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Making sense of the alphabet soup
of SPD regulations
by Ray Taurasi
Q
JCAHO, AAMI, FDA, AORN, EPA, CDC, IAHCSMM, SGNA, DPH, ASHCSP... as a
relatively new SPD coordinator all this alphabet soup has my head spinning.
I feel like I am drowning in a sea of regulations. Then there are all sorts
of requirements specified by manufacturers.
Quite frankly I am having a
rough time unraveling all this information and at times I feel like some of
the information is contradictory. It’s very stressful thinking that if I
miss one of these regulations my hospital could be shut down. How can one be
expected to implement all of these standards and regulations into policies
and procedures that can be strictly enforced? It seems to me that it would
be a whole lot easier if there was just one source of information or body
that regulates SPD operations.
A
Being a newbie to the wonderful world of SPD I understand how overwhel-ming
all this might seem to you. Let’s see if we can zoom in on all this alphabet
soup and unravel some of the confusion for you. There are regulations,
standards and guidelines which are considered and utilized in establishing
protocols, procedures and policies relative to the practice of reprocessing
and sterilization technology. Entities such as, FDA (Food and Drug
Administration), EPA (Environmental Protection Agency), and OSHA
(Occupational Safety and Health Administration) are all Federal Government
agencies in such they are regulatory bodies. Each one of these agencies does
have very specific regulations that impact SPD work practices, under the law
their regulations must be implemented and enforce. Each one of these Federal
agencies also has regional, state and or municipal divisions. All
subdivisions or municipal bodies of these Federal agencies at minimum must
abide by the Federal regulations. State or municipal divisions of these
Federal Agencies may implement and mandate additional and or stricter
regulations. In addition to federal agencies, states, counties, towns and
cities might have other established regulatory agencies, such as, DPH
(Department of Public Health). Therefore in the development of department
policies the SPD manager must be familiar with the Federal, as well as, the
local, state and municipal governing bodies’ regulations. Regulations are
established and enforced by governmental empowered agencies. Institutions
are bound by the legal system to implement and enforce regulations;
violators are subject to severe penalties and fines. Penalties could include
loss of license to operate.
JCAHO (Joint Commission for Accreditation of Healthcare
Organizations), AAMI (Association for the Advancement of Medical
Instrumentation), AORN (Association Operating Room Nurses), CDC (Center for
Disease Control and Prevention), IAHCSMM (International Association of
Healthcare Central Service Materiel Management), SGNA (Society of
Gastroenterology Nurses and Associates, ASHCSP (American Society of Central
Service Professionals) as well as many more not mentioned are all
organizations that are very important to the practice of Sterile Processing.
Each of these entities do publish recommendations, guidelines and
recommended standards of practice. These entities are not empowered by the
government and their published guidelines are not regulations. Participation
in these organizations and the compliance to their recommendations and or
standards are generally considered voluntary. However there are local
governments that have incorporated some of these standards into their
regulations. Such is the case in the state of New Jersey where the state
Department of Health (DPH) requires that hospitals follow AAMI
recommendations, standards and guidelines.
JCAHO is a voluntary entity that conducts audits,
assessments and accreditation for healthcare organizations. While JCAHO
accreditation is voluntary its importance is critical to most healthcare
organizations. Without accreditation a hospital may not be able to receive
certain benefits, funding and reimbursement for programs and services they
render.
The fact that these entities are voluntary and non
governmental does not dismiss their importance and or value to sterile
processing practitioners. The documents, guidelines and recommendations they
publish have often been developed based on sound scientific, technical and
clinical data. Contributors to the development of their documents and the
pre publication reviewers are comprised of highly qualified and seasoned
professionals from the many specialized fields of practice in the clinical
and manufacturing disciplines. Most of the published standards and
guidelines provide supported rationale and sound reasoning for each
recommendation. It is very important that sterile processing managers are
familiar with and keep abreast of the standards and guidelines published by
professional entities. The knowledge gleaned from these documents provides
an excellent resource and reference base for you to utilize in the
development of your policies and procedures. It is impossible for the
professional entities to address every possible scenario, medical device,
piece of equipment, or technology–the dynamics in today’s healthcare
environment precludes this. Each hospital has its own uniqueness.
Technological advances are occurring all the time and new products are being
introduced into the marketplace that may affect the way we practice.
Therefore certain recommendations or guidelines might not be a fit or apply
to your unique situation or facility’s operations. In such you may choose
not to implement or follow certain recommendations or guidelines published
by voluntary entities. As professionals we are expected to be competent,
educated, knowledgeable, and well informed. We are responsible for what we
do and must ensure that we maintain excellence in the quality of patient
care including minimizing the risk of infection or injury to the patient.
When developing SPD polices and procedures you must consider the
recommendations of professional entities, and manufacturers. Much of what we
do in SPD aside from the aforementioned government regulations require sound
judgment in practice. All matters are not black and white. There are gray
areas and choices which require a judgment call and for a decision to be
made by you the SPD manager. You must be able to indisputably defend
your decisions. This is especially so when your decision or practice may
differ from guidelines and recommendations set forth by professional
entities. Although not binding by law such guidelines and recommendations
can become standards of practice and could possibly be entered as evidence
in legal cases involving malpractice and or negligence.

Ray Taurasi is eastern regional director of clinical sales
and services for Healthmark Industries.
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