HHM Compatibility Special Edition Feb/Mar 2020 HHM Compatibility Special Edition Feb:Mar 2020 | Page 9

of Healthcare Value Analysis Professionals (AHVAP) and
principal, of Barbara Strain Consulting LLC. “The same
publications include discussion of the instructions for use
(IFUs), prevention of bacterial, viral and fungal transmissions,
roles of the EPA and CDC, but most do not caution end
users of the potential effects that may alter the function
of the equipment/technology or deface key labeling and/or
instructions important for use.”
Strain continues, “End users are very good problem-solvers
and report issues to biomed, aka clinical engineering, supply
chain, infection prevention, etc., when surface degradation
or equipment malfunctions occur. The standard resolution
is to immediately call for replacement equipment or suggest
a change to the cleaning/disinfection agent. The bigger
question is to determine what to attribute the issues to;
without an appropriate problem-solving session with subject
matter experts (SMEs) to identify root causes as quickly as
possible, the immediate solutions may mask the issue or in
the worst-case scenario acerbate the issue.”
She adds, “The best education is to participate in the
selection of the equipment or surfaces that are going to
need to be cleaned and/or disinfected. Participation takes on
many forms, for example, primary end user groups can be
represented by department SMEs, senior leaders can appoint
an oversight group and mutually agree on who should be
actively involved. In addition to the groups mentioned
above nursing, education services, environmental services,
equipment distribution and value analysis should be included.
Evaluation and testing of equipment- and surface-related
goods should be internally reviewed to assess compatibility
with the results shared with the manufacturer and any
changes mutually agreed upon. For ease of compliance,
a chart with equipment, products and surface-related
goods, along with the tested and approved cleaning and/or
disinfectant products, should be readily available. Access to
newsletters, emails, reports communicated to staff should
be available electronically for reference 24 hours a day.”
While they represent some of the most significant
challenges in the healthcare environment, surfaces are not
the only objects susceptible to damage.
One biomedical expert who has witnessed first-hand the
impact of the compatibility issue is Richard Fechter, a principal
developmental engineer at UCSF Medical Center and UCSF
Benioff Children’s Hospital, who helps manage nearly 40,000
pieces of medical equipment. As the primary investigator for
medical device incidents, he has seen numerous alarming
examples of equipment and device failures that jeopardize
patient safety.
“For me, the whole issue began in 2004 with an incident
involving a syringe pump,” recalls Fechter, who is also a
member of the FDA Medsun Medical Product Safety Network
and the American College of Clinical Engineering (ACCE).
His reports have resulted in numerous recalls and medical
device corrections including critical life-support equipment.
“The healthcare facility had recently changed its cleaning
products. Prior to 2004, almost everyone used isopropyl
alcohol, but our infection control team decided that doesn’t
kill all the germs that we want to eliminate so they wanted
to try something new – a quat. So, they rolled that out and
proliferate or rebound to pre disinfection levels. It is so
important that surfaces be tested for compatibility of all
categories of EPA-registered disinfectants and an electron
microscopic scan be done to evaluate if the surface has
been damaged microscopically. We don’t always know
how microbes can be acquired and transmitted, and we
also don’t necessary know how deeps microbes may
harbor away from the reach of biocides.
HHM Describe the current lack of testing, stan-
dardization and guidance that is confounding the
problem – and what is the solution?
LL: The Healthcare Surfaces Institute conducted a
literature review in 2018. Between 50 and 60 search terms
producing an estimated 2,300 articles. We expected gaps
but we didn’t expect the inconsistencies in test methods,
and inconsistencies in the microbes used for testing. There
were significant gaps of knowledge and fragmentation
of information. Definitions of cleaning and disinfection
were different between 31 different organizations. Other
definitions that were inconsistent and quite frankly out in
left field were non-porous, moisture resistant, sanitize and
disinfection. No wonder front-line environmental services
workers can be confused regarding which definition of
clean and disinfect must be followed.
HHM What role is the Institute playing in this
challenge?
LL: We are in the process of developing a Healthcare
Surface Certification program. This will be a program
that will support manufacturers in knowing what to
test for and it will provide healthcare facilities with a
valuable guideline and seal of approval from HSI from
the manufacturers they are interested in purchasing
from. It will also require surface materials be tested
before they are made into products for the healthcare
setting. Knowing that they can be effectively cleaned
and disinfected using hospital grade disinfectants as
well as no touch technology such as UV and hydrogen
peroxide vapor.
HHM What should the various hospital stake-
holders demand of designers, manufacturers and
other parties to help steer the course toward
a better understanding of surface materials
compatibility challenges?
LL: Healthcare professionals must demand surfaces
and final products be tested for compatibility and that
effective instructions for use have been written. An
IFU isn’t any good if it states you must clean with soap
and water when you are trying to mitigate the spread
of C. difficile. Teacher manufacturers about infection
prevention protocol particularly in high-contamination
and high turn-over areas. Addressing the surfaces issue
begins at design! 
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