Manufacturer’s
IFUs
What Are They and Why Are They
So Important?
Speaker Disclaimer
Chuck Hughes
VP, Infection Prevention Consulting Services
SPSmedical Supply Corp. now part of Crosstex International
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, OSAP,
and numerous other organizations, including AAMI and CSA where he contributes to
sterilization standards. A popular speaker at regional, national and international
Health care conferences, Chuck has visited thousands of health care facilities during
his career providing infection prevention consulting services that include fee based
and complimentary audits of instrument reprocessing areas.
Objectives
At the end of this program, participants will be able to:
• explain what IFU stands for,
• discuss why manufacturer’s IFUs are important to
have and to comply with,
• describe how to secure manufacturer’s IFUs.
Manufacturer’s IFU
(Instructions For Use)
In the U.S. medical device industry, IFU stands for
“instructions for use” and in Canada they say MIFU
which stands for “manufacturer’s instructions for use”.
Reusable medical devices are a critical component of
modern health care and for patient safety reasons, they
must be reprocessed according to the manufacturer’s
(MFR’s) written and validated IFU. With instruments
and other medical devices becoming more and more
complex, having and following each MFR’s IFU is
critical.
New FDA Regulations
The FDA released a new guidance document on 3/17/15
explaining what is now required of MDMs who request
510(k) clearance for a new device. For reusable medical
devices, validated reprocessing instructions are expected.
Recently, the Dental Trade Association (DTA) met with
the FDA and discussed the new regulations, along with
the issues in a 510(k) application that can result in a
Refuse to Accept letter (denial).
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM253010.pdf
Medical Device Regulations
These new FDA regulations require medical and dental
instrument manufacturers to validate their product label
claims of reusability and provide complete and
comprehensive written IFUs for:
•
•
•
•
•
cleaning,
disinfection,
testing,
packaging,
sterilization and drying.
Medical Device Regulations
Other device manufacturers, such as sterile packaging,
chemical and biological indicators, as well as sterilizer
are also being required to provide written IFUs.
Sterilizer Manufacturers
Are being required to validate to AAMI
standard cycles to avoid conflicting IFUs with
sterile packaging systems and sterilization
indicators used to monitor their cycles.
Medical Device Manufacturers
Validating to AAMI standard
cycles is also being required
for new instruments, sterile
packaging (pouches, wraps,
containers and cassettes),
chemical indicators or
integrators and biological
indicators (also called spore
tests).
MFR’s IFU
(Instructions For Use)
For patient safety, compliance with MFR’s written IFUs
is stated in AAMI Standards, such as ST79 and the CDC
Infection Control Guidelines (dental is being updated this
year).
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 ST79
List Price: $290.00 plus shipping
Member Price: $174.00 plus shipping
www.aami.org
Where Do You Get MFR’s IFUs?
Many health care facilities rely on Sales Representatives
to provide IFUs; however, I recommend you contact the
device manufacturer’s Corporate office and ask for
Quality Control or Regulatory Affairs.
Quality Control and/or Regulatory Affairs personnel are
the ones most familiar with IFUs and should be eager to
provide them to you.
Where Do You Get MFR’s IFUs?
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.
It is important to know…
National survey organizations now audit health care
facilities for strict compliance with standards, guidelines,
and MFR’s IFUs.
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.
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 Certification
document to include more stringent audits in the areas
of 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.
Instructions for Use (IFU)
It is critical you follow the device
MFR’s validated cleaning IFU
with regards to water temperature,
water type, brush, detergent and
specific cleaning procedures.
It is also critical to follow device
MFR’s validated sterilization IFU
with regards to which process and
cycle parameters.
Why Are IFUs Important?
“If manufacturer’s instructions are not followed, then
the outcome of the sterilizer cycle is guesswork, and the
practice should be cited as a violation of Section 42
CFR 416.44(b)(5).”
Centers for Medicare & Medicaid Services (CMS)
So, let’s take a look at some existing DENTAL IFUs to
see what dental reprocessing personnel are dealing
with…
Young Dental Sug-O-Vac Evacuator Tip
December 3, 2012
Re: Surg-O- VacTM autoclave information request
The Young Dental Sug-O- Vac plastic high volume evacuator tips
can be autoclaved up to 135°C prior to use per autoclave
instructions. Although the tip may be autoclaved prior to use, the
product remains a single use device, and must be disposed of after
one use. The initial autoclave may be done at the user’s discretion
according to the autoclave manufacturer’s recommendations.
Please let me know if you have any additional questions or
concerns.
Sincerely,
Sarah Moore
Regulatory Affairs
What’s missing?
ITL Dental Adjustable Torque Wrench
Cleaning & Autoclaving
Before initial use and after each procedure, clean the
torque wrench with a wet towel or disinfectant wipe.
Rinse under warm tap water and wipe dry.
The torque wrench may be autoclaved.
Follow the autoclave manufacturer’s instructions.
20 minutes at 135°C (275°F) is recommended.
Do not store is sealed autoclave bag.
After autoclaving, rotate the setting dial to ensure that
the wrench is operating correctly.
What about this?
Anything missing?
3M ESPE Elipar S10 LED Curing Light
Sterilization
Effective cleaning and disinfection are absolutely essential requirements
for effective sterilization.
Only steam sterilization is approved as a sterilization procedure:
- Maximum sterilization temperature 134°C (273°F)
- Sterilization time (exposure time at sterilization temperature)
at least 20 min. at 121°C (250°F) or
at least 3 min. at 132°C (270°F) /134°C (273°F).
These cycles do not match
AAMI standard cycles
DUX Dental
Sterilizing Procedures for Bur Blocks, Code Rings*,
Set-up Trays, Instrument Mats, Mirrors, SteriCassettes
and SteriCages
These items can be processed through an autoclave or
Chemiclave cycle. The time/temperature ratio of the moist
heat cycle is determined when selecting the appropriate
(unwrapped, wrapped, pouches, packs) cycle, as
determined by the manufacturer of the equipment. Any
cycle is appropriate to process all plastics where the
heat does not exceed 275ºF. A biological monitor is always
recommended to assure that sterilization has taken place.
What does the FDA say about who is responsible
for validating the cycle parameters?
Hu-Friedy Dental Hand Instruments and Accessories
3.1.4.2 Manual Cleaning
Procedure: Cleaning
1. Completely disassemble the instruments, if applicable.
2. Soak the disassembled instruments for the recommended soaking
time in the cleaning solution and make sure that the instruments are
sufficiently immersed.
If applicable: Rinse all lumens of the instruments five times at the
beginning and at the end of the soaking time with a single-use syringe
(minimum volume 50 ml) or a suitable rinsing adapter.
3. Remove the instruments from the cleaning solution and post rinse
them intensively with low contaminated and deionized water (i.e. aqua
purificata).
4. Inspect the instruments for proper cleaning.
Lumens are very difficult to clean, as
seen by this MFR’s validated cleaning IFU.
Hu-Friedy Dental Hand Instruments and Accessories
3.1.4.3 Ultrasonic Cleaning
The use of a cassette system like the Hu-Friedy IMS-System is recommended
(limitations see 4.0 Special Procedures section).
Procedure: Cleaning
1. Completely disassemble the instruments if applicable. Soak the disassembled
instruments for the recommended soaking time in the cleaning solution, and
make sure that the instruments are sufficiently immersed. Use the processing
time recommended by the manufacturer of the detergent and/or the cassette
system. Note: There should not be any contact between the instruments. If
applicable: Rinse all lumens of the instruments five times at the beginning and
at the end of the soaking time by application of a single-use syringe (minimum
volume 50 ml).
2. If you are using the IMS Cassette System, the ultrasonic cleaning time has
to be at least 16 minutes, unless a longer exposure time is required by the
manufacturer of the detergent. Do not overload the Ultrasonic Cleaning unit.
Use “Sweep modus” if available.
3. Remove the instruments from the cleaning solution and post rinse them
intensively with low contaminated and deionized water (i.e. aqua purificata)
for best results.
4. Inspect the instruments for a good cleaning result.
Hu-Friedy Dental Hand Instruments and Accessories
3.5 Sterilization
Please use only the recommended sterilization procedures listed below. Other sterilization
procedures are the responsibility of the user. Hu-Friedy recommends a 30 minute dry
time; however defer to the manufacturer’s instructions for the equipment used.
3.5.1 Steam sterilization
- fractionated vacuum or gravity procedure
- Sufficient product drying must be ensured after sterilization and before handling, see
table below for recommendations.
- steam sterilizer according to or AAMI/ANSI ST55 and AAMI/ANSI ST8
- validated according to or ANSI/AAMI ST79 (valid IQ/OQ (commissioning) and product
specific performance qualification(PQ))
Minimum cycle times for gravity-displacement steam sterilization cycles
Item
Exposure time at 121°C (250°F)
Drying times
Wrapped instruments
30 minutes
30 minutes
Minimum cycle times for dynamic-air-removal steam sterilization cycles
Item
Exposure time at 132°C (270°F)
Drying times
Wrapped instruments
4 minutes
30 minutes
These cycles match AAMI standard steam sterilizer cycles.
Star Dental Titan Low Speed Handpiece Motor
Sterilization
1. After each patient, flush air by running handpiece motor for 20 seconds.
2. Remove attachment.
3. Clean all internal surfaces at rear of handpiece motor with a cotton swab soaked in isopropyl
alcohol until clean.
4. Clean all external surfaces using a small toothbrush with isopropyl alcohol.
5. Dry thoroughly.
6. Place handpiece motor and swivel in sterilization bag – use paper or paper/plastic bags only.
Follow the sterilization guidelines as stated by the manufacturer of your sterilizer.
7. Remove handpiece motor from sterilizer after drying cycle ends and allow to cool in bag.
The handpiece motor must be cleaned and sterilized between patient use.
A wrapped handpiece motor should be steam sterilized at 132°C for a minimum of 10 minutes or
at 121°C for a minimum of 50 minutes. Do not exceed 135°C.
An unwrapped handpiece motor should be steam sterilized at 132°C for a minimum of 8 minutes
or at 121°C for a minimum of 30 minutes. Do not exceed 135°C.
Again, no description of what type of
steam sterilizer and both cycles do
not match AAMI cycles.
Dental Handpieces
Device MFG.
Device Description
Process
Time/Temperature/Dry
ADEC W&H
Synea Lighted HS Handpieces
Steam Pre-vacuum
Steam Gravity
4 min @ 134°C/273°F
6 min @ 121°C/250°F
W&H
TReND LS Straight Handpiece
and Contra-angle Handpieces
Steam Pre-vacuum
Steam Gravity
3 min @ 134°C/274°F
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
16 min @ 121°C/250°F
*In accordance with ANSI/AAMI ST42:1998
Sabra
Dental Handpieces
ANSI/AAMI ST79:A4 2013
Autoclave
Steam Dynamic Air Removal*
*Pre-vacuum or SFPP
Not a single IFU matches these AAMI cycles!
Steam Gravity Displacement
15 min @ 132°C
20 min @ 121°C
4 min @ 132°C/270°F
3 min @ 135°C/275°F
10 min @ 132°C/270°F
30 min @ 121°C/250°F
CONCLUSION
As you can see, there is a wide variance in MFR’s IFUs.
However, for patient safety, compliance with Standards,
and to stay out of the national Media; you must have and
must follow each device MFR’s validated IFU.
THANK YOU!
Chuck Hughes
VP, Infection Prevention Consulting Services
SPSmedical Supply Corp. now part of Crosstex International
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, OSAP,
and numerous other organizations, including AAMI and CSA where he contributes to
sterilization standards. A popular speaker at regional, national and international
Health care conferences, Chuck has visited thousands of health care facilities during
his career providing infection prevention consulting services that include fee based
and complimentary audits of instrument reprocessing areas.
References & Resources
Association for the Advancement of Medical Instrumentation
1110 North Glebe Road, Suite 220, Arlington, VA 22201-4795
703-525-4890 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 21244
www.cms.gov
The Joint Commission (TJC)
One Renaissance Boulevard · Oakbrook Terrace, IL 60181
www.jointcommission.org