Verna C. Gibbs MD Director, NoThing Left Behind®

Professor of Surgery UCSF; Staff Surgeon, SFVAMC

Prevention of Retained: Small Miscellaneous Items (SMIs)

Unretrieved Device Fragments (UDFs) Needles

TWO YEAR (2013-2014) CALIFORNIA COLLABORATIVE IN SURGICAL PATIENT SAFETY

This FREE webinar is sponsored by a

Ground Rules

•  This presentation is intended to be a “job aide”

•  The goal is to help participants clarify their thinking which should lead to clearer and stronger actions

•  Policy translation is site specific •  Predicated on the use of the Sponge

ACCOUNTing System

Four Classes of Items

1.  Soft Goods a)  Surgical Sponges* b)  Surgical Towels* c)  Dressing sponges, Towels, Packs, Prep

Swabs, Gauze pledgets

2.  Small Miscellaneous Items (SMI) includes parts of instruments

3.  Sharps/Needles 4.  Instruments (the whole instrument)

*cotton soft goods that contain a radiopaque marker for X-ray detection

Retained Surgical Items

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

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

The California Story

CDPH reports from 10/25/2007 – 10/24/2013 (7 years) 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 and UDFs

9 cases of a retained Instrument

(56% are visceral retractors)

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

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

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

Guidewires, portions of vascular sheaths, introducers, stents

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?

•  Objects post laparoscopic hysterectomy retained in the vagina increasingly reported

California AP events •  7 years of public reporting currently

includes cases from only 5 years - 2007 - 2011

•  75 reports = 15 cases/year ! 43 cases (57%) soft goods

•  11/43 (26%) Ob 7 > Gyn 4 cases •  28 laps; 12 raytex; 3 towels

! 23 cases (31%) SMI+UDFs ! 9 cases (12%) instruments ! 0 cases sharps

CDPH 2011 •  FOIA request by CHPSO •  114 releasable reports

! 52 (46%) no information

!  8 not RSI cases + no info = 53% ! 26 (23%) soft goods ! 19 (17%) UDFs

!  7 (6%)SMI + UDFs = 23% !  2 retained sharps (1 needle/1 blade) !  0 instruments

UHC 2011 •  100 academic medical centers •  428 RSI* reports

! 171 (40%)UDFs

! 137 (32%) soft goods ! 77 (18%) Instruments (I doubt this!

more likely SMI’s + Instruments) + UDFs = 58%

! 43 (10%) sharps

*TJC definition Williams, JACS Sept 2014

University Health Consortium

•  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

Unretrieved Device Fragments

•  Unretrieved Device Fragments (UDFs) •  “Official” FDA nomenclature, not “bits

and pieces”

•  Broken parts or pieces of devices and surgical items

•  These are the items where the “risk of retrieval > risk of retention” mantra is frequently invoked

ECRI’s Top 10

•  #7 Retained devices and unretrieved fragments

•  Second most common RSI

www.ecri.org

Emergency Care Research Institute

Device Fragments •  can lead to serious adverse events •  US FDA notification Jan 2008 •  Local tissue reaction, infection,

thrombosis, perforation, obstruction, emboli

•  Center for Devices and Radiological Health (CDRH) receives ~1000 adverse event reports a year related to UDFs

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

Disclosure vs. reporting

•  Retained small item or UDF. Clinical decision NOT to remove.

•  ?? can cause harm

•  DISCLOSE TO THE PATIENT

•  Discuss about reporting

Engage with OR leadership to hone multistakeholder prevention strategies

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A:

A:

A:

A:

Sentinel Event - Retained foreign object after surgerySometimes a needle or screw will break leaving a fragment behind. Is this a reviewable sentinel event?

What about a retained sponge following vaginal delivery?

When, exactly, is “after surgery?"

Why was this particular point in the process selected as the definition of “after surgery?"

Sentinel Event - Retained foreign object after surgery

Q: Sometimes a needle or screw will break leaving a fragment behind. Is this a reviewable sentinel event?

In some cases, a broken needle or screw fragment is recognized at the time of surgery anda clinical judgment is made to leave the fragment in the patient. That decision is based on

an assessment of the relative risks of leaving it in versus removing it. It would thereforenot be considered an unintentionally retained foreign object.

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Q: What about a retained sponge following vaginal delivery?

A retained sponge after a vaginal delivery is a reviewable sentinel event. The newlanguage in the definition of reviewable sentinel events is, “Unintended retention of a

foreign object in a patient after surgery or other procedure.” Note that it says “otherprocedure” not “other invasive procedure.” Vaginal delivery in the hospital is not an“invasive” procedure, but it is a procedure. More to the point, a retained sponge in thiscircumstance is indicative of the same underlying systemic problems that could causeother “retained foreign body” situations.

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Q: When, exactly, is “after surgery?"

“After surgery” is any time after completion of the skin closure; even if the patient is stillin the OR under anesthesia.

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Q: Why was this particular point in the process selected as the definition of “after surgery?"

The decision to define “after surgery” as the completion of skin closure was based on thepremise that a failure to identify and correct an unintended retention of a foreign object

prior to that point in the procedure represents a significant system failure, which requiresanalysis and redesign. It also places the patient at additional risk by virtue of extendingthe surgical procedure and time under anesthesia.

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“not an unintentionally

retained foreign object” so not a sentinel event so no RCA and

no reporting required

NQF Required Reporting 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

CDPH rules

Recommendations •  So the NQF does not consider the

unretrieved device fragments a SRE so probably not required to report

•  Except in California – you must report •  Voluntarily report to MedSun system •  Even if there is no requirement to

report, should DISCLOSE to the patient and should conduct an RCA

•  To inform the patient have to have info

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 •  Report to MedSun

Med Sun •  The FDA Safety Information and

Adverse Event Reporting Program

•  Report on the FDA’s MedWatch website ! http://www.fda.gov/Safety/MedWatch/

! Select “Report a Serious Medical Product Problem Online”

! Select “Health Professional” or “Consumer/Patient” on the right side of the page to begin the report

Patient Disclosure 1. Advise patients of the existence and

nature of the UDF (show them what the item looks like). 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

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?

•  Discuss needles by SIZE of the needle not by size of the suture

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

CT pelvis retained 34mm needle

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 •  Discuss needles by SIZE of needle

not by size of the suture

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

Small Needle Detection

Even if they can be seen, would they be removed?

Phantom X-ray model Skull   Skull   Pelvis   Pelvis  

Dense  bone   Less  dense     Dense  bone   So1  2ssue  

Needle  /  torchar  type  

0. 3.5 metric, 40mm, 1/2c, taper V   V   V   V  

3-0, 2.0 metric, 24mm, 3/8c, reverse cutting V   V   V   V  

5-0, 1.0 metric, 8.0mm, 1/4, spatula N   V   V   V  

6-0, 0.7 metric, 11mm, 3/8c, reverse cutting V   V   V   V  

6-0, 0.7 metric, 8.0mm, 3/8c, reverse cutting N   B   V   V  

6-0, 1.0 metric, 6.5mm, 3/8c, spatula N   V   N   V  

7-0, 0.5 metric, 6.5mm, 3/8c, spatula B   V   B   V  

8-0, 0.4 metric, 7mm, 1/2c, spatula N   N   N   V  

9-0, 0.3 metric, 5.5mm, 1/2c, spatula N   N   N   V  

9-0, 0.3 metric, 5mm, 3/8c, taper N   N   N   N  

9-0, 0.3 metric, 3.8mm, 3/8c, taper N   N   N   N  

10-0, 0.2 metric, 16mm, straight spatula N   N   N   V  

10-0, 0.2 metric, 13mm, 1/4c, tapercut N   N   N   V  

10-0, 0.2 metric, 6.5mm, 3/8c, spatula N   N   N   B  

10-0, 0.2 metric, 5.5mm, 1/2c, spatula N   N   N   B  

19 gauge trochar plug V   V   V   V  

20 gauge trochar plug V   V   V   V  

23 gauge trochar plug N   B   V   V  

Legend:  

V:  Visible  

B:  Barely  visible  

N:  Not  visible  

Courtesy of St. Louis University

Define Large as >15mm

LARGE

LARGE

What to do?

•  Develop a rational needle management plan to prevent lost needles

•  Best effort for risk reduction •  All needles come back to scrub person on

a needle holder to the safety zone •  Needles are put in needle container •  Keep numbers low •  Think and manage needles by SIZE of the

needle not size of the suture

Needle Management Safety Zone – Not any thing on the back table. Rectangular pan, made of plastic. Not metal – magnitizes the instruments

Sorting strategy – Large vs Small

Dry Erase Board

Large Goes in Foam

Keep numbers low

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

Close Calls

•  If nothing else, start reporting near miss events

•  Use this as an OR improvement opportunity

•  Review them to change/improve practice

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

Patient Disclosure Practitioner’s obligation to disclose is based on

norms of medical ethics, professionalism, public policy and law

Ethical tenets of the standards of non-maleficence, beneficence, autonomy and justice apply

Respect for autonomy requires avoidance of interfering with an individuals’ decision-making and presents an obligation of the MD to provide the necessary information for the patient to make a true decision

Notions of justice – fairness and equity require that patients be informed

Perspective

•  Anecdotal observation – as disclosure has been more widely enforced we have seen a decrease in the number of risk of retrieval > risk of retention cases….. hmmmmm

Apologies to MasterCard