Presented by SPS Medical Device MFR’s · PDF fileMedical Device Manufacturer’s IFU 1 Medical Device MFR’s IFU What Are They & Why Are They Important to Healthcare Facilities?

Medical Device Manufacturer’s IFU

1

Medical Device MFR’s IFU

What Are They & Why Are They Important

to Healthcare Facilities?

Presented by SPSmedical

• Largest sterilizer testing Lab in North America and now a part of Crosstex International, a Cantel Medical Company

• Develop and market sterility assurance products that offer advanced technologies

• Provide full day sterilization Seminars and on-site Facility sterilization audits

• Corporate member: CSA and AAMI, serving on numerous sterilization working groups

Cantel Medical Corp.At the end of this program, participants will be able to:

• explain what IFU stands for,

• discuss why the MFR’s IFU is so important for

healthcare facilities to have and to comply with,

• describe where to secure the MFR’s IFU, and

• understand ten (10) things healthcare facilities can

do to improve their medical device reprocessing.

Program Objectives

IFU stands for “instructions for use” in the medical device

industry. Reusable medical devices are a critical component

of modern health care, and for patient safety reasons must

be reprocessed according to the MFR’s validated IFU.

MFR’s IFU (Instructions For Use)

Reusable Medical Devices

Regulations enforced by the FDA in the USA require

medical device manufacturers to validate their product

label claims of reusability and provide complete and

comprehensive written instructions for:

• cleaning,

• disinfection,

• testing,

• packaging,

• sterilization and drying,

• plus aeration (if applicable).


2

For patient safety, national standards and recommended

practices stress the importance of securing and following

the MFR’s IFU when reprocessing reusable medical

devices.


ANSI/AAMI ST79:A4:2013

Considered the bible of sterilization, this comprehensive

guide to steam sterilization in healthcare facilities covers

all aspects of facility design, personnel and reprocessing

procedures.

Order Code: AAMI ST:79

www.aami.org

ANSI/AAMI ST58:2013

Provides guidelines for the selection and use of liquid

chemical sterilants (LCSs)/high-level disinfectants

(HLDs) and gaseous chemical sterilizers that have been

cleared for marketing by the FDA for use in hospitals and other health care facilities.

Order Code: ST58

www.aami.org

AAMI ST79 Section 7 - Cleaning and other Decontamination processesThe written instructions of the device manufacturer should always be followed.

AAMI ST79 Section 8.6 - SterilizationThe sterilizer manufacturer’s written instructions for cycle parameters should be followed. Any differences between the programmed cycle parameters recommended by the medical device manufacturer should investigated and resolved before items are processed.

Association for the Advancement of Medical Instrumentation

AAMI ST58 Section 6.6 - Cleaning and other Decontamination processesThe type of cleaning and/or microbicidal process appropriate for a particular device depends on: a) The device manufacture's written IFU

AAMI ST58 Section 8.6 - SterilizationTypically, after being thoroughly cleaned, an item is immersed in the LCS/HLD for a defined period of time at a set temperature; these parameters are determined by the manufacturer and indicated with the manufacturer’s written IFU.

Association for the Advancement of Medical Instrumentation

AORN RP: Care of Instruments

The manufacturer’s written, validated instructions for

handling and reprocessing should be obtained and

evaluated to determine the ability to adequately clean

and reprocess the equipment within the health care

facility before purchasing surgical instruments and

powered equipment.


3

Where Do You Get MFR’s IFU?

Many health care facilities rely on the MFR’s Sales Rep

to provide IFU; however, I recommend they contact your

Corporate office and speak directly with Quality Control

or Regulatory Affairs.

Quality Control and/or Regulatory Affairs personnel are

the ones most familiar with these documents and should

be eager to provide them to you.

Where Do You Get MFR’s IFU?

Another option is to hire a Company to do the search for

you and to keep the MFR’s IFU updated. For a monthly

or annual fee, they provide you with an internet based

library with electronic copies that can be printed out.

National survey organizations now audit U.S. hospitals

and ASCs for strict compliance with standards, guidelines,

and MFR’s instructions for use (IFU).

It is important to know…

June 15, 2009 - Update on The Joint Commission's Position

Based on discussions with experts in the field, professional

organizations, and government organizations, The Joint

Commission has decided to refocus its survey efforts on all

of the critical processes included in sterilization.

If a complete and effective process of sterilization is used,

it will be considered an effective sterilization method.

Therefore, surveyors will review the critical steps of

disinfection and sterilization to determine if the process is

appropriate.

Here is a brief overview of the 3 critical steps of reprocessing:

1. Cleaning and decontamination. All visible soil must be removed prior to sterilization because steam and other sterilants cannot penetrate soil, particularly organic matter. Manufacturers’ instructions are available for all instruments; these include directions for the cleaning and decontamination process. Some smooth metal instruments may be easily brushed clean, while complex products may require disassembly and special cleaning techniques. Many manufacturers specify that an enzymatic soak be used as

well.

2. Sterilization. Most sterilization is accomplished via

steam, but other methods are also available. Steam

sterilization of all types, including flashing, must meet

parameters (time, temperature and pressure) specified by

both the manufacturer of the sterilizer, the maker of any

wrapping or packaging, and the manufacturer of the

surgical instrument. In addition to these instructions,

physical, chemical and biological controls must be used

as designed and directed by their manufacturers.


4

3. Storage or return to the sterile field. Each newly sterilized instrument must be carefully protected to ensure that it is not re-contaminated. For full steam sterilization cycles, packs of instruments are wrapped and sealed. Instruments subjected to steam sterilization using methods other than full cycle sterilization may be transported in “flash pans” or other devices specifically designed for the prevention of contamination during and after the steam process.

In summary, Joint Commission surveyors will focus on all of

the critical steps and the integrity of the sterilization process.

The Centers for Medicare & Medicaid Services (CMS)has recently revised their Survey and Certificationdocument to include more stringent audits in the areasof infection control and sterilization.

Areas of emphasis include:

• Compliance with nationally recognized standards/documents.• Formal training in areas of infection control and sterilization.• Compliant cleaning, sterilization and monitoring procedures.• Established criteria for flash sterilization.

Reference:CMS Infection Control Surveyor Worksheet, Exhibit 351, 2009.

The Accreditation Association for Ambulatory

Healthcare (AAAHC) added an infection control chapter

to their standards handbook.

Infection control highlights included:

“Adhering to standards, guidelines, and manufacturer’s

instructions for cleaning, disinfection, and sterilization

of instruments, equipment, supplies, and implants.”

Reference:OR Manager Magazine, Volume 26, Number 2, 2010.

July 20, 2011 - Joint Commission Online

Beginning in 2010, surveyors have spent additional time

during surveys evaluating the cleaning, disinfection and

sterilization processes.

Earlier this year, Joint Commission surveyors received

in-depth training on sterilization processes. This

education was provided in collaboration with AAMI

and included a review of all aspects of the AAMI ST79

guideline on steam sterilization.

For patient safety and maintaining their accreditation, it is

critical that healthcare facilities receive and comply with

MFR’s IFUs. And they should be located, where they are

needed. Not some of them, all of them!


As most everyone knows…

Scientific advances in diagnostic and

therapeutic medicine have led to the

development of new and sophisticated

reusable medical devices for use by

healthcare practitioners.

However, not everyone knows that

many of the cleaning IFUs are very

detailed and time consuming for

these sophisticated devices.

4


5

EXAMPLE - Cleaning IFU

Orthopedic Instruments

1. Submerge in enzymatic detergent.

2. Flush port with 50 ml enzymatic detergent.

3. Soak for 10 min in protein soluble detergent.

4. Scrub with soft bristled brush (agitate instrument

while scrubbing).

5. Rinse with warm tap water (38-49°C)

6. Flush port with 50 ml warm tap water.

7. Place in bath of warm water (agitate by hand for at least

1 min). Repeat this process 2 additional times.

8. Ultrasonic for 10 min with neutral pH detergent (flush

port with 50 ml prepared detergent before sonication).

9. Flush port with clean tap water (3 times).

10. Rinse for at least 1 min with tap water.

11. Dry with clean, lint free cloth.

12. Inspect.

13. Lubricate tip mechanism and

finger slot (do not lubricate

flush port).

40 minutes?


Orthopedic Instruments

EXAMPLE - Cleaning IFU Orthopedic

Surgical Instruments

1. Completely submerge instruments in

enzyme solution and allow to soak for 20 min.

2. Rinse in tap water for minimum of 3 min.

3. Ultrasonic clean for 10 min.

4. Rinse in purified water for at least 3 min.

5. Repeat sonication and rinse steps.

6. Remove excess moisture from the instrument with

a clean, absorbent and non-shedding wipe.

50 minutes?


Biopsy Needle

1. Submerge in neutral pH enzyme solution

for at least 20 min and flush vigorously.

2. Rinse under running warm water.

3. Clean with stiff nylon brush in neutral pH detergent.

4. Rinse under running water. Vigorously flush under

pressure all lumens, holes and other areas.

5. Disassemble devices.

6. Ultrasonic for minimum of 10 min w/equipment

manufacturer’s detergent.


Biopsy Needle

7. Vigorously rinse with warm running water.

Flush parts under pressure.

8. Perform second sonication for 10 minutes.

9. Inspect.

10. Vigorously rinse with deionized water. Flush lumens,

holes and other parts with deionized water under

pressure.

60 minutes?

• Do all of your HCFs have an

ultrasonic cleaner and is it working?

• Do they know which devices require

ultrasonic cleaning and for how long?

• Do they have enough equipment?

• Do they have enough instruments?

• Do they have enough time?


6

NextLet’s discuss MFR’s IFU for sterilization

As with cleaning, complex devices may require a

different sterilization cycle than what is programed on

the sterilizer. It is important for HCFs to know which

and how many of their devices require “different”

sterilization parameters than their standard cycle.


Extended Cycle (example)

60 min @ 270°F Gravity

25 min @ 270°F Pre-vacuum

25 min @ 270°F Pre-vacuum

DePuy Mitek

5 min @ 132 - 134°C Pre-vacuum

8 min @ 134 - 137°C Pre-vacuum8 min @ 270°F Pre-vacuum

How are HCFs dealing

with these different cycles?


7

Partial list of instruments processed in the OR at a hospital in NY.

This facility trained staff to adjust sterilizer to the MFR’s extended cycle times.

InstrumentationSterilization

Time @ 270°F Sterilizer Mode

Acufex ACL Tray 10 min Gravity

Acufex Meniscal Repair 10 min Gravity

Acufex T-Fix 10 min Gravity

Arthrex Bio-Fastak 18 min Gravity

Arthrex Chondro pick 18 min Gravity

Arthrex Gotham 18 min Gravity

Aesculap Laparoscopic grasper 20 min Gravity

Aesculap Laparoscopic scissor 20 min Gravity

Bariatric Basic 15 min Gravity

Biopsy tray cysto 15 min Gravity

Cataract tray 20 min Gravity

Globus Spine Tray Implants- Independence 10 min Gravity

Globus Spine Tray Instr - Independence 25 min Gravity

Partial list of instruments processed in the SPD at a hospital in CA.

This facility used a standard 4 minute @ 270°F pre-vacuum cycle for all loads.

InstrumentationSterilization

Time @ 270°F Sterilizer Mode

SYMMETRY Endoscopic 5 min Prevacuum

Biomet Orthopedics 5 min Prevacuum

Innomed Knee & Tibial Triangle 6 min Prevacuum

DePuy Hand Innovations 10 min Prevacuum

Katena Instruments 15 min Prevacuum

Stryker Spine Set 15 min Prevacuum

Abbott Spine Set 15 min Prevacuum

Sterilization Time @ 273°F Sterilizer Mode

Keeler Cryomaster 5 min Prevacuum

Scientix SACP System 18 min Prevacuum

Vilex CHI Sets 20 min Prevacuum

Mentor Gel Breast Implant Sizer 20 min GRAVITY ONLY

OSTEOMED Rigid Fixation System rev. 01/10 30 min Prevacuum

More examples of MFR’s that has at least one device requiring an “extended cycle”

• Abbott Spine

• Acclarent

• Acumed

• Biomet

• Blackstone

• Boss

• Boston Scientific

• CR Bard

• CarboMedics

• Cochlear

• D.O.R.C.

• DePuy Mitek

• DePuy Orthopedics

• DePuy Spine

• Drager

• Elekta

• Eilman

• Elmed

• EMS

• Encision

• Encore

• Estech

• Ethicon

• FCI

• FH Orthopedics

• FlashPak

• Genesis Biologics

• Globus

• Gore

• Greenwald

• Hand Innovations

• Heine

• Hitachi Medical Systems

• Hu-Friedy

• Hydrocision

• Innovasis

• Insight

• Integra

• Invuity

• Jardon

• K2M

• Kapp

• Lanx

• LDR Spine USA

• Medacta

• Medartis

• Mednext

• Metronic

• Microline

• Missonix

• Nuvasive

• On-X

• Ortho Development

• Orthofix

• Osteomed

• Pega Medical


• Respironics

• Rhein Medical

• Richard Wolf

• Ruggles

• SeaSpine

• Small Bone Innovations

• Spinal Elements

• Spine Weave

• Stryker

• Suprasson

• Surgipro

• Synthes

• The Electrode Store

• Thompson Surgical

• Thoramet

• TriMed

• Unisensor

• US Spine

• Vacumetrics

• Varian

• Viasys

• Vilex

• Wallach

• Welch-Allyn

• Wells-Johnson

• Wexler

• Zimmer


Dental Handpieces

Device MFG. Device Description Process Time/Temperature/Dry

ADEC W&H Synea Lighted HS Handpieces Steam Pre-vacuum 4 min @ 134°C/273°F Steam Gravity 6 min @ 121°C/250°F

W&H TReND LS Straight Handpiece Steam Pre-vacuum 3 min @ 134°C/274°F and Contra-angle Handpieces Steam Gravity 4 min @ 134°C/274°F

Anthogyr NiTi Control Endo Handpiece Steam 18 min @ 135°C

Kavo Dental MULTIflex HS Handpieces Steam or C-Vapor up to max 135°C/275°F

Piezosurgery Inc. Dental Handpiece Autoclave 4 min @ 134°C/273°F *In accordance with ANSI/AAMI ST42:1998 16 min @ 121°C/250°F

Sabra Dental Handpieces Autoclave 15 min @ 132°C 20 min @ 121°C

ANSI/AAMI ST79:A42013 Steam Dynamic Air Removal* 4 min @ 132°C/270°F*Pre-vacuum or SFPP 3 min @ 135°C/275°F

Steam Gravity Displacement 10 min @ 132°C/270°F

30 min @ 121°C/250°F

Not a single IFU matches the AAMI ST79 Standard for steam sterilization parameters!


8

Medical Device MRG’s IFUs

As you can see, there is a wide variance in MFR’s IFUs.

Manufacturers and their Distributors have an obligation

to provide and inform HCFs of this information when

reusable medical devices are purchased, borrowed or

trialed.

AAMI/FDA Medical Device Reprocessing Summit

In 2011, nearly 250 healthcare professionals attended a

Summit held at FDA headquarters in Silver Spring, MD.

The focus was on having and complying with MFR’s

IFUs for cleaning and sterilization. Let’s look at ten (10)

recommendations that came out of this October Summit.

10 Things Your Organization

Can Do Now to Improve Reprocessing

1) The basics:

Cleaning and disinfection/sterilization of reusable

devices are separate, equally important processes

and must be performed before each patient use

according to the device manufacturer’s written

instructions for use (IFU).



2) The right tools:

Have the IFU as well as all cleaning implements

and equipment required by the IFU readily

available in all the reprocessing areas.



3) Create a multidisciplinary committee to review

the priority issues and set a plan for solving them

throughout the organization.

4) Share lessons learned.

5) Establish written procedures.



6) Standards matter:

Know the current standards, recommended practices,

and manufacturer’s IFUs.


9



7) Purchasing:

Sterile processing should be included in

purchasing decisions for reusable devices, to

provide input on whether the device can be

reprocessed appropriately and with the facility’s

existing resources.



8) Separate and standardize functions and locations.

9) Train and retrain reprocessing personnel.

10) Assessment:

Conduct an audit of compliance with standards

and regulations, using any number of available

tools and resources.

www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofReusableMedical Devices/ucm252941.htm

CONCLUSION

HCFs must have and must follow each manufacturer’s

written IFU for…

• compliance with national standards,

• passing accreditation surveys,

• patient safety, and

• peace of mind!

Make sure your medical devices are validated to comply

with national standards and never say “just follow your

normal reprocessing procedures”.

Chuck Hughes

VP, Infection Prevention Consulting Services

Cantel Medical c/o SPSmedical Supply Corp.

6789 W. Henrietta Road · Rush, NY 14543 USA

(800) 722-1529 · E-mail: [email protected]

Certified as a Health Education teacher, Chuck has worked for over 25 years in the

manufacturing industry in areas of Regulatory Affairs, R&D, Marketing, Microbiology

and Sterilization Training. He is a corporate member AORN, AST, IAHCSMM, SGNA

and numerous other organizations, including AAMI and CSA where he contributes to

sterilization standards. A popular speaker at regional, national and international

healthcare conferences, Chuck has visited thousands of healthcare facilities during

his career providing sterilization consulting services that include fee based and

complementary audits of instrument reprocessing areas.

Thank You!

References & Resources

Association for the Advancement of Medical Instrumentation 1110 North Glebe Road, Suite 220, Arlington, VA 22201-4795703-525-4890 Fax: 703-276-0793 www.aami.org

Accreditation Association for Ambulatory Health Care (AAAHC) 5250 Old Orchard Road, Suite 200 · Skokie, IL 60007 www.aaahc.org

Centers for Disease Control and Prevention

1600 Clifton Road Atlanta, GA 30333

800-232-4636 www.cdc.gov

Centers for Medicare & Medicaid Services (CMS)7500 Security Boulevard · Baltimore, MD 21244www.cms.gov

The Joint Commission (TJC)One Renaissance Boulevard · Oakbrook Terrace, IL 60181www.jointcommission.org

Documents

Presented by SPS Medical Device MFR’s · PDF fileMedical Device Manufacturer’s IFU 1 Medical Device MFR’s IFU What Are They & Why Are They Important to Healthcare Facilities?