Example Policy for the Integrity Test for Daily Verification of Heat

Example Policy for the Integrity Test for Daily Verification of Heat-sealing Device and Self-Sealing

Pouches

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NOTE: This document is an example of a policy that may be instituted in a health-care facility

for the actual policy in a facility must be based on variables, logistics, and risk-assessments that

are specific to your facility.

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Subject: Peel Pouch Daily Integrity Test

Department: CPD, CSSD, SPD, SPA, MDRD, dental, medical, and other offices using a heat

sealer to package items in peel pouches.

Approved By: [Approved by Dept Supervisor/Manager]

Effective: [Enter the date when it goes into effect]

Revised: November 2021

Purpose: To monitor the seal quality of the heat-sealing device to ensure the peel pouch barrier

is intact.

Policy: Inspect and test any heat-sealing device with the pouch integrity test to ensure proper

seal of peel pouch sterile barrier systems and test self-sealing pouches. The pouch integrity tests

will be conducted every day that a heat-sealing device is used for paper/poly and Tyvek

/poly

pouches with a push indicator dye test. This test is to be done per the manufacturer’s instructions

for use (IFU)

and

the test results will be documented according to facility policy for

documentation of performance quality tests.

Rationale: There are many reasons why electrical/mechanical devices may fail. Failures of such

devices are not always evident to the end user. Additionally, the ability of a staff member to

identify problems with the equipment will be widely variable based on the individual’s

experience and attention to detail. Performing a standardized, daily test of the equipment will

help any end user to identify whether the equipment/product is functioning properly.

Standard and Professional Society Recommendations:

ANSI/AAMI ST90:2017 (3.19) defines performance qualification (PQ) as a process of obtaining

and documenting evidence that the equipment (installed and operated in accordance with

operational procedures) consistently performs in accordance with predetermined criteria and,

thereby, yields product meeting its specification.

Example Policy for the Pouch Integrity Test for Daily Verification of Heat-Sealing Device and Self-Sealing Pouches

Healthmark Industries Company, Inc. © November 2021.

ANSI/AAMI ST90:2017 (7.1), regarding equipment used to process medical equipment, states

the following:

The healthcare organization shall plan and develop processes for incorporating new devices,

equipment, and materials necessary for effectively and safely processing medical devices. This

plan shall be consistent with the requirements of the other quality system processes and

communicated with other departments as necessary.

In planning for new devices, equipment, and material, the healthcare organization shall specify:

a) Quality controls, quality assurance checks, and safety objectives for the device,

equipment, or material

b) Processes, documents, inspection requirements, test activities, and necessary resources

c) Criteria for acceptance and rejection in accordance with device, material, or equipment

manufacturer recommendations.

d) Records needed to provide evidence that the planning processes and new device,

equipment, or material meet the predetermined requirements.

Procedure:

Pouch Seal Integrity Test (IFU)

Sealing Process Test:

To test the integrity of the seals for heat-seal and self-seal pouches:

1. Check temperature on heat-sealing unit.

2. Set temperature between 120

℃

– 130 ℃ for sealing Tyvek

/poly pouches, unless

otherwise indicated by your Tyvek

/poly pouch manufacture’s IFU.

3. With gloves on, place push indicator dye test (model # TPS-001) for Tyvek

pouches

inside a Tyvek

pouch with the pointed side of the indicator dye test pointing toward the

open-end of the pouch.

4. Seal the pouch.

5. Place the pouch on a cleanable surface, as ink may leak through the pouch and stain

surfaces underneath.

6. Push indicator dye test inside the pouch by sliding three fingers in the direction of the

arrow of the push indicator until it breaks.

7. Once the ink has been expelled from the push indicator dye pack, pick up the pouch and

make sure the dye is reaching the entire seal of the pouch.

8. Examine visually for any dye leaking through the sealed part of the pouch.

9. If you do not see any tunneling of the ink (through the seal), this indicates that the seal is

good.

a. Test is finished

b. Document your results according to your hospital policy.

10. If you do see tunneling of the ink through the seal of the pouch:

a. Document test results

Example Policy for the Pouch Integrity Test for Daily Verification of Heat-Sealing Device and Self-Sealing Pouches

Healthmark Industries Company, Inc. © November 2021.

b. Notify your supervisor

c. Follow your hospital policy for reporting equipment failure.

11. Retry the test following the steps above.

Once the test passes for your Tyvek

/poly pouch, test the paper/poly pouch seal:

1. Set the temperature on the heat-sealing unit to 160

℃

– 180

℃ for sealing paper/poly

pouches.

2. With gloves on, place push indicator dye test (model # PS-001) for paper/poly pouches

inside a paper/poly pouch with the pointed side of the indicator dye test pointing toward

the open end of the pouch.

3. Seal the pouch.

4. Place the pouch on a cleanable surface, as ink may leak through the pouch and stain

surfaces underneath.

5. Push indicator dye test inside the pouch by sliding three fingers in the direction of the

arrow of the push indicator until it breaks.

6. Once the ink has been expelled from the push indicator dye pack, pick up the pouch and

make sure the dye is reaching the entire seal of the pouch.

7. Examine visually for any dye leaking through the sealed part of the pouch.

8. If you do not see any tunneling of the ink (through the seal), this indicates that the seal is

good.

a. Test is finished

b. Document your results according to your hospital policy.

9. If you do see tunneling of the ink through the seal of the pouch:

a. Document test results

b. Notify your supervisor

c. Follow your hospital policy for reporting equipment failure.

10. Retry the test following the steps above.

Principle:

The dye in this test provides the user with a visual indicator to determine the quality of a heat-

sealed peel pouch.

Range Of Application:

For paper/poly heat-sealed pouches and Tyvek

/poly heat-sealed pouches.

Interferences:

If dye leaks through the heat-seal, an item inside the pouch could interfere with the heat-sealing

device, or a problem may exist with the heat-sealing device—requiring service.

Storage:

Store at room temperature.

Shelf Life:

Expiration date provided on each container of pouch seal integrity tests.

Example Policy for the Pouch Integrity Test for Daily Verification of Heat-Sealing Device and Self-Sealing Pouches

Healthmark Industries Company, Inc. © November 2021.

Responsibility:

The department manager (or their designee) is responsible for ensuring proper

training/competency of staff, compliance with this policy, and documentation related to this

performance qualification test of the department heat-sealer.

• Ensure all Pouch Seal Integrity Test(s) are documented correctly by reviewing records

daily or each day a test is taken/performed.

• Ensure that corrective action is taken on any failed test before the heat-sealer is put back

in service.

Pouch Seal Integrity Test Log Sheet

Equipment name_________________ Equipment Serial number #____________________

Date

Tested

Tester’s

Initials

Lot number

Heat

Seal/Self-

Seal

Paper-

Poly/Tyvek

Pass/Fail

Action

Comment

Sample Competency for Pouch Integrity Test Policy to test the seal integrity of the seals for

heat-seal and self-seal pouches

Example Policy for the Pouch Integrity Test for Daily Verification of Heat-Sealing Device and Self-Sealing Pouches

Name:

Competency Statement: Complies with policy and procedure for testing lumened/channeled

items and endoscopes for residual moisture.

Key:

1 = Performs independently and consistently. Asks for assistance in new situations.

2 = Performs with minimal guidance and direction. Asks for assistance when necessary.

3 = Performs with maximal guidance and direction. Preceptor dependent. Consistently needs

assistance.

Comments:____________________________________________________________________

______________________________________________________________________________

Competency Achieved: _________________________________________ Date: __________

Evaluator: ____________________________________________________________________

Learner: _____________________________________________________________________

Critical Behavior

1. Set/check temperature is in the correct range for the

peel pouch product being used. (120

℃ – 130

℃ for

Tyvek®, 160 ℃ – 180 ℃ for paper).

2. Collect materials needed for integrity test:

a) PPE

b) Integrity test pack

c) Peal pouch product.

3. Don gloves.

4. Place seal integrity test in peel pouch (with arrow

pointing toward open end of pouch) being sure to

use proper test for type of pouch.

a) PS-001 for paper/poly pouches

b) TPS-001 for Tyvek

/poly pouches

5. Seal the pouch.

6. Place pouch on cleanable surface.

7. Push the indicator dye pack with your fingers in the

direction of the arrow until the dye bursts from the

package.

8. Pick up package and ensure that dye reaches entire

seal.

9. Identify any dye leaks in the seal.

10. Document results per facility policy.

Example Policy for the Pouch Integrity Test for Daily Verification of Heat-Sealing Device and Self-Sealing Pouches

11. Report any failed dye test findings per facility

policy.

References:

Healthmark Industries. (2019). Instruction Instructions for Use: Pouch Seal Integrity Test.

Healthmark.info. http://www.healthmark.info/SterilizationProducts/HeatSealers/Pouch_S

eal_Integrity_Test_IFU_.pdf

Association for the Advancement of Medical Instrumentation. (2017). ANSI/AAMI ST90:2017.

(Section 3.19., p 5). AAMI.

Association for the Advancement of Medical Instrumentation. (2017). ANSI/AAMI ST90:2017.

(Section 7.1., p 13). AAMI.