Title: Prevention of Surgical Site Infections (SSI)
1Prevention of Surgical Site Infections (SSI)
- MSIPC Fundamentals of Infection Prevention
Control - October 2015
- Karen Hoover, RN
- Infection Prevention Coordinator
- St. Marys of Michigan, Saginaw
2SSI A Complication of Surgical Care
- gt 51.4 million surgical procedures/year in US
- 31 of all HAIs due to SSI, second only to UTI
- gt 91,000 readmissions for SSI Rx
- 1 million additional inpatient days
- 1.6 billion excess costs
- Associated mortality rate of 3
- Cost Pay for performance patient safety
- CDCs Guideline for Prevention of Surgical Site
Infection, 1999.8 - Jan 2014 CDC
3Common Surgeries/Procedures
- 719,000/year Total knee
- 498,000 Hysterectomy
- 395,000 CABG
- 332,000 Total Hip
- 1.3 million Cesarean sections
- Ambulatory
- 1.3 million cataracts
- 923,000 Lens implants
- 499,000 Endoscopies of lg. intestine 1.1
million of sm. intestine - 735,000 Injections of spine
- Approx. 40 have more than 1 procedure
- CDC http//www.cdc.gov/nchs/fastats/inpatient-surg
ery.htm (2010) - CDC www.cdc.gov/nchs/data/nhsr/nhsr011.pdf
4Risk Factors for SSI identification
opportunities for intervention
- Risk factor variable with significant,
independent association with development of SSI - Patient age, nutrition, diabetes, smoking,
obesity, immunocompromised, pre-op LOS,
micro-flora, other infection - SSI prevention measure action(s) to reduce SSI
risk, antibiotic prophylaxis, skin
prep/antisepsis - Operation patient peri-op personnel, duration,
ATB re-dosing, surgical asepsis, traffic flow,
surgical technique (robotic), hair removal,
immediate use sterilization, glove/instrument
change - Environmental cleaning, disinfectant contact
time, UV light, OR environment-HVAC - Risk of SSI after receipt of blood products 3.5
5Principles for Prevention of SSI
- Minimize access of bacteria to the surgical site
- Measures to neutralize that do gain access to
site - Reduce that which is conducive to infection
- Enhance the host defenses - look at risk factors
- Follow established guidelines
6Pathogenesis of Surgical Site Infection (SSI)
- Dose x virulence
- Resistance of Host
- risk of SSI
- gt 105 / gm tissue ?risk with foreign body only
100/gm is needed to cause SSI - Pathogens
- Endogenous flora normally contained
- Exogenous healthcare personnel, environment,
devices/materials used
7Key Concepts on Source of SSI Pathogen OR
personnel or patient?
- Every surgical site has bacteria by the end of
the procedure! - Four Clinical variables determine infection
- Inoculum of bacteria
- Virulence of bacteria
- Microenvironment
- Host defenses
- Endogenous flora normally contained
8Distribution of Pathogens Causing SSIs
Mangram AJ. AJIC 19992797-134
9Risk Classification for SSI
- CLASS III/CONTAMINATED WOUNDS--open, fresh,
accidental wounds. In addition, surgical
procedures in which a major break in sterile
technique occurs (eg, open cardiac massage) or
there is gross spillage from the gastrointestinal
tract and incisions in which acute, nonpurulent
inflammation is encountered are included in this
category. - Class IV/Dirty-Infected
- Old traumatic wounds with retained devitalized
tissue and those that involve existing clinical
infection or perforatedviscera. This definition
suggests that the organisms causing postoperative
infection were present in the operative field
before the operation.
- CLASS I/CLEAN WOUNDS--an uninfected surgical
wound in which no inflammation is encountered and
the respiratory, alimentary, genital, or
uninfected urinary tracts are not entered. - CLASS II/CLEAN-CONTAMINATED WOUNDS--a surgical
wound in which the respiratory, alimentary,
genital, or urinary tracts are entered under
controlled conditions and without unusual
contamination.
http//www.cdc.gov/hicpac/SSI/table7-8-9-10-SSI.ht
ml
10Smoking Surgery Bad combination
- Randomized, controlled trial 48 smokers(S) vs 30
never smoked (NS) - 228 wounds evaluated
- SSI rate 12 S vs 2 in NS
- SSI rate significantly less for S if abstain for
4wks (27 vs.1.1) - Wound rupture 12 S vs. 0 NS
- Smokers nearly 40 more likely to die
- (within
30 days) - When to stop 30 days?
- 2-6months? at least 1 yr?
http//health.clevelandclinic.org/2013/08/facing-s
urgery-kick-cigarettes-now
11Preoperative Patient Shower with Antimicrobial
Soap
- Bacterial counts on skin are 9-fold lower after
shower - chlorhexidine - CDC SSI Guidelines Require patients to bathe
with antiseptic on at least the night before
their operation - CHG cloth use night before day of surgery
12Intranasal De-colonization Prevention of SSI
- Orthopedic cardiothoracic patients -
significant reduction in SSI among treated1-3 - However these were retrospective used
historical controls - Another randomized trial in ortho.surg found less
S. aureus nasal carriage but no signif. Reduction
in SSI rate4
Mupirocin decolonization of nasal Staphylococcus
aureus prior to surgery decreases surgical site
infections, however, treatment requires 5 days,
compliance is low and resistance occurs.
13Preventing Surgical Site Infection System-level
success Usry GH, et al. AJIC 200230434-6.
Intervention Intranasal mupirocin 48 hrs prior
to through 5 days post op Results 94 of
patients Rx Rate of SSI dropped by 53
overall 55 for deep sternal
Rate Per 100 CABGs
14New Study (2015) Povidone-Iodine Solution 5
- Assurance - Reduces bacterial counts in the
nares, including S. aureus by 99.5, so you know
you're helping address another variable in the
fight against surgical site infectionsControl -
Works within one hour - One at a time, the foam-tipped applicators are
saturated with the appropriate solution using a
vigorous stirring motion for at least 10 seconds.
The subjects nostrils are prepped for 30 seconds
each using separate applicators. This process was
then repeated using two additional applicators
for a total application time of 1 minute per nare
(2 minutes total).
15Surgical Care Improvement Project (SCIP)
- Antibiotic Timing - lt60min
- Antibiotic Selection type/body location
- of procedure
- - dosing for body wt.
- - duration of procedure
- - PCN allergy?
- - cost of antibiotic
- 2006
- http//www.medscape.org/viewarticle/531895_2
- Ancef
- Vancomycin or Clindamycin
16Surgical Care Improvement Project (SCIP)
within 24 hours surgery end time Stop ATB 24
Hours of OR end time 48 for Cardiac
Surgery Blood sugar lt200 POD 1 2 S Controlled
_at_ lt 200 by 6STTTTTTGKLBLK a.m. POD 1 2
Appropriate Hair removal no razors DVT
Prophylaxis Beta-blocker given before OR and
after unless contraindicated ICD (Int.
Compression Device), TEDs, Heparin, Warfarin
Foley cath remove by POD 2 or physician note
why not
17Centers for Medicare Medicaid Services (CMS)
Actions
- Payment reforms for inpatient hospital services
in 2008 - ensure that Medicare no longer pays for the
additional costs of certain preventable
conditions (including certain infections)
acquired in the hospital - Serious preventable events Object left in
during surgery air embolism Delivering
ABO-incompatible blood or blood products - 2) catheter-associated urinary tract infections
- 3) pressure ulcers
- 4) Vascular catheter associated infection
- 5) Mediastinitis after CABG surgery
- 6) Patient falls
- 7) VAE
- 8) Influenza vaccination rates
- 9) Future MRSA, S. aureus BSI, CDAD (C. diff)
18Impact of SSI Occurring After Discharge
-
- Many/Most SSI not identified until after
discharge - Cost for care with SSI were 2.9 times greater
- 19.5 of readmits 18 of ER visit some at
other facilities - Post discharge SSIs can impair physical mental
health - Surveillance (PDS) is inconsistent phone/paper
honest - Education - ? enough/consistent/updated
- Host defense acute and chronic medical
conditions - Effective management to minimize consequences
- http//www.hfma.org/Content.aspx?id28199 Feb 2015
19.
Stitch/ Stitch/ Superficial Deep
Pt. DOB Surg Class Room Procedure Description Staple Staple Incisional Incisional
J 5/22/63 3/7 1 OR 12 DECOMPRESSIVE LAMINECTOMY L4-5, L5-S1, NEURO FORAMOTOMY L4-5, L5-S1
J 4/8/54 3/7 1 OR 12 KNEE ARTHROSCOPY LEFT
J 7/29/59 3/30 1 OR 12 KNEE ARTHROSCOPY RIGHT, PARTIAL MENISCECTOMY,
J 6/20/62 3/14 1 OR 12 KNEE ARTHROSCOPY LEFT, PARTIAL MENISECTOMY, PARTIAL CHONDROPLASTY
J 11/19/68 3/21 1 OR 12 KNEE ARTHROSCOPY RIGHT, PARTIAL CHONDROPLASTY, RELEASE PLICA
J 1/28/32 3/28 1 OR 12 KNEE TOTAL ARTHROPLASTY LEFT
J 8/31/91 3/28 1 OR 12 left KNEE ARTHROSCOPY with fixation of osteochondyle fx, debridement of
J 8/18/40 3/21 1 OR 12 LEFT TOTAL HIP REPLACEMENT
J 9/10/30 3/11 1 OR 10 OPEN REDUCTION, PINNING RIGHT FEMORAL NECK
J 1/29/05 3/15 1 OR 8 REALINEMENT WITH PINNING AND CASTING LEFT ELBOW
J 9/16/60 3/14 1 OR 12 RELEASE OF ACHILLES TENDON RIGHT
J 2/24/32 3/7 1 OR 12 REMOVAL OF FOREIGN BODY RIGHT THIGH ANTIBIOTIC BEADS
J 5/14/59 3/30 1 OR 12 REVISION LEFT TOTAL KNEE ARTHROPLASTY, EXTENSIVE SYNOVECTOMY
J 11/1/44 3/28 1 OR 12 REVISION, POLY LEFT KNEE, DEBRIDMENT, LATERAL RELEASE
J 1/13/25 3/21 1 OR 12 RIGHT KNEE ARTHROSCOPY, CHONDROPLASTY, PARTIAL MENISCECTOMY
J 12/1/38 3/28 1 OR 12 RIGHT OPEN QUADRICEPS REPAIR WITH AFLEX GRAFT
Stitch/staple Stitch/staple minimal inflammation and discharge confined to the points of suture penetration minimal inflammation and discharge confined to the points of suture penetration
Superficial Incisional Superficial Incisional Superficial Incisional Purlent drainage from the superficial incision or pain or tenderness, localized swelling, redness, or Purlent drainage from the superficial incision or pain or tenderness, localized swelling, redness, or Purlent drainage from the superficial incision or pain or tenderness, localized swelling, redness, or Purlent drainage from the superficial incision or pain or tenderness, localized swelling, redness, or Purlent drainage from the superficial incision or pain or tenderness, localized swelling, redness, or
heat, and superficial incision is deliberately opened by surgeon, and is culture-positive or not cultured heat, and superficial incision is deliberately opened by surgeon, and is culture-positive or not cultured heat, and superficial incision is deliberately opened by surgeon, and is culture-positive or not cultured heat, and superficial incision is deliberately opened by surgeon, and is culture-positive or not cultured heat, and superficial incision is deliberately opened by surgeon, and is culture-positive or not cultured
If from secondary incison (e.g., donor site leg incision for CABG), please note Y- SIS If from secondary incison (e.g., donor site leg incision for CABG), please note Y- SIS
Deep incisional Deep incisional Deep incisional a. purulent drainage from the deep incision but not from the organ/space a. purulent drainage from the deep incision but not from the organ/space
b. incision spontaneously dehisces or is deliberately opened by a surgeon and is culture-positive or not cultured b. incision spontaneously dehisces or is deliberately opened by a surgeon and is culture-positive or not cultured b. incision spontaneously dehisces or is deliberately opened by a surgeon and is culture-positive or not cultured b. incision spontaneously dehisces or is deliberately opened by a surgeon and is culture-positive or not cultured b. incision spontaneously dehisces or is deliberately opened by a surgeon and is culture-positive or not cultured b. incision spontaneously dehisces or is deliberately opened by a surgeon and is culture-positive or not cultured
a. purulent drainage from the deep incision but not from the organ/space a. purulent drainage from the deep incision but not from the organ/space
during reoperation, or by histopathologic or radiologic examination during reoperation, or by histopathologic or radiologic examination
20The Challenge of Surveillance of SSIs expanding
universe of health care delivery
- Major trend towards delivery in wide range of
settings - Short lengths of stay inter-facility transfer
is common - NEW PACE (Program of All-inclusive Care for the
Elderly) Home care for 55yr who met Medicaids
LTC eligibility with 24 hr call line, respite
care - http//www.michigan.gov/mdch/0,4612,7-132-2945_425
42_42543_42549-87437--,00.html
Networking!
21Ambulatory Surgery Risk Free?
Cluster of Endoph-thalmitis after cataract
surg. Acremonium kiliense 4 patients Risk Factor
1st case, Mondays Humidified air in ventilation
likely source Fridkin SK. Clin Infect Dis
1996 Steroid Injection Outbreak
- Cluster of fungal contamination of saline breast
implant - Saline bottle stored under water-damaged ceiling
- OR in negative pressure
- Kainer MA. 40th IDSA (abstr)
22 CMS for Ambulatory Care
- 42 CFR Part 416 Medicare and Medicaid Programs
Ambulatory Surgical Centers (ASC), Conditions for
Coverage - require the ASC to designate a qualified
professional, such as a registered nurse, as the
infection control officer - The infection control condition places
accountability on ASCs to prevent, control, and - investigate infections and communicable diseases,
and take action that result in improvements
23Waterless Alcohol-based Hand Rub for Surgical
Hand Antisepsis
- Randomized trial, 4387 pts.
- Hand rub vs scrub with antimicrobial soap water
- SSI rate in hand rub (2.4) vs scrub (2.5) not
signif. - Better compliance, less skin irritation/dryness
with hand rub in personnel
Parienti JJ. JAMA 2002 288722-77
WHO
24Possible SSI Prevention Measures
- Subcuticular suturing vs skin stapling technique,
CABG - 2 studies no consistent results (Mullen
JC. Can J Cardiol 19991565- Chughtai T. Can J
Cardiol 2000161403-) - Quill Suturing? expensive
- Anemia leukocyte-depleted red blood cell
transfusion - studies have had mixed results
more study needed(Jensen LS. Transfusion
199535719- Titlestad IL. Int J Colorectal Dis
200116147-van de Watering LM. Circulation
199897562-) - Laminar Airflow Orthopedic Surgery - Mixed
results difficult to demonstrate clear cost
effectiveness (Berbari EF. Clin Infect Dis
1998271247-) - UV light vs Xenon gas
25Possible SSI Prevention Measures
- Supplemental perioperative oxygen- randomized
trial found lower SSI with 80 O2 among 500
colorectal surgery pts.however-high SSI rate
risk index in control population - Need
confirmation (Grief R. N Engl J Med
2000342161-7) - Periop. normothermia - randomized trial of 200
patients, colorectal surgery pts. lower SSI
rate with additional warming(forced air IV
fluids) vs those with regular care more
investigation needed for wider application (Kurz
A. N Engl J Med 19963341209-15) - Changing Gloves/equipment - before
closure(spillage) - Invanz/Ertapenem new studies suggesting not as
effective - More patients who received ertapenem developed
Clostridium difficile infection - http//dicon.medicine.duke.edu/sites/dicon.medicin
e.duke.edu/files/documents/October20201320DICON
20newsletter--Avoiding20Ertapenem.pdf
26Category IA SSI Prevention Recommendations
- Patient-focus
- treat existing infections first before OR
- avoid hair removal but if needed use clippers
- Asepsis technique
- aseptic principles IV, inserting catheters,
administering medications
AJIC 19992797-132
27Category IB SSI Prevention Recommendations
- Patient-focus
- control serum blood glucose
- encourage tobacco cessation
- preop shower
- clean skin incision site apply antiseptics
- Surgical Team
- no artificial nails
- surgical hand antisepsis
AJIC 19992797-132
28Category IB SSI Prevention Recommendations
- Intraoperative
- Positive pressure in OR
- Min. 15 air changes/hour
- Filter supply air
- Keep OR doors closed as much as possible
- sterilize surgical instruments limit flash
sterilization - Surgical Team
- surgical mask, hair cover
- gown sterile gloves
- Gentle handling of tissue
AJIC 19992797-132
29Category IB SSI Prevention Recommendations
- Surveillance
- Use CDC definitions
- Apply risk index
- Periodically calculate risk stratified SSI rates
- Report SSI rates to surgical personnel
- Use standard case finding methods
AJIC 19992797-132
30Surgical Site Infection Criteria
- Superficial incisional SSI
- Infection occurs within 30 days after any NHSN
operative procedure and - involves only skin and subcutaneous tissue of the
incision and - patient has at least one of the following
- a. purulent drainage from the superficial
incision. - b. organisms isolated from an aseptically-obtained
culture of fluid or tissue from the superficial
incision. - c. superficial incision that is deliberately
opened by a surgeon and is culture-positive or
not cultured - and patient has at least one of the following
signs or symptoms pain or tenderness localized
swelling - redness or heat. A culture negative finding
does not meet this criterion. - d. diagnosis of a superficial incisional SSI by
the surgeon or attending - physician or other designee (see reporting
instructions).
31Two specific types of superficial
incisional SSIs
- Superficial Incisional Primary (SIP)
- superficial incisional SSI that is
identified in the primary incision in a patient - that has had an operation with one or more
incisions - (e.g., C-section incision or chest incision
for CABG) - Superficial Incisional Secondary (SIS)
- superficial incisional SSI that is
identified in the secondary incision in a - patient that has had an operation with more
than one incision - (e.g., donor site incision for CBGB)
-
- Do not report a stitch abscess, stab wound or pin
site infection as SSI - Diagnosis of cellulitis, by itself, does not
meet criterion for superficial incisional SSI. -
-
32Deep incisional SSI
- Infection occurs within 30 (most) or 90 days
(implant) after the NHSN operative - procedure and involves deep soft tissues of
the incision (e.g., fascial and muscle - layers) and patient has at least one of the
following -
- a. purulent drainage from the deep incision.
-
- b. a deep incision that spontaneously dehisces or
is deliberately opened by a surgeon - and is culture-positive or not cultured
and patient has at least one of the following - S/S
- -fever (gt38C) localized pain
or tenderness. - c. an abscess or other evidence of infection
involving the deep incision - d. diagnosis of a deep incisional SSI by a
surgeon or attending physician - or other designee
-
-
33Organ/Space SSI
- Infection occurs within 30 or 90 days after the
NHSN operative procedure and - infection involves any part of the body,
excluding the skin incision, fascia, or muscle
layers, that is opened or manipulated during the
operative procedure and - patient has at least one of the following
- a. purulent drainage from a drain that is placed
into the organ/space - b. organisms isolated from an aseptically-obtained
culture of - fluid or tissue in the organ/space
- c. an abscess or other evidence of infection
involving the - organ/space
-
34Special Comments
- Occasionally an organ/space infection drains
through the incision and is considered a
complication of the incision. Therefore, classify
it as a deep incisional SSI. - Report mediastinitis following cardiac surgery
that is accompanied - byosteomyelitis as SSI-MED rather than
SSI-BONE. - If meningitis (MEN) and a brain abscess (IC)
are present together - after operation, report as SSI-IC.
- Report CSF shunt infection as SSI-MEN if it
occurs within 90 days - of placement if later or after
manipulation/access, it is - considered CNS-MEN
- Report spinal abscess with meningitis as SSI-MEN
following spinal - surgery.
35Environmental Infection Control Guidelines, 2003
- HVAC
- Positive pressure ventilation
- Filtration
- Environmental Cleaning
- Preventing water-associated illness
- Preventive maintenance
MMWR 200352RR-10
36A Surgeons Perspective on Prevention of SSI
- The most critical factors in the prevention of
postoperative infections, although difficult to
quantify, are the sound judgment and proper
technique of the surgeon and surgical team, as
well as the general health and disease state of
the patient - -Nichols RL. Emerg Infect Dis
20017(No.2)220-4.
37How to Display SSI data
- Target state in IP Plan
- Just ? what if 1 of 2 procedures develop SSI?
- Denominator numerator?
- Graphs
- Previous year 2 years?
- Scorecards
- Compare with NNIS vs Standard Infection Ratio
(SIR) - Special Investigations
- High volume surgery
- Surgeon specific?
- Tell them/show them what they need to see
38Sample of displaying SSIs
2013 2014
Surgery Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Total Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Total
Total hip 1 1 1 3 1 1 1 3
done 10 12 7 12 11 10 17 19 8 13 10 12 141 11 9 9 10 8 8 5 16 14 19 7 8 124
SSI rate/month 14.3 7.7 10.0 2.1 9.1 12.5 7.1 2.42
Total knee 2 1 3 1 1 1 1 1 5
done 20 12 16 16 18 18 21 15 19 20 21 14 210 24 20 17 19 16 23 20 20 12 22 20 19 232
SSI rate/month 12.5 4.8 1.4 5.9 6.3 4.3 5.0 8.3 2.16
Vascular 1 1 2 1 1
done 4 4 8 4 1 3 4 2 0 3 2 3 38 4 5 4 2 2 6 0 2 1 4 3 4 37
SSI rate/month 25.0 33.3 5.3 50.0 2.7
39Post discharge Data Surveillance
Patient Name DOB Surgery Class Room
Procedure Description Name of hospital __________
_______ Education New surgeons/Annually
(definitions) Skin/staple related? dont count
Incisional skin or sub-Q , drainage,
dehisence, ID Any cultures? Readmit? Within 30
days vs NEW 2013 90 days (implants)
40SSI Surveillance Prevention Intervention
- Feedback surgeon/surgical personnel or committee
(s) - Result Overall SSI rate/SIR for given (targeted)
surgeries - Action Plan Quality Improvement education,
equipment, timing, etc.
41Summary Aspects of Surveillance Program for
Prevention of SSIs
- SSIs cause considerable morbidity and mortality
and are expensive complications to treat -
prevention therefore is cost effective - Surveillance Interventional Epidemiology is an
effective component of a facilitys patient
safety/performance improvement program - Feedback of process outcome data is helpful but
broad partnership involving multiple disciplines
is likely key to success
42Skin Soft Tissue Infections
- Changing Pattern of Community- Associated Skin
and Soft-Tissue Infection with methicillin-Resista
nt Staphylococcus aureus (CA-MRSA) - Almost three quarters of the soft-tissue
infections were caused by CA-MRSA (N389
patients) - King MD, et al. Ann Intern Med 2006 144309-317.
43Example of Surgeon-Specific data
44Conclusions
- SSIs will always be with us
- MDROs will challenge us
- New techniques and technology will evolve
- Government agencies will change how we measure
quality performance (NHSN) - Reimbursement can effect our process, advancing
to new equipment or products, how we stay in
business
45Sterile Processing
- From Acquisition to Reuse
46Sterilization of Equipment
- Certified technicians
- Cleaning ultrasonic (5 to 10 min) open
instruments DRY/inspect - Wrapping trays
47Sterilization
- - Steam 121oC (250oF) and 132oC (270oF).
Manufacturers recommendation. - Bowie-Dick test is used to detect air leaks
and inadequate air removal - Biological monitor Geobacillus
stearothermophilus (formerly Bacillus
stearothermophilus) - Monitored using a printout (or graphically)
by measuring - temperature, the time at the temperature,
and pressure - - Sterrad
- -Portable (table-top) steam sterilizers
- - Immediate use
- www.roboz.com/catalog20pdfs/Sterilization_and_Mai
ntenance.pdf quick chart - www.cdc.gov/hicpac/Disinfection_Sterilization/13_0
Sterilization.html
48Correct loading /unloading
- Sufficient space must occur around the packages
- place items on edge and no chamber wall touching
- do not stack packages or cassettes one upon the
other - paper of one pouch next to the plastic of the
adjacent pouch - Basins, bowls or other devices on their sides
- running a load with both linens and medical
instruments, place the linen packs on the top
shelf - heavy medical items or large trays flat on the
bottom shelves - Some steam sterilizers have an automatic dry
cycle - opening the door about ½ inch after the pressure
equalizes and let items sit inside the chamber
for 30 to 60 minutes - Wet packages that exist at the end of
steam-sterilization cycles should not be handled
49 Steam Sterilizer recall
- Recalls due mechanical, chemical and biological
- -Who you going to call?
- Retrieval of processed items
- Notify your sterilizer service representative
- Re-validated with three consecutive negative
biological monitors in three consecutive cycles - AAMI recommends that sterilizers be biologically
monitored at least once a week, preferably daily,
when normal cycles are used, in each flash
sterilization load and in any load containing an
implantable device. - http//www.spdceus.com/recalls.htm for online
info quiz