INSTRUMENT READINESS

Patient Safety Beneath the 

Surface 

Patricia Hercules, RN, MS 

Director System Clinical Education 

Memorial Hermann Healthcare System 

Houston, Texas, USA

Instrument “readiness” is a patient 

safety issue and is impacted by 

efforts to compensate for lack of 

readiness. 

Diving deep beneath the surface is 

revealing. 

Instrument readiness should be a 

nursing competency and is a “best 

practice.”

12 Hospitals-3 in Medical Center 

Greater than 3000 beds 

20,000 employees 

177 OR suites-3 HVI suites 

75,000 Surgical procedures 

$300 M uncompensated care 

3

Hospitals are in the Spotlight 

The Public is Watching 

The IOM Report-1999 

44,000-98,000 die in hospitals yearly 

The report that caused a frenzy 

The report that caused a national focus to 

increase the knowledge base about safety. 

Learning from errors with reporting 

systems 

Raising performance standards 

Implementing safety systems to ensure 

safe practices at the point of service 

Creating a culture of safety that focuses 

on systems rather than people

Operating Rooms s are in the Spotlight 

The Public is Watching 

The Joint Commission Sentinel Event 

Alerts 

Wrong site, wrong person, or wrong 

procedures 

1998-Initial review of 15 cases 

2001 –report on 150 surgical errors 

reported during procedures 

Unusual equipment or set-ups in the OR 

at 13% 

WHO Surgical Safety Checklist-2008 

Surgery at the rate of 234 M 

procedures/year 

Significant % have preventable 

complications and deaths 

OR Checklist launched-safer surgery 

Clear that sterile, functional, available 

instruments-time out phase

A term used to verify that instruments or 

associated equipment, or both, are 

IMMEDIATELY AVAILABLE 

FUNCTIONAL 

STERILE

Right 

Here

The Instrument 

Scramble! 


Process improvement 

becomes 

a real Key 

15,902 cases (2012 data) 

594 delays 

3.7% 

Causes: 

Equipment, 

Instruments 

Supplies not available


TOLEDO, OHIO 

70-80 procedures/day 

1400 instrument 

sets/trays 

Thousands of single 

items 

--------- 

Instruments available 

64% 

36%-problems expected 

PROCESS STUDY 

Errors in instrument tray set ups 

• Missing instruments 

• Instrument tracking issues 

• Poor communication between 

departments 

• No regular repair schedules 

• Poorly trained staff.


Any hospital…… 

Right Total Knee 

Replacement 

Implant inventory 

System 

Hasty selection 

process 

Elderly male patient….

It Works

What happens that makes 

it not work? 

Mishandled-Nonfunctioning 

Designed improperly-Nonfunctioning (hazardous) 

• Function (even in the tiniest places in the 

patient) 

• Capacity for reprocessing 

Repaired improperly-Nonfunctioning (hazardous)

Laparoscopic gallbladder grabber 

Grabber of laparoscopy set with crack in 

plastic sleeve covering end of instrumentpiece 

broken off in patient. 

Investigation?

Department 

Veteran 

Affairs-2007 

SPD-OR 

Coordination 

Study 

25% facilities-instrument trays 

or surgical case carts had 

instruments broken, incorrect, 

missing 

Occasionally receiving unsterile 

instruments 

Broken process in the flow from 

the SPD to the ORS 

Cause-unknowledgeable staff

Work arounds and substitutions to correct the 

availability issues 

Fetching from extra supplies 

Interchanging parts that don’t function 

properly -Grand Rounds (AORN)

MISHANDLING 

Source of Nonfunctioning

STACKING IS MISHANDLING 

“Instruments are treated 

like children’s toys or 

placed like tools in the tool 

box.”

® 2012 Integrated Medical Systems International, Inc. All rights reserved. IMS is a registered 

trademark of Integrated Medical Systems International, Inc. All other marks are property of their 

respective owners, and IMS is not affiliated with those owners. 

® 2012 Integrated Medical Systems International, Inc. All rights reserved.

Scope Instruments 

Fragile scopes-easily damaged with 

stacking, transporting, and cleaning 

® 2012 Integrated Medical Systems International, Inc. All rights reserved. IMS is a registered trademark of 

Integrated Medical Systems International, Inc. All other marks are property of their respective owners, and 

IMS is not affiliated with those owners. 

Inner makings of a 

laparoscope or any other rigid 

scope-series of glass rods.

Basin placed on scope shaft 




Stacking items on scope during 

transportation 



respective owners, and IMS is not affiliated with those owners.

Laser burned scope tip 

® 2012 Integrated Medical Systems International, Inc. All rights 

reserved. IMS is a registered trademark of Integrated Medical Systems 

International, Inc. All other marks are property of their respective 

owners, and IMS is not affiliated with those owners. 

Failure to clean window with 

alcohol results in build-up of antifog 

compound 

® 2012 Integrated Medical Systems International, Inc. All rights reserved. 

Dust from improper transport 

® 2012 Integrated Medical Systems International, Inc. All rights reserved. IMS is a 

registered trademark of Integrated Medical Systems International, Inc. All other 

marks are property of their respective owners, and IMS is not affiliated with those 

owners.





registered trademark of Integrated Medical Systems International, Inc. All other marks are 

property of their respective owners, and IMS is not affiliated with those owners. 

Camera-cable has been 

wound too tight for a 

clear image 


registered trademark of Integrated Medical Systems International, Inc. All other marks are 

property of their respective owners, and IMS is not affiliated with those owners.

STERILE 

IS THE PATIENT SAFE?

A Hospital in Texas- 2009 

Study Released-December 2011 

http://video.today.msnbc.msn.com/today/46479070#46479070 

(please access website for video)

Issue: Infections of Pseudomonas 

Aeruginosa , in a Texas hospital, April –May 2009 

Goal: Determine the source of the outbreak and 

prevent future infections 

Studies 

Environment samples-sinks, drains, water, samples from 

equipment 

Laboratory records reviewed 

Surgical procedures were observed 

Surgical equipment samples analyzed 

Instrument reprocessing practices reviewed 

Surgical instrument lumens inspected to assess cleanliness 

Endoscopic exam on the shaver handpiece and its cleaning 

practices

Results 

Endoscopic evaluation of Arthoscopic instruments 

revealed retained tissue in the lumen of the 

inflow/outflow cannulae and arthroscopic shaver hand 

piece. 

Changes in instrument reprocessing protocols were 

implemented 

Safety alert issued by US FDA about concern of retained 

tissue in arthroscopic shavers 

Conclusions 

SSI related to surgical instrument contamination with 

Pseudomonas during instrument reprocessing 

Retained tissue in inflow/outlaw cannula and shaver 

hand pieces could have allow bacteria to survive 

sterilization procedures.

Not an Isolated Case 

The Center for Disease Control (CDC) estimates 100,000 

deaths/yr from Hospital Acquired Infections (HAI) 

alone – all considered preventable. 

2010 – Office of the General (OIG) audit of Medicare 

patient charts -Estimated 15,000 preventable deaths per 

month – just in Medicare patients 

The overall estimate -over 200,000 preventable 

deaths/yr in the US 

half from HAIs or 100,000 

17 % from SSIs 

half from other kinds of errors 

Is Costly to all concerned

Swedish medical errors prove ever more 

costly-Published: 4 Jan 11 09:29 CET 

The cost of paying for harm done to patients 

in the Swedish healthcare system has nearly 

doubled in the last decade, according to a new 

report. 

Orthopedic injuries 

Surgical errors 

Infection 

Live Blog: 2012 Nobel Prize announcements (15 Oct 

12)

Public Reporting 

National Healthcare 

Safety Network –NHSN 

Center for Medicare and 

Medicaid Services- CMS 

Now-Total Hips and Knees, 

colons and abdominal 

hysterectomies 

Next-January 2013 

CAB 

Hip Arthroplasty 

Abdominal Aortic 

Aneurysm 

Carotid Endarterectomy 

Peripheral Vascular Bypass 

Graft 

Vaginal Hysterectomy

Surgical procedure 

Enzymatic Cleaner 

Transport to Sterile 

Processing 

Pre Wash 

Cleaning 

Chemo thermal 

Disinfection 

Intermediate rinse 

Final rinse 

Drying 

Packaging 

Sterilization/Final 

Disinfection 

Storage 

Pulling for cases 

Surgical procedure

Laparoscopic Instruments (cautery tips, scissors, non-take 

aparts) 

da Vinci Robotic Instruments (arms, scissors) 

Suctions (Fujita, Yankauer, trumpet valve) 

Stryker 6 Handpiece / Attachments / Midas Rex 

Vendor Instruments (total joint / spine) 

Rongeurs 

Forceps (bi-polar) 

Cannulae / Cautery Tips (lumen, distal end) 

Instruments Exposed to Bone Cement (Kochers, dental 

instruments) 

Flexible Reamers 

Flexible Scopes 

Graspers (cysto, thoracic long) 

“Instruments and devices becoming more and more complex every day” 

® 2012 Integrated Medical Systems International, Inc. All rights reserved. IMS is a registered trademark of Integrated Medical Systems International, Inc.

Damaged rigid endoscopes-a standard stainless steel rigid 

scope damaged due to mishandling 

® 2012 Integrated Medical Systems International, Inc. All rights reserved.

® 2012 Integrated Medical Systems International, Inc. All rights reserved. IMS is a registered trademark of Integrated Medical Systems 

International, Inc. All other marks are property of their respective owners, and IMS is not affiliated with those owners.

daVinci Robotic Instruments (arms, scissors) 

Prograsp Forceps-Endoscopic Robatic Surgery 

(2) 




owners. 

DaVinci robotic grasper-extremely difficult to clean these instruments

Suctions (Fujita, Yankauer, Trumpet Valve) 

(3) 

® 2012 Integrated Medical Systems International, Inc. All rights reserved. IMS is a registered trademark of Integrated 

Medical Systems International, Inc. All other marks are property of their respective owners, and IMS is not affiliated with 

those owners. 

Trumpet Valves for irrigation 

Valves are made to be taken apart for a reason

Stryker 6 Hand piece / Attachments / Midas Rex 

(4) 

Stryker 6 Handpiece 

Seeing on the outside

Vendor Instruments (total joint / spine) 

(5) 

Total Joint Trays-cased 


trademark of Integrated Medical Systems International, Inc. All other marks are property of 

their respective owners, and IMS is not affiliated with those owners.




owners. 




owners.






owners. 

® 2012 Integrated Medical Systems International, Inc. All rights 

reserved. IMS is a registered trademark of Integrated Medical 

Systems International, Inc. All other marks are property of their 

respective owners, and IMS is not affiliated with those owners.

Instruments Exposed to Bone Cement 

(9) 

Pneumatic micro drill-ENT/H&N 

Motor enclosure and sleeve 

® 2012 Integrated Medical Systems International, Inc. All rights reserved. IMS is a registered trademark of Integrated Medical 

Systems International, Inc. All other marks are property of their respective owners, and IMS is not affiliated with those owners.

Reamers 

(10) 


International, Inc. All other marks are property of their respective owners, and IMS is not affiliated with those owners. 

42

Shortcut to Flex bioburden.jpg.lnk 




owners. 

Patches of bioburden (using Flex UV glue which 

causes cracks for bioburden to enter. Should have 

used Sealant apoxy adhesive instead. 




owners. 

Example of not inspecting it 

before it goes to the patient.

Resulted from Lack of cleaning 

In the OR. 

Cannot be flushed out with manual 

cleaning. 

Back end of lap grasper 



Bioburden 

• Human tissue on sterilized instruments 

• Number of microorganisms on a contaminated 

object, surface, device or instrument 

• Referred to as bioload. 

Biofilm- formation of living and non-living debris that 

adheres to and grows on wet surfaces 

•forms a protective web over organisms 

• enables organisms to develop into infections which, 

because of the web, resist medical therapy. 

• also referred to as slime 

• can be prevalent in natural, industrial and hospital 

settings

Failure to remove 

• Interferes with disinfection and sterilization 

and brings contamination to the field 

• Becomes a foreign body inside patient-SSI 

• Stimulate patient's defense mechanism to 

reject or wall it off 

• Causes damage to instruments-corrosion, 

rust, pitting 

• Causes operating time to be lost 

• Causes prolonged anesthesia

Ultimate End Result 

• Substitutions and work arounds 

• Stress and Unsafe Performance 

• Survey of stressors (Florida hospital) 

• Patients Dying 48% 

• Pressure to work faster 41% 

• Equipment that did not work 41% 

• Impact on the nurse: Balancing Act between the 

organization, the profession, and themselves as persons 

• Result-potential adverse effects and near misses 

• Interruptions in the flow of care (OR ) 

• Lack of Efficiency, Effectiveness, and 

Throughput

Follow reprocessing guidelines for 

Inspection and cleaning 

Decontamination/disinfection 

Processing/re-processing 

Storage 

Distribution 

Use decontamination products to break down 

bioburden 

Follow medical device manufacturers' 

recommendations for cleaning/disinfection of 

instruments/medical devices

When choosing instrumentation/medical 

devices for purchase, consider: 

Equipment needed to process/re-process 

Special solutions needed 

Device complexity: can it be disassembled? Flushed? 

Immersed? 

Number of uses (some devices are semi-disposable) 

Time needed to re-process 

Special sterilization requirements (steam, plasma, 

EO/ETO, etc.) 

Becki Harter, CST, CRCST, is president and CEO of Indianapolis-based consulting firm 

Sterilization By Design, Inc., extracted November 2012, 

http://www.infectioncontroltoday.com/articles/2003/04/bioload-doesn-t-have-to-be-aburden.aspx

Monitor the way instruments are maintained, 

cleaned , inspected and packaged for use. 

Implement preventative maintenance and 

instrument management programs for surgical 

instrumentation. 

Of Extreme Importance: 

Perioperative Standards and Recommended 

Practices, AORN, Denver, 2012.

What Can I do? 

FIRST DO NO 

HARM

Things are not always as they seem. 

Saker och ting är inte alltid som de verkar.

References 

1. Clarke JR. Is my patient safe in the operating room? Paper presented 

at: New York State Patient Safety Conference 2007; May 21-22, 2007; 

Albany, NY. http://www.health.state.ny.us/professionals/ 

patients/patient_safety/conference/2007/. Accessed June 9, 2009. 

2. Office of Inspector General, Department of Veterans Affairs. 

Review of patient safety in the operating room in Veterans Health 

Administration Facilities. 

http://www.va.gov/oig/54/reports/VAOIG-05-00379-91.pdf. Report 

No. 05-00379-91. Published February 28, 2007. Accessed June 9, 2009. 

3. Committee on Quality of Health Care in America, Institute of Medicine. 

To err is human: building a safer health system. http://www.iom.edu/Object. 

File/Master/4/117/ToErr-8pager.pdf. Published November, 1999. 

Accessed June 9, 2009. 

4. Leape L, Lawthers AG; Brennan, TA, et al. Preventing medical injury. 

Qual Rev Bull. 1993; 19(5):144-9.

5. The Joint Commission. A follow-up review of wrong site surgery. 

Sentinel Event Alert. 2001; (10). http://www.jointcommission.org/ 

SentinelEvents/SentinelEventAlert/sea_24.htm. Published December 5, 

2001. Accessed June 9, 2009. 

6. The Joint Commission. Universal protocol. 

http://www.jointcommission.org/PatientSafety/UniversalProtocol. 

Updated June 9, 2009. Accessed June 9, 2009. 

7. AORN. ACS, The Joint Commission partner with AORN on National Time 

Out Day. http://www.aorn.org/AORNNews/NationalTimeOutDay. 


8. World Health Organization. About WHO. http://www.who.int/about/en/. 


9. World Health Organization. New checklist to help make surgery safer. 

http://www.who.int/mediacentre/news/releases/2008/pr20/en/index.html. 

Published June 25, 2008. Accessed June 9, 2009.

10. World Alliance for Patient Safety. Implementation manual, WHO surgical 

safety checklist (first edition): safe surgery saves lives. 

http://www.who.int/patientsafety/safesurgery/tools_resources/SSSL_Ma 

nual_finalJun08.pdf. Accessed June 9, 2009. 

11. The Joint Commission. Clarification of Universal Protocol compliance. This 

Month for Physicians. February 2009:2. 

http://www.jointcommission.org/NR/rdonlyres/5425360E-DE36-447C- 

9779-3307A27A2DEA/0/02_09_this_month_phys.pdf. Accessed June 9, 

2009. 

12. Prephan L. Surgical instrument availability. AORNJ 2005;81( 5):1017-22. 

13. Girard NJ. Perioperative grand rounds: Are the instruments ready? AORNJ 

2009;89(1):244, 119. 

14. Agency for Healthcare Research and Quality. Case & commentary: making 

do. Commentary by Bradley, LD. Morbidity and Mortality Rounds on the Web. 

September 2003. http://www.webmm.ahrq.gov/case.aspx?caseID=28. 

Accessed June 9, 2009.

15. Kingdon B, Halvorsen, F. Perioperative nurses’ perceptions of stress in 

the workplace. AORNJ 2006; 84(4):507-14. 

16. The Joint Commission. Behaviors that undermine a culture of safety. 

Sentinel Event Alert. 2008; (40). 

http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/se 

a_40.htm. Accessed June 9, 2009. 

17. PA PSRS Patient Saf Advis 2006 Mar;3(1):20-4. 

18. In the aftermath of an Outbreak, Process, Device, Design Come 

Under Scrutiny, Infection Control Today, July 2012. 

19. Horran, T; Andrus, M. Dudeck, MA, CDC/NHSN surveillance definition 

of Healthcare-associated infection and criteria for specific types of 

infections in the acute care setting. National Healthcare Safety Network 

Division of Healthcare Quality, CDC, Atlanta, GA. 2008, American 

Journal of Infection Control 2008:36:309-32.

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