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Value Analysis Guide Pressure Ulcer Prevention and Safe Patient Handling Solutions Heel Off-Loading Devices Safe Patient Handling

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Value Analysis GuidePressure Ulcer Prevention and Safe Patient Handling Solutions

HeelOff-Loading

Devices

SafePatient

Handling

2

“Rates of musculoskeletal injuries from overexertion in healthcare occupations are among the highest of all U.S. industries. The single greatest risk factor for overexertion injuries in healthcare workers is the manual lifting, moving and repositioning of patients, residents or clients, i.e., manual patient handling.”

Safe Patient Handling and Mobility (SPHM) (2019, January 19) Retrieved from https://www.cdc.gov/niosh/topics/safepatient/default.html

3

This Value Analysis Guide provides product solutions and program resources for Heel Off-

Loading and Safe Patient Handling. Please share this guide with members of your Value

Analysis Team and other key decision makers in your facility. Content within this guide can

be printed or shared electronically for educational and training purposes. Contact your

local DeRoyal sales representative for additional information.

PRUventor™ & PRUventor™ II

Heel Off-Loading Devices

PRUventor TurnPRO™

Turning & Positioning System

Product Features & Benefits

Protocol Development Guides

Clinical Decision Trees

Competency Checklists

Product Application Guides

Product Solutions:

Resources:

4

Lower Leg Securement Straps:Adjustable and customizable

Silbac™:Anti-microbial technology

Bilateral Straps: Keeps the foot in a neutral position

Open Heel Design: Helps prevent pressure injury

Anti-Rotation Wedge:Helps prevent foot rotation

Silbac™ antimicrobial technology has the ability to reduce elevated levels of bacteria without disrupting levels of normal skin bacterial flora. This technology maintains its antimicrobial properties throughout the life of the product, even after disinfecting.

PRUventor™ Heel Off-Loading DevicePRODUCT FEATURES & BENEFITS

SOLUTION FOR HIGH RISK PATIENTS

5

Leg Securement Strap:Adjustable and customizable

Foot Securement Strap (optional):Improves patient compliance

Structured Foot Rest:Additional foot-drop support

Silbac™:Anti-microbial technology

StaticBilateral Straps: Keeps the foot in a neutral position

Anti-Rotation Wedge:Helps prevent foot rotation

SCD/ICD Exits:Outlined by blue stitching

FOR ENHANCED FOOT-DROP SUPPORT

PRUventor™ II Heel Off-Loading DevicePRODUCT FEATURES & BENEFITS

6

Preventing Heel Pressure Injury and Plantar Flexion

PRUventor™ & PRUventor™ IICLINICAL PROTOCOL TEMPLATE

POLICY:

The PRUventor™ Heel Off-loading Device will be used on all patients at risk for developing pressure ulcers and plantar flexion of the foot. The PRUventor™ Anti-Rotation Wedge will be used in conjunction with the heel off-loading device to help prevent external rotation.

PURPOSE:

To help prevent pressure ulcers on the heel by maintaining heel suspension and to help prevent plantar flexion by maintaining the neutral position of the foot.

RISK FACTORS/CONDITIONS:

• Total Braden Score of 18 or less• Braden Mobility Score of 1 or 2• Braden Activity Score of 1 or 2• Expected Immobility > 6-8 hours• Inability to move leg or legs, numbness of leg(s),

arteriosclerosis of leg(s) (absent pulse, hair)

KEY CO-MORBIDITIES:

• Diabetes mellitus, stroke, PVD, hemiparesis, quadriparesis, malnutrition (low albumin < 3.5/Braden Nutrition Score of 1 or 2)

• Unconscious, comatose, spinal cord or head injury, peroneal nerve injury, leg or other trauma

• Orthopedic and other surgeries that limit motion of the legs (hip fractures, THR, TKR), leg compartment syndrome

• On medications such as sedatives, paralytics and vasopressive medications

PRODUCT NEEDED:

PRUventor™ or PRUventor™ II Heel Off-loading Device with optional Anti-Rotation Wedge

PROCEDURE:1. Follow skin care procedures for assessment, cleansing,

moisturizing and treatment of the heel and foot:

a. Remove the heel protector q-shift and inspect the patient’s skin for signs of breakdown.

b. Cleanse and moisturize the skin daily. Be sure to dry thoroughly prior to re-application of the device.

c. Follow your facility’s procedures for assessing pedal pulses and performing range of motion exercises.

2. Apply the heel protector on the patient:

a. Place the heel protector on the bed next to your patient’s leg. Make sure all straps are open.

b. Carefully lift the leg and position the heel over the opening. Support the knee to prevent hyperextension.

c. With the heel resting in the opening, pull the heel protector’s sides up and around the foot, ankle and lower leg. Make sure each side is pulled up completely (to properly seat the heel, ankle and lower leg).

d. Attach all securement straps and make sure two fingers fit between the straps and the patient’s leg.

e. Verify the heel is positioned in the opening at the bottom of the heel off-loading device. If it is not, reposition the heel and readjust the securement straps.

f. The heel off-loading device is to be used in bed only. Do not stand or walk while wearing the device.

3. Using the heel protector with a sequential compression device:

a. Put the sequential compression device on the patient according to your facility’s protocol.

b. Follow steps (a) through (d) as explained above.

c. Before attaching the securement straps, feed the tubing through the opening in the bottom side of the device.

d. Verify the heel is positioned in the opening at the bottom of the heel off-loading device. If it is not, reposition the heel and readjust the securement straps.

e. Make sure the tubing is not kinked or compressed against the patient’s skin.

4. Cleaning the heel protector:

Wipe down surface using a cloth and/or a hospital approved disinfecting wipe. Air dry completely prior to reapplication. Do not use bleach or oxidizing agents.

5. Documentation:

Document completion of the procedure on the appropriate form.

7

Decision Tree for Heel Pressure Injury Prevention

PRUventor™ & PRUventor™ IIDECISION TREE

STARTHERE

Is patient able to help with re-positioning?

IS PATIENT AT AN INCREASED RISK FOR FOOT DROP?

PRUventor™

Heel Off-Loading DevicePRUventor™ IIHeel Off-Loading Device

• Establish patient appropriateness

• Review Clinical Protocol for PRUventor™

Heel Off-Loading Device

PATIENT MUST• Be NON-AMBULATORY

• Have a total Braden Score of 15 or less

• Have at least TWO of the co-morbidities

listed in the Clinical Protocol.

If a patient does not meet the above criteria, but the

nurse has concerns about heel protection, call for a

wound care consult to assess patient.

• Establish patient appropriateness

• Educate patient on pressure reducing

techniques

PATIENT MUST• Have the potential to be AMBULATORY

• Be AMBULATORY

• Be recommended for heel off-loading

through gait/mobility assessment

• Be referred to Physical Therapy

NO

NO YES

YES

8 DeRoyal Industries | 200 DeBusk Lane | Powell, TN 37849888.938.7828 | 865.938.7828 | www.deroyal.comRev 01/19 | Reprint # 0-2441

The DeRoyal logo and Improving Care. Improving Business., are registered trademarks of DeRoyal Industries, Inc.

PRUventor is a trademark of DeRoyal Industries, Inc.

Copyright© 2018, DeRoyal. All rights reserved.

PRUventor™ PRUventor™ IIWhere is device applied? LEFT RIGHT BOTH

The operator has shown proficiency in the following activities: N/A Satisfactory Unsatisfactory

Places foot into device properly

Adjusts foot flaps and side flaps properly

Places two lateral straps along each side of boot

Does not criss-cross two lateral straps

Applies lower leg strap(s) properly

Ensures two fingers fit between patient’s skin and strap

Applies wedge properly to help prevent rotation

Ensures SCD/ICD tubing exit device properly

If moderate foot drop is present, reassesses and considers alternative

I understand my facility’s policy/protocol regarding the use of this device:

Signature: ________________________________________________ Date: __________________

Date: ____________________________________________________________________________________

Facility Name: _____________________________________________________________________________

Operator: _________________________________________________________________________________

Department: ______________________________________________________________________________

Instructor: _________________________________________________________________________________

Notes:

PRUventor™ & PRUventor™ IIHEEL OFF-LOADING DEVICES COMPETENCY CHECKLIST

Reprint # 0-2441

9

QUICKAPPLICATION

CARD

*Device may be applied across lower leg with single or double strap(s)

Heel Off-Loading Device

1

3

2

4*

QUICKAPPLICATION

CARD

1

3

2

4

Heel Off-Loading Device

DeRoyal Industries | 200 DeBusk Lane | Powell, TN 37849888.938.7828 | 865.938.7828 | www.deroyal.comRev 01/18 | Reprint # 0-2455

DeRoyal, Improving Care. Improving Business., and the DeRoyal Logo are registered trademarks of DeRoyal Industries, Inc.

PRUventor is a trademark of DeRoyal Industries, Inc.

Copyright© 2019, DeRoyal. All rights reserved.

• Check to make sure heel is off-loading.

• Do not criss-cross lateral straps.

• Ensure sequential or intermittant compression device tubing is not in contact with patient’s skin.

NOTE: Perform periodic skin assessment as specified by hospital policies and procedures.

This quick reference guide does not supercede the instructions given by a prescriber or the information contained in the Instructions For Use (IFU) which accompany this device. Please refer to the IFU for all warnings, cautions, and complete instructions.

IMPORTANTREMINDERSHeel Off-Loading Device

CLEANING AND/OR MAINTENANCEWipe down surface using a cloth and/or a hospital approved disinfecting wipe. Air dry completely prior to reapplication. Do not use bleach or oxidizing agents.

DeRoyal, Improving Care. Improving Business., and the DeRoyal Logo are registered trademarks of DeRoyal Industries, Inc.

PRUventor is a trademark of DeRoyal Industries, Inc.

Copyright© 2019, DeRoyal. All rights reserved.

• Check to make sure heel is off-loading.

• Make sure blue hook connects to the blue loop and black hook connects to black loop.

• Ensure sequential or intermittant compression device tubing is not in contact with patient’s skin.

NOTE: Perform periodic skin assessment as specified by hospital policies and procedures.

CLEANING AND/OR MAINTENANCEWipe down surface using a cloth and/or a hospital approved disinfecting wipe. Air dry completely prior to reapplication. Do not use bleach or oxidizing agents.

This quick reference guide does not supercede the instructions given by a prescriber or the information contained in the Instructions For Use (IFU) which accompany this device. Please refer to the IFU for all warnings, cautions, and complete instructions.

IMPORTANTREMINDERSHeel Off-Loading Device

DeRoyal Industries | 200 DeBusk Lane | Powell, TN 37849888.938.7828 | 865.938.7828 | www.deroyal.comRev 01/18 | Reprint # 0-2456

Reprint # 0-2456

Reprint # 0-2455

PRUventor™ & PRUventor™ IIQUICK REFERENCE CARDS

10

Turning & Positioning System

The PRUventor TurnPRO™ System is an easy-to-use safe patient handling solution for clinicians.

3

2

1

Silbac™ antimicrobial technology has the ability to reduce elevated levels of bacteria without disrupting levels of normal skin bacterial flora. This technology maintains its antimicrobial properties throughout the life of the product, even after disinfecting.

11*https://mcairlaids-usa.myshopify.com/products/laydry-adult-bed-pads

• Ergonomic Handles Comfortable, secure place to hold

• High Friction Top Keeps absorbent pad stationary

• Universal Sizing Accommodates most of the patient population

• Sacral Locater Sticker Ease of locating sacrum and applying wedges

• TurnGRIP™ High Friction Surface Keeps wedges positioned under sheet

• Wipeable Cover Silbac™ Antimicrobial Technology

• High Density Foam Accommodates varying patient weight

• 30 Degree Angle Supports turning protocol to off-load sacrum

• Top Layer Soft, breathable, moisture-managing top layer

• Bottom Layer Quiet, non-slip back to keep pad in place

• Leakproof To help prevent contamination of sheets

• Patented SuperCore® Technology* Premium absorbency and moisture wicking capabilities

1Sheet

2Wedges

3Pad

Turning & Positioning SystemSYSTEM COMPONENTS

12

Preventing Sacral Pressure Ulcers with a Friction-Reducing Device

Policy:

The DeRoyal® PRUventor TurnPRO™ system is intended to assist and maintain proper positioning of the patient and to provide assistance to the caregiver when repositioning. The system helps to prevent pressure injury when instituted in pressure injury prevention bundles to aid in turning and positioning the patient (PRUventor TurnPRO™ sheet and wedges), offloading the sacrum (PRUventor TurnPRO™ wedges), and through control of the skin micro-environment by dissipating body heat and wicking moisture away from the skin (absorbent pad). The system is also designed to help protect and assist the patient and caregiver during repositioning of the patient. This protocol template is designed to assist facilities to identify at risk patients that require a PRUventor TurnPRO™ system and to provide information for safe use to utilize the PRUventor TurnPRO™ system.

Disclaimer:

Pressure injury prevention requires a comprehensive bundle that considers skin and pressure injury risk assessments, skin care, nutrition, support surfaces, education (patient and staff), and other interventions (i.e. PRUventor heel offloading device) designed to prevent pressure injuries1–3. These other components must be implemented within a pressure injury prevention bundle to achieve success in protecting patients from pressure injuries.

Evidence-based guidance to determine when to use TurnPRO system:Assess patient risk for pressure injury with risk assessment tool (i.e. Braden score or facility risk assessment tool) at admission (within 8 hours), whenever the patient’s clinical condition changes, at least once every 24 in acute care and every shift in critical care patients, or according to facility protocol frequency1–4. The risk assessment should be documented in the patient’s records to monitor progress and identify when the PRUventor TurnPRO™ system should be started or discontinued2.

Patients determined to be high-risk for pressure injury by Braden score or other risk-assessment metric, receives abnormal skin assessment, or the patient meets one or more of the following risk criteria1,2,5,8:

a. Patient requires assistance to reposition, slides down frequently in bed, or receives a Braden friction and shear sub-score of ≤ 2 1–3,5–10

b. Patient does not move or makes only slight/non-significant occasional movements and determined at risk for friction and shear (friction/shear sub-score: ≤ 2) and/or skin moisture (moisture sub-score ≤ 3) on Braden scale1–8,10

c. Patient determined incontinent (urine and/or stool) or receives Braden moisture sub-score of 2 or less (Skin often or always moist)1,2,7–11

d. Patient determined to have poor nutrition or low albumin1,2,7,9,10,12

e. Patient likely will require ventilation greater than 24 hours, has current or history of pressure injuries, hypotension, and/or evidence of hypoperfusion (i.e. edema, third-spacing, etc.) of skin.1–5,7,9

f. Impaired sensation that prevents patient from feeling pain or discomfort at bony prominences, specifically the sacrum, or inability to communicate discomfort or pain (Braden sensation sub-score: ≤ 3)1,8

g. Patient suffers intractable pain with movement 1,9,13,14

i. Patient placed on progressive mobility protocol 14–17

References:1. Berlowitz D. Preventing Pressure Ulcers in Hospitals - A Toolkit for Improving Quality of Care. Agency Healthc Res Qual. 2013.2. NPUAP, EPUAP, PPPIA. National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers:

Quick Reference Guide. Emily Haesler (Ed.). Cambridge Media: Osborne Park, Australia; 201. 2nd ed. Cambridge Media; 2014. http://www.npuap.org/wp-content/uploads/2014/08/Quick-Reference-Guide-DIGITAL-NPUAP-EPUAP-PPPIA-Jan2016.pdf. Accessed November 1, 2018.

3. OSHA. Ergonomics for the Prevention of Musculoskeletal Disorders. US Dep Labor. 2009. doi:http://dx.doi.org/10.1016/B0-08-043076-7/03919-X.4. Pressure Injury Prevention Points. National Pressure Ulcer Advisory Panel. http://www.npuap.org/wp-content/uploads/2016/04/Pressure-Injury-Prevention-Points-2016.pdf. Published 2016.

Accessed January 11, 2018.5. Stansby G, Borthwick J, Broad N, et al. Pressure Ulcer Prevention: The Prevention and Management of Pressure Ulcers in Primary and Secondary Care. Clinical G. London: National Institute for

Health and Care Excellence; 2014. https://www.ncbi.nlm.nih.gov/books/NBK248068/pdf/Bookshelf_NBK248068.pdf.6. Lyder C, Ayello E. Pressure ulcers: a patient safety issue. In: Hughes R, ed. Patient Safety and Quality: An Evidence-Based Handook for Nurses. Rockville, MD: Agency for Healthcare Research

and Quality; 2008.7. Coleman S, Gorecki C, Nelson EA, et al. Patient risk factors for pressure ulcer development: Systematic review. Int J Nurs Stud. 2013;50(7):974-1003. doi:10.1016/J.IJNURSTU.2012.11.019.8. Braden B, Ayello E. How and Why to Do Pressure Ulcer Risk Assessment. Adv Skin Wound Care. 2002;15(3):125-131. doi:10.1097/00129334-200205000-00008.9. Cooper KL. Evidence-based prevention of pressure ulcers in the intensive care unit. Crit Care Nurse. 2013;33(6):57-66. doi:10.4037/ccn2013985.10. Tung JY, Stead B, Mann W, Pham B’, Popovic MR. Assistive technologies for self-managed pressure ulcer prevention in spinal cord injury: A scoping review. 2015;52(2):131-146. doi:10.1682/

JRRD.2014.02.0064.11. Lachenbruch C, Ribble D, Emmons K, VanGilder C. Pressure Ulcer Risk in the Incontinent Patient. J Wound, Ostomy Cont Nurs. 2016;43(3):235-241. doi:10.1097/WON.0000000000000225.12. Posthauer ME, Banks M, Dorner B, Schols JMGA. The Role of Nutrition for Pressure Ulcer Management. Adv Skin Wound Care. 2015;28(4):175-188. doi:10.1097/01.ASW.0000461911.31139.62.13. Hyun S, Li X, Vermillion B, et al. Body mass index and pressure ulcers: improved predictability of pressure ulcers in intensive care patients. Am J Crit care. 2014;23(6):494-500; quiz 501.

doi:10.4037/ajcc2014535.14. Dambaugh LA, Ecklund MM. Progressive Care of Obese Patients. Crit Care Nurse. 2016;36(4):58-63. doi:10.4037/ccn2016510.

Turning & Positioning System CLINICAL PROTOCOL TEMPLATE

13

Decision Tree for Safe Turning & Positioning

STARTHERE

NO

YES

Partially Able Fully Able

Can patient assist with turning and positioning?

Encourage patientto assist using

a positioning aid or cues.

Use full-body sling lift or friction-reducing device

and 2 or more caregivers.

Caregiver assistance not needed; patient may/may not use positioning aid.

If patient is <200 pounds:Use a friction-

reducing deviceand 2-3 caregivers.

If patient is >200 pounds:Use a friction-

reducing deviceand at least 3 caregivers.

Important Information:This is not a one person task - DO NOT PULL FROM HEAD OF BED.

When pulling a patient up in bed, the bed should be flat or Trendelenburg position to aid in gravity, with the side rail down.

For patient with Stage III or IV pressure ulcers, care should be taken to avoid shearing force.

The height of the bed should be appropriate for staff safety (at the elbows).

If the patient can assist when repositioning “up in bed,” ask the patient to flex the knees and push on the count of three.

Source: Guidelines for Nursing Homes OSHA 3182-3R 2009 https://www.osha.gov/ergonomics/guidelines/nursinghome/final_nh_guidelines.pdf

Turning & Positioning System DECISION TREE

14 DeRoyal Industries | 200 DeBusk Lane | Powell, TN 37849888.938.7828 | 865.938.7828 | www.deroyal.comRev 01/19 | Reprint # 0-2457

The DeRoyal logo and Improving Care. Improving Business., are registered trademarks of DeRoyal Industries, Inc.

PRUventor TurnPRO is a trademark of DeRoyal Industries, Inc.

Copyright© 2019, DeRoyal. All rights reserved.

System Components: Sheet Wedges Absorbent Pad

The operator has shown proficiency in the following activities: N/A Satisfactory Unsatisfactory

Prepares the bed for proper application

Unfolds the sheet and pad along the side of the patient lengthwise and positions top of the sheet directly above patient’s shoulders

Properly positions sheet and pad underneath patient with handles draped over side of the bed

Grabs handles at level of patient’s shoulders and hips

Stands with a wide base of support with one foot in front of the other

Places weight on forward foot and bends from the hips and knees

Instructs the patient that the turn will occur on the count of three

Demonstrates proper application of sacral locator sticker

Places wedges to maintain patient in lateral position and off-load sacrum

Returns the bed to original position, raises the side rails, and places call light within reach

Demonstrates knowledge of cleaning instructions and utilizes replacment components as needed

I understand my facility’s policy/protocol regarding the use of the PRUventor TurnPRO™ device:

Signature: ________________________________________________ Date: ______________________

TURNING & POSITIONING SYSTEM COMPETENCY CHECKLIST

Notes:

Date: ____________________________________________________________________________________

Facility Name: _____________________________________________________________________________

Operator: _________________________________________________________________________________

Department: ______________________________________________________________________________

Instructor: _________________________________________________________________________________

Reprint # 0-2457

15

SYSTEMCOMPONENTS

3

2

1

This quick application card does not supercede the instructions

given by a prescriber or the information contained in the Instructions For Use (IFU)

which accompany this device. Please refer to the IFU for all warnings, cautions, and complete instructions.

Sheet with secure, comfortable handles and Sacral Locator Sticker

TurnGRIP™ positioning wedges with anti-slip feature

Absorbent pad with temperature management and moisture wicking technology

1

2

3

This quick reference guide does not supercede the instructions given by a prescriber or the information contained in the Instructions For Use (IFU) which accompany this device. Please refer to the IFU for all warnings, cautions, and complete instructions.

Date: _______________________________________________________________

Patient Room Number: ________________________________________________

Start Time: _______________________ End Time: __________________________

Clinician Name: _______________________________________________________

System Components:Sheet Wedges Absorbent Pad

Check for the following prior to use. ✔

Patient is maintaining a lateral position

Sacrum is pressure free

Clean absorbent pad is in place

Proper documentation intiated

TURN SCHEDULE

CLOCK

QUICKAPPLICATION

CARD

SECURING THE HANDLES

APPLYING WEDGES

TURNING PATIENT; LOCATING SACRUM

MAINTAINING LATERAL POSITION

1

3

2

4

DeRoyal, Improving Care. Improving Business., and the DeRoyal Logo are registered trademarks of DeRoyal Industries, Inc.

PRUventor TurnPRO and TurnGRIP are trademarks of DeRoyal Industries, Inc.

Copyright© 2019, DeRoyal. All rights reserved.

DeRoyal Industries | 200 DeBusk Lane | Powell, TN 37849888.938.7828 | 865.938.7828 | www.deroyal.comRev 01/18 | Reprint # 0-2458

TURN SCHEDULE

CLOCK

_____init.

ampm

_____init.

ampm

_____init.

ampm_____

init.

ampm

_____init.

ampm

_____init.

ampm

DeRoyal, Improving Care. Improving Business., and the DeRoyal Logo are registered trademarks of DeRoyal Industries, Inc.

PRUventor TurnPRO is a trademark of DeRoyal Industries, Inc.

Copyright© 2019, DeRoyal. All rights reserved.

DeRoyal Industries | 200 DeBusk Lane | Powell, TN 37849888.938.7828 | 865.938.7828 | www.deroyal.comRev 01/18 | Reprint # 0-2459

Reprint # 0-2459

Reprint # 0-2458

PRUventor TurnPRO™QUICK APPLICATION CARD & TURN CLOCK

DeRoyal Industries, Inc. 200 DeBusk Lane I Powell, TN 37849 1.800.DEROYAL or 865.938.7828 | www.deroyal.com

DeRoyal, the DeRoyal logo, Improving Care, Improving Business., PRUventor, PRUventor TurnPRO, and TurnGRIP are trademarks or registered trademarks of DeRoyal Industries, Inc.

SuperCore is a registered trademark of McAirlaid’s Vliesstoffe GMBH.

© 2019, DeRoyal. All rights reserved. | Rev. 1/19 | Reprint #0-2454

PRUvent

or™ II

PRUvent

or™