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Physician
groups lobby European Union to reduce sharps injuries
LEADING European physician groups are pressing the European Union
to reduce the number of injuries from needles and other sharps.
| Infection
with
contaminated sharps
represents major hazard
A number of national and international groups warn that infection
from contaminated sharps continues to pose a major risk to
surgeons and other health professionals.
World
Health Organisation
“Contaminated needles and syringes, accidentally or
intentionally, are potentially causing many millions of hepatitis
B virus infections and many thousands of human immunodeficiency
virus infections each year, particularly in the developing
countries. The cost to society of the treatment of disease
caused by an unsafe injection is thought to be equivalent
to about 22 cents US per injection – considerably more
than the cost of preventing disease caused in this way.”
International
Sharps Injuries Prevention Society
“There are more than 100,000 needle stick injuries in
UK hospitals each year. Needle stick injuries are virtually
undocumented in many developing countries, but probably equal
or exceed those in the industrial world.
“Healthcare workers worldwide are concerned about these
accidental needle sticks and other sharps injuries resulting
in life-threatening infections. Far too often, healthcare
workers are becoming patients after being injured by contaminated
medical sharps. These health care workers are contracting
potentially deadly infections from sharps injuries that are
largely preventable. Health care workers from other disciplines
have received sharps injuries including: surgeons, anaesthesiologists,
cleaning staff and house-keeping staff.”
UK
Medical Devices Agency
“The problem of needle stick and sharps injuries remains
a major issue. The cause of these injuries is not restricted
solely to the use of needles but also involves other medical
devices, surgical instruments, bone fragments and glass vials.
These injuries carry the risk of transmission of blood borne
viruses.
“In all cases emphasis should be placed on the correct
handling before, during and after use and the safe disposal
of such devices. Appropriate training of staff is essential
in reducing the risks of needle stick and sharps injuries.
However it is possible for needle stick and sharps injuries
to occur as a result of accidents and the risk associated
with these may be reduced by the use of devices incorporating
safety features developed during the design of the devices.”
US
National Alliance for the Primary Prevention of Sharps Injuries
An estimated 800,000 medical sharps injuries occur each year
in healthcare facilities across the US. alone. At risk is
any health care worker who handles sharp devices or equipment
such as lancets, suture needles, scalpels, or hypodermic needles.
Emergency Care Research Institute
“Any time a needle is used, the potential for a needle
stick injury exists — either during or after use or
during or after disposal. Injuries that occur after use –
for example, if a needle is accidentally left in bed linens
– and those that occur after disposal – for example,
if exposed needles are protruding from an overfilled sharps
container – can be especially problematic.
“In these cases, it is unlikely that the injured person
or subsequent caregivers will be able to identify the source
patient. As a result, they won't know crucial information
about the contamination status of the needle. Because the
prudent response in such cases is to assume that the needle
had been contaminated, these injuries can lead to unnecessary
anxiety and treatment expenses.
“By eliminating needles whenever possible, you'll not
only eliminate the risk of injury to the user, but you'll
also eliminate the possibility of injuries occurring after
the needle has been discarded”.
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The call follows increasing fears among surgeons, including ophthalmologists,
about the risk
of contracting hepatitis and HIV through needle-sticks during surgery.
In a new manifesto, the European Medical Association and European
Institute of Medicine have joined nursing, industry and patient
groups to press the EU to ensure:
•
Consistent compliance with existing EU Worker Safety and Health
Directives among EU healthcare providers
• Better information and education of physicians and other
health care workers about the risks
of exposure, prevention methods and effective incident reporting
• Safer working practices, including better use of protective
clothing, safer disposal of sharps and more effective responses
to sharps injuries
• Use of “Sharps Protection” Technology especially
for high-risk medical procedures.
“Injuries
caused by needles and other sharp medical devices and the related
risk of potentially fatal disease transmission remain a major threat
to the health and safety of health care workers across the European
Union today,” reads the manifesto, which was originally drafted
by EUCOMED, the European Medical Technology Industry Association.
In addition to the two physician groups, five other groups to date
have signed on to the manifesto: the European Dialysis and Transplant
Nurses Association/European Renal Care Association; the International
Alliance of Patients' Organisations; the European Federation of
Public Service Employees; and the Standing Committee of Nurses of
the European Union.
Studies
cited by manifesto indicate that:
• Surgeons, like any other health care workers who regularly
work with such sharp instruments as scalpel blades and suture needles,
face a high risk of contracting hepatitis B, hepatitis C and even
HIV through jabs and sticks when treating infected patients
• The primary route of infection is by percutaneous injury
from blood-filled needles
• Hospital staff members incur as many as 30 needlestick injuries
per 100 beds each year. However, it is estimated that between 60%
and 80% of incidents go unreported.
The risk of infection from a contaminated sharp, of course, depends
on the pathogen.
Studies
indicate that the risk of transmission of infection from an infected
needle is:
•
one in three workers for hepatitis B
• one in 30 for hepatitis C
• one in 300 for HIV
The
EU debate over needle-stick injuries follows a similar debate in
the United States.
There, the US Centre for Disease Control estimates that between
62% and 88% of sharps injuries could be prevented by specific safety
features for handling the medical device or preventing accidental
pricking.
Against such a background, the American Congress enacted a special
law, the Needlestick Safety and Prevention Act.
The act required the US Occupational Safety and Health Administration
to revise regulations governing blood-borne pathogens standards
to facilitate the use of “safer medical devices”, including
sharp objects with built-in safety mechanisms and needle-less systems.
Under the revised US safety and health regulations, employers must
select safer needle devices as they become available and involve
employees in identifying and choosing such devices. The updated
regulations also require employers to maintain a log of injuries
from contaminated sharps.
Just how the EU responds to the risk of infection from needles will
unfold over the next few months as the European Parliament begins
a debate on sharps and the re-use of disposable medical devices.
So far, EU regulatory officials in Brussels contend that no new
law is necessary. Rather, more publicity and better enforcement
of existing health and safety laws are what is needed, according
to Francisco Jesus Alvarez Hidalgo PhD, who oversees health and
safety issues in the European Commission’s directorate of
Employment and Social Affairs.
“There is a general idea or feeling that existing legislation
is enough,” Dr Hidalgo told a March meeting on sharps, sponsored
by the European Parliament.
“Maybe it can be modified maybe it can be improved. But in
general terms it is enough. This is a good piece of legislation
and if we manage to implement it, it would be a very important step
forward.”
Regardless of whether Europe proceeds with new laws or just guidelines,
any attempt to reduce injuries from sharps must be practical, warns
Ms Minerva Malliori, a Greek member of the European Parliament who
is charged with drawing up a parliamentary report on the sharps
issue.
“I think that the most difficult part of our discussion has
to do not only with the directives, the legislation and the guidelines,
but with their implementation,” Ms Mallori told the March
Parliament meeting.
“Do the member states have the facilities or the funding to
react, to implement or to monitor what we decide? Usually, we are
very quick with legislation and we don’t care about the implementation.
This is something that we must keep in mind.”
EU
law ignores specific risk of needle-stick injuries
Although a number of EU laws generally oblige hospitals and
physicians to identify risks and do whatever they reasonably
can to eliminate or reduce such risks, no specific law addresses
the use and disposal of needles and other sharps.
The
existing body of EU law includes:
EU
Council Directive 391 of 1989
This directive requires that, if risks cannot be totally eliminated,
they must be combated at source. Dangerous practices must
be replaced by the non-dangerous or the less-dangerous. Employers
are also responsible for adapting their operations to technical
progress by using newer technology, which can reduce or eliminate
risk.
EU Council Directive 665 of 1989
This directive obliges employers to provide a safe working
environment. In this context medical devices are ‘work
equipment’ and they must be chosen with a view to avoiding
or minimising risk.
EU Council Directive 54 of 2000
Under this directive, employers must assess risk and prevent
workers’ exposure to biological risks. If prevention
is not technically practicable, the directive obliges employers
to reduce the risk to the lowest risk level for adequate protection
by means of work place design, engineering control measures,
hygiene measures and safe handling of waste. In addition,
the directive requires employers to make available their risk
assessment information to the appropriate authorities in the
individual EU country.
Medical Devices Directive 42 of 1993
Under the Medical Devices Directive, manufacturers must undertake
a risk analysis of all medical devices before they place such
devices on the market. In doing so, manufacturers should take
account of the European Standard for risk assessment, known
as “EN 1441” and the European Standard for risk
management, known as “EN ISO 14971”. The Medical
Devices Directive also requires manufacturers to monitor their
devices once they are approved for use. Such monitoring should
include following up on reports of adverse events about their
devices and taking reasonable measures to manage any risks
that users of the devices highlight. |
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