CONF-18-Cheron-Rojo.pdf

1、Findings of an Internal Auditing Study of Insulation Testing Practices to Improve Healthcare Facility Testing Practices and Patient OutcomesCheron Rojo,BS,FCS,CHL,CIS,CER,CFER,CRCSTSenior Clinical Education Specialist,Healthmark IndustriesThe Root-Cause of the AIM September of 2020 my daughter becam

2、e ill Emergency lap appendectomy Facility did not perform insulation testing 7-days later daughter returned to emergency with complications(not related to arching)This incident was a(near miss)Had some data for a 2019 from a preliminary study,published in 2021 Then a more robust study in 2021-2022AI

3、M The aim of the study was to identify how common insulation testing failures and malfunctions are in insulated medical devices used in healthcare facilities.The study is a retrospective cross-section 12-month study that was conducted from May 2021 to May 2022 at 49 healthcare facilities that consis

4、ted of 416 insulted instrumentations.The study was published in the 2023 March/April Edition of the PROCESS Magazine(HSPA).Methods Auditing of random laparoscopic insulated trays Bipolar insulated forceps using an insulation tester with variable power settings and a variety of adapters to fit the in

5、strument being tested.A cable continuity tester was utilized to identify any disruption of the electrical current within reusable monopolar and bipolar cables.An enhanced inspection microscope was used to evaluate the damage identified with the insulation tester and other visible damage observed.NOT

6、E:Personnel at the healthcare facility observing the audit were notified of any failures.Methods Continued A qualitative survey question was administered to operating room nurses randomly across the United States asking if they had experienced events such as arcing of electrical current during a pro

7、cedure.In addition,the FDA MAUDE database was searched for adverse events on insulation failures reported within the same timeframe to determine if any significant patient risk existed.This Photo by Unknown Author is licensed under CC BY-SA-NCfda maude database-Bing imagesLimitations The inconsisten

8、cies between each facilitys insulation inventory and the amount of insulated laparoscopic instruments within a container/tray skewed the percentage of failures.The amount of insulated bipolar forceps a facility could afford to release to test was another factor and made the sample size smaller.There

9、 were also inconsistencies with not all facilities using reusable cables,resorted to single use,and/or a mixture of both,which affected the sample size for that category of instrumentation.Results Of the total 416 instruments tested,223 showed failures on insulation testing or inspection.With 16 fac

10、ilities showing a failure rate of 75%100%of all devices tested.Results On average,insulated cables demonstrated a 6%failure rate for continuity across 32 facilities.Results Bipolar forceps had the highest failure rate with 27 facilities having a 75%100%failure rate for those devices Results In one o

11、f the 27 facilities,19 insulated bipolar forceps were tested from ready-to-use backup inventory.13 of the 19 were identified as having insulation failures Results For the qualitative aim of the study,operating room(OR)nurses were asked about their personal experience with insulation malfunctions dur

12、ing a surgical procedure during their career.A total of 66 responses were received by respondents:Yes:42.24%(28/66),No:54.55%(36/66),N/A:3.03%(2/66).Results 07-26-2021:an insulated laparoscopic handle was found to have an insulation integrity failure and,“it was reported that product arced resulting

13、 in blisters to the patients skin.”08-10-2021:an insulated laparoscopic 34CM Cautery Probe was identified with damage to the insulation coating and,“the instrument melted and arced from the side,burning an unintended portion of the liver.”03-15-2022:a monopolar-HF cable“reportedly exploded during th

14、e procedure and burnt towards the end where the HF cord connects to the generator unit,and a minor deformation/kink was noted on the cable.”Concurrent Adverse Events(FDA)Food&Drug Administration,Maude Reporting System(United States)Results 07-26-21Insulated Handle 08-10-21 Laparoscopic Instrument 03

15、-15-22 Monopolar CableInstruction-For-Use in(Adverse Events Reported)“inspect for burns,cuts,and abrasions in the electrical insulation on the insert and/or the handle for instruments equipped with electrosurgical capabilities.”“These instructions were developed using the guidance from AAMI TIR 12,I

16、SO 17665,and AAMI ST79,and(_)recommends users observe these standards.”“Conduct a visual and functional inspection of the device per the Assembly and Disassembly instructions.”“Insulation failures may result in burns or other injuries.Visual inspection alone may not be sufficient to confirm that the

17、 insulation is intact,and dielectric strength testing should be additionally considered.”“Visually inspect the cable and the plugs for irregularities on the surface,”“Before use make sure that the product has been properly reprocessed,inspected,and tested.”Contributing Factors from the Results The r

18、esults shown revealed that there were numerous contributing factors to unnoticed insulation damage.The factors included:Inadequate magnification to clearly identify the damage(e.g.,only standard lighted magnification and not enhanced magnification microscopes to visualize at a higher magnification).

19、Insufficient insulation testers lacking the sensitivity and the ability to test a wide range of insulated instrumentation(e.g.,bipolar forceps).Damaged and missing accessories and insulation unit.Lack of education for technicians in identifying damage and operation of the insulation testers.Contribu

20、ting Factors from the ResultsFactors also included:Deficient containers/trays housing insulated laparoscopic instrumentation or correct container/tray but with the overflow of insulated instruments damaged by mixing with metal instrumentation.Inappropriate storage for backup insulated instruments(e.

21、g.,bins too small,excess amount of instrumentation,and tight spaces).Contributing Factors from the ResultsFactors also included:Insufficient repair service for insulated instrumentation(e.g.,poor repairs,not in the contract,not frequent enough).Contributing Factors from the ResultsInsufficient repai

22、r service included the following:Pull back(new damage)at the distal end of laparoscopic insulated instrumentation with no fraying for non-take-apart Pull back(old damage)at the distal end for laparoscopic instrumentation that has frayed insulation for non-take-apart Insulation layover Hangnail Effec

23、t,where the insulation is laid over the distal working mechanism instead of being flush against it.Over time,this can cause the insulation to separate and/or pieces of the insulation to fray and pull back like a hangnail Contributing Factors from the ResultsInsufficient repair service included the f

24、ollowing:Pull back at the proximal end for laparoscopic instrumentation that has separated from the base/handle for non-take-apart Newly insulated laparoscopic instrumentation with a glossy look and bumps along the shaft This is an insufficient repair where the inner insert was not completely cleane

25、d/removed of old insulation,then insulated over the existing pieces.Contributing Factors from the ResultsInsufficient repair service included the following:Worn and weathered(old damage)nicks,scratches,and gouges on insulated instrumentation Insulation(old damage)that is gray,white,dull in color,and

26、/or fuzzy for all insulated instrumentation Contributing Factors from the ResultsInsufficient repair service included the following:Separation or excessive amount of epoxy resin that lifts from the base at the proximal end of an insulated bipolar forceps where the base connects to the tins of the fo

27、rceps Conclusion The study identified numerous failures in insulation integrity found in patient-ready instruments and trays awaiting assembly,which is a clear patient safety risk.These failures highlight the need for improved internal testing practices,audits,and continuing education on insulation

28、testing practices.A robust quality system consisting of a high-quality insulation testing program will decrease adverse events in the patient population and healthcare staff related to stray electrical energy in insulated devices,which can cause burns,fires,shocks,and even death.References1.United S

29、tates Food and Drug Administration.Maude Adverse Event Report:Stryker Endoscopy-San Jose PKG,5mm PEEK HANDLE,45CMEndoscopic Grasping/Cutting Instrument,Non-Powered.Event date July 26,2021.Accessed May 5,2022.(fda.gov).2.United States Food and Drug Administration.Maude Adverse Event Report:Microline

30、Surgical Inc.Renew Electrocautery Probe,34CM,Reusable Manual Detachable Surgical Instruments.Event date April 09,2021.Accessed May 5,2022.(fda.gov).3.United States Food and Drug Administration.Maude Adverse Event Report:Olympus Winter&IBE GMBH HF Cable,Monopolar HF-Cable.Event date March 15,2022.Acc

31、essed May 5,2022.(fda.gov).4.United States Food and Drug Administration.Recommendations to reduce surgical fires and related patient injury:FDA safety communication.Published May 29,2018.Accessed February 2,2021.https:/www.fda.gov/medical-devices/safety-communications/recommendations-reduce-surgical

32、-fires-and-related-patient-injury-fda-safety-communication.5.International Association of Healthcare Central Service Materiel Management/Healthcare Sterile Processing Association IAHCSMM/HSPA.Complex Surgical Instruments.In:IAHCSMM Instrumental to Patient Care:Central Service Technical Manual.8th ed

33、.International Association of Healthcare;2016:203242.6.Guideline for instrument cleaning.In:Guidelines for Perioperative Practice.Denver,CO:AORN,Inc;2022:436-438.7.ANSI/AAMI ST79:Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities,Amendment A.2(2020).Arlingto

34、n,VA:Association for the Advancement of Medical Instrumentation;2017.8.Millennium Surgical.100-Series Electrosurgical Bipolar Coagulating Forceps Instructions for use/Revision A.August 2020.9.V.Mueller.Bipolar Forceps and Accessories.Instruction for use/Revision February 2021.10.KARL STORZ Endoscopy

35、-America,Inc.CLICKLINE Insulated Outer Tube 5 mm x 30 cm Instruction for use/Revised August 2014.11.ELMED Reusable Monopolar and Bipolar Cables Recommendations for Maintaining Cleaning and Sterilization Instructions for use/RevisedOctober 2021.12.MICROLINE Surgical Inc.ReNew 34CM Reusable Laparoscop

36、ic Handpieces Instruction for use/Uploaded October 2021.13.Stryker Endoscopy Laparoscopic Manual Instruments IFU,5 mm x 33 cm Micro Grasper,Instruction for use/Revised December 2015.14.OLYMPUS HF Monopolar Cable AO393,instruction for use/revised January 2020.Thank youCheron Rojo,BS,FCS,CHL,CIS,CER,CFER,CRCSTSenior Clinical Education Specialist,Healthmark Industries