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Evaluating Device Design and Cleanability of Orthopedic Device Models

Contaminated with a Clinically Relevant Bone Test Soil

Article in Biomedical Instrumentation & Technology · October 2015

DOI: 10.2345/0899-8205-49.5.354

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RESEARCH
Evaluating Device Design and
Cleanability of Orthopedic Device
Models Contaminated with a
Clinically Relevant Bone Test Soil
Anne D. Lucas, Srinidhi Nagaraja, Edward A. Gordon, Victoria M. Hitchins

About the Authors Abstract Cleaning, including precleaning at point of

Reusable medical devices need to be cleaned use, is a critical first step in reprocessing
Anne Lucas, PhD,
is a research prior to disinfection or sterilization and subse- reusable medical devices. The medical device
chemist at the U.S. quent use to prevent infections. The cleanability being reprocessed must be adequately
Food and Drug of medical devices depends in part on the design cleaned before any disinfection or steriliza-
Administration‘s of the device. This study examined how models tion. Dirty devices may lead to transmission
Center for Devices of microorganisms and/or foreign matter to
of orthopedic medical devices of increasing
and Radiological
complexity retain calcium phosphate bone subsequent patients.1,2 The US Food and
Health. E-mail: anne.lucas@fda.
hhs.gov cement, a relevant test soil for these devices. Drug Administration (FDA) labeling regula-
Methods: The dye Alizarin Red S and tion requires that reusable medical devices
Srinidhi Nagaraja, micro-computed tomography (μCT) were used have adequate directions for reprocessing.3
PhD, is a
to assess the amount and location of bone In addition to cleaning and following direc-
mechanical
engineer at the cement debris in a series of model orthopedic tions for reprocessing, a clinically relevant
U.S. Food and devices. Testing was performed after soiling and test soil is strongly recommended for
Drug cleaning once, and soiling and cleaning 10 times. cleaning validation performed by the device
Administration‘s Results: The color change of the dye after manufacturer.1–4 The development, applica-
Center for Devices and Radiological tion, and validation of individual test soils for
reacting with the bone cement was useful for
Health. E-mail: srinidhi.nagaraja@fda.
indicating the presence of bone cement in these cleaning are not well established for repro-
hhs.gov
models. High-resolution μCT analysis provided cessing medical devices. There are 22
Edward A. the volume and location of the bone cement. different test soils listed in AAMI TIR30
Gordon, AA, Models that were more complex retained 2011: A compendium of processes, materials,
senior engineering
significantly more bone debris than simpler test methods and acceptance criteria for
technician,
worked as a designs. Model devices repeatedly soiled and cleaning reusable medical devices.
support scientist cleaned 10 times retained significantly more bone
and graphics debris than those soiled and cleaned once. In addition to cleaning and following
artist at the U.S. Food and Drug Conclusion: Significantly more bone cement
Administration‘s Center for Devices directions for reprocessing, a
was retained in the more complex lumen
and Radiological Health, before
structures. This information may be useful in
clinically relevant test soil is strongly
retirement.
designing reusable orthopedic devices, and other recommended for cleaning validation
complex medical devices with lumens. performed by the device manufacturer.

354 Biomedical Instrumentation & Technology September/October 2015

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An International Standards Organization ineffective at measuring these clinically

Technical Specification document (ISO/TS relevant soils. The concern of how device
15883-5),5 lists 19 test soils with ingredients design affects the cleanability of medical
that are not well characterized chemically devices extends to all instruments, not just to
such as egg, butter, and water-soluble orthopedic devices.2,6 Water-soluble debris in
adhesive wallpaper paste. a device can become
Presently, commercially An essential consideration insoluble and adhere to
available test soils are often in cleaning a reusable device surfaces as a result
sold as powders with of the heat and chemicals
medical device is the
directions to reconstitute used in sterilization if not
with water, which may make device design. Devices thoroughly cleaned prior
the test soil easy to remove with narrow lumens, to sterilization.10
from the device with water, hinges, inaccessible Haugen et al.11 developed
not posing a reasonable cracks and crevices, and a method to determine
challenge of worst-case total mass of loose insolu-
cleaning of a contaminated
particularly those with ble orthopedic debris in
device. In this study, we use complex geometries are models of increasing
a test soil that is difficult to difficult to clean. complexity ranging from a
remove from a device with straight lumen to a replica
water, but is used to demonstrate the influ- of an arthroscopic shaver handle. This work
ence of device design on cleanability. modeled the capture of loose debris one
An essential consideration in cleaning a might find inside used orthopedic devices.
About the Authors
reusable medical device is the device design. The test soil contained bone meal that was a
Devices with narrow lumens, hinges, mixture of various uncharacterized bone Victoria M. Hitchins
inaccessible cracks and crevices, and particu- meal types and artificial coagulated blood.11 PhD is a research
microbiologist
larly those with complex geometries are Quantification was done by filtering the
at the U.S.
difficult to clean.1,2,5,6,7 Residual debris in a debris from an aqueous extract of medical Food and Drug
medical device may protect microorganisms devices and medical device models and then Administration‘s
from the sterilants and disinfectants used in weighing the solid debris. This study indi- Center for Devices
reprocessing.3 Therefore, methods for cated that the more complex the device and Radiological Health. E-mail:
cleaning validation or verification of reusable design, the more debris was retained. [email protected]

complex orthopedic devices that are used to However, this method did not account for
remove bone and cartilage pose a serious orthopedic material that may be trapped in or
challenge. To demonstrate that the recom- adhered to the internal surface of a medical
mended cleaning procedure consistently device nor did it provide information on the
works to predetermined specifications, locations within the models.
manufacturers must conduct validation As a follow up to the Haugen study,11
studies. 1,4
identical model devices were used, but were
Patient soil found on reusable orthopedic made with clear acrylic. These transparent
devices includes bone and cartilage, which do model devices were soiled with bone cement,
not contain large amounts of protein or water- allowed to dry, and then minimally cleaned
soluble carbon. The primary component in to mimic the worst case scenario of orthope-
bone is hydroxyapatite, Ca10(PO4)6(OH)2.8 dic debris trapped in or adhering to the These transparent model
Recently, insoluble tissue debris was found inside of a device. Methods to detect the bone devices were soiled with
in arthroscopic shaver handles, an orthopedic cement were developed. Alizarin red S dye
device used to shave cartilage and bone.2,9 provided a rapid, qualitative indication that
bone cement, allowed to
This incident demonstrated the importance bone cement was present. Micro-computed dry, and then minimally
of evaluating medical device designs for tomography (μCT) was used to accurately cleaned to mimic the
cleanability of solid debris. Using solid assess the total amount and spatial location worst case scenario
debris, such as bone and cartilage, in a of bone cement in our model devices. The
of orthopedic debris
cleaning validation assay may prove problem- μCT uses X-rays to produce non-destructive
atic because commonly used tests to measure high resolution, 3D images of the debris in trapped in or adhering
protein and total organic carbon (TOC) are these models. to the inside of a device.

Biomedical Instrumentation & Technology September/October 2015 355

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Material and Methods Bone Cement: Initially, bone cement was

Chemicals: Polyphosphoric acid, β tricalcium made as previously detailed.12 For conveni-
phosphate, and Alizarin Red S were pur- ence, an equivalent bone cement was
chased from Sigma (Sigma Aldrich Co. LLC, purchased from Himed (Bethpage, NY) and
St. Louis, MO); sucrose was obtained from consisted of calcium phosphate bone cement
Fisher Scientific. Distilled deionized water powder (73.2% tetracalcium phosphate,
was produced with a Barnstead NANOpure 26.8% dicalcium phosphate anhydrous) and
Diamond water purification unit liquid solution (trisodium citrate acid). Three
(ThermoScientific Inc., Rockford, IL). grams of the bone cement powder was added

Figure 1. Device design models used in this study. Direction of flow indicates the direction the bone cement was
pulled through. To better compare the design feature as it relates to cleanability, the shaded areas in each of the
device design models show where the local μCT analysis was done. The length of A1 and E1 was 1 cm, B1 and C1
was 0.25 cm, B2 and C2 was 0.75 cm, D1 and E2 was 1.5 cm. The length of the models is 10.16 cm. The bend in
the lumen was 60° for D and 90° for E. The amount of bone cement was normalized to the total volume in which
the bone cement was quantified.

356 Biomedical Instrumentation & Technology September/October 2015

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to 6 ml citrate solution to facilitate working sucrose and then thoroughly crushing the
with the slurry before it hardened; after solids using a mortar and pestle. Serial
adding the liquid to the bone powder, stirring dilutions of pulverized bone cement with
with a Teflon spatula began immediately and sucrose were created by taking a known
continued for 30 seconds at which time the weight of the crushed bone cement in sucrose
bone cement was used. To simulate the use and adding it to a known weight of the
of a device with a complex design such as an sucrose followed by thorough crushing with
arthroscopic shaver, immediately after the a mortar and pestle. The limit of detection
30 sec mixing period a house vacuum (-0.8 to for the bone cement with 1 mL of 0.01%
-0.9 bar) was used to pull the bone cement Alizarin Red S dye was 10 μg bone cement.
slurry through the device. This same mixture
was made fresh for each and every soiling of Application of Bone Cement to Devices
Device Models A through E (Figure 1). Note Application of bone cement to model devices
that the arrow in Figure 1 indicates the (Figure 1) was accomplished by mixing bone
direction the bone cement was pulled cement and pulling it through the lumens of
through the device. The model devices were the various models using a house vacuum.
laid horizontally to dry overnight at room Although one can make hydroxyapatite cement
temperature before cleaning as described by with commercially available chemicals12,
Haugen et al.11 One set of model devices was it was convenient to purchase the prepared
soiled and cleaned one time; a second set was powder that was well characterized chemi-
soiled and cleaned 10 times to simulate cally. After allowing it to harden overnight,
possible accumulation of soil after multiple the model devices were gently tapped on the
uses and cleanings. lab bench to displace any loose debris. The
Models: Five individual samples for each of model devices were cleaned mimicking a
the five models, A–E (Figure 1), were used for worst case scenario as previously described,11
each series of soiling and cleaning. The clear rinsed 10 seconds with tap water (about
acrylic models were custom fabricated at the 23°C), brushed 5 times with appropriate
FDA machine shop where identical devices sized brushes, and rinsed again for 10
in aluminum were made for Haugen.11 The seconds with warm tap water. A Parafilm-
dimensions are detailed in Figure 1. oated stopper was firmly placed in the 5 mm
end of the model opening (Figure 1 the left
Dye Assay side of the device) and 0.01% Alizarin Red S
Detection of the bone cement was made was placed in the open end of the lumen and
possible by using a dilute solution of Alizarin allowed to react with the bone cement for
Red S dye (0.01% w/v in water). The presence about 15 minutes at room temperature (about
of the bone cement was estimated by meas- 23°C). Following this, the dye was removed
uring the absorption at 525 nm.13 A standard by placing the end of the device that had not
curve for bone cement was created by taking been plugged over a 15 ml test tube and
0.1 g of hardened bone cement and 0.9 g removing the plug. The absorbance of the

Soiled and Cleaned Once Soiled and Cleaned Ten Times

Bone cement Bone cement
μg/ml SD μg/ml SD
A 3.3 2.2 930.2 657.2
B 30.7 17.9 1789.2 239.8
C 2513.8 1498.7 817.9 92.3
D 333.5 348.8 518.3 197.0
E 74.2 63.1 1830.8 651.8

Table 1. Dye Assay: The average amount of bone cement (μg/ml) remaining in each of five different device designs
(see Figure 1), as determined by the qualitative dye assay for the entire device. One set of device design models was
soiled and cleaned once (left) and soiled and cleaned ten times (right).

Biomedical Instrumentation & Technology September/October 2015 357

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reacted dye was read at 525 nm with the concen- model was examined. Second, once seg-
tration extrapolated from the standard curve. mented, the volume of bone cement was
Because the model devices held different quantified locally in distinct regions within
volumes of dye, the concentration of bone each model (see Figure 1). For device
cement was normalized per ml of dye used. model A, a 1 cm length in the middle of the
channel was analyzed. For device models B
Microcomputed Tomography and C, a 1 cm length at the transition
Microcomputed tomography (μCT) 100, between the large and small diameters was
Scanco Medical, Basserdorf, Switzerland) was examined. For device model D, bone cement
used to obtain high resolution (34–48 µm/ in a 1.5 cm length along the angled portion of
voxel) three-dimensional images of each the channel was quantified and a 1 cm region
device model post soiling and cleaning. at the 90 degree bend in device model E was
These gray-scale images were set to threshold investigated. Bone cement volume was then
levels with a constant value to observe the normalized by the total volume in each
spatial distribution of bone cement for two region resulting in a bone cement volume
separate analyses. First, the entire acrylic fraction (mm3/cm3).

Figure 2. Device design models C (Figure 1), one with no residual bone cement (1), one soiled and cleaned once
(2), and one soiled and cleaned ten times (3). The Alizarin Red S dye changes from yellow (no bone cement,
λmax 425nm) to red (with bone cement, λmax 525nm). The μCT image of model C is shown in column 4.

358 Biomedical Instrumentation & Technology September/October 2015

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The detection and quantitation of insoluble or trapped debris from

orthopedic procedures cemented inside a medical device poses more
difficult questions of detection within these narrow lumen devices such as
arthroscopic shaver handles.

Statistical Analysis of weighing very small amounts of bone

Statistical analysis for comparison of one set cement (data not shown). Sucrose was used
of model devices to another used a student’s to mix with the bone cement as other
T-test. A set of model devices consisted of five common laboratory solids (citric acid,
individual models for each of the five differ- sodium borate sodium, chloride, calcium
ent designs A through F. Comparison of all chloride, disodium phosphate, etc.) inter-
model device designs utilized a one way fered with the colorimetric endpoint.
ANOVA to evaluate any significant differ- The residual amount of bone cement
ence. Significance level was set at p < 0.05. detected by the Alizarin Red S assay is
presented in Table 1. In some of the acrylic
Results and Discussion model devices, the dye interaction is at the
In most orthopedic devices, tissue debris is surface and does not penetrate all the way
primarily bone and cartilage. The composi- through the bone cement. This was observed
tion of this patient tissue debris is composed when the cement was thicker than a few
mostly of hydroxyapatite and structural millimeters; the values reported in Table 1
proteins such as collagens.8 Detection of this reflect this and show no clear trend. This is
type of debris, especially if deposited as a also seen in model C in Figure 2, where the
water insoluble mass inside a medical device, progression of color change from control
cannot be measured using protein or total (column 1) to soiled and cleaned once
organic carbon assays. In cleaning orthopedic (column 2), to soiled and cleaned ten times
devices, some insoluble debris may remain (column 3). In column 3, one observes the
loose and extractable in the device and a white bone cement in the device, whereas in
method such as the one proposed by column 2, the dye has penetrated and the
Haugen, et al.11 could be used. However, the color of the entire sample is uniform. A μCT
detection and quantitation of insoluble or image of model C soiled and cleaned ten
trapped debris from orthopedic procedures times (column 4) is shown for comparison.
cemented inside a medical device poses more Therefore, the dye assay is not an accurate
difficult questions of detection within these reflection of the total amount of bone cement
narrow lumen devices such as arthroscopic present, but a qualitative measure of the
shaver handles. presence of bone cement. This dye assay may
be utilized to quickly assess the presence of
Dye Results bone cement; however this assay will not
Alizarin Red S reacts with hydroxyapatite.13 reveal the exact amount or location of the
The dye binds calcium from the hydroxyapa- bone cement debris within an opaque device.
tite bone cement and releases phosphate
from the bone cement. This reaction causes a μCT Entire Model Results
color change when bone cement is added to The quantitative μCT results of bone cement
the dye causing a pH shift from 5.3 to 8.7. (mm3/cm3) for the entire model device for all
This shift in pH changes the color of the dye models are reported in Table 2. Overall
from yellow to red and is easily seen in device ANOVA analysis of the data indicate soiling
design model C in Figure 2. The λ max of the and cleaning once or ten times generate
dye solution increases from 425 nm to significant differences (p=0.008, p=0.000
525 nm in the presence of bone cement. respectively). Individual student T-test for
Construction of a standard curve by crushing those sets of models cleaned and soiled once
the solid polymerized bone cement with showed that only models C and D retaining
sucrose successfully overcame the limitations significantly more bone cement debris than

Biomedical Instrumentation & Technology September/October 2015 359

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Soiled and Cleaned Once Soiled and Cleaned Ten Times

Bone cement Bone cement
mm3/cm3 SD T-test mm3/cm3 SD T-test
A 0.02 0.03 25.79 19.07
B 2.16 4.82 0.3158 82.41 12.67 5.55E-04
C 9.21 5.64 0.0066 154.28 34.01 7.85E-04
D 3.44 1.42 0.0007 49.32 12.39 4.94E-02
E 0.81 1.05 0.1334 83.85 26.09 3.86E-03

Table 2. μCT Entire model: The average amount of bone cement (mm3/cm3) remaining in each of five different
device design (see Figure 1, five replicates for each model each soiling and cleaning set) as determined by μCT for
the entire device. One set of device design models was soiled and cleaned once (left) and soiled and cleaned ten
times (right). Student T-test results show any significant difference of the various device design models relative to A.
ANOVA analysis for the set soiled and cleaned once is P=0.0077, and for the set soiled and cleaned ten times is
P=0.0000.

model A. Student T-test comparison between diameter, 5 mm, could be used on either end
the five different device designs show that of the model. It is important to note that 2 of
models B–E were significantly different than the model D and 3 of the model E were devices
model A when soiled and cleaned ten times completely clogged and did not undergo a
(Table 2). There appears a trend from model full 10 soil and clean cycles. All other devices
A to B to C with increasing residual bone could be soiled and cleaned 10 times.
debris trapped in the lumen with increasing
complexity of these linear lumen models. μCT Localized Model Results
Model A is statistically significantly different Figure 3 shows the average amount of bone
than model B and C, but this is not true for cement (mm3) per volume of the model
model B compared to model C when soiled device (cm3) in the specified area in the
and cleaned ten times (p=0.116). However, lumen (denoted by the shaded area in
model D is significantly different than model Figure 1). Overall ANOVA analysis of the
E (p=0.028) when soiled and cleaned ten amount of bone cement per volume for those
times. Whether soiled and cleaned once or model device designs soiled and cleaned
ten times, model C retained on average the once, was p=0.790. However, when soiled and
most bone cement debris. After soiling, cleaned ten times, an ANOVA of the five
devices were laid down lengthwise and different device designs becomes significant
allowed to dry. This facilitated debris retained with a p=0.000. Individual student T-test
in the center of model C as the larger lumen comparison of the model devices that are
in the middle of model C could not be soiled and cleaned only once, show only C
cleaned because only brushes of smaller and D are significantly different than A
(p=0.048, p=0.011 respectively; data not
shown). However, when these model devices
One Time Ten Times P-value were soiled and cleaned ten times, the
A 0.02 25.79 0.0642 significant difference between A and all other
B 2.16 82.41 0.0000
model devices is apparent (Figure 3).
Additionally, both models D and E retain
C 9.21 154.28 0.0000
significantly more bone cement than B.
D 3.44 49.32 0.0000
Between models C, D, and E there is no
E 0.81 83.85 0.0001
significant difference as these designs had
larger internal lumens (C), and angles too
Table 3. Student T-test values for comparing the amount of
sharp to be easily cleaned with a brush. Two
bone cement (mm3/cm3) for the same model device soiled and
cleaned one time to that of soiled and cleaned ten times using of the model D and 3 of the model E were
μCT analysis for the entire device. Five individual samples for devices completely clogged and did not
each of the five models, A–E (Figure 1), were used for each undergo a full 10 soil and clean cycles.
series of soiling and cleaning.

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All other devices were able to be soiled and This indicates that there is a build-up of
cleaned 10 times. bone cement with subsequent use and
cleaning for more complex device designs.
Cleaning Once or Ten Times Some areas beyond the scope of this study
The effect of soiling and cleaning these five include (1) disinfection or sterilization of
different model device designs once or ten accumulating debris within these models,
times for the entire model device was also (2) the effect of brushing that may alter There is a build-up
evaluated. Table 3 shows the student T-test internal surfaces (e.g., scratching), (3) use of
results for this comparison. Soiling and detergents and rigorous cleaning protocol,
of bone cement with
cleaning ten times results in statistically (4) the adherence of this specific bone test subsequent use and
significantly more bone cement deposition soil on a particular device material and cleaning for more
for all designs except A (p=0.064); as expected (5) the use of bone cement with blood, complex device designs.
A has a straight lumen and is the easiest to synovial fluid, and/or other common clini-
clean. Ten-fold to thousand fold increases in cal soils associated with orthopedic surgeries
bone cement were noted in the model may change the outcome of cleanability
devices soiled and cleaned ten times com- of devices, especially those with
pared to those soiled and cleaned once. complex designs.

Bone cement T-test relative to

mm /cm
3 3
SD A B C D
A 31.47 24.42
B 155.69 57.27 0.0040
C 241.96 91.40 0.0021 0.1484
D 316.27 108.03 0.0009 0.0303 0.3243
E 309.51 91.54 0.0004 0.0215 0.3269 0.9263

Figure 3. μCT localized: Results of local analysis using μCT for the 5 device models soiled and cleaned 10 times;
5 individual models for each of the 5 designs were tested, error bars represent one standard deviation. Figure 1
boxed off area indicates where the localized analysis took place. Student T test was used to assess any significant
differences relative to model A.

Biomedical Instrumentation & Technology September/October 2015 361

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Conclusion Medical Device Part 801 Labeling. United States

This study shows the importance of how Food and Drug Administration; 2005. Available
device design may influence cleanability. from: www.accessdata.fda.gov/scripts/cdrh/
A device that can be easily cleaned can also cfdocs/cfcfr/CFRSearch.cfm?CFRPart=801.
Accessed Dec. 31, 2014.
be more effectively disinfected or sterilized to
ensure patient safety. Methods to detect the 4. Association for the Advancement of Medical
presence of clinically relevant test soils in Instrumentation. TIR 12. Designing, testing, and
these reusable devices are essential. Alizarin labeling reusable medical devices for reprocessing
red S dye binds to bone and bone cement, in health care facilities: A guide for medical device
causing a color change in the solution that manufacturers. Arlington [VA]: Association for
can be used to indicate the presence or the Advancement of Medical Instrumentation;
A device that can be absence of bone. However, this is not a 2010.

easily cleaned can also quantitative method and cannot be used to

5. International Standards Organization. ISO/
accurately assess the amount and location of
be more effectively TS 15883-5:2005: Washer-disinfectors—Part 5:
orthopedic debris that may adhere to the
Test soils and methods for demonstrating cleaning
disinfected or sterilized internal surfaces of reusable medical devices. efficacy. Geneva, Switzerland: International
to ensure patient safety. A model of the medical devices in acrylic or Organization; 2005.
other radiolucent material followed by μCT
analysis illuminates where and how much 6. Malchesky PS, Chamberlain VC, Scott-Conner
debris is retained. The amount of bone C, Salis B, Wallace C. Reprocessing of Reusable
cement remaining in all the model devices Medial Devices. ASAIO Journal. 1995;41:146–151.
after 10 soiling and cleaning cycles was 7. Patel A, Pope J, Neilson M. Design
significantly more than after one soiling and Considerations for Medical Device Manufacturers.
cleaning. When comparing different lumen Biomed Instrum Technol. 2012;73–75.
diameters and angles in model devices,
significantly more bone cement was retained 8. Clarke B. Normal Bone Anatomy and Physiology.
Clin J Am Soc Nephrol. 2008;3: S131–S139.
in the more complex lumen structures. This
information may be useful in designing 9. United States Food and Drug Administration.
reusable orthopedic devices and other FDA Safety Alert: Ongoing Safety Review of
complex medical devices with lumens Arthoscopic Shavers. Updated 2014. Available
because the validation of the cleanability of at: www.fda.gov/MedicalDevices/Safety/
the medical device can be quantitatively AlertsandNotices/ucm170639.htm. Accessed
assessed and aid in designing future devices Dec. 31, 2014.
that can be easily cleaned for eventual
10. Aziz J, Basile RJ. The Need to Verify the
effective disinfection. n
Cleaning Process. Biomed Instrum Technol.
2012;49–54.
Disclaimer References
1. Association for the Advancement of Medical 11. Haugen SP, Duraiswamy N, Hitchins VM.
The mention of commercial Instrumentation. TIR30. A compendium of Quantification by mass of residual debris in
products, their sources, or processes, materials, test methods, and acceptance reusable medical devices. Biomed Instrum
their use in connection with criteria for cleaning reusable medical devices. Technol. 2012;61–67.
material reported herein is
Arlington [VA]: Association for the Advancement
not to be construed as either 12. Grover LM, Hofmann MP, Gbureck U,
of Medical Instrumentation; 2011.
an actual or implied endorse- Kumarasami B, Barralet JE. Frozen delivery
ment of such products by the 2. Azizi J, Anderson SG, Murphy S, Pryce S. of brushite calcium phosphate cements.
Department of Health and Uphill Grime: Process Improvement in Acta Biomaterialia. 2008;1916–1923.
Human Services. The findings
Surgical Instrument Cleaning. AORN Journal.
and conclusions in this article 13. Misra DN. Reaction of Alizarin Red S with
2012;96(2):152–162.
have not been formally dis- hydroxyapatite: Stoichiometry and surface effect.
seminated by the U.S. Food 3. United States Food and Drug Administration. Colloids and Surfaces. 1992;66:181–187.
and Drug Administration and Office of the Federal Register. Code of Federal
should not be construed to
Regulations: Title 21: Food and Drugs. Chapter I
represent any agency determi-
Food and Drug Administration Department of
nation or policy.
Health and Human Services Subchapter H—

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