Sterilization of Surgical Implants: Did You Know… Surgical Implants1106.pdf · ‘implants’.” [21 CFR 812.3(d)].2 Ideally, implants and implantable devices should come indivdual

78 November 2006MANAGING INFECTION CONTROL

ObjectivesAfter completion of this self-study

activity, the learner will be able to:1. Define surgical implants/implantable

devices.2. Discuss the Association of periOperative

Registered Nurses (AORN) and theAssociation for the Advancement ofMedical Instrumentation’s (AAMI’s )recommended practice on sterilization of implants.

3. Explain why flash sterilization of implantsis not recommended.

4 . Develop a policy and procedure for sterilization of implants.

Education & Training

Many thanks to the team at 3M Health Care for working withManaging Infection Control to provide the following accre d i t e dcourse. IAHCSMM has awarded one (1) contact point for completionof this continuing education lesson toward IAHCSMM recertification.The CBSPD has preapproved this inservice for one (1) contact hourfor a period of five (5) years from the date of publication, and to beused only once in a recertification period. This inservice is 3M HealthC a re Provider approved by the California Board of Registere dNurses, CEP 5770 for one (1) contact hour. This form is valid up tofive (5) years from the date of publication. Instructions for submittingresults are on page 95.

Managing Infection Control and 3M Health Care will beworking collaboratively to provide continuing education courses inmonthly editions of Managing Infection Control.

Sterilization of Surgical Implants: Did You Know… by Rose Seavey, RN, MBA, CNOR, ACSP


Test QuestionsTrue or False

1. Implants are devices that are placed inside the humanbody but removed within 30 days.

2. For dependable assurance of the sterility of processeditems, it is essential that all phases of steam sterilizationprocessing be performed and supervised by knowledge-able staff.

3. The efficacy of saturated steam sterilization depends on adependable system for lowering and limiting bioburdenbefore sterilization, appropriately preparing devices forsterilization, selecting the correct sterilization parameters,and establishing and implementing controls to maintainthe sterility of sterilized items until they are used.

4. Implants should be held in quarantine until the results ofthe biological indicator (BI) are read as negative.

5. If an implant is released before the result of the BI isknown in such cases like trauma-related orthopedicsscrew-plate sets, documentation is not necessary.

6. If an emergency situation makes flash sterilizationunavoidable, a rapid-action biological monitoring deviceshould be used along with a class V chemical integrator.The implant should not be released until the rapid-actionindicator provides a negative result.

7. AAMI and AORN recommend flash sterilization ofimplants.

8 . It is critical that sterilization documentation of all implants,including flashed items, is traceable back to the patient.

9. Regardless of whether the items are wrapped, there is nostorage or shelf life of flash-sterilized items because ofthe higher probability of contamination after the sterilizerdoor is opened and the items are removed.

10. Flash sterilization should never be used for as a substitutefor inadequate instrument or implant inventory.

Introduction A major responsibility of healthcare providers is to

minimize patient risks. In the operating room, this is particu-larly important in regard to surgical wound infections. A v i t a lway to help prevent surgical wound infections is to presents u rgical items that are free of contamination at the time of use.1

Healthcare workers must make certain that all surgicalinstruments and medical devices used in procedures onpatients have been appropriately cleaned, disinfected or sterilized according to the nature of the item and the manner inwhich it is to be used. Of particular importance is the sterilizationassurance and documentation of surgical implants. Implantsare foreign bodies that increase the threat of surgical site i n f e c t i o n . Therefore, they require additional attention to thesterilization and quality control process.2


There is a higher degree of risk of infection to patientswith an implant because:1. “First, they are left behind at surg e r y, so if there are

microorganisms on them, these will remain in the body.Infections associated with implants may not be evidentfor up to a year after surgery.

2. “Second, the placement of an implant often means theremoval of tissue, with interruption of blood supply and significant manipulation of the tissues immediatelyadjacent to the implant, creating an area of potentialsafety for microorganisms to multiply, further increasingthe risk of infection.

3. “Third, because there is interrupted blood supply, antibiotics cannot easily get to the microorganisms if theydo multiply enough to cause a clinical infection.

4. “Fourth, the implant itself may be vital to continuingfunction of a body system, such as would occur with a total joint replacement, vascular graft, or intraocularlens placement. An infection may not be curable with theimplant in place, and removing it could cripple or kill the patient.”3

In addition: “The mortality rate (deaths) associated with infected total hip replacements approaches 50%, fromthe infection itself and from the complications associatedwith the resulting impaired mobility, such as blood clots and pneumonia.”3

This article will focus on sterilization of surgical implantsas discussed in the new Association for the Advancement of Medical Instrumentation standard C o m p rehensive guide to steam sterilization and sterility assurance in health carefacilities ANSI/AAMI ST79:2006, as well as the 2006Association of Perioperative Registered Nurses’ ( A O R N )Recommended Practices on Sterilization in the PerioperativePractice Setting.

What is considered an implant or implantable device?

According to the Food and Drug Administration (FDA),an implant/implantable device is a “device that is placed intoa surgically or naturally formed cavity of the human body if itis intended to remain there for a period of 30 days or more.FDA may, in order to protect public health, determine thatdevices placed in subjects for shorter periods are also‘implants’.” [21 CFR 812.3(d)].2

Ideally, implants and implantable devices should comeindividually wrapped and sterile from the manufacturer.Sometimes this is not feasible, and the implantable devicesmust be processed by the healthcare facility. The preferredmethod for implants processed in a healthcare facilty is steamsterilization. For dependable assurance of the sterility of


processed items, it is essential that all phases of steam sterilization processingbe performed and supervised by knowledgeable staff. Effective sterilization isvital, and manufacturers’ written instructions for appropriate sterilization timefor each type of implant must be followed.

The ideal method for sterilization, especially implants, is wrapped (orcontainerized). The main function of packaging is to allow the sterilization ofthe contents, maintain the sterility until the package is opened and provide for aseptic presentation at the point of use. Packaging allows for labels, such as process indicators, product identification, and lot numbers and expirationstatements, to be affixed to the item.

Steam sterilizationOne of the oldest methods to sterilize medical devices used in healthcare

facilities is steam under pressure. In-house facility processed implants are mostcommonly sterilized via steam. Since steam sterilization has been around for solong it is thought to be an uncomplicated method, one that is understood and easily controlled. Conversely, steam depends on four phases that are significantly dependant on each other to produce and maintain a sterile product.The efficacy of saturated steam sterilization depends on a dependable systemfor lowering and limiting bioburden before sterilization, appropriatelypreparing devices for sterilization, selecting the correct sterilization parameters,and establishing and implementing controls to maintain the sterility of sterilizeditems until they are used.2

Personnel considerationsAccountability for performing sterilization processes should be assigned to

competent individuals who have knowledge of all aspects of disinfection andsterilization procedures and safety precautions.

Supervisory personnel responsible for sterilization and disinfection shouldhave formal training and be knowledgeable about each method used. Theyshould be aware of the need to acquire and follow the device and sterilizer


m a n u f a c t u r e r’s written instructions for use that may require extended sterilizationcycles. As with all processing activities,employees performing these duties should be given special training, and their compe-tencies should be verified.2

Release criteria for implantsEach implant should be labeled with a

lot control identifier (sterilizer identificationnumber or code, date of sterilization andcycle number) to assist in the event of arecall. “Ideally, every reprocessed medicaldevice, especially an implant, should be fullytraceable to the patient on whom it is used orin whom it is implanted; such traceability canbe accomplished by recording the sterilizerload identifier on the patient chart or thepatient name on the load record.”2

Sterilization records should be main-tained for each cycle. This informationshould include: lot number; contents of load; exposure time and temperature if not on

a recording chart; operator identification; results of BI testing; results of the Bowie-Dick testing; results of chemical indicator (CI) in the

PCD (BI challenge test pack, BI chal-lenge test tray, CI challenge test pack);

any reports of inconclusive or nonre-sponsive CIs in the load.

The sterilizer operator should review thephysical monitors, the results of the externalchemical indicator on every package, theinternal chemical indicator inside eachpackage, and the BI for the BI PCD (processchallenge device) in each load to determine ifthe results are appropriate. If not, the loadshould be reprocessed.

Implants should be held in quarantineuntil the results of the BI are read as negative. A A M I ’s newest master documenton sterilization, C o m p rehensive guide tosteam sterilization and sterility assurance inhealth care facilities (ANSI/AAMI ST79:2006), has specific recommendations on therelease criteria for implants (10.6.3).



“As with all cycles, the sterilizer operator should reviewthe sterilizer chart or printout and the results of other indicatorsthat have been used to monitor the sterilization process. Theload should be quarantined until the results of the BI testing areavailable (CDC, 2003a).

“When documented medical exceptions dictate (e.g., theneed for trauma-related orthopedic screw-plate sets), it couldbe necessary to release an implantable device before the BIresults are known. In this case, the release of the device beforethe BI results are known should be documented; the BI resultobtained later should also be documented. [See Annex L, p. 84and 86, for examples of an implant log and an exceptionform.] It is critical that this documentation be fully traceableto the patient. Releasing implants before the BI results areknown is unacceptable and should be the exception, not the rule. Emergency situations should be defined in written

guidance developed in consultation with infection preventionand control, the surgeon, and risk management. Steps shouldbe taken to reduce the frequency of emergency release ofimplantable items. For example, ongoing periodic reviews ofthe exception forms and implant logs could reveal consistentpatterns of events that are causing emergency release and thatcould be corrected.

“Rationale: Patient safety could be adversely affected bythe implantation of a nonsterile device. The sterilization ofimplantables should be closely monitored and each loadcontaining implants should be quarantined until it is verifiedthat BI testing has yielded negative results. In defined e m e rgency situations in which the quarantine of implantscannot be maintained, breaking of the quarantine is allowed fordocumented medical exceptions in accordance with facilitypolicies and procedures.”2

Date Description Dept. Time Sterilizer # Load # Date/time Date/time Early Date/time Released of implants sterilized BI in and release? released by

(specify incubator BI result to OR (full name)AM/PM)

Annex L (Informative)

Example of documentation of premature release of implantsThis Annex provides an Implantable Devices Load Record and an Exception Form for Premature Release of ImplantableDevice/Tray, as examples of the forms recommended in Section 10.5.3.3.

Implantable Devices Load Record

Figure L.1—Implantable devices load record



Exception Form for Premature Release of Implantable Device/Tray

N O T E—In a documented emergency situation, implantable devices will be released from quarantine in Central Service without the biological monitor result. This form should accompanythe implant to the Operating Room. Operating Room personnel should complete this form andreturn it to Central Service within 24 hours.

PLEASE COMPLETE ALL INFORMATION:

DATE: ___________________________ SHIFT: ____________ TIME: __________ AM PM

PERSON COMPLETING THIS REPORT IN CENTRAL SERVICE: _____________________

The following implantable devices/trays were prematurely released to the Operating Room:

______________________________________________________________________________

______________________________________________________________________________

NAME OF OR PERSON REQUESTING PREMATURE RELEASE OF DEVICES:

_____________________________________________________________________________

OPERATING ROOM REPORT:

PATIENT NAME: ______________________________________________________________

SURGEON NAME: ____________________________________________________________

TIME OF PROCEDURE: ____________________ AM PM DATE: ____________________

REASON PREMATURE RELEASE WAS NEEDED: __________________________________

____________________________________________________________________________

____________________________________________________________________________

WHAT COULD HAVE PREVENTED PREMATURE RELEASE OF THIS DEVICE/TRAY?

_____________________________________________________________________________

____________________________________________________________________________

____________________________________________________________________________

NAME OF OR PERSON COMPLETING THIS REPORT: _______________________________

DATE REPORT COMPLETED: ________ RETURNED TO CENTRAL SERVICE ON: _________

Figure L.2—Exception form for premature release of implantable device/tray

Reprinted with permission from the Association for the Advancement of Medical Instrumentation, Inc.Copyright 2006 AAMI. www.aami.org. All rights reserved.

Healthcare facilities need to develop written guidance as to what emergency situationsare. This guidance should bedeveloped by a committee thatincludes infection preventionand control, the surgeon, andrisk management. What aresome examples of emerg e n c ysituations? Is it when the life orlimb of the patient would be lostif the surgery was not done?

Healthcare facilities usuallyhave some kind of reportingstructure for documenting unusualincidents, sometimes called incident reports. These incidentreports are usually reviewed by risk management. As a resultof these reports, risk assess-ments are frequently conductedto decrease the occurrence ofthis type of incident. In the same way that other incidentsare reviewed, the documenta-tion of the medical exceptionsfor early release of implantsshould be reviewed by riskmanagement, infection controland surg e r y. These records can be very useful in deter-mining the causes of emerg e n c yrelease of implants and howthat could be corrected. T h eanalysis may show: which devices or implants

are in short supply due to case volume. This mayhelp justify the purchase of additional items fornecessary backup if an itemis broken or dropped.

which surgeons are notcontacting vendors soonenough to allow appropriatesterilization of implants.

which vendors, if contactedsoon enough, are not deliv-ering the items in time toallow appropriate steriliza-tion of implants.

87November 2006 MANAGING INFECTION CONTROL

which vendors do not have enough instruments and/orimplants for the number of facilities they are supplying.

surgical schedules that do not allow enough time to processimplants by the wrapped or containerized methods.

lack of communication between the Operating Room and theSterile Processing Department.

the need to increase sterile processing departments hours ofoperation if not 24/7.

the need for a BI that can be read out in a shorter amount of time.

In all cases the objective is to not release implants before theBI is negative so that patient safety is not adversely affected.

Frequently with implants, especially those that are used oftenor are borrowed, timing is a huge factor in the sterilizationprocess. Much of that time is spent waiting for the BI to incubateand show a negative before being able to release the implants.Some types of BIs contain spores with an enzyme-based early-readout capability. With this type of BI, implants can be


released in one or three hours after incubation of the spore,rather than having to wait up to 48 hours. If using early-readout with spore growth, periodic verification of the early readout with spore growth should be performed in accordance with the manufacturer’s instructions andfacility policy and procedures.2

At the Children’s Hospital in Denver, for all but a veryfew emergency cases, we are able to quarantine our implantsuntil the BI, with an enzyme-based early-readout capability,has been read as negative. This gives us a three-hourwindow once the BI is placed into the incubator. Steam sterilized devices need a cool down phase, usually about onehour, before they can be touched. Once they can be removedfrom the sterilizer rack, we place them on another “waiting”rack until the BI results are read, before we release themeither to the shelf or to the OR for use. For emergencies, wedocument the incident and reason for early release using thehospital incident reporting process.



Implants should NOT be flashedA O R N ’s 2006 Recommended Practice on Sterilization in the

Perioperative Practice Setting (RPIV 6.) does not recommend flash sterilization of implants.

“Flash sterilization should not be used for i m p l a n t a b l ed e v i c e s . Implants are foreign bodies, and they increase the risk ofs u rgical site infections. Careful planning, appropriate packaging, andinventory management in cooperation with suppliers can minimize theneed to flash sterilize implantable medical devices. When animplantable device is sterilized at a health care facility, a biologicali n d i c a t o r should be run with the load and the implant should bequarantined until the results of the biological indicator are known.If an emergency situation makes flash sterilization unavoidable, arapid-action biological monitoring device should be used alongwith a class V chemical integrator. The implant should not bereleased until the rapid-action indicator provides a negative result.After the rapid-action negative result is obtained, the implant can bereleased for use in the immediate situation. If the implant is not used,it cannot be saved as sterile for future use. Resterilization of the deviceis required. If the biological indicator is later determined to have


a positive result, the surgeon should be notified as soon asthe results are known.”1

Each facility should have written guidelines on whatconstitutes an emergency situation. If it is determined per the facility’s written policy that flashing of implants isunavoidable, it is extremely important that appropriate documentation is completed and traceable to the patient forwhom the implants were used. A sterilization log or databaseshould include information on each load, including: Device(s) processed Patient receiving the items(s) Reason for flash sterilization.1

If you must flash…Flash Sterilization (i.e., abbreviated/express cycle) is

defined as a process designed for the steam sterilization ofpatient care items for immediate use.1,2

Flash sterilization should be used only in selected clinicalcircumstances and in a restricted manner, and the use of flashsterilization should be kept to a bare minimum. If you must

use flash sterilization, AORN recommends that the followingconditions are met: The device manufacturer’s written instructions are

available and followed. Items are disassembled and thoroughly cleaned with

detergent and water to remove soil, blood, body fats andother substances.

Lumens are flushed with the cleaning solution and rinsed thoroughly.

Items are placed in a sterilization container or tray in a manner that allows steam to contact all instrument parts.

Measures are taken to prevent contamination duringtransfer to the sterile field.

Documentation of cycle information and monitoringresults is maintained to provide tracking of flasheditems(s) to the individual patient.1

Figure 1 shows an example of documentation for flashcycles that we currently use at our hospital (Record of FlashSterilization, p.90). This record is used for any flash cycle and




Figure 1—Record of Flash Sterilization

The Children’s Hospital—Denver Perioperative Services

Steam Sterilizer ID _________

91MANAGING INFECTION CONTROLNovember 2006

documents the load number, room number, sterilization parameters, patientidentification, contents of the load, and the results of chemical integrator and BI results (if used). In the rare instance in which we must flash implantssuch as trauma-related orthopedic sets including implants, we run BIs anddocument it on this sheet. We use the enzyme-based early-readout BI thatgives us results within one hour. For the most part, the BI is read before theimplant is placed in the patient. If the emergency situation dictates the implantgoes in before the one-hour window, we have all the information documentedon this sheet. If the BI is positive, the physician, infection control and riskmanagement are notified immediately.

AAMI states: “A flash sterilization cycle is one that has been designed tomeet the following criteria:1. “The cycle is preprogrammed to specific time-temperature setting

established by the manufacturer based on the sterilizer control (i.e.,gravity-displacement, dynamic air-removal) and selected by the userbased on the configuration of the load (i.e., the presence or absence ofporous materials).

2. “The items to be processed are usually unwrapped, although a singlewrapper may be used in certain circumstances if the sterilizer or packaging manufacturer’s instructions permit. Some rigid sterilizationcontainer systems have been designed and validated by the containermanufacturer for use with flash cycles.

3. “Since drying time is not usually part of a preprogrammed flash cycle, theitems processed are assumed to be wet at the conclusion of the cycle.

4. “The processed item(s) must be transferred immediately, using aseptictechnique, from the sterilizer to the actual point of use, usually the sterilefield in an ongoing surgical procedure. Regardless of whether the itemsare wrapped, there is no storage or shelf life of flash-sterilized itemsbecause of the higher probability of contamination after the sterilizer dooris opened and the items are removed.”2

How to avoid flash sterilizationSterilization by the flash method should be used only when there is

inadequate time (e.g., urgent situations) to process by the preferred wrapped orcontainer method. Flash sterilization should never be used as a substitute forinadequate instrument inventory. Eliminating the need to flash sterilizeimplantable device can be achieved through cautious planning, suitable packaging (e.g., see through packaging that permits the user to visualize theitem for proper size and confirmation of features), and inventory managementin collaboration with the vendor.1,2


Flash sterilization should never beused as a substitute for inadequateinstrument inventory.

Most hospitals use some kind of block scheduling for theOR. This means that surgeons are given blocks of time toschedule their cases. This works well for both the surgeon andthe OR. Unfortunately, block scheduling is the cause for a lot ofthe flashing that is done in hospitals. The physicians want to doback-to-back cases in their assigned block time. Frequentlythey need the same type of instruments or implants. If theinventory does not allow time to reprocess the items in theusual way, flashing of the items is done.

The Children’s Hospital of Denver has developed anotherapproach to decrease the incidents of flashing orthopaedicinstruments and implants. The orthosurgical team meets once aweek to discuss its upcoming cases. The Ortho Nursing ServiceLeader reviews the list of needed versus available instrumentsand implants. If loaner medical devices are needed, the OrthoNursing Service Leader makes arrangements to get the loaneritems into the hospital in time to be reprocessed in-house by thewrapped or containerized method. A special documentationform called O rtho Loaner Instrument and Implant Tr a c k i n g

Form (See Figure 2 on p. 93) was created. Once this documentis completed, a copy of the form is then sent to the SterileProcessing Department so its members can anticipate thearrival of these loaner items.

SummaryHealthcare providers are responsible for minimizing

the risks to patients. The risk of surgical wound infections canbe decreased by ensuring that all surgical items are free ofcontamination at the time of use. Implants are devices that are placed inside the human body and intended to remain there for 30 days or more. Because they are foreign bodies,implants pose an increased risk of surgical site infections. It isimperative these devices are sterile.

The defined medical exceptions, such as the use of e m e rgency trauma-related orthopedic screw-plate sets, shouldbe developed in consultation with infection control, thes u rgeon and risk management. In emergency situations, it maybe necessary to release an implantable device before the BI



93MANAGING INFECTION CONTROLNovember 2006


Figure 2—An Example of a Tracking Form

Ortho Loaner Instrumentation and Implants Tracking Form

results are known. This should be documented as a medical exception. It iscritical that this documentation be fully traceable to the patient. Releasingimplants before the BI results are known is unacceptable and should be the exception, not the rule.

Flash sterilization of implants is not recommended. Flash sterilization maybe connected to an increased risk of infection to patients because pressure onpersonnel may result in the omitting of one or more steps in the cleaningprocess as well as the demands to release the flashed items before the BI resultsare read.

If an emergency situation makes flash sterilization unavoidable, a rapid-action biological monitoring device should be used along with a class Vchemical integrator. The implant should not be released until the rapid-action indicator provides a negative result. It is imperative that the devicem a n u f a c t u r e ’s written instructions for temperature and exposure times areconsulted and followed. Documentation of cycle information and monitoringresults must be maintained to provide tracking of flashed items(s) to the individual patient.

And, finally, flash sterilization should NEVER be used as a substitute forinadequate instrument or implant inventory.

Patient’s Name

Procedure Type

Surgeon

Procedure Date: Time:

Instruments needed

Implants needed

Ordered by

When ordered Date: Time:

* Estimated Delivery time Date: Time:

Mfg. reprocessing Requested when ordered? Yes ____________instructions

*Items must be delivered directly to SPD decontam no later than 5 p.m. the night before thecase is scheduled.

The Children’s Hospital


Ordering InformationAAMI

ANSI/AAMI ST79:2006, C o m p rehensive guide to steam sterilizationand sterility assurance in health care facilities

Order code: ST79 or ST79-PDFAvailable in an attractive binder featuring sturdy metal rings,

l e d g e r-weight pages, and a laminated tab for each section for easy navigation. AAMI will issue revised pages that can be substituted intothe binder when changes are made.

Also available in PDF format and as part of AAMI’s electronic CDand subscription products.

Price/Member discount price: $200/$100

AAMI documents can be purchased through AAMI by credit cardusing the following four options:1. Internet: http://marketplace.aami.org/eseries/ScriptContent/Index.cfm 2. Call: 800.332.2264, ext 217 or 703.525.4890, ext 2173. Fax: 703.525.14244. Mail: AAMI, Customer Service Center, 1100 N. Glebe Road, Suite

220, Arlington, VA 22201-5762


AORNAORN Standards can be purchased through

AORN using the following options:1. Internet: www. a o r n . o rg / b o o k s t o r e / o r d e r i n g . h t m2. Call: 800.755.2676, ext 1 or 303.755.6304 ext

1 (Monday-Friday, 8 a.m. to 4:30 p.m. MST)3. Fax: 303.750.32124. By mail: AORN, Inc., Customer Service/Book

Orders, 2170 South Parker Road, Suite 300,Denver, CO 80231-5711

Payment can be made by VISA, MasterCard,American Express or Discover, either online or bymail/fax/phone.

By authorized PO, and AORN will bill you($100 minimum purchase). Sorry, we cannot acceptPOs for education conferences or services. (Notavailable for online orders.)

A CD-rom of the standards is available for thefirst time this year.



References1. Recommended Practices for Sterilization in

Perioperative Practice Settings. A s s o c i a t i o nof periOperative Registered Nurses. AORNStandards, Recommended Practices, andGuidelines. 2006.

2. The Association for the Advancement ofMedical Instrumentation. Comprehensiveguide to steam sterilization and sterilityassurance in health care facilities. A N S I /AAMI ST79:2006.

3. Schultz, Janet. Monitoring and Load Releasefor Implants Sterilized by Steam Wi t h i nHealthcare Facilities. Managing InfectionControl. Jan 2004

Rose Seavey, RN, MBA, CNOR, ACSP,is the Director of the Sterile Pro c e s s i n gDepartment at The Children’s Hospital ofDenver and past president of A S H C S P(2003), on whose board of directors she hasserved for three years. She was elected o nthe 2005-2007 AORN National NominatingCommittee and has served on the nationalRecommended Practices Committee forAORN. She is a past president of theDenver Chapter of AORN. In addition, sheis a member of several AAMI workingg roup committees that are developingrecommended practices and is currently a co-chair for the AAMI ST8, Hospitalsteam sterilizer working group.

Nursing CE Application Form3M Health Care provider approved by the California Board of Registered Nurses, CEP

5770 for 1 contact hour. This form is valid up to five years from the date of publication.1. Make a photocopy of this form.2. Print your name, address and daytime phone number and position/title.3. Add your social security number or your nursing license number.4. Date the application and sign. 5. Answer the CE questions. 6. Submit this form and the answer sheet to:

Workhorse PublishingManaging Infection ControlPO Box 25310, Scottsdale, AZ 85255-9998

7. Participants who score at least 70% will receive a certificate of completion within30 days of Managing Infection Control’s receipt of the application.

ApplicationPlease print or type.

Name______________ _ _ _ _ _ _ _ _ _ _ _____ _ _ _ _ _ _ _ __ _ _ _ _ _ _ _______________ ___

Mailing Address__________________________________ _ _ _ _ _ _ _ _ _ _ _ _ _ ____ _ __

City, State, Country, Zip __________________________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _____

Daytime phone ( )_____________________ _ _ _ _ _ _ _ _ _ _ _ _ _ ____ _ _ __

P o s i t i o n / Ti t l e _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ____ _ __

Social Security or Nursing License Number _________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _____

Date application submitted ___________________________ _ _ _ _ _ _ _ _ _ _ ________

Signature _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ___________________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ____ _ _ _

Offer expires November 2011

On a scale of 1-5, 5 being Excellent and 1 being Poor, please rate this programfor the following:

1) Overall content ___________________

2) Met written objectives ______________

3) Usability of content ________________

Sterile Process and Distribution CEU Information

CEU Applicant Name _________________________________________________

Address_________________ _ _ _ _ _ _____ _ _ _ _ _ _ _ _ _ _ ______ _ _ _ _ __ _ _ ________

City____________________________ State________ Zip Code _______ _ _ _ _ ___

The CBSPD (Certification Board for Sterile Processing and Distribution) haspre-approved this inservice for 1 contact hour for a period of five years from the dateof publication and to be used once in a re-certification period. Successful completionof the lesson and post test must be documented by facility management and thoserecords maintained by the individuals until re-certification is required. DO NOT SENDLESSON OR TEST TO CBSPD.

For additional information regarding Certification contact: CBSPD, 2 IndustrialPark Road, Suite 3, Alpha, NJ 08865 or call 908.454.9555 or visit Web site atwww.sterileprocessing.org.

IAHCSMM has awarded 1 contact point for completion of this continuing educationlesson toward IAHCSMM recertification.

1. F2. T3. T4. T5. F

6. T7. F8. T9. T10. T

ANSWERS

<11/06>

Copyright©2007/Workhorse Publishing L.L.C./All Rights Reseved.Reprint with permission from Workhorse Publishing L.L.C. 70-2009-7476-7

Documents

Sterilization of Surgical Implants: Did You Know… Surgical Implants1106.pdf · ‘implants’.” [21 CFR 812.3(d)].2 Ideally, implants and implantable devices should come indivdual