I really need is the cleaning and decontamination written recommendations specifically for ABC Company I.M. Flexible Reamers Response attached a 10 page document Instructions for reprocessing ABC Company reusable devices March 10 th (Wednesday) 14 This is pretty generic. Is there any specific for the IM flexible rods. They are really, really difficult to clean and there should be more specific instructions for this particular product.

15 Obtaining Flexible Reamers IFU for Cleaning 15 March 12 th ( Friday) Response from Sterilization Sciences I spoke to the contact at ABC Trauma and they said there is no such specific set of instructions to clean IM Flexible Rods. ABC only provides corporate policies, in respect to sterilization, which I have already provided to you. Unfortunately, due to the nature of this topic, I am not at liberty to provide further instruction or suggestions as means to accomplish cleaning a medical device instrument.

16 Obtaining Flexible Reamers IFU for Cleaning 16 March 12 th (Friday Response from Sterilization Sciences con t) Ultimately, you are looking for a protocol for the removal of medical waste. I believe the burden is placed on the hospital, which can be broken down into two parts: 1. Hospital approved chemicals that are capable of cleaning the instrument while maintaining the instrument's integrity. 2. A technique, device/machine, and or system to remove medical waste residuals ABC company only provides the sterilization instructions. If there is any other information you need, please let me know and I will do my best to provide it to you.

17 Obtaining Flexible Reamers IFU for Cleaning 17 March 24 th (Wednesday) Obtained a copy of 123 Company s IFU for flexible reamers Sent to ABC Company as an example Threatened to report to MedWatch: The FDA Safety Information and Adverse Event Reporting Program March 25 th (Thursday) I contacted a colleague I knew at ABC company and explained the situation. Promised to get me a better document.

18 Obtaining Flexible Reamers IFU for Cleaning 18 March 26 th (Friday) Received extended recommendations for cleaning of ABC Orthopedic IM Flexible Reamers from the Senior Microbiologist at Sterilization Sciences dated January 27, 2008! due to the complexity of the Intramedullary Flexible Reamers, a list of additional recommendations is provided upon request of the end user. The following outlines the procedure to effectively clean and remove medical debris from Intramedullary Flexible Reamers 23 days total and this was for one device!

19 Recommendations for Requirements 19 IFUs need to be readily available Clear, specific to the items (if complicated device) Categories of instruments Design consideration FDA labeling Like items standardized Updates or modifications notifications Consistent and timely Vendors reps: Knowledgeable about current published standards Provide accurate information, and specific IFU in writing HC professionals Obtain specific IFUs Use MedWatch: The FDA Safety Information and Adverse Event Reporting Program

20 Evidence Based References TJC, CDC, CMS does not specifically reference AAMI and AORN. Why? NPSG EP3: 20 Implement policies and practices aimed at reducing the risk of surgical site infections. These policies and practices meet regulatory requirements and are aligned with evidence-based guidelines (for example, the Centers for Disease Control and Prevention (CDC) and/or professional organization guidelines). (Joint Commission, 2010b) (CDC 7/11) Guide to Infection Prevention in Outpatient Settings the reader is referred to other CDC and HICPAC guidelines and websites for more detailed information and for recommendations concerning specialized infection prevention issues (e.g., sterilization and disinfection of equipment,...). Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

21 Thank you 21