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U.S. Department of Health and Human Services

MedSun: Newsletter #57, February 2011

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Newsletter #57, February 2011

Articles

Breast Implants: FDA Review Indicates Possible Association With A Rare Cancer

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FDA MedWatch Safety Alert

FDA announced a possible association between saline and silicone gel-filled breast implants and anaplastic large cell lymphoma (ALCL), a very rare type of cancer. Data reviewed by the FDA suggest that patients with breast implants may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant.

Additional Information:

FDA MedWatch Safety Alert. Breast Implants: FDA Review Indicates Possible Association With A Rare Cancer. January 26, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm241101.htm

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Fresenius Medical CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors - Class I Recall

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FDA MedWatch Safety Alert

The hemodialysis blood tubing sets may develop kinking of the arterial line. Kinking can cause the destruction of red blood cells which may result in serious injury and/or death. Customers were instructed to check their stock immediately to determine if they had any of the affected lots. If they did, customers were instructed to immediately discontinue using the affected lots and place the products in a secure and separate area for return to the company.

Additional Information:

FDA MedWatch Safety Alert. Fresenius Medical Care North America, CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors for Use with the Blood Volume Monitor. January 20, 2011.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm240547.htm

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AngioScore Inc., AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018' ' Platform - Class I Recall

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FDA MedWatch Safety Alert

The device was recalled because of a design defect causing unintended fracture and peeling, and has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. Use of affected devices may lead to retained device fragments or significant arterial injury which may lead to death, or need for additional surgical intervention. AngioScore Inc. is advising customers to immediately discontinue use of any affected product, examine their inventory, and quarantine all affected product.

Additional Information:

FDA MedWatch Safety Alert. AngioScore Inc., AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018" Platform - Class I Recall. January 5, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239029.htm

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Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to Potential Microbial Contamination

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FDA MedWatch Safety Alert

Triad Group, a manufacturer of over-the-counter products and FDA notified healthcare professionals and patients of the recall involving all lots of alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad but sold as private labels at the consumer level. This recall has been initiated due to concerns about potential contamination of the products with Bacillus cereus. This recall involves those products marked as STERILE as well as non-sterile products. Use of contaminated alcohol prep pads, alcohol swabs, and alcohol swabsticks could lead to life-threatening infections, especially in at-risk populations, including immune suppressed and surgical patients.If a consumer has any of these types of products in their possession listing "Triad Group" as the manufacturer, they should not use the product and should return it to the place it was purchased for a full refund.

Additional Information:

FDA MedWatch Safety Alert. Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to Potential Microbial Contamination. January 28, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239319.htm

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Equipment-related Incidents in the Operating Room: an Analysis of Occurrence, Underlying Causes and Consequences for the Clinical Process

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PubMed Abstract

Equipment-related incidents in the operating room (OR) can affect quality of care. In this study, the authors determined the occurrence and effects on the care process in a large teaching hospital. Equipment-related incidents occurred frequently in the involved hospital sites (up to 15.9%) and resulted in some extra work and additional minutes of delay per event. Management decisions have considerable influence on the occurrence of equipment-related incidents.

Additional Information:

PubMed. Equipment-related Incidents in the Operating Room: an Analysis of Occurrence, Underlying Causes and Consequences for the Clinical Process. December 2010.
http://www.ncbi.nlm.nih.gov/pubmed/20554572

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Our Patient Just Died from a Medical Error: What Next?

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SafetyShare newsletter, Premier healthcare alliance

Every day these clinical adverse events occur within our healthcare system and cause physical and psychological harm to our patients, families, staff, the community and organizations. In the crisis that emerges, positively or negatively, the organization displays its understanding of its culture of safety, the role of the board of trustees and executive leadership; advanced planning for such an event; the balanced prioritization of the needs of the patient, family, staff and organization; and how actions immediately and over time bring empathy, support, resolution, learning and improvement. The risk of not responding to adverse events quickly and effectively are huge, and include loss of trust, no learning or improvement, the sending of mixed messages about what is really important to an organization, increased likelihood for regulatory action or lawsuits, and challenges by the media.

Additional Information:

Premier SafetyShare. Our Patient Just Died from a Medical Error: What Next? January 11, 2011.
http://www.premierinc.com/safety/safety-share/Bulletin-IHI.jsp

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Highlighted MedSun Reports

Highlighted Reports

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This section contains a sample of reports from all the MedSun reports received during a particular period. The reports were submitted by MedSun Representatives. In some instances the reports have been summarized and/or edited for clarity. The entries that follow represent a cross section of device-related events submitted by MedSun reporters during the period November 1 through November 30 2010. All other reports can be searched under the ‘MedSun reports’ menu pane. Note: the two month delay is due to quality control and follow-up.


CARDIOVASCULAR

Device:
Type: External Defibrillator
Manufacturer: Physio Control, Inc.
Brand: Lifepak 20
Model#: LP20

Problem:
Patient had an AED defibrillator on a crash cart in the room as a secondary monitoring device (the defibrillator was powered off). Charge nurse went into the room to check the device. Patient was fully hooked up to AED defibrillator, i.e., pacer hands free defib pads attached to the patient, along with the EKG monitoring leads. Device was powered off (as originally intended) when the charge nurse went into the room. Device was turned on to check working condition. After the device (defibrillator) was powered up it delivered a shock (discharge from the defibrillator) to the patient. Device was found to be unplugged from electrical outlet. The nurse believed this appears to be the reason it (defibrillator) was off (powered off). Analysis of the log indicated that no problems were found with the device. Device recording data indicated the nurse had pressed the charge and discharge button, causing the defibrillator to discharge the patient.


Device:
Type: Opti QSxo2/cco Catheter
Manufacturer: Hospira, Inc.
Brand: Opti QSvo2/cco Catheter
Cat #: List # 52511-13

Problem:
Inconsistent Cardiac Output and Cardiac Input numbers. It does not correlate with patient's clinical picture.
======================
Health Professional's Impression
======================
Manufacturer response for Opti Q SxO2/CCO Catheter, Opti Q SvO2/CCO Catheter
======================
We had many discussions with the manufacture's representative. We followed their recommendations and we continue to have product malfunctions. This interferes with patient care.


Device:
Type: Telemetry Transmitter, Physiological
Manufacturer: Philips Medical Systems
Brand: Intellivue
Model#: M2601B
Cat #: M2601B
Other #: 453564007681, ABA037AAMS03

Problem:
RN sent Philips telemetry pack to Biomed because it persisted in displaying "low battery." Biomed changed AA batteries and got the same issue of "low battery" within 1-2 minutes. Tech opened battery case and on removing one of the two batteries found it to be extremely hot to touch. On further investigation it was found that the negative pole spring (the battery towards the out side of the case) had slipped over the top of retaining clip and come into contact with wire from the battery closer to the touch pad. The load on outside battery was greatly increased and overheated. The battery indicator was displaying "low battery" on the unit's screen. In a simulated situation it was demonstrated that the outside battery was heating up to ~ 196.5 F degrees. The plastic retaining clip "grinds down" over time. There is no apparent way to replace the clip. Patients have complained the pack gets hot but we had never discovered the cause until now.

Health Professional's Impression: Wear and tear on a plastic retaining clip that allows a negative pole battery spring to slip up over top of clip and come into contact with second AA battery. This is a subtle problem that nursing staff cannot easily visualize or fix.

See device images:
New Philips unit with retaining clip intact

Negative pole battery wire positioner clip allows wire to slide over the top and short to the other battery.  This photo shows the negative spring in the correct position.


CLINICAL CHEMISTRY

Device:
Type: Analyzer, Chemistry,
Manufacturer: Beckman Coulter
Brand: Dxi 800
Model#: 973100
Cat #: 448229 AB

Problem:
Provider called the lab with a request to retest TSH samples on a few patients who had lower values than expected. After retesting the values were significantly higher. The lab did some troubleshooting and found that when the Lithium heparin tubes are inverted prior to sampling results for TSH, the results were significantly lower.
======================
Health Professional's Impression
======================
There is an interferent in the Lithium heparin tube that is causing falsely decreased values for TSH on the Beckman DXI.


EAR, NOSE, & THROAT

Device:
Type: Tube, Tympanic
Manufacturer: Gyrus ACMI, Inc.
Brand: Micron Titanium Bobbin Ventilation Tube
Model/Cat#: 14-5272
Lot #: 0625683013

Problem:
Patient had previous ossicular reconstructive surgery. After about two months, patient unable to hear. Physician brought patient to Operating Room to do another ossicular reconstruction and noted during surgery the prosthesis from the initial surgery was broken. Prosthesis removed and a new one implanted.


GENERAL & PLASTIC SURGERY

Device:
Type: Applier, Clip
Manufacturer: Ethicon Endo Surgery
Brand: Ligamax 5
Model/Cat#: EL5ML
Lot #: G4TU6E

Problem:
Surgeon was performing a laparoscopic cholecystectomy with intraoperative cholangiogram. When surgeon applied the first clip to the patient's artery, the Ligamax 5 mm Endoscopic Multiple Clip Applier would not release after firing. The clip applier was jammed and the device would not revert back to the open position. The concern was that the artery could have been damaged. The only other option would have been to open the abdomen and try to free the device. However, the surgeon was able to safely remove the clip off the artery with the clip applier still in the closed position. No injury was done to the patient, but this put the patient at risk and the surgeon had to make a decision to try to work the device off or open the patient up to try to remove it. This posed a significant issue during the procedure. Another clipper was used from the same lot number without a problem.
======================
Health Professional's Impression
======================
Device would not release after clipping artery.


Device:
Type: Endo Clip
Manufacturer: Covidien/US Surgical
Brand: Autosuture Endo Clip
Model#: REF 176630
Lot #: N0H0411

Lollipop Icon

Problem:
Child admitted with lesion in his left lower chest. Child underwent a video assisted thorascopic surgery. During the procedure, after two clips had been placed on an artery, the clip applier jammed during the placement of the third clip. The surgeon replaced clip applier with another to place the third clip and then performed a partial transection of the artery. The first two clips; however had not closed the artery and the bleeding necessitated conversion of the thorascopic procedure to an open chest procedure.


Device:
Type: Instrument, Surgical
Manufacturer: Spineology Inc
Brand: Spineology EShaper Blade
Model#: 315-0014

Problem:
During a lumbar laminectomy and fusion L4-5, L5-S1 the tip of the Spineology Shaver blade broke off in the L5 disc space.
======================
Health Professional's Impression
======================
The doctor did not express dissatisfaction with the shaver blade.
======================
Manufacturer response for Sterile, single-use, surgical instrument subcomponent intended to be used in conjunction with the 1500E OptiMesh Implant System. This device is designed to aid in cavity creation prior to introduction of the 1500E OptiMesh Implant, Spineology E Shaper Blade
======================
Manufacturer requested broken instrument be returned. We have not returned to date. Apologized for their representative not notifying hospital central sterile staff that this instrument recently changed to single use one month prior to this event date. It is not known if this single use instrument was used prior to this event date.


Device:
Type: Tip Cover Accessory
Manufacturer: Intuitive Surgical
Brand: Davinci Tip Cover Accessory
Lot #: C10216
Cat #: 400180
Other #: Tip cover accessory made by Microtek Medical for the DaVinci systems

Problem:
The daVinci tip cover accessory had holes in it. This was discovered prior to use, and the lot was pulled from the shelf and returned to the manufacturer for credit. Had it been used, the potential existed for there to be arcing.


Device:
Type: Tray, Surgical
Manufacturer: Total Pack Management
Brand: Ir Cath Tray
Lot #: T005422
Cat #: TPM-IRCHFB-1
Other #: Manufacturer date: 10/2010

Problem:
Patient in room waiting for procedure for IVF filter. The first tray was opened and a "mucous looking particle" was observed in the small bowl; second tray opened and "plastic flecks" was observed in small bowl. There was a "metallic-like particle" observed in the large bowl (guide wire bowl). The procedure was delayed due to repeated set-ups. Clinicians pulled needed supplies by hand to complete the case.


Device:
Type: Tray, Surgical
Manufacturer: Medline
Brand: Medline Sterile Laceration Tray
Lot #: 10IB4116
Cat #: DYNDL1228

Problem:
We are reporting a total of 10 devices of the same lot and from the same manufacturer with this one report. MD reports that he opened a laceration tray and had difficulty opening and closing the hemostat needle holder in the kit. Another tray was opened and the same difficulty was encountered. There appears to be nothing wrong with the device visually. There are no problems with any of the other contents of the tray. A total of 10 laceration trays were found with this same problem. All were from the same lot number. The 11th tray that was opened had no difficulties. As expected, the hemostat needle holder opened and closed smoothly without difficulty. The 11th kit also was from the same lot number. None of the affected devices came into contact with the patient and there was no patient harm involved in this event.
======================
Health Professional's Impression
======================
The staff feels that the bolt/screw used to keep the two pieces of the device together may have been put on too tightly.
======================
Manufacturer response for Needle holder hemostat, Medline sterile Laceration Tray
======================
Manufacturer was contacted. We are currently awaiting return instructions and plan to send the device back to the manufacturer for their inspection and analysis.


GENERAL HOSPITAL

Device:
Type: Catheter, Picc
Manufacturer: BD Medical Systems
Brand: L-cath
Cat #: 384539

Problem:
PICC found to be leaking at catheter hub site. Clinician attempted to remove line at that time. Resistance felt and warm compress applied to patient for one hour. The second attempt caused PICC line to snap leaving 1cm above skin line. The third attempt caused the second line to snap leaving a section inside the patient. The remaining line was surgically retrieved the next day. Patient stable.
======================
Health Professional's Impression
======================
Device failed to pull out with minimal force.
======================
Manufacturer response for Peripherally Inserted Central Catheter (PICC), L-Cath
======================
Manufacturer provided Ref#58290 and sent pre-packaged mailer to have PICC returned for evaluation.


Device:
Type: Catheter, Picc
Manufacturer: Medical Components, Inc
Brand: Vascu-picc
Lot #: MBBK 950
Other #: Ref # MRVSP41003

Problem:
Leaking noted at the PICC catheter site. Small tear noted above hub on the clear part of the tubing. PICC removed.


Device:
Type: Filter, Infusion Line
Manufacturer: Pall Medical
Brand: Intravenous Total Nutrient Admixture Filter
Lot #: 016611

Problem:
TPN (total parenteral nutrition) filter and TPN tubing broke. The TPN had to be discontinued and surgeon called for another type of replacement fluids. Registered Dietician and Pharmacy states this has been happening frequently throughout the hospital, however not all are being reported. Pharmacy states that the filter and tubing are attached to the TPN under the hood and when everything is taken out of the hood the filter becomes very loose and requires tape to hold it secure as a "work around".
======================
Health Professional's Impression
======================
A possible faulty TPN tubing/filter. This is the 3rd of 4 reported and I've been told this is continually happening and not just in one area or by one Pharmacy tech connecting the tubing/filter to the TPN.


Device:
Type: Scale, Infant
Manufacturer: Cardinal Health
Brand: Detecto Scale
Model#: 6745
Cat #: 62450-300
Other #: PO# 10263100

Lollipop Icon

Problem:
Baby Scale readings inaccurate by 5-10% wt differences. Biomed has calibrated and attempted to remedy the issue, and when the scale reads their test using a 10 pound weight it reads accurately, but when weighing a moving infant the weights are consistently off by 5-10% of the actual weight.
======================
Health Professional's Impression
======================
Scale does not read accurately and consistently especially with infant moving intermittently.


Device:
Type: Warmer, Infant Radiant
Manufacturer: Draeger
Brand: Babytherm 8004
Model#: Babytherm 8004

Lollipop Icon

Problem:
Nursing reported the following: temperature probe connected to patient and bed and temp settings set to 36.5. Open warmer showed patient's temperature at 37.3, but still within normal limits. Heart rate was high so temperature was checked rectally which showed a temp of 39.0. Patient's temperature should have been regulated correctly with open warmer being connected to patient through temperature probe. The infant was removed and placed in another warmer; monitored vital signs closely.

It was determined that this overheating was caused by a known problem referred to as the Stem Effect. (Technical information available here http://bit.ly/eb6nZI)

Our facility’s current policy is to coil the temperature probe to avoid the effects of the Stem effect.

Our policy is as follows:
Thermoregulation for all patients admitted into radiant warmers and incubators:
1. Warm bed prior to admission. See CPG table Neutral thermal environment for temperature range to select. (This requires weight and age of patient)
2. Select proper skin temp probe.
3. For low-birthweight patients and those with fragile skin, place a barrier of duoderm between the temp probe cover and patient skin.
a) Cut the duoderm into a circle. Cut out the center portion. Place this against the skin.
b) Place the temp probe into the center of the duoderm against the skin.
c) Make a few coils of the temp probe wiring under the temp probe cover, and place this cover over the duoderm.
4. For patients without specialized skin care needs, place the temperature probe and coils of wiring on the sticky surface of the temperature probe cover and place this on the patient's body.
5. Ensure the incubator/ radiant warmer is set to skin control or servo control, rather than air temperature or manual.
6. Adjust control temperature to maintain baby within normal range. Measure axillary temperatures with cares.


Coiling prevents inadvertent cooling of the temperature probe tip, and helps to maintain a consistent temperature. Improper technique in placing skin probe can cause inadvertent over heating of the patient.

We originally found out about the stem effect in 1993. Manufacturer was involved at that time.


OBSTETRICS/GYNECOLOGY

Device:

Type: Clamp, Circumcision
Manufacturer: Cardinal Health
Brand: Gomco Circumcision Clamp
Cat #: 02-01-0500

Lollipop Icon

Problem:
During circumcision with Gomco, it became difficult to remove the foreskin from the penis. This caused a splitting tear at the foreskin incision junction requiring six sutures to close.


PHYSICAL MEDICINE

Device:
Type: Heel Warmer, Infant
Manufacturer: Cardinal Health
Brand: Infant Heel Warmer With Tape
Cat #: 11460-010T
Other #: (01) 0 0630140 01739 4

Lollipop Icon

Problem:
I was made aware of a medical device failure involving an infant warmer in the Family Care Center. The warmer's heating element had failed due to the introduction of a liquid while the element was heated. The introduction of the liquid to the heated element caused the liquid to instantly flash to the surrounding reflector and down upon the infant. Upon investigation with the Director of the Family Care Center, it was determined that the liquid was a chemical compound used in a product called "Infant Heel Warmer with Tape" and is manufactured by Cardinal Health. The Director provided the incident report that detailed the event with the following comments: "Heel warmer pack squeezed per instruction – heel pack popped open causing a 1 cm chemical burn on infant's abdomen. The chemical flew up into heating element of the infant warmer causing damage to the warmer". The Director went on to explain that the baby was under an oxygen hood, which covered most of the body. Without the hood in place the infant most likely would have been burned much more severely from head to abdomen. The incident will be reported to the FDA.
======================
Health Professional's Impression
======================
The health professional's comment was that they followed the instructions on the package. They feel the product and/or instructions for use are designed poorly.


Device:
Type: Heel Warmer, Infant
Manufacturer: DeRoyal
Cat #: HNICU-100

Lollipop Icon

Problem:
Heel warmer was activated by phlebotomist. The device is hard to activate and requires a significant amount of pressure to do so.

The warmer ruptured, splashing the phlebotomist in the face and forearm. She experienced a burning sensation. She immediately flushed the affected areas with water and then went to the Emergency Room for care. The employee was noted to have erythema to her left cheek and minimal erythema to her forearm. She was sent home by the ED physician to shower with unscented soap and instructed to treat the areas with Aloe Vera or antibiotic ointment.


RADIOLOGY

Device:
Type: X-ray System, Rad/fluoro
Manufacturer: Siemens Medical Solutions USA, Inc.
Brand: Sireskop Sd
Model#: 8890415

Problem:
The footboard failed while the patient was at a 50 degree angle while undergoing a GI series. The patient slid (fell) to the floor, sustaining no injury. The footboard is rated for 400 lbs. BioMed tested the footboard with maximum weight load rating (400lbs) with calibrated weights to 90 degrees in various footboard positions and wiggling the footboard with weight applied. Footboard held without releasing.

The footboard latches may not have been completely engaged. There are green lines visible to the radiology staff which should provide a visible check that the latches are locked. These green lines are not too easy to see when a patient is on the table in various positions. There is a slight audible click heard when properly latched.

See device images:
Close-up image of footboard latch which shows 2 green lines that are visible to radiology staff, which provide a visible check that the latches are locked. These green lines are not too easy to see when a patient is on the table in various positions.

Image of footboard latch from a distance


~~~
Lollipop Icon
Special Note: The lollipop icon distinguishes highlighted reports that describe medical device events involving neonatal or pediatric patients, or those events involving a medical device that is indicated for use in neonatal and pediatric patient populations. FDA defines pediatric patients as less than 21 years of age.



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Medical Device Problem Summaries

Summary of MedSun Reports Describing Adverse Events With Sterilization Process Indicators

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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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Updated February 1, 2011

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