STILL > ZERO

BECAUSE….. RSI are considered to be NEVER EVENTS and the Incidence is

1.  Small Miscellaneous Items (SMIs)

2.  Unretrieved Device Fragments (UDFs) 3.  Needles

The Surgical Junkyard Webinar

Four Classes of Items

1.  Soft Goods a)  Sponges b)  Towels

2.  Small Miscellaneous Items (SMI) and Unretrieved Device Fragments (UDF)

3.  Sharps/Needles 4.  Instruments

National Quality Forum Serious Reportable Events (SRE) 2011 Update

Event

•  Unintended retention of a

foreign object in a patient after surgery

or other invasive procedure

•  Applicable Settings: –  Hospitals

–  Outpatient/Office-based Surgery

Centers –  Ambulatory Practice Settings/

Office-based Practices

–  Long-term Care/Skilled Nursing

Facilities

Additional Specifications

•  Includes medical or surgical items intentionally placed by

provider(s) that are unintentionally left in place

•  Excludes:

a)  objects present prior to surgery or other invasive

procedure that are intentionally left in place;

b) objects intentionally implanted as part of a planned

intervention and;

c)  objects not present prior to surgery/procedure that are intentionally left in when the risk of removal exceeds the

risk of retention (such as microneedles, broken screws)

Implementation Guidance

This event is intended to capture:

–  Occurrences of unintended retention of

objects at any point after the surgery/ procedure

ends regardless of setting (post anesthesia recovery

unit, surgical suite, emergency department,

patient bedside) and regardless of whether the

object is to be removed after discovery

–  Unintentionally retained objects (including such

things as wound packing material, sponges, catheter tips, trocars, guide wires) in all applicable settings

When is it Retained?

•  It’s considered to be retained if the item is in the patient ! AFTER SURGERY

•  When is it after surgery?

After Surgery is …

•  After all incisions have been closed in their entirety

•  Devices have been removed •  Final surgical counts have

concluded •  Patient has been taken from the

operating/procedure room

http://www.qualityforum.org/projects/hacs_and_sres.aspx

ECRI’s Top 10

•  #7 Retained devices and unretrieved fragments

The California Story

Reviewed CDPH reports from 10/25/2007 – 10/24/2013 where hospitals received administrative penalties of

$25,000 - $100,000

75 Retained Surgical Item cases

43 cases involving Soft Goods

28 laps ; 12 raytex; 3 towels (1 ROT)

23 cases of Small Miscellaneous Items

9 cases of a retained Instrument

(56% are visceral retractors)

1.  Small Miscellaneous Items (SMIs)

The Surgical Junkyard Webinar

Small Miscellaneous Items •  Small Miscellaneous Items and Unretrieved

Device Fragments (UDFs) are frequently retained •  Increasingly reported

! 70% of retained items in the Minnesota Hospital Association reports

! 50% of items from the California Dept of Public Health

! Majority of items from California Hospital Patient Safety Organization voluntary reporting system

! Probably the second most common item other places (e.g. Pennsylvania, VA reports) •  have been “bundled” in the instrument category

SMI Data Project

•  Collaboration with CHPSO •  Reports are Patient Safety Work

Product ! Confidential ! Privileged ! Deidentified

•  Illinois, Michigan, Missouri, Nebraska, North Carolina, California, Tennessee participated – ended October 2012

•  Together with data from NLB sources there are 105 cases

Retained Items

2.5 foot plastic drape 2.5 cm temporary neck pin

stapler head in rectum 1x8" xeroform gauze ring band sizer for heart valve sizing Raney clips blade extender electrocautery tip tip of Bullard laryngoscope 8x5mm metal screw cap 3.5 cm piece of lumbar drain catheter Piece of screwdriver head retractor blade patellar protector metal portion of Heart String device piece of Rhotan dissector 2-4mm drill bits x 10 cases Suture sleeve of AICD lead 4 cm portion of fetal scalp electrode 5mm tip of right angle clamp piece of Weck cell sphere plastic tip of bipolar device endoscopic anti-fog solution bottle Steinman pin Breakaway part of lami bolt Part from Capio device Portion of uterine manipulator Nasal suction bulb

Observations

•  Problems with the quality of reporting – insufficient information provided ~20% had no info [13/67]

•  Of material cases, 54% had a retained SMI/UDF [29/54]

•  10/54 cases;18% were near miss but the information provided was so sketchy often difficult to discern

Observations

•  In this series, Orthopedic surgeons had 38% of the UDF’s

•  followed by vascular proceduralists leaving guidewires, sheaths, stents and parts of wires and sheaths in vascular spaces.

•  It was difficult to determine how many of these items were removed

Interesting Findings

•  Needles are the most frequently miscounted items in the OR yet very few reports of retained needles

•  Under-reporting of retention or just miscounted?

•  Two Types of Case based on LOCATION of event

I. OR CASES a. Radiopaque items

b. Non-Radiopaque items II. Non-OR CASES

NLB Vernacular

OR Cases

•  Radiopaque Items

•  Screws, bolts, parts of retractors

•  Wires, baskets •  Drill bits, metallic

fragments

•  Stapler heads, suction tips

NLB Vernacular

Radiopaque Items •  Identify early if something is missing •  Usually will be the scrub person

! the circulating nurse is out of the field

! the surgeon is focused on operation ! discovery in SPD is too late

•  Obtain an intraoperative x-ray

•  Usually can find and retrieve these items

•  Recognition is key

OR Cases •  Non-Radiopaque

Items •  Plastic trocars,

vessel loops, •  Rubber stoppers,

flanges, eye protectors

•  Tips from tunneling devices

•  Pieces of wood

NLB Vernacular

Non- Radiopaque Items •  Identify early if something is missing •  Usually will be the scrub person

! the circulating nurse is out of the field

! the surgeon is focused on operation ! discovery in SPD is too late

•  Obtain an intraoperative x-ray - why?

•  Make a plan for further post-operative studies e.g. CT scan

•  Report the incorrect final item count

Surgeon

•  Every case should have a methodical wound examination performed before closing

•  Use two sensory modalities – touch and sight

•  It’s a human endeavor which might fail, but should be done

Scrub Position

•  Content experts on materiel ! Check condition of all items passed

and returned on the field ! Requires knowledge about

instruments, tools, surgical items ! Standardized back table

! Must speak up and question if something is amiss

NLB Vernacular

Standardize Tables

•  Reduce variation on how STs set up and maintain back tables

•  Aids with discovery of a missing item

•  Everything in its place

•  Not “my table” •  Beyond counting

Non-OR Cases

1) Intravascular ! Everywhere: cardiology, radiology,

anesthesiology, ICU ! Guidewires, catheters, sheaths,

introducers

2) Interstitial ! Subcutaneous space, breast tissue ! Catheter parts, broken drains, wires

NLB Vernacular

Guidewires

•  Interventional Radiology can successfully remove these >90% of the time IF recognized and removed early

•  Late discovery leads to fibrous adherence

Removal is desired

•  MRI procedures problematic

•  Magnetic fields can cause movement, migration

•  Radiofrequency fields cause heating

Retention Prevention

•  At least for Guidewires: •  Prevention

! Proceduralist competency and expertise •  Training and experience

! CLABSI protocol has last element on checklist:

•  Guidewire is IN THE KIT •  Mitigation of Harm:

! Immediate Post-procedure CXR

Infusion Device Pieces 2) Interstitial

! Subcutaneous space

•  Insertion and removal techniques lead to retention

•  Post- removal inspection of device is key

Why do they occur?

•  Catheter and guide wire fractures that result in UDFs can be caused by these inappropriate techniques:

•  withdrawing a catheter through or over a needle

•  shaping a device to conform to the patient’s anatomy when the device wasn’t designed to be reshaped

Why do they occur?

•  using undue force and torque (rotational force) on insertion or withdrawal

•  improperly manipulating a catheter using devices that are too small or too large

•  using a device for an off-label purpose

Essential causes

A.  Provider errors and mistakes in use of the device

!  This is the most common finding B. Provider uses the device correctly but

there is a problem with the device !  1) Manufacturer defects !  2) Worn and Used equipment !  3) New Unfamiliar Devices •  Multiple separable parts •  Non-radiopaque pieces of a multi-

part device

Essential causes

A.  Provider errors and mistakes in use of the device

!  This is the most common finding B. Provider uses the device correctly but

there is a problem with the device !  1) Manufacturer defects !  2) Worn and Used equipment !  3) New Unfamiliar Devices •  Multiple separable parts •  Non-radiopaque pieces of a multi-

part device

1.  Small Miscellaneous Items (SMIs)

2.  Unretrieved Device Fragments (UDFs)

The Surgical Junkyard Webinar

Device Fragments

•  Unretrieved Device Fragments (UDF) can lead to serious adverse events

•  US FDA notification Jan 2008 •  Local tissue reaction, infection,

thrombosis, perforation, obstruction, emboli

•  CDRH receives ~1000 adverse event reports a year related to UDFs

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm070187.htm

When device breaks •  Collect all available parts •  Sequester them – do NOT throw

them away

•  Consider getting an x-ray of site •  Obtain information about the item

e.g. model #, lot and serial number •  Save an unbroken item for

comparison with damaged goods •  Complete an incident report

Patient Disclosure 1. Advise patients of the existence and

nature of the UDF to include the following information: 1. material composition of the UDF, 2. the measurement/size of the fragment,

3.  location, 4. x-rays findings with interpretation,

5. potential for injury e.g. migration, infection, embolization, thrombosis and

6. any procedures or treatments to be avoided or to be obtained

2. Report to MedSun

Disclosure vs. reporting

•  Retained small item but clinical decision NOT to remove.

•  Impossible to retrieve

•  ?? can cause harm

•  DISCLOSE TO THE PATIENT

•  Discuss about reporting

Engage with OR leadership to hone multistakeholder prevention strategies

CDPH rules

1.  Small Miscellaneous Items (SMIs)

2.  Unretrieved Device Fragments (UDFs) 3.  Needles

The Surgical Junkyard Webinar

Retained Needles

•  Most frequent item associated with miscounts

•  What injury results from a lost suture needle?

•  Do we have to take an xray if a miscount occurs?

Can cause symptoms

•  Retained needle in eye

•  Retained needle after thyroidectomy

•  Retained needle in pelvis, causing pelvic pain, ! hysterectomy

•  Needles associated with symptoms were >13mm

What to do?

•  A 9mm needle was unaccounted for at the end of an open heart surgery.

•  Do we have to disclose to the patient?

•  Do we have to report this event to CDPH?

Answer

•  This is an incorrect final count for needles and sharps

•  Disclose to the patient, give them an option….. •  ?Get a CT scan with 4-5mm cuts or not

•  If +, you know where the needle is •  If -, you know that the needle isn’t in the patient

•  No CT?, You do not know with certainty that the needle is NOT in the patient. Report it to CDPH

•  Do NOT charge the patient for the CT – it’s need is a consequence of error

What to do?

•  Develop a rational needle management plan to prevent lost needles and reduce # of xrays

•  Best effort for risk reduction •  Determine a size cut-off where xrays

won’t be taken for lost needle •  Perform a test of change to see if it’s

possible

Animal model

•  Cadaver pig model •  insertion of 39 surgical needles from

4-77mm •  Random selection of 9 segments in

abdomen •  8 plain radiographs •  5 independent radiologists reviewed films •  Reviewers knew they were looking for

surgical needles

Ponrartana S. et.al. Annal of Surg 247:8, 2008

Results

•  Total of 195 needles for each reviewer •  69% overall sensitivity – 135/195 detected •  80% specificity - 32 false positives •  Needle size significant predictor of

sensitivity (p<0.0001) ! 4-10mm 29% ! 11-24mm 84% ! >25mm 99%

•  Detection sensitivity under 50% for needles <10mm

Define Large as >15mm

LARGE

LARGE

A Needle Algorithm •  Keep numbers of needles on back table low

( <30), use needle counter boxes •  Separate small from large (>15mm) needles •  If a MISCOUNT occurs: look for needle then

! If large needle (>15mm) get xray ! If small needle no xray:

•  unlikely will see needle on xray, unlikely will be able to find it, unlikely to result in injury

•  Document the incorrect needle count and decisions if the needle isn’t found

•  Disclose to the patient

Perspective

•  Lessons learned from OR mistakes should be shared with the new proceduralists so they don’t have to learn the hard way

•  On the “backs of the patients”

SAFER SURGERY

www.nothingleftbehind.org