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11/24/2010 1 Complex Wound Care with Negative Pressure Wound Therapy (NPWT): Adverse Events & Litigation

Thursday, November 17, 2010 Thursday, November 17, 2010 Med League Support Services Webinar Med League Support Services Webinar

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Pat Iyer

Welcome to the Webinar

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What you need to do

For best results, close other programs. p g

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11/24/2010 2

The GoToWebinar Attendee View

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How to Participate Today

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• Submit text questions
• Q&A addressed throughout the

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Diane Krasner PhD RN CWCN CWS MAPWCA FAAN Diane Krasner PhD RN CWCN CWS MAPWCA FAAN

Wound & Skin Care Consultant & Wound & Skin Care Consultant & WOCN/Special Projects Nurse WOCN/Special Projects Nurse Rest Haven Rest Haven – York York York PA York PA

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Wecome to Tonight’s Webinar! Who are you?

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Welcome to Tonight’s Webinar!

Have you used NPWT in your Have you used NPWT in your clinical practice? clinical practice?

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11/24/2010 4 Objectives

By the end of this presentation, the By the end of this presentation, the participant will be able to: participant will be able to:

Explain the rationale for the use of negative

Explain the rationale for the use of negative pressure wound therapy (NPWT) pressure wound therapy (NPWT)

Evaluate the standards of care for the entire

Evaluate the standards of care for the entire healthcare team related to the use of NPWT healthcare team related to the use of NPWT

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Objectives (continued)

Identify sources for standards of care for

Identify sources for standards of care for NPWT NPWT

Recognize common problems related to the use

Recognize common problems related to the use

• f NPWT that leave facilities open to adverse
• f NPWT that leave facilities open to adverse

events and litigation events and litigation

Analyze a complex wound care case involving

Analyze a complex wound care case involving NPWT and a wrongful death NPWT and a wrongful death

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Resources

NPWT Product Listing www.woundsource.com Individual device manufacturers have educational and clinical materials on their websites NPWT Overview chapter in Chronic Wound Care (4th edition) www.chronicwoundcarebook.com

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Why is litigation Why is litigation related to NPWT on the rise? related to NPWT on the rise?

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• Increased usage -> increased potential for misuse
• Used for complex & difficult wounds
• Steep learning curve for using the device
• Each wound patient’s wound plan of care must be

individualized individualized

• A team approach is essential to optimize healing
• utcomes with NPWT

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• Increased acceptance of NPWT by the

international wound healing community

• Since 1995 more than 1 million patients

treated

• Evidence-base for NPWT increasing

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• Over 300 peer-reviewed articles
• Over 15 RCTs

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NPWT: Defined

A device that applies negative pressure

A device that applies negative pressure (sub (sub-

• atmospheric pressure

atmospheric pressure – – suction) via a suction) via a pump ranging from 50 to 200 mmHg to the pump ranging from 50 to 200 mmHg to the p p g g g p p g g g wound beds of acute and chronic wounds wound beds of acute and chronic wounds (e.g. wounds, burns, ulcers, flaps and (e.g. wounds, burns, ulcers, flaps and grafts). grafts).

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NPWT stimulates wound healing by:

Creating a local environment that enhances wound healing

Creating a local environment that enhances wound healing

Removing wound

Removing wound exudate exudate (drainage) from the wound (drainage) from the wound D i d ( lli ) D i d ( lli )

Decreasing edema (swelling)

Decreasing edema (swelling)

Increasing local perfusion (blood flow)

Increasing local perfusion (blood flow)

Increasing angiogenesis (new blood vessel formation)

Increasing angiogenesis (new blood vessel formation)

Promoting granulation tissue formation

Promoting granulation tissue formation

Reducing dressing change frequency

Reducing dressing change frequency 17

NPWT: Devices

FDA Group 2 Devices (different from

FDA Group 2 Devices (different from wound care dressings) wound care dressings)

Indications, Contraindications, Warnings

Indications, Contraindications, Warnings

Indications, Contraindications, Warnings

Indications, Contraindications, Warnings

Require a Physician’s Order

Require a Physician’s Order

Reimbursed by Medicare and Medicaid for

Reimbursed by Medicare and Medicaid for qualifying wounds qualifying wounds

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Case 1 s/p Abdominal Surgery with Dehiscence

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Case 1

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Photo

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11/24/2010 10 NPWT: Indications

Acute wounds

Acute wounds

Chronic wounds

Chronic wounds

Traumatic wounds

Traumatic wounds Traumatic wounds Traumatic wounds

Dehisced wounds

Dehisced wounds

Partial thickness burns

Partial thickness burns

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NPWT: Indications (continued)

Ulcers (Diabetic, Pressure)

Ulcers (Diabetic, Pressure) Fl Fl

Flaps

Flaps

Grafts

Grafts

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NPWT: Contraindications

Presence of exposed

Presence of exposed anastomotic anastomotic sites (sites where structures join) sites (sites where structures join)

Exposed vasculature

Exposed vasculature Exposed vasculature Exposed vasculature

Exposed nerves

Exposed nerves

Exposed organs, necrotic

Exposed organs, necrotic tissue (dead tissue) with tissue (dead tissue) with eschar eschar present present

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11/24/2010 11 NPWT: Contraindications (continued)

Untreated

Untreated osteomyelitis

• steomyelitis (bone

(bone y (

infection)

infection)

Non

Non-

• enteric and unexplored fistulas

enteric and unexplored fistulas

Malignancy in the wound

Malignancy in the wound

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NPWT:

Risk Factors to consider before use

High risk for bleeding/hemorrhage

High risk for bleeding/hemorrhage

Anticoagulants or platelet

Anticoagulants or platelet aggregation factors aggregation factors

Friable vessels / infected blood

Friable vessels / infected blood vessels vessels

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NPWT:

Risk Factors to consider before use

Vascular

Vascular anastomosis anastomosis

Infected wounds

Infected wounds

Osteomyelitis

Osteomyelitis

Exposed organs, vessels, nerves,

Exposed organs, vessels, nerves, tendon and ligaments tendon and ligaments

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11/24/2010 12 NPWT is NOT: A suction device A suction device A method of wound A method of wound A method of wound A method of wound debridement debridement A type of dressing A type of dressing

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NPWT: Learning Curve

Variables

Suction pressures from 50

Suction pressures from 50-

• 200 mmHg

200 mmHg

Intermittent or continuous suction

Intermittent or continuous suction F f D i Ch F f D i Ch

Frequency of Dressing Changes

Frequency of Dressing Changes

Type of Foams / Dressings

Type of Foams / Dressings

Contact layers

Contact layers These variables should be specified in the These variables should be specified in the physician’s orders physician’s orders

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NPWT: Learning Curve

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11/24/2010 13 NPWT: Interprofessional Issues & Patient-Centered Concerns

Informed consent / other options

Informed consent / other options presented presented

Coordination with other modalities e g

Coordination with other modalities e g

Coordination with other modalities, e.g.

Coordination with other modalities, e.g. hyperbarics hyperbarics, MRI , MRI

Pain management

Pain management

Patient/caregiver training (trouble

Patient/caregiver training (trouble-

• shooting, emergencies)

shooting, emergencies)

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Case 2: Insect Bite Lower Leg

Chronic wound present for over one year

Chronic wound present for over one year

Using

Using povidone povidone-

• iodine wet

iodine wet-

• to

to-

• dry

dry dressings dressings

Exquisitely painful

Exquisitely painful

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NPWT: Standards of Care

Specific orders for an individual

Specific orders for an individual patient & wound patient & wound e g VAC Therapy @ 125 mmHg e g VAC Therapy @ 125 mmHg e.g. VAC Therapy @ 125 mmHg e.g. VAC Therapy @ 125 mmHg continuous x 48 hours, then continuous x 48 hours, then

• intermittent. Change dressing q
• intermittent. Change dressing q

48 hours x 2 weeks with 48 hours x 2 weeks with Granufoam Granufoam, then reevaluate. , then reevaluate.

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NPWT: Sources for Standards of Care

Manufacturer’s clinical

Manufacturer’s clinical guidelines guidelines

Consensus statements/Reports

Consensus statements/Reports

Clinical Literature

Clinical Literature

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11/24/2010 16 NPWT: Common Practice Challenges

Primary / Secondary dressing selection

Primary / Secondary dressing selection

Frequency of dressing change to prevent

Frequency of dressing change to prevent d i d i i th i th dressing dressing ingrowth ingrowth

Assuring that multiple pieces of dressing are

Assuring that multiple pieces of dressing are removed and none left behind removed and none left behind

Pain at dressing change (often related to

Pain at dressing change (often related to dressing dressing ingrowth ingrowth) )

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NPWT: Less Common Practice Challenges

Periwound

Periwound maceration or erosion maceration or erosion

Infection

Infection

Bleeding

Bleeding

Hemorrhage

Hemorrhage

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NPWT: Adverse Events

Dressing retention

Dressing retention

Dressing

Dressing ingrowth ingrowth complications complications

Infection

Infection

Bleeding

Bleeding

Hemorrhage

Hemorrhage

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11/24/2010 17 FDA WARNING November 13, 2009 FDA Preliminary Public Health FDA Preliminary Public Health Notification: Notification:

Serious Complications Serious Complications Associated with Negative Associated with Negative Pressure Wound Therapy Pressure Wound Therapy Systems Systems

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FDA WARNING November 13, 2009

6 deaths

6 deaths

77 injuries over 2 years

77 injuries over 2 years

Most of the deaths occurred at home or in a

Most of the deaths occurred at home or in a

Most of the deaths occurred at home or in a

Most of the deaths occurred at home or in a long term care facility long term care facility Recommendations: Healthcare professionals should carefully Healthcare professionals should carefully select patients of NPWT, considering select patients of NPWT, considering contraindications and patient risk factors. contraindications and patient risk factors.

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Case 3: Necrotizing Fasciitis

s/p Arteriogram

s/p Arteriogram

Transferred to major medical center for

Transferred to major medical center for

Transferred to major medical center for

Transferred to major medical center for debridement and hyperbaric oxygen debridement and hyperbaric oxygen therapy therapy

NPWT used simultaneously at three

NPWT used simultaneously at three wound sites wound sites

Delayed primary closure

Delayed primary closure

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NPWT Wrongful Death Case Analysis

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Overview: Mr. McDonald

50 year old, Diabetes, Hypertension, Obesity,

50 year old, Diabetes, Hypertension, Obesity, PAD, PVD, Sleep Apnea, Smoker PAD, PVD, Sleep Apnea, Smoker

s/p Bilateral Fem

s/p Bilateral Fem-Pop Bypass for Pop Bypass for claudication claudication in in s/p Bilateral Fem s/p Bilateral Fem Pop Bypass for Pop Bypass for claudication claudication in in 2003 2003

s/p redo with Reverse

s/p redo with Reverse Saphenous Saphenous Vein Grafting in Vein Grafting in 2005 2005

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Overview: Mr. McDonald

May 2006 Rt. Femoral

May 2006 Rt. Femoral Endarterectomy Endarterectomy + patch + patch angioplasty (bovine) angioplasty (bovine) -

• Florida Medical Center

Florida Medical Center (FMC) (FMC) ( ) ( )

3 weeks later: pain, redness, swelling at the groin

3 weeks later: pain, redness, swelling at the groin site, fever, N/V site, fever, N/V

Presents to Physician’s Office on a Wednesday

Presents to Physician’s Office on a Wednesday morning, I & D of groin site. Admitted with morning, I & D of groin site. Admitted with diagnosis of “wound infection right groin” diagnosis of “wound infection right groin”

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Overview: Mr. McDonald

Wednesday afternoon VAC applied by wound

Wednesday afternoon VAC applied by wound nurse per physician order. Wound has tunneling, nurse per physician order. Wound has tunneling, but nurse chooses routine VAC care (M but nurse chooses routine VAC care (M-

• W

W-

• F

F changes changes GranuFoam GranuFoam 125 mmHg) 125 mmHg) changes, changes, GranuFoam GranuFoam, 125 mmHg) , 125 mmHg)

Friday afternoon wound has slough, nurse calls in

Friday afternoon wound has slough, nurse calls in the PA who says D/C Mr. McDonald home with the PA who says D/C Mr. McDonald home with IV IV Vanco Vanco and home care and home care – – it’s a holiday weekend it’s a holiday weekend

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Overview: Mr. McDonald

Home care arrangements for VAC fall through the

Home care arrangements for VAC fall through the

• cracks. VAC home care visit not scheduled until
• cracks. VAC home care visit not scheduled until

Tuesday (PRN Discharge Planner) Tuesday (PRN Discharge Planner)

Monday morning at 4 am Mr. McDonald

Monday morning at 4 am Mr. McDonald exsanguinates exsanguinates through the VAC in front of his through the VAC in front of his wife and grandson. He is pronounced dead in wife and grandson. He is pronounced dead in FMC’s ER. FMC’s ER.

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Analysis: Mr.McDONALD 10 TOP FAILURES

• 1. Failure to appreciate the signs and symptoms of

Failure to appreciate the signs and symptoms of wound infection and develop a plan of care wound infection and develop a plan of care accordingly accordingly

• 2. Failure to perform cultures in a timely manner and

Failure to perform cultures in a timely manner and then direct IV therapy based on the culture results then direct IV therapy based on the culture results (Vanco Vanco did not cover all the organisms) did not cover all the organisms)

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Analysis: Mr.McDONALD 10 TOP FAILURES

• 3. Failure to properly evaluate Mr. McDonald for

Failure to properly evaluate Mr. McDonald for VAC Therapy and consider other options VAC Therapy and consider other options

• 4. Failure to document VAC dressing change orders

Failure to document VAC dressing change orders (with specifics) in the Medical Record and in the (with specifics) in the Medical Record and in the Discharge Instructions for the Home Care Discharge Instructions for the Home Care Agency Agency

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Analysis: Mr.McDONALD 10 TOP FAILURES

• 5. Failure to utilize appropriate VAC dressings and

Failure to utilize appropriate VAC dressings and dressing change schedules according to KCI dressing change schedules according to KCI dressing change schedules according to KCI dressing change schedules according to KCI Clinical Practice Guidelines (FDA Device) Clinical Practice Guidelines (FDA Device) [i.e. [i.e. Mepitel Mepitel, , VersaFoam VersaFoam, , Granufoam Granufoam Silver Silver daily] daily]

• 6. Failure to educate patient and family about VAC

Failure to educate patient and family about VAC risks, home care, etc. risks, home care, etc.

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Analysis: Mr.McDONALD 10 TOP FAILURES

• 7. Failure to train staff (nursing and medical) in the

Failure to train staff (nursing and medical) in the appropriate use of the VAC and VAC Clinical appropriate use of the VAC and VAC Clinical appropriate use of the VAC and VAC Clinical appropriate use of the VAC and VAC Clinical Practice Guidelines Practice Guidelines

• 8. Failure to arrange an individualized plan of care

Failure to arrange an individualized plan of care for home care for home care

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Analysis: Mr.McDONALD 10 TOP FAILURES

• 9. Failure to communicate between members of the

Failure to communicate between members of the interprofessional interprofessional team and up the chain of team and up the chain of command when necessary command when necessary

• 10. Failure to report death to the FDA Center for

Failure to report death to the FDA Center for Devices and Radiologic Health (CDRH) Devices and Radiologic Health (CDRH)

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Conclusion

LAWSUIT FILED BY LAWSUIT FILED BY PLAINTIFF’S WIFE AGAINST: PLAINTIFF’S WIFE AGAINST: Physicians & PAs Physicians & PAs Hospital Hospital KCI KCI

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Conclusion

DEPOSITIONS: DEPOSITIONS:

Wife

Wife

Physicians & PAs

Physicians & PAs

Wound Nurse

Wound Nurse

Discharge Nurse

Discharge Nurse

KCI Medical Director & KCI Nurse

KCI Medical Director & KCI Nurse Educator Educator

Plaintiff’s Expert

Plaintiff’s Expert

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CASE WENT TO CASE WENT TO ARBITRATION & ARBITRATION & SETTLED FOR SETTLED FOR SETTLED FOR SETTLED FOR MULTIPLE MILLIONS MULTIPLE MILLIONS

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Lessons Learned: Lessons Learned: Assuring Successful Outcomes Assuring Successful Outcomes with NPWT with NPWT

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Interprofessional team training and collaboration is essential. Certification is desirable. Lessons Learned: Lessons Learned: Assuring Successful Outcomes Assuring Successful Outcomes with NPWT with NPWT

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Incorporating safety materials provided by NPWT manufacturers (CGPs, order forms, checklists, etc.) can optimize outcomes. Lessons Learned: Lessons Learned: Assuring Successful Outcomes Assuring Successful Outcomes with NPWT with NPWT Utilizing the educational materials

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Utilizing the educational materials for patients and caregivers provided by the manufacturer should be the standard operating procedure.

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Ten Questions

t id h i to consider when using NPWT Devices or Reviewing NPWT Cases

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NPWT Question 1

Is the use of NPWT appropriate for Is the use of NPWT appropriate for the patient and the patient’s wound the patient and the patient’s wound at this point in time? at this point in time?

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NPWT Question 2

Have device indications, Have device indications, contraindications, precautions and contraindications, precautions and warnings been taken into warnings been taken into consideration? Have other consideration? Have other treatment options been considered? treatment options been considered?

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NPWT Question 3

Are members of the Are members of the interprofessional interprofessional wound team wound team properly trained in the use of properly trained in the use of NPWT? NPWT?

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NPWT Question 4

H th h i i d d th d i H th h i i d d th d i Has the physician ordered the device Has the physician ordered the device with the appropriate settings and with the appropriate settings and specifications (e.g. pressure in specifications (e.g. pressure in mmHg, continuous vs. intermittent, mmHg, continuous vs. intermittent, frequency of dressing changes)? frequency of dressing changes)?

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NPWT Question 5

Is appropriate and function Is appropriate and function Is appropriate and function Is appropriate and function equipment being utilized (e.g. pump, equipment being utilized (e.g. pump, canisters, tubing)? canisters, tubing)?

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NPWT Question 6

H th t d i t i l H th t d i t i l Have the correct dressing materials Have the correct dressing materials been ordered and utilized ( been ordered and utilized (e.g e.g foam, foam, silver foam, contact layers, drapes)? silver foam, contact layers, drapes)?

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NPWT Question 7

Have appropriate arrangements Have appropriate arrangements Have appropriate arrangements Have appropriate arrangements been made for the use of NPWT been made for the use of NPWT across the continuum of care (acute across the continuum of care (acute care to long term care or home care care to long term care or home care

• r outpatient)?
• r outpatient)?

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NPWT Question 8

Have arrangements been made for Have arrangements been made for wound reevaluation to determine wound reevaluation to determine when NPWT can be discontinued? when NPWT can be discontinued?

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NPWT Question 9

Has the patient and his/her Has the patient and his/her Has the patient and his/her Has the patient and his/her caregivers been trained in how to caregivers been trained in how to monitor the device, device alarms, monitor the device, device alarms, and what to do in the case of and what to do in the case of problems or emergencies? problems or emergencies?

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NPWT Question 10

H th id i l d d H th id i l d d Have the providers included Have the providers included appropriate documentation in the appropriate documentation in the medical record? medical record?

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Questions ????

• Dr. Diane L. Krasner

dlkrasner@aol.com

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