Summary of MedSun Reports Describing Adverse Events With Sterilization Process Indicators
MedSun: Newsletter #57, February 2011

Sterilization Process Indicators are used to monitor the adequacy of or measure parameters associated with sterilization procedures. There are two main types of indicators:

Biological sterilization process indicator -
A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. (Code of Federal Regulations, 2010)

Physical/chemical sterilization process indicator –
A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device. (Code of Federal Regulations, 2010)

Over the past 4 years, MedSun has received 17 adverse event reports associated with devices manufactured by the following firms: 3M Company, Advanced Sterilization Products, Cardinal Health, Getinge USA, SPSmedical Supply. The reports were submitted by 7 hospitals between 2007 and 2010.

The reported device problems were:
• Non-standard device design causing confusion (8)
• Indicator did not change when parameters were appropriate/user expected (5)
• Leaking indicator (1)
• Dry indicator (1)
• Defective indicator (1)
• Retained foreign body within indicator (1)

None of the reports provided information concerning patient harm due to exposure to instruments that may have been affected by problematic Sterilization Process Indicators.

These MedSun reports, in addition to manufacturer, healthcare, and voluntary reports contributed to FDA awareness of the device problems.

The following recall(s) are associated with Sterilization Process Indicators since 2007. The Medsun Reported events may, or may not, be involved in the recall(s) listed.

Recall Number: Z-0066-2010
Date Posted: October 20, 2009
Product: Sterrad CycleSure Biological Indicator, Product Code 14324. The Sterrad
CycleSure Biological Indicator is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilizer cycles.
Code Information: All Lots
Recalling Firm/Manufacturer: Advanced Sterilization Products
33 Technology Drive
Irvine, California 92618
Action: An Important Product Labeling Correction - New Instructions for Use dated, June 26, 2009, has been proposed to be sent by the firm for Cyclosure Biological Indicators to consignees. The revised instructions reduce the maximum read time for the indicators to 3 days (72 hours). The letter also states why ASP changed the Instructions. Questions are to be directed to ASP Customer Care Center.
Distribution: Worldwide Distribution.

Information online: http://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfRES/res.cfm?id=83495

Recall Number: Z-1531-2010
Date Posted: April 29, 2010
Product: Violet Ink sterilization indicators Violet Ink (Class 6) and Violet Ink (Bowie
Dick). Product numbers: CI 144, BD 115, PL 315, PL319, PL232, PL236, PL237, PL
238.
Code Information: Lot numbers: 061001, 061101, 070201, 070401, 070601, 070701, 080101, 080801, 080901, 081001, 0900201, 090301, 090401, 090402
Recalling Firm/Manufacturer: Steritec Products Mfc. Co., Inc.
74 Inverness Dr E
Englewood, Colorado 80112-5114
Action: Notify accounts by e-mail and letter, offering to exchange product for product with revised expiration date. Products exhausted by proper expiration date need not be returned or relabeled. Questions are directed to the firm at (303) 660-4201.
Distribution: Nationwide Distribution: IL, MI, NY, OH, VA

Information online: http://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfRES/res.cfm?id=83980

Recall Number: Z-2330-2008
Date Posted: September 20, 2008
Product: Propper short gas-chex EO sterilization indicators, 250 strips per box, Reorder
No. 269001, Propper Manufacturing Co., Inc., Long Island City, N.Y. 11101
Code Information: Reorder No. 269001; Lots 6081, 6043, 6021, 7042, and 7013
Recalling Firm/Manufacturer: Propper Mfg Co Inc
36-04 Skillman Avenue
Long Island City, New York 11101-1730
Action: On 2/07/08, Propper Mfg. Co. sent URGENT: DEVICE RECALL letters (dated 2/07/08) to the direct consignees, informing them of the recall of the affected lots of Gas-Chex EO Indicator Strips. The letters also instructed them to: (1) check their inventory to determine if they have the recalled lots in stock; (2) discontinue use of the affected lots; (3) reprocess any unused packs that have been processed with the affected lots of Gas-Chex EO Indicator Strips with non-recalled lots or an alternative product from another supplier; (4) return the affected lots to Propper Manufacturing; (5) complete the enclosed form and return via fax to Propper Mfg. Propper Mfg. will send a postage-paid label and instruction for return of the product, and will ship replacement product as soon as possible. Propper also recommended that consignees review the risk associated with items that have been monitored with the subject chemical indicators although a sterilization cycle failure is unlikely due to equipment controls and other monitoring methods. For questions, please contact Propper at 1-800-832-4300 during regular business hours (9 am to 4:30 pm).
Distribution: Nationwide and Puerto Rico

Information online: http://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfRES/res.cfm?id=72429

Recall Number: Z-1568-2008
Date Posted: August 08, 2008
Product: 3M Comply EO Chemical Indicators Strips, Catalog #1251 The Comply 1251 Chemical Indicator Strip is a paper strip 1.5cm wide by 20 cm long (0.625 inches wide by
8 inches long) printed with a chemical indicator ink that turns from red to green when exposed to ethylene oxide (EO) sterilization process. It is designed to indicate whether EO has penetrated to the point of placement of the strip, usually the center of the pack. Each strip is perforated at the center if a shorter internal chemical indicator is preferred. An internal chemical indicator should be used inside each pack to be sterilized. 3M Health Care 3M Center Bldg
275-4E-011, St. Paul, MN 55144-1000
Code Information: 2008-02AA, 2008-03AA, 2008-04AA, 2008-05AA, 2008-08AA, 2008-10AA, 2008-10AB, 2008-12AA, 2009-02AA, 2009-02AB, 2009-04AA, 2009-05AA, 2009-08AA, 2009-09AA,
Recalling Firm/Manufacturer: 3M Company / Medical Division
3M Center, Bldg 275-05-W-06
South St Paul, Minnesota 55144
Action: Customers and Distributors were each sent a "Voluntary Product Recall" letter dated 3/17/08 on 3/19/08. The letter states that use of the affected product should immediately be discontinued, stocks should be checked for any remaining inventory, and reprocess any unused packs using the product not from the affected lot or from an alternative supplier. The letter requested consignees to notify 3M whether the facility has affected product or not by sending the "Product Return Form". Replacements will be provided to those with affected products remaining in their stock.
Distribution: Nationwide Distribution --- including states of AL, AR, AZ, CA, CO, CT,DC, DE, FL, GA,HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS,MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV.
Information online: http://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfRES/res.cfm?id=68615


The following table lists the MedSun reports that are described in the device problem summary above. [Note: The reports have been edited for clarity]
Adverse Events Associated with Sterilization Process Indicators
Manufacturer, DeviceDevice Identifiers (Catalog Number, Lot Number) Event Description
Cardinal Health GENESIS, AG2-2 In the three different types of sterilization (ETO gas, steam and hydrogen peroxide sterilization) there are multiple color changes to indicate that the items were processed. For each method and each vendor, there is no standardization of color coding for the arrow, tape, paper and incheck sterilization packaging indicators. Instead, there is dependence on memorization increasing the chance for error in identifying that sterilization has occurred.
Cardinal Health GENESIS, AH2-1 In the three different types of sterilization (ETO gas, steam and hydrogen peroxide sterilization) there are multiple color changes to indicate that the items were processed. For each method and each vendor, there is no standardization of color coding for the arrow, tape, paper and incheck sterilization packaging indicators. Instead, there is dependence on memorization increasing the chance for error in identifying that sterilization has occurred.
Cardinal Health GENESIS, AS2-2 In the three different types of sterilization (ETO gas, steam and hydrogen peroxide sterilization) there are multiple color changes to indicate that the items were processed. For each method and each vendor, there is no standardization of color coding for the arrow, tape, paper and incheck sterilization packaging indicators. Instead, there is dependence on memorization increasing the chance for error in identifying that sterilization has occurred.
Advanced Sterilization Products STERRAD, 14202 In the three different types of sterilization (ETO gas, steam and hydrogen peroxide sterilization) there are multiple color changes to indicate that the items were processed. For each method and each vendor, there is no standardization of color coding for the arrow, tape, paper and incheck sterilization packaging indicators. Instead, there is dependence on memorization increasing the chance for error in identifying that sterilization has occurred.
Advanced Sterilization Products STERRAD, 14100 In the three different types of sterilization (ETO gas, steam and hydrogen peroxide sterilization) there are multiple color changes to indicate that the items were processed. For each method and each vendor, there is no standardization of color coding for the arrow, tape, paper and incheck sterilization packaging indicators. Instead, there is dependence on memorization increasing the chance for error in identifying that sterilization has occurred.
3M Company N/A, 1224-6 In the three different types of sterilization (ETO gas, steam and hydrogen peroxide sterilization) there are multiple color changes to indicate that the items were processed. For each method and each vendor, there is no standardization of color coding for the arrow, tape, paper and incheck sterilization packaging indicators. Instead, there is dependence on memorization increasing the chance for error in identifying that sterilization has occurred.
3M Company COMPLY 3M, 1251 In the three different types of sterilization (ETO gas, steam and hydrogen peroxide sterilization) there are multiple color changes to indicate that the items were processed. For each method and each vendor, there is no standardization of color coding for the arrow, tape, paper and incheck sterilization packaging indicators. Instead, there is dependence on memorization increasing the chance for error in identifying that sterilization has occurred.
3M Company COMPLY 3M, 00107 In the three different types of sterilization (ETO gas, steam and hydrogen peroxide sterilization) there are multiple color changes to indicate that the items were processed. For each method and each vendor, there is no standardization of color coding for the arrow, tape, paper and incheck sterilization packaging indicators. Instead, there is dependence on memorization increasing the chance for error in identifying that sterilization has occurred.
SPSmedical Supply Corp STEAMPLUS INTEGRATOR, SSI-1000 Over two days, a total of three (3) sterilization integrators leaked onto instruments being sterilized. Manufacturer was contacted and defective product is being returned to manufacturer today. Leak required cleaning of instruments and repeating sterilization. Manager also noted that there had been one other integrator which leaked on two months previous. We were unable to explain the leaks based upon handling of devices here.
3M Company ATTEST, 1296 The sterile processing department technician was opening a test pack after pack had been through sterilizer. The tech discovered brown presumably human hair in the middle of the pack. It was clearly not the tech's own hair, which is grey, and the tech wears a cap while working
3M Company STERIGAGE The steam integrators used by the sterile processing department to verify steam sterilization were defective. The main or discovered the problem. The integrators had changed color when subjected to the steam. The first ones we found looked like they had been through multiple load runs i.e.; giving the appearance of having been overly wet or through a washer cycle with the color change runny. I do not know if they ran tests with other integrators. I believe they replaced all of our bad lot with replacements the rep. Brought in that day.
3M Company COMPLY STERI GAGE INDICATOR, N/A Small flashpak was used to sterilize a screwdriver for a case in progress. Screwdriver was placed in small flashpak with indictor in pack. Indicator did not change to black after 5 minute cycle. Screwdriver was not used. It should be noted that the valves on these flashpaks were recently replaced after a change in mfr process. This flashpak has the new valve.
3M Company COMPLY STERIGAGE, 1243 When items are placed within these pans to flash sterilize, the indicators do not change color to indicate that the sterilization process has taken place.
3M Company COMPLY BOWIE-DICK TEST PACKS, 1233LF The bowie dick test pack was ran and the outcome showed white areas that should have turned black. Ran one that appeared to fail, ran 2nd and appeared to fail again. Ran from another lot and results were appropriate, ran from first lot and failed again, all other parameters were met with the sterilizer.
3M Company STERIGAGE, 1243 The small pellets in the packs are intended to disperse as the sterilization cycle proceeds. This pellet pack did not, therefore the sterility of the instruments could not be verified.
Gettinge USA, INC BIOSIGN SSI, N/A Purple indicators did not completely turn to green. Manufacturer response (as per reporter) for Biosign SSI test pack, SSI test pack phone call placed to rep
Gettinge USA, INC BIOSIGN SSI TEST PACK, N/A Staff was in the process of running pre-vac biological tests in the operating room sterilizer. Two of the instant read SSI packs were dry, which made it unable to process properly in the incubator. Staff are seeing trends with these packs with regards to either dry or missing strips.


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