Rotary Pen Devices Safety Alert
March 3, 2006
There has been an influx of reports to the SPCP recently
regarding disinfection or sterilization issues of rotary pen machines. The
SPCP board and its administration share the same concerns as initially
reported by our membership. This alert particularly addresses rotary pens
that use a sponge to control body fluid contamination to the motor assembly
of the device.
If a machine’s safety is questioned, we have the
responsibility to investigate and make a determination based upon our Code
of Ethics to determine if the negative report indeed has merit.
While we do not endorse or recommend any particular device or machine for
the permanent cosmetics industry, the SPCP Board has adopted as an
interpretation of our code of ethics the California Conference of Local
Health Officials Proposed Model Program relating to rotary pen machines
which indicates: “Any rotary pen that uses a sponge at the opening of the
chamber to stop the pigment or body fluids from getting into the machine or
is designed in a manner that does not allow it to be properly cleaned and
sterilized shall not be permitted.” The motor assembly also has to break
away completely and all parts attaching to it have to be disposed of, or
heat sterilized after each use. Furthermore, all parts that come in contact
with a gloved hand (grips) must be disposable or able to be heat sterilized.
No machine should be used that requires the user to handle the actual needle
grouping (needle tips) before and/or after its use.
Additionally, the manufacturer of the KP96 rotary pen recently
became aware of other safety concerns. They have now developed a new model
that does not pose the same issues. However, it is reported the KP96 model
is still being sold. Upon review by our technical advisor and acknowledgment
of the company, the machine must remain vertical and upright to avoid any
reverse flow of pigment and contamination. They are providing a stand free
of charge to keep the machine in this position. While motor assemblies in
other rotary devices may become contaminated if held upside-down, it is felt
that laying a machine on its side is common practice for this industry.
Additionally, depending on the type or work being done, a horizontal
position of a machine is not uncommon during a procedure, therefore the SPCP
Board, in conjunction with its Health and Safety and Ethics Committee
advises technicians using this equipment to exercise caution in observing
the manufacturer’s instructions on the use of the KP96 to ensure the machine
is not laid on its side and the new machine holder is utilized at all times.
The manufacturer advises the machine can be autoclaved, check with the
manufacturer before doing so for instructions.
As SPCP members,
we are bound by our Code of Ethics to protect our clients from situations
that would cause them harm. The SPCP encourages manufacturers, distributors,
and users of all Permanent Cosmetics tools to periodically conduct quality
audits of their devices to ensure that design, use instructions provided for
the consumer, and consumer use and maintenance meet the highest health and
safety standards. Our industry depends on it.
Update
May 12, 2008
Devices that employ a sponge for the sole purpose of
reducing needle vibration and noise reduction are not included in this
safety alert.
- SPCP
