Required text book: BIODESIGN – The Process of Innovating Medical Technologies
Describe the regulatory pathway you would take your hypothetical innovation thru on its way to the market. If a device,
describe its class (see Table 4.2.1), the FDA center (see p. 275), the division (see Table 4.2.2) and pathway (see Table
4.2.3). Go to the FDA medical devices databases
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/default.htm) and click on PRODUCT CLASSIFICATION
and find the device closest to your innovation and provide a detailed description of the classification.
If your innovation falls under one of the other FDA centers (food, drug, cosmetic) – please answer the DQ to the extent
it is applicable (foods and devices are different… but you can still answer the question of which regulatory pathway
you would take). For example, for devices you would need an IDE to file a PMA; for drugs you would need an IND to file an
NDA.If your innovation falls under one of the other FDA centers (food, drug, cosmetic) – please answer the DQ to the
extent it is applicable (foods and devices are different… but you can still answer the question of which regulatory
pathway you would take). For example, for devices you would need an IDE to file a PMA; for drugs you would need an IND to
file an NDA.
CARDIAC SURGERY PRESSURE ULCER PREVENTION
CARDIAC SURGERY PRESSURE ULCER PREVENTION
Pressure ulcer is a condition where the skin and underlying tissues develop complex le -sions that are of different sizes
and severity. They cause a lot of frustrations and pain to the pa -tients. This problem develops after cardiac surgery,
and patients that are undergoing the surgery
are prone to develop this problem. Other groups of people who are prone this disease are blacks
or Hispanics, those who have a low boy weight, and those who have physical or cognitive im-pairments (Hamric, Spross,
Hanson & Hamric, 2009).
The incidence rate of cardiac surgery patients is 17-19% while the prevalence rate is 7%.
The length of surgery also affects the prevalence rate as shown in the table below
Figure 1. Effect of length of surgery on prevalence rate
Pressure ulcers are caused by three types of tissue forces; friction, shear force and pres -sure. These forces play a
significant role in the occurrence of cardiac surgery pressure. When
cardiac surgery is being conducted, the patients are made to be immobile and unable to feel the
pain that is a result of spending more hours in the operation room. When the pressure prolonged,
perfusion decreases causing tissue necrosis and ischemia (Jonas & DiNardo, 2004).
The treatment for cardiac surgery pressure varies depending on the stage of the ulcers.
The modes of treatment vary as follows.
Antibiotics- these are medications that are given to cardiac surgery patients to treat the
ulcer and prevent the infection from spreading. At times, antiseptic creams are also applied to the
pressure ulcers to kill any present bacteria
Nutrition-cardiac surgery pressure ulcer patients are advised to take foods with particular
dietary supplements. These include zinc, vitamin C and proteins. The nutrients are known to fa -cilitate the healing of
wounds. Lack of the above nutrients makes one vulnerable to attack by
Debridement- sometimes it necessitates for the removal of dead tissues from the ulcer to
help facilitate the healing process. Mechanical debridement can be done in various techniques
including ultrasound, surgical debridement, laser and cleansing and pressure irrigation (Makle -bust & Sieggreen, 2001).
Electrical stimulation- this is used as adjunctive therapy for cardiac surgery patients. It
speeds up of the healing of the wound after cardiac surgery. However, this method has proved to
have adverse effects where it causes skin irritation. This method is also not very good for frail
Foam dressings- patients suffering from pressure ulcers are dressed using hydrocolloid or
foam dressings so as to reduce the size of the wound. Radiant heat dressings are also used to
dress the wound of cardiac surgery patients since it facilitates healing of the wound (Cruz-Jentoft, 2011).
Surgery- when pressure ulcers in cardiac surgery patients become severe, it necessitates
for them to undergo surgery again. In this case, the wound will be cleaned and closed, either di -rectly or by flap
Other ways of preventing and treating pressure ulcers in cardiac surgery patients include
making a good choice of mattresses and cushions.
The prevalence of pressure ulcers in cardiac surgery patients is high. The patients should
embark on recommended diet and medication to prevent cardiac surgery ulcers.
(2015). Retrieved 13 April 2015, from http://www.halyardhealth.com/media/1513/
Cruz-Jentoft, A. (2011). Pressure ulcers. European Geriatric Medicine , 2(6), 377. doi:10.1016/
Hamric, A., Spross, J., Hanson, C., & Hamric, A. (2009). Advanced practice nursing . St. Louis,
Jonas, R., & DiNardo, J. (2004). Comprehensive surgical management of congenital heart dis-ease . London: Arnold.
Maklebust, J., & Sieggreen, M. (2001). Pressure ulcers. Springhouse, Pa.: Springhouse Corp.
Medical News Today,. (2014). What are bed sores (pressure ulcers)? What causes bed sores? .
Retrieved 13 April 2015, from http://www.medicalnewstoday.com/articles/173972.php
Morison, M. (2001). The prevention and treatment of pressure ulcers. New York: Mosby.
The Incidence of Pressure Ulcers in Surgical Patients
of the Last 5 Years: A Systematic Review
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Hong-Lin Chen; Xiao-Yan Chen; Juan Wu
Volume 24 – Issue 9 – September 2012
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The Incidence of Pressure Ulcers in Surgical Patients of the Last 5 Years: A Systematic Review
Hong-Lin Chen; Xiao-Yan Chen; Juan Wu
Index: WOUNDS. 2012;24(9):234–241.
Abstract: This systematic review looks at the incidence of pressure ulcers in surgical patients of
the last 5 years. Methods. The authors searched Pubmed and Web of Science for studies published
after 2005. Screening and data abstraction were performed independently by 2
reviewers. Results. Seventeen studies (5,451 patients) met the inclusion criteria. The incidence of
surgery-related pressure ulcers ranged from 0.003 to 0.574. The pooled incidence was 0.15 (95% CI
= 98.2%). For cardiac surgery, hip fracture surgery, and patients on the surgical inten-sive care unit, the pooled
incidence was 0.18 (95% CI 0.14-0.22, I
= 62.8%), 0.22 (95% CI
= 98.4%), and 0.11 (95% CI 0.09-0.13, I
= 98.5%), respectively. Conclusion. The data
on the incidence of surgery-related pressure ulcers indicates that appropriate monitoring and treat-ment need to be
Pressure ulcers are a common problem for patients, causing significant pain and additional costs.
Many studies have investigated the incidence and the prevalence of pressure ulcers. The incidence
of pressure ulcers is 0.4% to 38%; within long-term care, 2.2% to 23.9%; and in home care, 0% to
Patients undergoing an operation are prone to develop pressure ulcers during the proce -dure.
It has been accepted that pressure ulcers are caused by 3 different tissue forces: pressure,
shear force, and friction, all of which have an important role in the occurrence of surgery-related
pressure ulcers. Contributing factors to the incidence of surgery-related pressure ulcers include the
fact that during surgery, patients are immobile, and not able to feel pain caused by prolonged pres-sure on the operating
table; the use of anesthetic agents can cause a loss of muscle tone that in-creases pressure over bony prominences; and
prolonged pressure causes decreased perfusion,
leading to ischemia and tissue necrosis. In addition, shearing and friction injury can occur as patients
are repositioned on tables then transported. Shear force can cause the pinching off of blood vessels,
which may aggravate ischemia and tissue necrosis, and friction may cause excess shedding of lay-ers of epidermis. Some
cardiac surgery patients have to use intra-aortic balloon pumps postopera-tively; movement is not allowed when these are
in use. This combination of factors may cause
surgery-related pressure ulcers, which exhibit some different epidemiological characteristics com -pared with general
pressure ulcers. In 1999, a national survey on 104 usable facilities with a total of
1,128 surgical patients showed the overall incidence based on a beta binomial was 8.5% (95% con -fidence interval: 6.1%
But after that, there wasn’t a large-scale survey to show the inci-dence of surgery-related pressure ulcers. Over the
past decade, pressure ul-cer prevention and treatment strategies have changed as many new methods
are emerging. The objective of this systematic review was to describe the inci-dence of surgery-related pressure ulcers
reported in prospective longitudinal studies of the last 5
Data sources and search strategy. The authors searched Pubmed and Web of Science databas -es. A search strategy of
(“pressure ulcer” [MeSH Terms] AND “surgical procedures,
operative” [MeSH Terms] AND (“incidence” [TW] OR “prevalence” [TW]) AND “humans” [MeSH
Terms]) was used in Pubmed advanced search. A search strategy of (TS = (Pressure SAME Ulcer*)
or TS = (Pressure SAME Sore*) or TS = (Bed SAME Sore*) or TS = (Decubitus SAME Ulcer*) AND
TS = (Surg* or Operat*) AND TS = (incidence or prevalence) was used in Web of Science advanced
search. The time span was set from 2005 to 2011 in the 2 databases. The searches were performed
on August 3, 2011. Study selection criteria. To identify relevant studies, a list of inclusion and ex -clusion
criteria was generated. The authors included studies: (1) that investigated the incidence of
surgery-related pressure ulcers of all stages, not including suspected deep tissue injury, in the last 5
years; (2) were conducted for purposes other than determining the prevalence and incidence of
surgery-related pressure ulcers, but from which the authors could extract the data of the surgery-re -lated pressure
ulcers incidence; (3) were cross-sectional, cohort, case control studies, and random -ized clinical trials. The authors
excluded studies that: (1) only investigated the prevalence of surgery-related pressure ulcers, but did not include
incidence data; (2) investigated the incidence of pressure
ulcers, not only for surgery-related pressure ulcers, such as data from medical and surgery centers,
and data from comprehensive ICUs; (3) investigated the incidence of pressure ulcers complicated by
a kind of disease which included patients not treated with surgery, such as spinal cord injury or hip
fracture; and (4) investigated the incidence of pressure ulcers, not including
stage I. Study data extraction. Each abstract of the identified articles in 2
databases were reviewed. From each article meeting the selection criteria, a uniform data extraction
tool to collect the following data was used: first author, published year, number of events, sample
size, type of surgery, and patient characteristics. When this data could not be extracted from the ab -stract, a
full-text analysis of the study was carried out. Two reviewers independently extracted data.
Disagreements were resolved by consensus and discussion with a third reviewer. Statistical
analysis. For each of the selected studies, the incidence with 95% confidence intervals (CI) was
computed. For the meta-analysis, the overall pooled incidence with 95% CI was estimated by Der
Simonian and Laird’s random-effects model.
The heterogeneity was analyzed by Cochran’s Q test
statistic. A P < 0.05 by Cochran’s Q test indicated significant heterogeneity; an I
> 50% indi -cated substantial heterogeneity. Analyses were all performed using Meta DiSc
1.4 (version 0.6).
Eligible studies. The authors initially retrieved 84 potentially relevant articles from Pubmed, and 222
articles from Web of Science. A total of 67 repeated articles were excluded. Of these 239 articles,
191 were inappropriate and excluded. An additional 31 articles did not meet the eligibility criteria and
were excluded. Thus, 17 articles
with 5,451 patients were included for analysis
(Figure 1). Table 1 summarizes the major characteristics of the included studies.
Study sample sizes ranged from 60 to 896. Included studies represented a great
diversity across many countries: 5 studies from the United States,
from the Netherlands,
2 studies from Brazil,
and the remaining 7 studies were
from the Czech Republic,
or Pan-European countries.
Patients included are divided into 4 categories: pa-tients who underwent cardiac surgery; patients who underwent surgery
for hip fracture; patients on
the surgical ICU; and those who underwent other procedures, including orthopedic, neuro-, cardio-thoracic, general,
vascular, ob-gyn, or shoulder surgeries). Pooled incidence of
surgery-related pressure ulcers. The incidence of surgery-related pressure ul-cers of the included studies ranged from
0.003 to 0.574. The pooled incidence
of surgery-related pressure ulcers of the 17 included studies was 0.15 (95% CI
0.14 – 0.16, I
= 98.2%). (Figure 2A.) Two studies
assessed the pressure
ulcer incidence for cardiac surgery. The incidence of the 2 studies was 0.21 (95% CI 0.15 – 0.28) and
0.14 (95% CI 0.15 – 0.28), respectively. The pooled incidence was 0.18 (95% CI 0.14 – 0.22, I
62.8%). (Figure 2B.) Three studies
assessed the pressure ulcer incidence
for hip fracture surgery. The incidence of the 3 studies was 0.34 (95% CI 0.29 –
0.40), 0.08 (95% CI 0.06 – 0.11), and 0.30 (95% CI 0.26 – 0.33), respectively.
The pooled incidence was 0.22 (95% CI 0.20 – 0.24, I
= 98.4%). (Figure 2C.)
assessed the pressure ulcer incidence for the surgical ICU.
The incidence of the 3 studies was 0.24 (95% CI 0.29 – 0.40), 0.18 (95% CI 0.13 – 0.24), and 0.03
(95% CI 0.02 – 0.04), respectively. The pooled incidence was 0.11 (95% CI 0.09 – 0.13, I
(Figure 2D.) The other 8 studies
assessed the pressure ulcer incidence for orthopedic,
neuro-, cardiothoracic, general, vascular, or ob-gyn surgeries. The surgery-related pressure ulcers
incidence ranged from 0.032 to 0.548. One study
assessed 896 patients having arthroscopic or
combined arthroscopic and open shoulder procedures. Each patient had an axillary roll during
surgery. Three pressure ulcers occurred. The incidence was 0.003 (95% CI 0.000 – 0.010).
Some available evidence showed that, due to more effective strategies and better prevention, the
pressure ulcer prevalence and incidence in long-term care facilities and other health care facilities
decreased in the last 10 years.
Surgery-related pressure ulcers are the most common hospital-acquired ulcers. The principle finding from this systematic
review is that the pooled incidence of the
included studies was 0.15 (95% CI 0.14 – 0.16). The data from a national survey
pressure ulcers in 1999 indicated that among the 1,128 included patients, of the 544 (48%) patients
that had no comorbidities, 7% developed ulcers; of the 584 (52%) with at least one comorbidity,
9.1% developed ulcers; and the overall incidence was 8.5% (95% CI 60.1% – 10.9%). Compared
with this survey 10 years ago, the current study’s results show the incidence of surgery-related pres -sure ulcers has
not decreased, but increased. Studies confirmed that an age > 60 years, complica-tions with diabetes or renal
insufficiency, low American Society of Anesthesiologists (ASA) or New
York Heart Association (NYHA) Functional Classification scores, and length of surgery, were the in-dependent risk factors
for surgery-related pressure ulcers.
Due to the development of surgical
techniques, the number of elderly surgical patients, surgical patients with complex complications,
and patients needing surgery of a longer duration, increased. The result may be the increased inci-dence of
surgery-related pressure ulcers of the last 5 years. The results show appropriate monitoring
and treatment for surgery-related pressure ulcers needs to be performed in order to lower surgery-related pressure ulcer
incidence. The national survey
in 1999 also showed the most common sur-gical procedures related to pressure ulcers were cardiac (29.3%),
general/thoracic (27.7%), ortho -pedic (20.6%), and vascular (9.8%). The author’s systematic review included patients who
under -went cardiac surgery; patients who underwent surgery for hip fracture; patients on the surgical ICU;
and those who underwent orthopedic, neuro-, cardiothoracic, general, vascular, ob-gyn, or shoulder
surgery. This systematic review showed the pooled incidence for cardiac surgery-related pressure
ulcers was 0.18 (95% CI 0.14 – 0.22, I
= 62.8%). A literature review indicated that except for pres -sure, shear force, and friction, additional risk factors
for pressure ulcers included the tissue tolerance
for oxygen as temperature manipulation; vasoactive drugs; hypotensive periods; reduced he -moglobin and hematocrit
levels; time on the operating room table; frequency of repositioning; immo-bility time; age; low albumin level; and
Prevention measures for cardiac surgery-related pressure ulcers should be aimed at supporting tissue tolerance for
pressure and oxygen, and
relieving devices on the operating room table or postoperatively in bed.
this systematic review, the pooled incidence for hip fracture surgery-related
pressure ulcers was 0.22 (95% CI 0.20 – 0.24, I
=98.4%). Hip surgery compli -cated with pressure ulcers resulted in delayed patient mobilization. Some intrin -sic
patient characteristics (eg, nutritional status and continence status) and the
extrinsic exposures (eg, longer interval between admission and surgery, longer duration of surgical
anesthesia, comprehensive measures of comorbidity, and disease severity) are the risk factors for
hip fracture surgery-related pressure ulcers.
Hip fracture surgical patients are still associated with a
high risk of pressure ulcers. For preventing and treating hip fracture surgery-related pressure ulcers,
Lindholm recommended performing risk assessment and skin observation with special attention to
patients > 71 years,
or with significant Braden risk factors; observing and correcting dehydration;
and observing patients with diabetes mellitus and cardiovascular and pulmonary diseases. In this
systematic review, the pooled incidence of pressure ulcers in the surgical ICU was 0.11 (95% CI 0.09
– 0.13, I
= 98.5%). Studies showed the risk factors for pressure ulcers were the same as other pro-cedures: elder age, diabetes,
and low Braden Scale score.
In addition to these 3 types of
surgery, orthopedic, neuro-, cardiothoracic, general, vascular, and ob-gyn surgery were included to
review the incidence of surgery-related pressure ulcers. The incidence of surgery-related pressure
ulcers with these procedures ranged from 0.032 to 0.548. Because only 1 study of each type of
surgery was included, the authors cannot conduct the meta-analysis. However, the authors found
the surgery that most frequently becomes complicated with pressure ulcers is vascular surgery. A
study that assessed the incidence of pressure ulcers after arthroscopic or combined arthroscopic
and open shoulder procedures was included. The incidence was 0.003 (95% CI 0.000 – 0.010).
Pressure ulcers occurred because of axillary roll position for the duration of a long operation. While
the incidence of pressure ulcers was low, this surgery can easily be complicated with pressure ul -cers.
First, the included studies were not all special surveys for the incidence of
surgery-related pressure ulcers, but clinical studies which reflected the inci -dence of surgery-related pressure ulcers.
This may have resulted in the imprecision of the pooled
data. Second, it was found that the I
of each meta-analysis was > 50%, which indicated substantial
heterogeneity. This may have resulted in some degree of measurement bias.
The findings suggest pressure ulcers are still one of the more common complications of these sur-gical procedures.
Appropriate monitoring and treatment for surgery-related pressure ulcers needs to
be performed in order to lower surgery-related pressure ulcer incidence. This pooled incidence data
may provide a benchmark to evaluate surgery-related pressure ulcers.
Running Head: SENSOR BASED MATTRESS
Sensor Based Mattress for preventing pressure ulceration
SENSOR BASED MATTRESS
Sensor based mattress for preventing pressure ulceration.
Cardiac surgeries take a lot of time with the patient immobile and have to depend on
others for any movement. The patient is under prolonged pressure, shear and friction forces
during surgeries. These are the major causes of cardiac pressure ulcers. Treatment of this
condition is by either of the following ways: administering antibiotics, dietary supplements,
debridement, electrical stimulation, foam dressing and surgery depending on the stage of the
ulcers. In order to lower cardiac pressure ulcers cases, preventive measures aiming at supporting
tissue tolerance for pressure and oxygen have been developed. Sensor based mattress is an
invention that senses and sends signals of changes in both the physical environment and the
patient. The development of sol-gels has made this invention successful as it is environmental
responsive to different stimuli.
The sensor system obtains information about the patient and determines if the ulcers are
developing, sending a signal to the signal conditioning and data transfer unit. Controller receives
a signal and makes necessary calculations then communicates with the central monitoring system
that is used to monitor signals from other signal conditioning and transfer units at different
locations. When pressure is applied on the pressure sensor, the sol-gels contract increasing the
density of the conducting particles and lowering the resistance of the sol-gel.
SENSOR BASED MATTRESS
The first sensor is a chlorine sol-gel sensor that determines presence or absence of
chlorine. The second sensor includes a pressure sol-gel and pressure liquid crystal sensor that
contracts when pressure is exerted to send a signal. The third and last sensor, temperature crystal
sensor, detects changes in a factor that causes bedsore and is an early stage of cardiac pressure
SENSOR BASED MATTRESS
Patents, (2007, march 15). Sensor based mattress /seat for monitoring pressure, temperature and
sweat concentration to prevent pressure ulcerations: Patents . Retrieved from http://
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