Update on Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care

Transcription

1 Update on Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Terrell Cunningham, BSN, RN Scientific Reviewer, Team Leader Personal Protective Equipment Infection Control Branch Division of Anesthesiology, General Hospital, Infection Control and Dental DevicesCenter for Devices and Radiological Health March 31,

2 Key Efforts Draft Guidance Published June 2015 Final Guidance Published December 8, 2015 Webinar on the Guidance January 21, 2016 AAMI-Protective Barrier & ASTM F23.40 Joint Meeting April 19, 2016 Proposed Joint CDC/FDA Gown Workshop (Pending) Plan to Update 1993 Gown Guidance Document (Pending) 2

3 Background CDRH published Guidance for Surgical Gowns & Drapes 2000 All other surgical apparel other than surgical gowns and surgical masks exempted from premarket review AAMI PB70 liquid barrier categorization published, recognized by FDA in 2004 January 2015-NIOSH released results of study of Isolation gowns used in health care settings 3

4 Guidance Scope Limited to gowns making liquid barrier protection claims and intended for use in health care settings. Minimal or Low Barrier protection ANSI/AAMI PB70 Level l protection or equivalent; or ANSI/AAMI PB70 Level2 protection or equivalent. Moderate or High Barrier protection ANSI/AAMI PB70 Level 3 protection or equivalent; or ANSI/AAMI PB70 Level 4 protection or equivalent 4

5 Class II Gown Subject to Premarket Notification Submission [510(k)] Surgical Gowns Surgical Isolation Gowns Isolation Gowns are Class I devices but become Class II devices if additional claims are made, such as moderate or high barrier function claims Isolation Gowns with such barrier function claims are defined as surgical isolation gowns 5

6 FDA Premarket Review of Gowns 1993 guidance document for surgical gowns 2015 guidance document for surgical gowns Performance Testing Resist blood and liquid penetration - ANSI/AAMI PB70 Safety Testing Biocompatibility Sterilization method and validation (surgical only) ( Other properties: physical strength, comfort, heat dissipation, vapor transmission, linting, flammability, dyes 6

7 FDA Expectations for Manufacturers Manufacturers proposing to market or those currently marketing Class II gowns as described in this guidance should: Submit a 510(k) for the gown to the Agency within 60 days of publication of the final guidance Have a 510(k) submission for the gown accepted by the Agency for review within 75 days of publication of the final guidance Obtain 510(k) clearance for the gown within 180 days of publication of the final guidance. 7

8 Objectives To understand how the clinical use of surgical and isolation gowns has changed with the development of new technologies and terminology. What are the clinically relevant performance parameters? What exposure are gowns subjected to? Are manufactures and/or health care industry moving to a one-size-fits-all product line? If so do variable exposure conditions matter? 8

9 Objectives To determine the current performance standards are adequate. If not, what are the appropriate, clinically relevant metrics for the current use paradigm? Are the current performance tests appropriate for the intended use of the gowns? AATCC 42 and 127 ASTM 1670 and 1671 Surgical vs. non-surgical/isolation gowns Should there be a review of all testing labs 9

10 Objectives Objective: To determine if the current sampling, validation, and monitoring ensures that existing performance standards are met or should measure be taken to improve compliance, if so, what can be done to improve that compliance? Are the current sampling strategies prescribed in the standard(s) adequate? Testing is typically performed in the design or production validation stage. Is there value in continuous or periodic testing post production phase? Are the current AQL of 4% and RQL of 20% adequate 10

11 Standards for Performance Testing of Surgical Gowns Barrier Performance ANSI/AAMI PB70: Levels of Performance at an AQL of 4% Level 1 AATCC 42:2000 </= 4.5gm Level 2 AATCC 42:2000 AATCC 127:1998 </= 1.0gm >/= 20cm Level 3 AATCC 42:2000 AATCC 127:1998 Level 4 ASTM F 1671:2012 </= 1.0gm >/=50cm PASS 11

12 Objectives Determine if there is a need to revise the definition of an isolation gown? Should open back gowns be included in the definition? 12

13 Discussion/Questions 13