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SIGNpost 00674

*SAFE INJECTION GLOBAL NETWORK* SIGNPOST *

Post00674 Waste + Supply + Atlas + Abstracts + News 07 November 2012

CONTENTS
1. Health Care Without Harm Receives Grand Challenges Explorations Grant
For Groundbreaking Research in Global Health and Development
2. 2012 Global Health Supply Chain Summit: Registration Now Open
3. New! WHO AFRO: The Atlas of Health Statistics, 2012
4. Abstract: Mycobacterium massiliense outbreak after intramuscular
injection, South Korea
5. Abstract: Blood and Body Fluid Exposures in Health-Care Settings: Risk
Reduction Practices and Postexposure Prophylaxis for Health-Care Workers
6. Abstract: Prevalence of Occupational Accidents/Injuries among Health
Care Workers in a Federal Medical Centre in Southern Nigeria
7. Abstract: Seroprevalence of hepatitis C virus infection among surgical
nurses, their patients and blood donation candidates in Poland
8. Abstract: An investigation of bloodborne pathogen transmission due to
multipatient sharing of insulin pens
9. Abstract: Stochastic modelling of intra-household transmission of
hepatitis C virus: Evidence for substantial non-sexual infection
10. Abstract: Innovative financing for health: what is truly innovative?
11. Abstract: Strengthening Medical Product Regulation in Low- and Middle-
Income Countries
12. Abstract: Assessment of medical waste management at a primary health-
care center in São Paulo, Brazil
13. Abstract: Applications of life cycle assessment and cost analysis in
health care waste management
14. Abstract: Life cycle assessment perspectives on delivering an infant in
the US
15. Abstract: Prevalence of hepatitis C infection in HIV-seropositive
individuals in and around Belgaum, south India
16. Abstract: “The 3/3 Strategy”: A Successful Multifaceted Hospital Wide
Hand Hygiene Intervention Based on WHO and Continuous Quality
Improvement Methodology
17. Abstract: Modeling the transmission risk of emerging infectious
diseases through blood transfusion
18. Abstract: Peri-articular Steroid Injection in Total Knee Arthroplasty:
A Prospective, Double Blinded, Randomized Controlled Trial
19. Abstract: Evaluation of bactericidal effects of low-temperature
nitrogen gas plasma towards application to short-time sterilization
20. News
– USA: Maryland confirms first hepatitis C case linked to arrested med
tech Infection of Baltimore VA Medical patient ‘closely related’ to
others identified in probe
– USA: Meningitis patients struck by 2nd illness
– UK: Hospital porter cut by used needles lifts lid on scandal
– Study reveals dangerous levels of contamination on hospital keyboards
– No more needles! Scientists develop vaccine that melts under the tongue

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__________________________________________________________________
________________________________*_________________________________

1. Health Care Without Harm Receives Grand Challenges Explorations Grant
For Groundbreaking Research in Global Health and Development

Congratulations to our friends at HCWH! www.noharm.org/global/issues/waste/
__________________________________________________________________

http://www.noharm.org/global/news_hcwh/2012/nov/hcwh2012-11-01.php

Health Care Without Harm Receives Grand Challenges Explorations Grant For
Groundbreaking Research in Global Health and Development

Health Care Without Harm Press Release (01.11.12)

Health Care Without Harm announces today that it is a Grand Challenges
Explorations winner,
www.grandchallenges.org/Explorations/Pages/Introduction.aspx an initiative
funded by the Bill & Melinda Gates Foundation.
www.gatesfoundation.org/Pages/home.aspx

HCWH Science and Policy Coordinator, Ruth Stringer, will pursue an
innovative global health and development research project, titled
“Assessing environmental impacts of different small scale technologies for
the disinfection of immunization waste”

“We are thrilled to be working with the Gates Foundation on this important
initiative,” said HCWH President and Co-Founder Gary Cohen. “A recent study
found that health care waste has a negative impact on the health of about
half the world’s population. Figuring out how to safely manage immunization
waste is particularly tricky because immunization campaigns often take
place in isolated rural areas without much infrastructure.”

Grand Challenges Explorations (GCE) funds individuals worldwide who are
taking innovative approaches to some of the world’s toughest and persistent
global health and development challenges. GCE invests in the early stages
of bold ideas that have real potential to solve the problems people in the
developing world face every day. Ruth Stringer’s project is one of over 80
Grand Challenges Explorations Round 9 grants announced today by the Bill &
Melinda Gates Foundation.

“Investments in innovative global health research are already paying off,”
said Chris Wilson, director of Global Health Discovery and Translational
Sciences at the Bill & Melinda Gates Foundation. “We continue to be
impressed by the novelty and innovative spirit of Grand Challenges
Explorations projects and are enthusiastic about this exciting research.
These investments hold real potential to yield new solutions to improve the
health of millions of people in the developing world, and ensure that
everyone has the chance to live a healthy productive life.”

To receive funding, Ruth Stringer and other Grand Challenges Explorations
Round 9 winners demonstrated in a two-page online application a creative
idea in one of five critical global heath and development topic areas that
included agriculture development, immunization and communications.
Applications for the current open round, Grand Challenges Explorations
Round 10, will be accepted through November 7, 2012.

This project will focus on immunization waste in Nepal. The usual disposal
route for immunization waste there, and in many other countries, is open
burning or burial. This is not as simple as it seems: sparks from burning
can spread to grass roofs during the dry season; in the rainy season,
burning can be difficult and burial is hampered by the very high water
table, or simple lack of space. Burning also causes pollution, can harm
human health and destroy the materials that the syringes and packaging are
made of, a lot of which are recyclable.

Ruth Stringer and HCWH will be working with Health Care Foundation Nepal
(HECAF), and the World Health Organization, while basing the investigation
at Bir Hospital and the National Kidney Center, both of which have led the
way in environmentally friendly waste treatment in Nepal. Researchers will
gather and test different types of syringes used in immunization programs
to determine the recycling value of the materials they are made of, and
identifying the most economical way of disinfecting them using different
autoclave (steam sterilization) methods. Environmental and economic
benefits will be compared with the current practices. The project will
produce a decision making tool which will foster informed decisions about
the safest and most sustainable way to dispose of immunization waste.

About Grand Challenges Explorations

Grand Challenges Explorations is a US$100 million initiative funded by the
Bill & Melinda Gates Foundation. Launched in 2008, over 700 people in 45
countries have received Grand Challenges Explorations grants. The grant
program is open to anyone from any discipline and from any organization.
The initiative uses an agile, accelerated grant-making process with short
two-page online applications and no preliminary data required. Initial
grants of US$100,000 are awarded two times a year. Successful projects have
the opportunity to receive a follow-on grant of up to US$1 million.

http://www.noharm.org/global/issues/waste/
__________________________________________________________________
________________________________*_________________________________

2. 2012 Global Health Supply Chain Summit: Registration Now Open
__________________________________________________________________
2012 Global Health Supply Chain Summit: Registration Now Open

Registration is now open for the 2012 Global Health Supply Chain (GHSC)
Summit on November 14-16, 2012, in Kigali, Rwanda.

To register and access information about the event, please visit the Summit
website at http://www.ghsc-2012.com/ghsc_2012/homepart.php

The Summit will feature two days of educational sessions on three key
topics—understanding and managing risk in the supply chain, taking supply
chain innovations to scale, and benchmarking supply chain performance.

A third day will be dedicated to “open space technology” and discrete
meetings, including educational content and networking for members of the
International Association for Public Health Logisticians (IAPHL). This is
the first time the summit is held in Africa, and IAPHL – founded in part by
JSI – will be taking part as a sponsors and organizer.
5th Global Health Supply Chain Summit ghsc-2012.com
“Fostering interaction between implementers and academics to build
knowledge and learning – bringing supply chain challenges forward from the
field to the research agenda” The 5th Global Health Supply Chain Summit
(GHSCS) a…
__________________________________________________________________
________________________________*_________________________________

3. New! WHO AFRO: The Atlas of Health Statistics, 2012

Crossposted from WHO AFRO with thanks. http://tinyurl.com/bslpvur
__________________________________________________________________
http://tinyurl.com/bslpvur

The Atlas of Health Statistics, 2012

The Atlas of Health Statistics, 2012, which provides a health situation
analysis of WHO’s African Region, is the most significant data output of
the African Health Observatory (www.aho.afro.who.int). Now in its second
edition, the Atlas is building on the ground-breaking work that was carried
out in preparing the initial edition. Not only has it been updated for
2012, but its coverage has expanded and further indicators have been
included. Another new development is the presence of the Atlas on the
African Health Observatory web portal. It is being launched not merely as
an electronic document, but as interactive web pages within the
Observatory, allowing users to carry out searches and conduct analyses of
their own. We aim to develop the Atlas on an ongoing basis, expanding its
reach, indicators and accuracy as we go.

Of course all the data comes from the countries, and we are entirely
reliant on data collection, cleaning, correction, evaluation and assessment
carried out first of all at country level in each of the 46 Member
Countries of WHO’s African Region. These data are further reviewed and
refined in WHO, both in its African country offices and Regional Office,
and by technical experts at WHO headquarters in Geneva. Mortality estimates
that are used to monitor internationally agreed goals, such as the MDGs,
are produced by inter-agency groups consisting of members from WHO, UNICEF,
and World Bank among others. The results of this system of analysis is data
which is as good as can be extracted from the raw inputs.

Looking back to the raw inputs, however, it is clear that the quality,
quantity, frequency of collection, and timeliness of data depends very much
on the strength of the national health information systems, which include
data collection at the district and peripheral levels. With some notable
exceptions, this has been an area of weakness within most national health
systems. By and large, the development of national health information
systems has been slow and uneven, despite many efforts over the years.

WHO seeks to support countries in strengthening their national health
information systems, and one mechanism that is being developed in response
to demands from the countries is the establishment of a network of national
health observatories. With support from WHO’s Regional Office for Africa, a
number of countries have taken steps to set up such observatories, often
with direct links to the district level, as a way to reinforce the national
health information system. The national observatories also link to the
African Health Observatory, in a collaborative, two-way system of
information, evidence and knowledge exchange. Such observatories serve at
both the regional and national levels as platforms for other activities
designed to foster monitoring and evaluation, which are essential
components of the cycle of development and policy work that lead to
national health policies and health development plans.

Thus, the collaborative networking approach embraced by the African Health
Observatory and the national observatories is intended to provide a
continuum between work at the regional and national levels, offering a
platform for many disparate supporting mechanisms and methodologies. This
should lead to a marked decrease of the fragmentation of efforts so
frequently found in public health policy and development work. The Atlas is
a product and promoter of such collaborative networking.

Download PDF (4.9 MB) http://tinyurl.com/dyvtbf9
__________________________________________________________________
________________________________*_________________________________

4. Abstract: Mycobacterium massiliense outbreak after intramuscular
injection, South Korea
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/22217328

Epidemiol Infect. 2012 Oct;140(10):1880-7.

Mycobacterium massiliense outbreak after intramuscular injection, South
Korea.

Kim HJ, Cho Y, Lee S, Kook Y, Lee D, Lee J, Park BJ.

Department of Preventive Medicine, Seoul National University College of
Medicine, Seoul, Republic of Korea.

We conducted an epidemic investigation to discover the route of
transmission and the host factors of an outbreak of post-injection
abscesses. Of the 2984 patients who visited a single clinic, 77 cases were
identified and 208 age- and sex-matched controls were selected for
analysis.

Injected medications per se were not found to be responsible, and a
deviation from safe injection practice suggested the likelihood of diluent
contamination.

Therefore the injected medications were classified according to whether
there was a need for a diluent, and two medications showed a statistically
significant association, i.e. injection with pheniramine [adjusted odds
ratios (aOR) 5·93, 95% confidence interval (CI) 2·97-11·87] and
ribostamycin (aOR 47·95, 95% CI 11·08-207·53).

However, when considered concurrently, pheniramine lost statistical
significance (aOR 8·71, 95% CI 0·44-171·61) suggesting that normal saline
was the causative agent of this outbreak.

Epidemiological evidence strongly suggested that this post-injection
outbreak was caused by saline contaminated with Mycobacterium massiliense
without direct microbiological evidence.
__________________________________________________________________
________________________________*_________________________________

5. Abstract: Blood and Body Fluid Exposures in Health-Care Settings: Risk
Reduction Practices and Postexposure Prophylaxis for Health-Care Workers
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23104585

Curr Infect Dis Rep. 2012 Oct 27.

Blood and Body Fluid Exposures in Health-Care Settings: Risk Reduction
Practices and Postexposure Prophylaxis for Health-Care Workers.

Narin I, Gedik H, Voss A.

Department of Clinical Microbiology, Infectious Diseases and Infection
Control, Canisius-Wilhelmina Hospital, Nijmegen, The Netherlands.

This review of last year’s literature on blood-borne pathogens (=
pathogenic microorganisms that are found in human blood) focuses on
hepatitis B (HBV), hepatitis C (HCV), and human immunodeficiency virus
(HIV) as the most common pathogens, despite the fact that other
microorganisms may cause blood-borne diseases as well.

Since the prevention of blood-borne diseases is something that, in the
past, has gotten a lot of attention and by now is fully integrated in all
safety structures in the U.S., the recent literatures mainly have been come
from resource-limited/developing countries and Europe (which, in the
definition of the financial word at the present time, in some parts
overlap).
__________________________________________________________________
________________________________*_________________________________

6. Abstract: Prevalence of Occupational Accidents/Injuries among Health
Care Workers in a Federal Medical Centre in Southern Nigeria
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23115096

West Afr J Med. 2012 Jan-Feb;31(1):47-51.

Prevalence of Occupational Accidents/Injuries among Health Care Workers in
a Federal Medical Centre in Southern Nigeria.

Isara AR, Ofili AN.

Department of Community Health, School of Medicine, University of Benin, P.
M. B. 1154, Benin City, Nigeria.

BACKGROUND: Health care workers (HCWs) are prone to occupational accidents
and injuries such as needle pricks in the course of their day to day
activities in the health care setting.

OBJECTIVE: To determine the prevalence of needle sticks and other
occupational exposures among HCWs in a Nigerian tertiary hospital.

METHODS: This was a descriptive cross sectional design involving all the
doctors, and all laboratory workers and a selection of nurses. A
structured, pre-tested, selfadministered questionnaire was the tool for
data collection.

RESULTS: A total of 167 HCWs made up of 47 (28.1%) doctors, 100 (59.9%)
nurses and 20 (12.0%) laboratory workers were interviewed. Twenty-five
(53.2%) doctors, 53 (53.0%) nurses and 10 (50.0%) laboratory workers making
a total of 88 (52.7%) HCWs had had needle pricks, while 28 (59.6%) doctors,
53 (53.0%) nurses and 8 (40.0%) laboratory workers making a total of 89
(53.3%) have had blood splashes. A higher proportion of nurses 54 (54.0%)
had cuts from drug ampoules than doctors (34.0%) while 16 (36.2%) doctors
had glove perforation during surgery compared to nine (9.0%) nurses. Only
43 (25.7%) HCWs reported to the staff clinic after sustaining
accidents/injuries.

CONCLUSION: The prevalence of needle sticks and other occupational
accidents/injuries among HCWs in the Federal Medical Centre, Asaba, Nigeria
is high. There is also a high rate of non-reporting of these injuries to
relevant authorities. All health facilities should have a written injection
safety policy and a post-exposure protocol and HCWs should be continually
educated on them.
__________________________________________________________________
________________________________*_________________________________

7. Abstract: Seroprevalence of hepatitis C virus infection among surgical
nurses, their patients and blood donation candidates in Poland
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23110996

J Hosp Infect. 2012 Oct 27. pii: S0195-6701(12)00325-8.

Seroprevalence of hepatitis C virus infection among surgical nurses, their
patients and blood donation candidates in Poland.

Ganczak M, Korzen M, Szych Z.

Department of Public Health, Pomeranian Medical University, Szczecin,
Poland. Electronic address: ganczak2@wp.pl.

OBJECTIVES: To assess the prevalence of anti-hepatitis C virus (HCV) in
surgical nurses and midwives, to compare the rate with other female groups
(their patients from the same hospitals and blood donation candidates) in a
cross-sectional serosurvey, and to evaluate the alleged risk factors for
acquiring an occupational infection.

METHODS: Between February 2008 and June 2009, participants from 16
hospitals selected at random in West Pomerania, Poland completed a written
questionnaire detailing potential risk factors for HCV infection. Serum
samples were assayed for anti-HCV using third-generation testing methods.

RESULTS: Of 414 staff members, six were found to be anti-HCV positive
[1.4%, 95% confidence interval (CI) 0.7-3.1%]. The seropositive status of
staff was discovered during this one-off screening. A logistic regression
model indicated that for anti-HCV seropositivity, only the length of
employment was associated with increased odds of being infected [odds ratio
(OR) 2.8; P < 0.006]. The prevalence of anti-HCV was 1.1% (12/1118, 95% CI
0.6-1.9%) in 1118 female patients, and 0% (0/801, 95% CI 0-1.1%) in 801
female blood donation candidates. A significant staff/patient difference in
anti-HCV prevalence was observed among those aged >50 years (6.9% vs 1.0%;
P < 0.007). For this age group, being a nurse was associated with higher
odds (OR 8.8; P < 0.005) of being infected with HCV.

CONCLUSIONS: Comparison of HCV prevalence rates pointed to a decreasing
trend in the order: surgical nurses/midwives, patients and blood donation
candidates; this may indicate occupational risk. The greatest risk factor
for contracting HCV infection was length of employment, suggesting a
possible effect of accumulated exposure to contaminated blood and other
body fluids. There is a need for better recognition of HCV infection as a
consequence of prolonged blood exposure among surgical and gynaecological
staff.

Copyright © 2012 The Healthcare Infection Society. Published by Elsevier
Ltd. All rights reserved.
__________________________________________________________________
________________________________*_________________________________

8. Abstract: An investigation of bloodborne pathogen transmission due to
multipatient sharing of insulin pens
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/22934373

Mil Med. 2012 Aug;177(8):930-8.

An investigation of bloodborne pathogen transmission due to multipatient
sharing of insulin pens.

Hakre S, Upshaw-Combs DR, Sanders-Buell EE, Scoville SL, Kuper JD,
Jagodzinski LL, Bradfield AN, Davison DC, Callis WG, Owens AB, Michael NL,
O’Connell RJ, Peel SA, Gardner JW, Thompson ND, Hu DJ, Kim JH, Tovanabutra
S, Scott PT, LaFon SG; Insulin Pen Investigation Team.

Epidemiology and Threat Assessment, U.S. Military HIV Research Program,
Henry M. Jackson Foundation for the Advancement of Military Medicine, 6720-
A Rockledge Drive, Suite 400, Bethesda, MD 20817, USA.

On January 30, 2009, nursing staff at a military hospital in Texas reported
that single-patient use insulin pens were used on multiple patients. An
investigation was initiated to determine if patient-to-patient bloodbome
transmission occurred from the practice.

Human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis
C virus (HCV) testing was offered to patients hospitalized from August 2007
to January 2009 and prescribed insulin pen injections.

Virus from HCV-infected patients’ sera was sequenced and compared for
relatedness.

An anonymous survey was administered to nurses. Of 2,113 patients
prescribed insulin pen injections, 1,501 (71%) underwent testing; 6 (0.4%)
were HIV positive, 6 (0.4%) were hepatitis B surface antigen positive, and
56 (3.7%) had HCV antibody. No viral sequences from 10 of 28 patients with
newly diagnosed and 12 of 28 patients with preexisting HCV infection were
closely related.

Of 54 nurses surveyed, 74% reported being trained on insulin pen use, but
24% believed nurses used insulin pens on more than one patient. We found no
clear evidence of bloodborne pathogen transmission.

Training of hospital staff on correct use of insulin pens should be
prioritized and their practices evaluated. Insulin pens should be more
clearly labeled for single-patient use.
__________________________________________________________________
________________________________*_________________________________

9. Abstract: Stochastic modelling of intra-household transmission of
hepatitis C virus: Evidence for substantial non-sexual infection
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23103288

J Infect. 2012 Oct 26. pii: S0163-4453(12)00306-4.

Stochastic modelling of intra-household transmission of hepatitis C virus:
Evidence for substantial non-sexual infection.

Akhtar S, Carpenter TE.

Department of Community Medicine and Behavioural Sciences, Faculty of
Medicine, Kuwait University, Jabriya 90805, Kuwait. Electronic address:
saeed.akhtar@hsc.edu.kw.

OBJECTIVE: To simulate the probability of HCV transmission from HCV a
seropositive index patient to susceptible household contacts through non-
sexual exposures.

METHODS: A modified Reed-Frost stochastic simulation model was used to
assess the probability of HCV transmission from an HCV seropositive index
patient to susceptible household contacts through non-sexual exposures.
This mathematical model used does not require the specification of
infection onset times for individual, nor is it necessary to identify the
chains of household infections. Therefore, this model can be used with
serologic data on detected asymptomatic infections. The HCV serological
data on 341 non- sexual household contacts of 86 HCV seropositive index
patients were used in this simulation study. The frequency distribution of
HCV infection of susceptibles for each household size of 4-8 initial
susceptibles was calculated. A maximum likelihood procedure was used to
estimate the non- sexual household transmission parameter for HCV infection
for the range of household sizes studied and was used in 1000 stochastic
iterations. The goodness-of-fit test was carried out to compare the
observed number of households where HCV transmission occurred to one or
more initial susceptible with mean expected simulated number of such
households with varying sizes ranging from 4 to 8 initial susceptibles.

RESULTS: The maximum likelihood estimates (90% probability interval (PI))
of binomial probability of HCV transmission within households with varying
number of initial susceptible non-sexual household contacts ranged from
0.248 (90%PI: 0.031, 0.560) to 0.164 (90%PI: 0.011, 0.440) for household
size of 4 and 8 respectively. The ?(2) goodness-of-fit test of observed and
mean expected simulated proportions of households wherein at least one of
the susceptibles was infected revealed good fit for households of all sizes
examined (P = 0.96). In a household, the probability of HCV transmission
from the index HCV seropositive patient to susceptible via non-sexual
contacts tended to decrease linearly as the household size increased from
four to seven.

CONCLUSION: Intra-household HCV transmission through non-sexual contacts
may have substantial impact on HCV transmission and needs to be considered
in an HCV control program.

Copyright © 2012. Published by Elsevier Ltd.
__________________________________________________________________
________________________________*_________________________________

10. Abstract: Innovative financing for health: what is truly innovative?
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23102585

Lancet. 2012 Oct 23. pii: S0140-6736(12)61460-3.

Innovative financing for health: what is truly innovative?

Atun R, Knaul FM, Akachi Y, Frenk J.

The Business School and Faculty of Medicine, Imperial College London,
London, UK. Electronic address: r.atun@imperial.ac.uk.

Development assistance for health has increased every year between 2000 and
2010, particularly for HIV/AIDS, tuberculosis, and malaria, to reach
US$26·66 billion in 2010.

The continued global economic crisis means that increased external
financing from traditional donors is unlikely in the near term. Hence, new
funding has to be sought from innovative financing sources to sustain the
gains made in global health, to achieve the health Millennium Development
Goals, and to address the emerging burden from non- communicable diseases.

We use the value chain approach to conceptualise innovative financing. With
this framework, we identify three integrated innovative financing
mechanisms-GAVI, Global Fund, and UNITAID-that have reached a global scale.
These three financing mechanisms have innovated along each step of the
innovative finance value chain-namely resource mobilisation, pooling,
channelling, resource allocation, and implementation-and integrated these
steps to channel large amounts of funding rapidly to low-income and middle-
income countries to address HIV/AIDS, malaria, tuberculosis, and vaccine-
preventable diseases.

However, resources mobilised from international innovative financing
sources are relatively modest compared with donor assistance from
traditional sources. Instead, the real innovation has been establishment of
new organisational forms as integrated financing mechanisms that link
elements of the financing value chain to more effectively and efficiently
mobilise, pool, allocate, and channel financial resources to low-income and
middle-income countries and to create incentives to improve implementation
and performance of national programmes.

These mechanisms provide platforms for health funding in the future,
especially as efforts to grow innovative financing have faltered. The
lessons learnt from these mechanisms can be used to develop and expand
innovative financing from international sources to address health needs in
low-income and middle-income countries.

Copyright © 2012 Elsevier Ltd. All rights reserved.
__________________________________________________________________
________________________________*_________________________________

11. Abstract: Strengthening Medical Product Regulation in Low- and Middle-
Income Countries
__________________________________________________________________
www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001327

PLoS Med 9(10): e1001327

Strengthening Medical Product Regulation in Low- and Middle-Income
Countries

Charles Preston*, Mary Lou Valdez, Katherine Bond
* E-mail: charles.preston@fda.hhs.gov

Office of International Programs, US Food and Drug Administration (FDA),
Silver Spring, Maryland, United States of America

Summary Points

Few global initiatives focus on strengthening low- and middle-income
country medical product regulatory systems.

However, globalization and the scaling up of medicines and vaccines to the
developing world are highlighting the urgent need for systems to assure
product efficacy, safety, and quality.

This article explores case studies in regulatory domains such as global
product supply chains, clinical trials, premarket approval, post-market
surveillance, and regulatory science to demonstrate the essential value of
medical product regulatory systems to low- and middle-income countries.
Here, a viable path is put forward for making this important topic a global
health priority.

Introduction Medical product regulatory systems are central to health
systems; they ensure high quality and safe interventions like drugs,
vaccines, and medical devices for patients who need and count on them. The
World Health Organization (WHO) recognizes this fact and includes
regulatory system functions as one of the six core building blocks of
health systems: access to medical products, vaccines, and technologies of
assured quality, safety, and efficacy [1].

Although WHO has recognized their importance, to date, little attention has
been focused on regulatory systems in low- and middle-income countries.
They have not featured prominently in global health and development
assistance programs, and few strategic documents of major global health
initiatives, including the United States Global Health Initiative,
reference regulatory systems [2].

The global activities that do involve regulatory systems typically involve
high-income countries. For example, the International Conference on
Harmonization of Technical Requirements for Registration of Pharmaceuticals
for Human Use (ICH), which harmonizes regulatory standards and processes
for the pharmaceutical industry, includes regulatory authorities from the
European Union, Japan, and the United States [3]. The membership of the
International Medical Device Regulators Forum is similarly comprised,
including Australia, Canada, the European Union, Japan, and the United
States. Brazil is the only low- or middle-income country that is a member
[4].

The lack of attention to medical product regulatory systems in low- and
middle-income countries is a significant gap that needs to be bridged.

Proposal We propose that strengthening regulatory systems in low- and
middle-income countries must become a global health priority, and explain
the imperative in terms of globalization and the rapid scale up of
medicines to the developing world. Here, we explore case studies from key
regulatory domains, for example, product supply chains, clinical trials,
pre-market approval, post-market surveillance, and regulatory science to
show the multiple ways that strengthening these systems can contribute to
global health.

Open Access article at:
www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001327

This is an open-access article, free of all copyright, and may be freely
reproduced, distributed, transmitted, modified, built upon, or otherwise
used by anyone for any lawful purpose. The work is made available under the
Creative Commons CC0 public domain dedication.

Funding: No specific funding was received for writing this article. The
authors are employees of the United States Food and Drug Administration.

Competing interests: The authors have declared that no competing interests
exist.

Provenance: Not commissioned; externally peer reviewed.
__________________________________________________________________
________________________________*_________________________________

12. Abstract: Assessment of medical waste management at a primary health-
care center in São Paulo, Brazil
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23122204

Waste Manag. 2012 Oct 30. pii: S0956-053X(12)00457-6.

Assessment of medical waste management at a primary health-care center in
São Paulo, Brazil.

Moreira AM, Günther WM.

Department of Environmental Health, School of Public Health, University of
São Paulo, Avenida Doutor Arnaldo 715, São Paulo 01246-904, Brazil.
Electronic address: anamariainforme@hotmail.com.

According to the Brazilian law, implementation of a Medical Waste
Management Plan (MWMP) in health-care units is mandatory, but as far as we
know evaluation of such implementation has not taken place yet.

The purpose of the present study is to evaluate the improvements deriving
from the implementation of a MWMP in a Primary Health-care Center (PHC)
located in the city of São Paulo, Brazil.

The method proposed for evaluation compares the first situation prevailing
at this PHC with the situation 1year after implementation of the MWMP, thus
allowing verification of the evolution of the PHC performance. For prior
and post-diagnosis, the method was based on: (1) application of a tool
(check list) which considered all legal requirements in force; (2)
quantification of solid waste subdivided into three categories: infectious
waste and sharp devices, recyclable materials and non-recyclable waste; and
(3) identification of non-conformity practices. Lack of knowledge on the
pertinent legislation by health workers has contributed to non-conformity
instances.

The legal requirements in force in Brazil today gave origin to a tool
(check list) which was utilized in the management of medical waste at the
health-care unit studied. This tool resulted into an adequate and simple
instrument, required a low investment, allowed collecting data to feed
indicators and also conquered the participation of the unit whole staff.
Several non-conformities identified in the first diagnosis could be
corrected by the instrument utilized.

Total waste generation increased 9.8%, but it was possible to reduce the
volume of non-recyclable materials (11%) and increase the volume of
recyclable materials (4%). It was also possible to segregate organic waste
(7%), which was forwarded for production of compost. The rate of infectious
waste generation in critical areas decreased from 0.021 to
0.018kg/procedure.

Many improvements have been observed, and now the PHC complies with most of
legal requirements, offers periodic training and better biosafety
conditions to workers, has reduced the volume of waste sent to sanitary
landfills, and has introduced indicators for monitoring its own
performance.

This evaluation method might subsidize the creation and evaluation of
medical waste management plans in similar heath institutions.

Copyright © 2012. Published by Elsevier Ltd.

http://www.ncbi.nlm.nih.gov/pubmed/23122204
__________________________________________________________________
________________________________*_________________________________

13. Abstract: Applications of life cycle assessment and cost analysis in
health care waste management
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23122202

Waste Manag. 2012 Oct 30. pii: S0956-053X(12)00460-6.

Applications of life cycle assessment and cost analysis in health care
waste management.

Soares SR, Finotti AR, Prudêncio da Silva V, Alvarenga RA.

Department of Sanitary Engineering, Federal University of Santa Catarina,
UFSC, Campus Universitário, Centro Tecnológico, Trindade, PO Box 476,
Florianópolis, SC 88040-970, Brazil.
Electronic address: soares@ens.ufsc.br.

The establishment of rules to manage Health Care Waste (HCW) is a challenge
for the public sector. Regulatory agencies must ensure the safety of waste
management alternatives for two very different profiles of generators: (1)
hospitals, which concentrate the production of HCW and (2) small
establishments, such as clinics, pharmacies and other sources, that
generate dispersed quantities of HCW and are scattered throughout the city.

To assist in developing sector regulations for the small generators, we
evaluated three management scenarios using decision-making tools. They
consisted of a disinfection technique (microwave, autoclave and lime)
followed by landfilling, where transportation was also included. The
microwave, autoclave and lime techniques were tested at the laboratory to
establish the operating parameters to ensure their efficiency in
disinfection.

Using a life cycle assessment (LCA) and cost analysis, the decision-making
tools aimed to determine the technique with the best environmental
performance. This consisted of evaluating the eco-efficiency of each
scenario. Based on the life cycle assessment, microwaving had the lowest
environmental impact (12.64Pt) followed by autoclaving (48.46Pt). The cost
analyses indicated values of US$0.12kg(-1) for the waste treated with
microwaves, US$1.10kg(-1) for the waste treated by the autoclave and
US$1.53kg(-1) for the waste treated with lime.

The microwave disinfection presented the best eco-efficiency performance
among those studied and provided a feasible alternative to subsidize the
formulation of the policy for small generators of HCW.

Copyright © 2012 Elsevier Ltd. All rights reserved.
__________________________________________________________________
________________________________*_________________________________

14. Abstract: Life cycle assessment perspectives on delivering an infant in
the US
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/22482785

Sci Total Environ. 2012 May 15;425:191-8.

Life cycle assessment perspectives on delivering an infant in the US.

Campion N, Thiel CL, DeBlois J, Woods NC, Landis AE, Bilec MM.

University of Pittsburgh, 949 Benedum Hall, Pittsburgh, PA 15261, USA.

This study introduces life cycle assessment as a tool to analyze one aspect
of sustainability in healthcare: the birth of a baby.

The process life cycle assessment case study presented evaluates two common
procedures in a hospital, a cesarean section and a vaginal birth. This case
study was conducted at Magee-Womens Hospital of the University of
Pittsburgh Medical Center, which delivers over 10,000 infants per year.

The results show that heating, ventilation, and air conditioning (HVAC),
waste disposal, and the production of the disposable custom packs comprise
a large percentage of the environmental impacts.

Applying the life cycle assessment tool to medical procedures allows
hospital decision makers to target and guide efforts to reduce the
environmental impacts of healthcare procedures.

Copyright © 2012 Elsevier B.V. All rights reserved.
__________________________________________________________________
________________________________*_________________________________

15. Abstract: Prevalence of hepatitis C infection in HIV-seropositive
individuals in and around Belgaum, south India
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23104759

Int J STD AIDS. 2012 Oct;23(10):e14-5.

Prevalence of hepatitis C infection in HIV-seropositive individuals in and
around Belgaum, south India.

Nagmoti MB, Patil CS, Jyoti MN, Mutnal MB, Mallapur MD.

Department of Microbiology, JN Medical College, Nehru Nagar, Belgaum,
Karnataka, India.

India has high prevalence of HIV infection. As HIV and HCV share common
routes of transmission, there is every chance of an HIV-infected patient
also having HCV infection.

We investigated the prevalence of HCV infection in HIV seropositive
individuals attending a tertiary care hospital at Belgaum, south India.

A total of 16,124 serum samples from suspected patients were screened for
the presence of HIV antibodies and those who tested positive for HIV were
screened for HCV antibodies by using enzyme- linked immunosorbent assay
(ELISA).

A total of 24 (3.52%) patients were found to be co-infected with HIV and
HCV. Among them, 16 (66.66%) were male and 8 (33.33%) were female.

This study has revealed a relatively high prevalence of HIV/ HCV co-
infection in and around Belgaum which suggests preventive and control
measures should be taken against the spread of such infection in this part
of India.
__________________________________________________________________
________________________________*_________________________________

16. Abstract: “The 3/3 Strategy”: A Successful Multifaceted Hospital Wide
Hand Hygiene Intervention Based on WHO and Continuous Quality
Improvement Methodology
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23110061

PLoS One. 2012;7(10):e47200. doi: 10.1371/journal.pone.0047200. Epub 2012
Oct 22.

“The 3/3 Strategy”: A Successful Multifaceted Hospital Wide Hand Hygiene
Intervention Based on WHO and Continuous Quality Improvement Methodology.

Mestre G, Berbel C, Tortajada P, Alarcia M, Coca R, Gallemi G, Garcia I,
Fernández MM, Aguilar MC, Martínez JA, Rodríguez-Baño J.

Nosocomial Infection Control Unit, Delfos Medical Center, Barcelona,
Catalonia, Spain.

BACKGROUND: Only multifaceted hospital wide interventions have been
successful in achieving sustained improvements in hand hygiene (HH)
compliance.

METHODOLOGY/PRINCIPAL FINDINGS: Pre-post intervention study of HH
performance at baseline (October 2007- December 2009) and during
intervention, which included two phases. Phase 1 (2010) included multimodal
WHO approach. Phase 2 (2011) added Continuous Quality Improvement (CQI)
tools and was based on: a) Increase of alcohol hand rub (AHR) solution
placement (from 0.57 dispensers/bed to 1.56); b) Increase in frequency of
audits (three days every three weeks: “3/3 strategy”); c) Implementation of
a standardized register form of HH corrective actions; d) Statistical
Process Control (SPC) as time series analysis methodology through
appropriate control charts.

During the intervention period we performed 819 scheduled direct
observation audits which provided data from 11,714 HH opportunities. The
most remarkable findings were: a) significant improvements in HH compliance
with respect to baseline (25% mean increase); b) sustained high level (82%)
of HH compliance during intervention; c) significant increase in AHRs
consumption over time; c) significant decrease in the rate of healthcare-
acquired MRSA; d) small but significant improvements in HH compliance when
comparing phase 2 to phase 1 [79.5% (95% CI: 78.2-80.7) vs 84.6% (95%
CI:83.8-85.4), p<0.05]; e) successful use of control charts to identify
significant negative and positive deviations (special causes) related to
the HH compliance process over time (“positive”: 90.1% as highest HH
compliance coinciding with the “World hygiene day”; and “negative”:73.7% as
lowest HH compliance coinciding with a statutory lay-off proceeding).

CONCLUSIONS/SIGNIFICANCE: CQI tools may be a key addition to WHO strategy
to maintain a good HH performance over time. In addition, SPC has shown to
be a powerful methodology to detect special causes in HH performance
(positive and negative) and to help establishing adequate feedback to
healthcare workers.

Free PMC Article http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3478274/
__________________________________________________________________
________________________________*_________________________________

17. Abstract: Modeling the transmission risk of emerging infectious
diseases through blood transfusion
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23113823

Transfusion. 2012 Nov 1.

Modeling the transmission risk of emerging infectious diseases through
blood transfusion.

Oei W, Janssen MP, van der Poel CL, van Steenbergen JE, Rehmet S,
Kretzschmar ME.

Julius Center for Health Science and Primary Care, University Medical
Center Utrecht, Utrecht, the Netherlands; National Institute for Public
Health and the Environment (RIVM), Bilthoven, the Netherlands; European
Centre for Disease Prevention and Control, Stockholm, Sweden.

BACKGROUND: A timely risk assessment is desired to guide decisions on
preventive transfusion safety measures during emerging infectious disease
(EID) outbreaks. The European Up-Front Risk Assessment Tool (EUFRAT) model
was developed to provide quantitative transmission risk estimates of EIDs
through blood transfusion.

STUDY DESIGN AND METHODS: The generic model comprises five sequential steps
to estimate the infection risks in the blood transfusion chain: 1) the
prevalence of infection in the donor population, 2) the risk of obtaining
infected donations, 3) infected components, 4) infected blood products, and
5) the risk of transmitting the infection to recipients. The model uses
inputs from epidemiologic characteristics of an EID and transfusion
practice. The model was applied to data from a recent chikungunya outbreak
in Italy.

RESULTS: Based on data from the outbreak peak, an estimated prevalence of
1.07 (95% confidence interval [CI], 0.38-2.03) per 100,000 donors would
lead to 0.04 infected donations (95% CI, 0.01-0.10), 0.13 infected blood
components, 0.13 infected end products, and 0.0001 severe infections in
recipients. This estimated risk can be reduced by increasing the duration
of quarantine of the donated blood and becomes zero after 7 or more days of
quarantine. The model also estimated the probability of a donor returning
from the outbreak area and subsequently donating infected blood in his home
country to be 0.30 (95% CI, 0.01-0.65) per 100,000.

CONCLUSION: The model can be used to quantify EID outbreak risks to blood
transfusion recipients and the effect of targeted safety interventions and
as such support public health decision-making.

© 2012 American Association of Blood Banks.
__________________________________________________________________
________________________________*_________________________________

18. Abstract: Peri-articular Steroid Injection in Total Knee Arthroplasty:
A Prospective, Double Blinded, Randomized Controlled Trial
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/23107810

J Arthroplasty. 2012 Oct 26. pii: S0883-5403(12)00562-1.

Peri-articular Steroid Injection in Total Knee Arthroplasty: A Prospective,
Double Blinded, Randomized Controlled Trial.

Chia SK, Wernecke GC, Harris IA, Bohm MT, Chen DB, Macdessi SJ.

Edgecliff NSW, Australia.

Total knee arthroplasty is a painful operation. Peri-articular local
anesthetic injections reduce post-operative pain and assist recovery. It is
inconclusive whether intra-operative injections of peri-articular
corticosteroids are of benefit. Therefore our clinical question was: in
patients with osteoarthritis who are undergoing TKA, does the addition of
high or low dose corticosteroid to peri-articular injections of local
anesthetic and adrenaline improve post-operative pain and range of motion?

We performed a prospective, double-blinded, randomized controlled trial of
two different doses of triamcinolone acetate (N = 42 in each group) added
to local anesthetic in TKA for osteoarthritis.

There were no significant differences in pain scores or ROM between the
control and corticosteroid groups. Differences in secondary outcomes were
also non-significant.

Peri-articular corticosteroids do not appear to be of benefit in TKA.

Copyright © 2012 Elsevier Inc. All rights reserved.
__________________________________________________________________
________________________________*_________________________________

19. Abstract: Evaluation of bactericidal effects of low-temperature
nitrogen gas plasma towards application to short-time sterilization
__________________________________________________________________
http://www.ncbi.nlm.nih.gov/pubmed/22469251

Microbiol Immunol. 2012 Jul;56(7):431-40.

Evaluation of bactericidal effects of low-temperature nitrogen gas plasma
towards application to short-time sterilization.

Kawamura K, Sakuma A, Nakamura Y, Oguri T, Sato N, Kido N.

Department of Medical Technology, Nagoya University School of Health
Sciences, Nagoya, Aichi 461-8673, Japan.

To develop a novel low-temperature plasma sterilizer using pure N(2) gas as
a plasma source, we evaluated bactericidal ability of a prototype apparatus
provided by NGK Insulators.

After determination of the sterilizing conditions without the cold spots,
the D value of the BI of Geobacillus stearothermophilus endospores on the
filter paper was determined as 1.9 min. However, the inactivation
efficiency of BI carrying the same endospores on SUS varied to some extent,
suggesting that the bactericidal effect might vary by materials of
sterilized instruments. Staphylococcus aureus and Escherichia coli were
also exposed to the N(2) gas plasma and confirmed to be inactivated within
30 min.

Through the evaluation of bactericidal efficiency in a sterilization bag,
we concluded that the UV photons in the plasma and the high-voltage pulse
to generate the gas plasma were not concerned with the bactericidal effect
of the N(2) gas plasma. Bactericidal effect might be exhibited by activated
nitrogen atoms or molecular radicals.

© 2012 The Societies and Blackwell Publishing Asia Pty Ltd.
__________________________________________________________________
________________________________*_________________________________

20. News

– USA: Maryland confirms first hepatitis C case linked to arrested med
tech Infection of Baltimore VA Medical patient ‘closely related’ to
others identified in probe
– USA: Meningitis patients struck by 2nd illness
– UK: Hospital porter cut by used needles lifts lid on scandal
– Study reveals dangerous levels of contamination on hospital keyboards
– No more needles! Scientists develop vaccine that melts under the tongue

Selected news items reprinted under the fair use doctrine of international
copyright law: http://www4.law.cornell.edu/uscode/17/107.html
__________________________________________________________________
USA: Maryland confirms first hepatitis C case linked to arrested med tech
Infection of Baltimore VA Medical patient ‘closely related’ to others
identified in probe
By Kevin Rector, The Baltimore Sun, Maryland USA (05.11.12)

Health officials in Maryland confirmed Monday the state’s first hepatitis C
case directly linked to traveling medical technician David Kwiatkowski,
whose arrest by federal law enforcement officials in July in connection
with a hepatitis C outbreak in New Hampshire sparked a nationwide probe of
patients he had contact with.

The Department of Health and Mental Hygiene said molecular testing
conducted at the Centers for Disease Control on a blood specimen from a
Baltimore VA Medical Center patient indicates the patient’s infection is
“closely related” to other infections linked to Kwiatkowski. (There have
been 31 at Exeter Hospital in New Hampshire.)

“This case is associated with the multi-state hepatitis C outbreak,” the
health department said in a news release.

The blood-borne viral infection can cause liver damage or failure, and lead
to chronic health problems.

According to an affidavit filed in federal court by FBI Special Agent
Marcie DiFede, Kwiatkowski has hepatitis C and routinely injected himself
with drugs meant for patients during surgeries by swapping prepared
syringes with similar ones he’d used before. Unknowing colleagues then used
the swapped syringes on patients, the affidavit alleges.

Last week, attorneys for Linwood Nelson, a Vietnam War veteran from
Baltimore, filed notice with the U.S. Department of Veterans Affairs their
intention to file a claim for damages, claiming Nelson was infected with
hepatitis C at the Baltimore VA Medical Center.

A health department spokeswoman said late Monday she could not confirm
whether the case identified at Baltimore VA Medical Center and confirmed to
be linked to Kwiatkowski by CDC testing was that of Nelson.

After the case broke in New Hampshire, four hospitals in Maryland
identified and began testing more than 1,700 patients who they believe came
in contact with Kwiatkowski.

Kwiatkowski worked at Baltimore VA Medical Center from May to November
2008, Southern Maryland Hospital between December 2008 and February 2009,
Johns Hopkins Hospital between July 2009 and January 2010, and Maryland
General Hospital from January to March 2010.

State health officials on Monday said although no reports of Kwiatkowski
diverting drugs have been made in Maryland, the CDC’s findings suggest he
may have done so in the state.

Investigations are ongoing at all four hospitals in the state and more
testing is expected, the health department said.

The department is also conducting a sweeping review of regulations for
traveling medical technicians and other personnel in the state.
__________________________________________________________________
__________________________________________________________________
USA: Meningitis patients struck by 2nd illness
UPI.com USA (03.11.12)

FRAMINGHAM, Mass., Nov. 3 (UPI) — People recovering from a meningitis
outbreak caused by a contaminated steroid drug have been struck by a second
illness, officials say.

The new problem, called an epidural abscess, was caused by the same
steroid, methylprednisolone acetate, which was injected into patients to
treat back or neck pain, The New York Times reported Friday.

Epidural abscesses are a localized infection affect the membranes covering
the brain and spinal cord. They formed in patients who were taking powerful
anti-fungal medicines to fight meningitis, putting them back in the
hospital for more treatment, often with surgery.

“We’re hearing about it in Michigan and other locations as well,” said Dr.
Tom M. Chiller, deputy chief of the mycotic diseases branch of the U.S.
Centers for Disease Control and Prevention. “We don’t have a good handle on
how many people are coming back.”

More than 400 cases have been reported nationwide.

Doctors are trying to figure out how to best treat patients with epidural
abscesses.

“We are just learning about this and trying to assess how best to manage
these patients. They’re very complicated,” Chiller said.

The meningitis outbreak, first discovered in late September, was caused by
steroids made by the New England Compounding Center in Framingham, Mass.
Three contaminated lots of the drug — more than 17,000 vials — were
shipped around the country, and about 14,000 people were injected with the
drug.

Twenty-nine people have died, often from strokes caused by the infection.

An inspection of the compounding facility, which has since been shut down,
uncovered extensive black mold contamination. The company, along with
another Massachusetts company, Ameridose, which was also shut down, has
recalled its products.
__________________________________________________________________
__________________________________________________________________
UK: Hospital porter cut by used needles lifts lid on scandal
By Jon Austin, Basildon Recorder, UK (01.11.12)

A PORTER slashed three times by used medical equipment has lifted the lid
on Basildon Hospital’s crisis with potentially hazardous contaminated
waste.

Stephen Courtnell says he had to have a total of four months off work after
three separate incidents when he was cut by used scalpels and a needle
while carrying bags of waste.

The whistleblower, from Whitmore Way, Basildon, who is still employed by
the trust, said he had to undergo a series of HIV and hepatitis tests and
boosters which left him physically sick.

In one case he was left with a 10cm gash in his leg after a used scalpel
ripped through a plastic waste sack supposed to contain just used tissues
and swabs.

Last month the Echo revealed environmental watchdogs were probing how
syringes and other used medical equipment were making their way into
general waste.

Mr Courtnell said: “The plastic bags should just be for swabs and tissues.
Any sharps should go in the special boxes, but it is not always happening.
I have even seen bodily organs thrown in a plastic bag.
“It is the laziness and negligence by nurses and medics. I had the stress
of waiting for test results and had to take tablets with symptoms like
malaria and stomach cramps.” He said he was paid out £4,750 compensation
and is pursuing two other claims.

A hospital spokeswoman said: “We do not comment on individual employees.
The safety of our patients and staff is of the utmost importance and this
is why we are in the process of reviewing our waste management
arrangements.”
__________________________________________________________________
__________________________________________________________________
Study reveals dangerous levels of contamination on hospital keyboards
BY JAMAL, Biomed Middle East (31.10.12)

Edmonton, Alberta Canada– OCTOBER 22, 2012: In the largest study of its
kind, an investigation into the extent of contamination of computer
keyboards in hospital setting has shown that 58% are contaminated with
harmful bacteria. The study sampled 230 keyboards across 3 different ward
types in 4 separate hospitals. Contamination rates were similar for all
hospitals and wards.

Previous studies have shown workplace keyboards to be one of the most germ-
infested surfaces, but the hospital workplace creates additional challenges
for cleanliness. The current study reveals a serious level of
contamination. The proliferation of computer technology in healthcare
introduces keyboards to all areas of the hospital care environment. “People
are going from wound care of a patient to immediately entering information
into the computer. They can carry the microbes from that procedure onto the
keyboard. Preventive technology, such as Cleankeys and CleanSweep, can be
game-changing in helping to reduce the spread of these hospital
pathogens”.” says Dr. John Conly, founder of the Medical Ward of the 21st
Century who conducted the study.

“Health care-acquired infections are one of the biggest problems facing
hospitals today,” says Randy Marsden, CEO of Cleankeys Inc. and inventor of
the Cleankeys keyboard. “We are excited to be part of the solution to
preventing these infections, protecting patients and staff, and reducing
these costs with Cleankeys. Given the contamination level of keyboards in
hospital settings, Cleankeys has the potential of significantly reducing
hospital-acquired infections.”

Infection control experts are taking notice, “Everything is swabbed and
wiped clean in a medical environment except the keyboard,” says Dr. Richard
Fedorak, Professor of Medicine at the University of Alberta. “We have no
real ability to clean them aside from blowing the dust off. This is not
sufficient to keep keyboards clean and prevent the transfer of infection.”
In fact, the study suggests that cleaning compliance is low to none.
Cleankeys is designed to solve this problem. The Cleankeys flat-surface
lacks the gaps and edges of conventional keyboards, and the touch-sensitive
glass surface stands up to hospital disinfectants. It cleans in seconds.
“Cleankeys keyboard complies with our department’s motto: It should be easy
to do it right!” says Birgitta Eriksson in the neonatal unit at Akademiska
Children’s Hospital in Sweden (Uppsala University Hospital).
__________________________________________________________________
__________________________________________________________________
No more needles! Scientists develop vaccine that melts under the tongue
By Claire Bates, Daily Mail, U.K (24.10.12)

Probiotic spores shown to deliver vaccines effectively via nasal spray

Found to work against flu, TB and tetanus. Tests to see if it could work
against C.Difficile

Could provide relief to one in 10 people have a pathological fear of
needles

Oral vaccines are less painful and safer to administer
People who avoid having various jabs because they’re scared of needles
could soon receive their immunisation like a breath freshener.
Researchers have developed a new method for delivering a variety of
vaccines directly into the bloodstream via a soluble film placed under the
tongue.

The technique was developed after scientists discovered they could use
‘good bacteria’ to administer various vaccines including flu and
tuberculosis.

Professor Simon Cutting, of Royal Holloway, University of London, said:
‘Rather than requiring needle delivery vaccines based on Bacillus spores
can be delivered via a nasal spray or as an oral liquid or capsule.
‘Alternatively they can be administered via a small soluble film placed
under the tongue in a similar way to modern breath fresheners.

‘As spores are exceptionally stable vaccines based on Bacillus do not
require cold-chain storage alleviating a further issue with current vaccine
approaches.’

Up to one-in-ten people have a pathological fear of needles and doctors
fear this puts many of them off from being immunised against various
illnesses.

In addition to being less painful than jabs oral vaccines are also safer to
administer – particularly in countries where HIV is a major concern.
Also these types of vaccines will be more cost effective to make and easier
to keep fresh – lowering the risk of adverse outcomes.

Bacillus subtilis spores are very stable so don’t require cold storage
Prof Cutting has carried out trials to determine the effectiveness of
Bacillus based vaccines for many different diseases such as influenza,
tuberculosis and tetanus.

Now he is is examining whether the vaccine can be used against Clostridium
difficile, a disease extremely prevalent in the West.

C difficile is a serious cause of diarrhea linked to antibiotics and can
result in intense inflammation of the colon.

Prof Cutting said: ‘C. difficile is a gastrointestinal infection that is
commonly picked up following hospital stays and causes around 50,000
infections and 4,000 deaths per year in the UK, mostly in elderly patients.
‘Currently there is no vaccine against the disease and although several
approaches are currently undergoing clinical trials none are expected to
provide full protection and new solutions are urgently needed.

‘Bacillus based vaccines offer distinct advantages as unlike other
approaches, oral delivery can cause a more specific immune response in the
gastrointestinal tract to fully eliminate C. difficile.’

Bacillus subtilis has caught the attention of microbiologists because it
has the capability of making spores that live millions of years until they
germinate in proper environmental conditions.

Prof Cutting said: ‘The mechanisms by which this process occurs have
fascinated microbiologists for decades making it one of the most
intensively studied bacteria. Its simple life cycle and ease of use make it
an ideal laboratory subject.’

Bacillus spores were found to be perfect for transporting antigens, which
cause the immune system to produce antibodies to protect against them.
__________________________________________________________________
________________________________*_________________________________
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