RECOMMENDATIONS | Environmental conditions and their control in RUMEDs

Recommendation of the Committee for Hygiene, Construction and Technology

Requirements for the environmental conditions and
their control in Reprocessing Units for Medical Devices
(RUMEDs)
Part 2

DGSV e.V. FA HBT

B. Hornei, M.-Th. Linner, A. Jones, J. Gebel, M. Wehrl, K. Wiese,H. Schunk, M.Roitsch, A.Carter, R.Stens

Preface possible when reprocessing medical de- Standard DIN EN ISO 13485 regulat-
Already in 2018, the Committee for vices.” ing QM systems calls for requirements
Hygiene, Construction and Technol- Attention is also drawn to the for the work environment as well as for
ogy (FA HBT) of the German Socie- KRINKO Recommendation “Hygiene re- monitoring, control and formulation of
ty of Sterile Supply (DGSV) discussed quirements for cleaning and disinfec- requirements for the microbial and par-
this topic in detail and initiated tests, tion of surfaces”: [6]: “For assessment ticulate cleanliness of sterile products
based on which a recommendation was of the inanimate environment (all sur- and for measures to ensure compliance
issued. That recommendation has now faces surrounding the patients and per- with such regulations. “If the working
been expanded to include additional sonnel), the following must be viewed environment conditions could adverse-
tests and revised. as potential infection risks: the ubiqui- ly affect the product quality, the organi-
tous presence of microorganisms and zation must document the requirements
Introduction persistence and infectiousness of path- addressed to the working environment
The aim of this publication is to pres- ogens (in the inanimate environment) and processes for monitoring and man-
ent information on the state of the art and their transmission pathways as agement of the working environment.”
and experience with respect to hospi- well as the infectious dose …“. Reliance There are no specific guidelines for
tal hygiene, microbiology and audits. on identification of visible soils alone is RUMEDs, as opposed to drugs (Good
This information lays the groundwork not an appropriate criterion for assess- Manufacturing Practise – GMP) [2].
for the formulation of requirements ment of the contamination levels of in- Similarly, the first recommendation did
for the environmental conditions and animate surfaces […]. For example, no not contain any specific reference val-
their control and for bringing the longer visible soils harbouring blood ues but did make suggestions for formu-
current publication into line with the may contain a hepatitis B viral load of lating in-house reference values. These
state of the art. The requirements for 102–103 infectious particles […]“. specifications are laborious and were
the air quality (microbiological, physi- “Following cleaning and disinfec- not applied in practice. The Committee
cal), its control and occupational safe- tion processes, recontamination of sur- for Hygiene, Construction and Technol-
ty and health aspects will not be ad- faces occurs within a few hours depend- ogy therefore decided to formulate ref-
dressed. ing on use […]; initial recontamination erence values based on more extensive
The information is intended for the is predominantly with apathogenic en- test series.
economic operators of Reprocessing vironmental microorganisms […].” For medical devices that are disin-
Units for Medical Devices (RUMEDs), There are legal regulations stipulat- fected but not sterile when used, strin-
RUMED management, hospital infec- ing the need for a quality management gent requirements are addressed to the
tion control officers and staff and the (QM) system. In Germany, for example, environment and handling to prevent
supervisory authorities. this is enshrined in the German Code of recontamination. These measures must
Social Law (SGB V Section 135a). be applied to the reprocessing processes
Are there specifications in place The KRINKO/BfArM Recommendation and subsequent processes such as pack-
for the environmental conditions in [1] stipulates that a QM system must aging, transport and storage.
a RUMED? also be in place regardless of the nature
Pursuant to the KRINKO/BfArM Recom- of the medical devices reprocessed or What areas are considered?
mendation [1], “Contamination of the the RUMED size. All surfaces in a RUMED – whether
environment must be avoided as far as Standard DIN EN ISO 17665-1, Sec- animate (people) or inanimate (room,
tion 7.10 c, regulating steam steriliza- equipment, work materials) – are con-
tion calls for control of the environment taminated but are not equally impor-
in which a product (medical device) is tant for the reprocessing quality of
[1] KRINKO/BfArM Recommendation: Recommen- manufactured, assembled and packed. medical devices.
dation for hygienic processing practices for medi- Environmental control tests may be Since the bioburden on the medi-
cal devices, jointly compiled by the Commission for conducted at regular intervals in areas cal devices being reprocessed is higher
Hospital Hygiene and Infection Prevention at the
Robert Koch Institute (RKI) and the Federal Insti- that could impact the microbial burden in the cleaning and disinfection zone
tute for Drugs and Medical Devices (BfArM) on the device. (C+D zone) than that of the surround-

298 Zentralsterilization | Volume 29 | 5/2021

ing environment, there is no relevant of cleanliness but these are difficult to ues, are largely dependent on the nutri-
risk of the environmental bioburden standardize since residues of disinfect- ent media used and set different refer-
negatively impacting the reprocessing ants, cleaning utensils, etc. could lead ence values e.g. 5 colony forming units
process. to false results. Besides, there is no line- (CFUs)/contact plate for class B clean
However, the risk assessment is dif- ar correlation with culture-based tests. room, 25 CFU/contact plate for class
ferent for medical devices being further [Dancer 2014, Watanabe 2014] C clean room, 4–10 CFU for surfaces
reprocessed in the packing zone and The KRINKO Recommendation “Hy- coming into contact with foodstuffs.
sterilization zone as they have only a giene requirements for cleaning and Swabbing or contact plating methods
low microbial count. Contamination of disinfection of surfaces” defines the aim can be used for sampling. The con-
surfaces and packaging materials in a of disinfection as not being “the elim- tact plating methods for measuring the
RUMED must be kept to a minimum, as ination of environmental pathogens aerobic mesophilic microbial counts
must the recontamination of medical but defined reduction of the number are described in DIN 10113-3 and the
devices after cleaning and disinfection. of pathogenic or facultative pathogen- semi-quantitative swabbing method in
ic microorganisms.” Tests carried out DIN 10113-2.
Control of environmental surfaces for the purpose of defining threshold Efforts have also been made to de-
Control procedures values for routine checks found that in fine a threshold value for the definition
In various areas of technical hygiene settings with healthcare-associated in- of cleanliness with regard to cleaning
targets have been defined on the basis fection (HAI) pathogen counts >1 CFU and disinfection processes in order to
of different concepts which can be re- per cm², bacteria such as MRSA, VRE, prevent healthcare-associated infec-
ferred to by way of comparison. Clostridium difficile, S. aureus (MRSA+ tions (HAIs). For high-touch surfaces
The introduction of any type of un- MSSA) were detected more often on the benchmark could be in the range
desirable extraneous materials, i.e. in- hand-touch surfaces. The absence of 2.5–5 CFU per cm². It has been demon-
cluding visible particles such as e.g. skin S. aureus (MSSA and MRSA) appears strated that detection of higher CFUs
scales, hair, dust or of invisible particles to be the best indicator of cleanliness, was associated with an increasing prob-
into patients must be avoided. One ap- whereas coagulase-negative staphylo- ability of contamination with Staphylo-
proach is to visually inspect medical de- cocci serve as indicators of hand contact coccus aureus and MRSA. However, to
vices immediately before the packing [Dancer 2014]. date that threshold value has not been
process; this is useful in particular for Nor are there in general any bind- adopted for routine checks [Dancer
detection of residual soils. Since this ing guidelines for medical devices that 2014] and would also apply to surfaces
is not suitable for identification of con- should harbour only a low microbial involved in direct patient care.
tamination with microorganisms, spe- count when used (disinfected medical From the requirements governing
cial control measures are needed. devices). Based on the requirements of medical device reprocessing, which in
Such methods entail pre- and the European and US American pharma- general stipulate that infection risks to
post-measurement tests or testing copoeias, the absence S. aureus and Pseu- the patient, user and third parties be
based on the use of test soils to demon- domonas aeruginosa on medical devices kept to a minimum or which in some
strate the efficacy of cleaning and dis- that come into contact with the mucous cases call for control of environmental
infection. membranes of the nose, oropharynx or conditions, it can be inferred that the
Another target could be to focus on vagina may be required [14]. target here is to reduce the total micro-
the optical state of environmental sur- Accordingly, the target here would bial counts to a minimum.
faces or of reprocessed medical devices be the ability to demonstrate the pres-
prior to packaging, while also using mi- ence or absence of “undesirable” micro- Conduct of tests for definition of
croscopic methods for particle detection. organisms through contact plating or reference values
These give no insights into the actual swabbing tests. In the following, the targeted accept-
state, instead focus on whether the ap- Suitable indicator organisms in der able level of contamination was defined
plied processes were properly executed RUMED would be microorganisms that on the basis of serial testing since there
under the specific conditions and thus indicate inadequate decontamination are no universally applicable threshold
achieve a target state. For practical rea- of surfaces or point to recontamination values for “clean or unclean surfaces”.
sons, this method cannot be used in es- with skin or mucosal flora or are able A series of tests were carried out in
tablishments offering 24-hour service. to demonstrate a direct health risk from accordance with the criteria, outlined
Structured observation of the con- reprocessed medical devices. below, in five representative RUMEDs
duct of cleaning/disinfection as well Another frequently applied concept with spatial separation of the C+D
as observation of workflow patterns has been the total microbial counts. and the packing zone and which had
aimed at avoidance of the introduction That has been regulated by GMP stand- in place a QM system. The test results
of particles through windows and doors ards for manufacture of drugs of vary- were evaluated in four different micro-
or materials could also contribute to ing degrees of purity. biology laboratories. At least 40 contact
control and protection of environmen- Likewise, total microbial counts are plating tests were run for each series.
tal conditions. The intervals and scope defined as target variables in the food-
must be defined for the target variables stuffs industry and for control of room Sites for microbiology tests
in the infection control policy. ventilation systems (based on VDI 1. Critical surfaces
ATP bioluminescence methods are 6022). These definitions are based on a. Hand-touch surfaces in the
commonly employed for measurement epidemiology data and empirical val- packing and sterilization zone

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 RECOMMENDATIONS | Environmental conditions and their control in RUMEDs

b. Worktops in the packing zone Method criteria. In two test series only critical
and storage surfaces in the pack- Label the underside with water- surfaces were included.
ing and sterilization zone proof pen. The qualitative evaluation results
2. Non-critical surfaces With disinfected hands, remove the of the contact plating tests are present-
a. Surfaces not coming into contact lid of the Rodac plate without touch- ed in Table 1, showing an expected mi-
with reprocessed medical devic- ing the nutrient medium. crobial spectrum. Hardly any potential
es Applying gentle pressure, press the pathogens were detected. The most rel-
nutrient medium evenly to the test evant pathogen was Staphylococcus au-
Documentation – Sampling surface for around 5–10 seconds reus, with detection not limited to hand-
Date, time, room, surface, without destroying the nutrient me- touch sites. In addition, a small number
In workflow dium and without generating fric- of bacteria belonging to the mucosal
Person taking sample: infection con- tion motion. flora were identified. Small numbers
trol staff/officer, external sampler Then replace and fit the lid immedi- of moulds and, with one exception also
ately without contaminating the nu- humidophilic microorganisms belong-
Test materials trient medium. ing to various species (Table 1, blue
Rodac plates (Replicate Organism Never sample the same surface marking) were detected in all series of
Detection and Counting) twice. tests of non-critical surfaces.
Size: 25 cm², round, rigid, with lid Summary quantitative evaluation
Trypticase soybean agar (TSA agar) Evaluation criteria was performed taking account of all sur-
with neutralizer (for neutralization 1. CFU count per Rodac plate faces. Spore-forming bacteria are pre-
of any surface disinfectant residues 2. Differentiation at species level: sented separately since the use of sporo-
on nutrient media which could lead Gram-negative rods, S. aureus, ente- cidal methods for surface disinfection is
to false results because of persistent rococci, streptococci including quanti- neither prescribed in the standards nor
bactericidal action on the nutrient tative specification in CFU/25 cm² commonly applied. Quantitative eval-
media). 3. Differentiation of spore-forming from uation was done for each series, while
Principle: Bacteria on the test sur- vegetative microorganisms calculating the median, mean and
face continue to adhere to the con- 4. Differentiation of other microorgan- standard deviation for vegetative and
tact plate when the plate is pressed isms as needed for further evalua- spore-forming microorganisms. The re-
onto the nutrient medium (nutri- tion (e.g. coagulase-negative staph- sults were evaluated for all surfaces as
ent agar surface) where they mul- ylococci, micrococci, moulds, Candida well as separately for only the critical
tiply in the laboratory under incu- spp.). surfaces. Due to the high microbial var-
bation conditions and over a peri- iance on the surfaces, which is expected
od of 48 hours. As such, bacterial, Results and can be tolerated in the operational
or also fungal, colonies which can Each RUMED was responsible for se- state, the standard deviation is corre-
be counted are grown (quantitative lecting the test sites but this was done spondingly high and the mean is greatly
evaluation) and their species identi- in accordance with the aforementioned
fied (qualitative evaluation).

RUMED 1-3 series RUMED 1 check after 3 months RUMED 2 RUMED 3 RUMED 4 RUMED 5

Pathogen group/ Pathogen group/ Pathogen group/ Pathogen group/ Pathogen group/
Total
Pathogen group / ward Total ward Total ward ward Total ward Total ward Total
Total 715 Total 95 Total 30 Total 64 Total 61 Total 61
CNS 263 CNS 39 KNS 7 KNS 31 KNS 36 KNS 32
Micrococci 223 Micrococci 21 Micrococci 5 Micrococci 17 Micrococci 12 Micrococci 13
Spore-forming Spore-forming Spore-forming Spore-forming Spore-forming
Spore-forming bacteria 133 bacteria 19 bacteria 0 bacteria 2 bacteria 0 bacteria 1
No pathogens No pathogens No pathogens No pathogens No pathogens No pathogens
detected 24 detected 4 detected 12 detected 14 detected 12 detected 5
Moulds 20 Moulds 3 Moulds 0 Moulds 0 Moulds 1 Moulds 4
Corynebacteria 16 Corynebacteria 5 Corynebacteria 4 Corynebacteria 4
S. aureus 8 Acinetobacter 2 Paracoccus 1 Neisseria 1
of which MRSA 1 Candida 2 Microbacterium 1 Rizobacter 1
Lactobacteria 7 Brevibacterium 2
Moraxella-Branhamella 6 Streptomyes 1
Pseudomonas 3
Other non-fermenters 3
Rothia mucilaginosa 2
Acinetobacter spp. 1
Arthrobacter 1
Aspergillus spp. 1
Brevibacterium spp. 1
Burkholderia spp. 1
Kytococcus schroeteri 1
Other Enterobacteriaceae 1

Table 1: Microbial spectrum

300 Zentralsterilization | Volume 29 | 5/2021

 Critical surfaces
Median

Standard deviation

Median

Standard deviation

Median

Standard deviation

Median

Standard deviation

Median

Standard deviation

Median

Standard deviation

Median

Standard deviation

Median

Standard deviation

Median

Standard deviation
RUMED 1_1 RUMED 1_2 RUMED 1_3 RUMED RUMED RUMED 2 RUMED 3 RUMED 4 RUMED 5
1_3 Mon 1_24 Mon

CFU spore-forming microorganisms CFU vegetative microorganisms Target value (median and standard deviation)

Fig. 1: Evaluation of all critical surfaces

Mean value

Median

Standard deviation

Mean value

Median

Standard deviation

Mean value

Median

Standard deviation

Mean value

Median

Standard deviation

Mean value

Median

Standard deviation

Mean value

Median

Standard deviation

Mean value

Median

Standard deviation

RUMED 1_1 RUMED 1_2 RUMED 1_3 RUMED RUMED RUMED 4 RUMED 5
1_3 Mon 1_24 Mon

CFU spore-forming microorganisms CFU vegetative microorganisms Total CFU Target value

Fig. 2: Evaluation alignment for all surfaces

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 RECOMMENDATIONS | Environmental conditions and their control in RUMEDs

influenced by individual peak values. The highest target value in our evalua- zone) than that of the surrounding en-
Therefore, the median was applied as tion was 18. vironment, there is no relevant risk of
an appropriate evaluation basis, as al- When all surfaces were included in the environmental bioburden negative-
ready proposed in the previous publica- evaluation, the highest target value was ly impacting the reprocessing process.
tion. This value is presented as a target 34. The median target values were 17, By contrast, environmental contam-
value in the evaluations. i.e. similar to that of critical surfaces. ination in the packing and sterilization
The median of the vegetative mi- However, the individual results were zones of a RUMED can impact the qual-
croorganisms identified on critical sur- much more variable. Spore-forming ity of the reprocessed medical devices.
faces was between 0 and 8 and the microorganisms did not play any ma- The environmental conditions under
standard deviation was between 6.11 jor role in any of the test series and are which medical device reprocessing pro-
and 16.27, giving rise to “target val- therefore not included in evaluation cesses are implemented must be con-
ues” between 8 and 18. The median and besides, as mentioned before, there trolled. Ways are shown how this con-
of the spore-forming microorganisms is no requirement that surface disinfec- trol can be performed and the results
was between 0 and 2.5 with standard tion processes be endowed with sporo- evaluated.
deviations between 0 and 9.6. cidal efficacy. The absence of pathogens is a realis-
Concordance between the test se- As in the references cited here on tic requirement even in establishments
ries was very good both in terms of time the formulation of threshold values for with ongoing operations. A combina-
(checks over two years) and for several routine checks, it was revealed that at tion of visual inspection and microbiol-
RUMEDs, hence generalization is pos- >1 CFU per cm² the probability of HAI ogy tests is advisable.
sible. pathogens increases, which was also 20 CFU/Rodac plate could be set as
In the overall evaluation of all sur- confirmed for the microbial spectrum threshold value for critical surfaces and
faces, the median of the vegetative mi- identified in our tests. That corresponds 25 CFU/Rodac plate (≤ 1 CFU/cm) for
croorganisms was between 3 and 10 to a target value of 25 CFU/Rodac plate, non-critical surfaces as well as in oth-
with standard deviations between 5.9 which is equivalent to the requirements er areas if no measures were taken in-
and 28.57. Once again, the number of for a GMP class C clean room. That tar- house to set a reference value; besides,
spore-forming microorganisms was get value is higher than the median the absence of S. aureus and humido-
low with a median between 0 and 2 range obtained in our tests and was ex- philic microorganisms and other path-
and standard deviations of 0 and 9.16. ceeded only in two cases in our tests. ogens is required.
Hence, the “target values” for the surfac- In one of these cases HAI pathogens like In the event of a threshold value be-
es were between 9 and 34. This means S. aureus and enterococci were also de- ing exceeded, the tests must be repeat-
that both the total microbial counts and tected. Hence, this target value is well ed at the site yielding an unsatisfactory
the variances on the non-critical surfac- established in the literature and – as result as well as at four additional and
es were higher. It is therefore important demonstrated in our tests – is realistic similar sites.
to evaluate these categories separately. and suitable for everyday practice. If threshold values are continually
Nonetheless, concordance between the More stringent requirements should exceeded, documented analysis of the
test series is sufficient for setting the be applied for critical surfaces, which causes must be conducted and remedial
general target value proposed here. is why in this case the median for our action taken.
tests was rounded up from 18 to 20. In
Discussion this way both peak values and median
In the previous publication it was pro- can be reflected in a threshold value.
posed that a RUMED-specific (in-house) In the majority of test series, com-
target value be set by running several prising non-critical surfaces, a very
series of tests, which should be used as small number of humidophilic microor-
the basis for that RUMED’s own qual- ganisms belonging to the most diverse
ity assurance purposes. That approach species was identified. Disinfection was
is very complicated and has not pre- generally carried out with commercial-
vailed in practice. We therefore evaluat- ly available, presaturated wipes, with
ed these tests over time and in various contamination risks kept to a minimum
RUMEDs to check the range of results when mixing disinfectant solutions and
obtained from surface contact plating reprocessing cleaning utensils.
tests carried out under real everyday Moulds were also routinely iden-
conditions. In doing so, we followed up tified and on surfaces were interpret-
one RUMED for two years and enrolled ed as microbes recently deposited on
four other RUMEDs of different siz- the surfaces. However, when identified
es and supply areas. This showed that in closed drawers or cabinets they can
the variances are smaller than initial- point to residual humidity.
ly feared. Indeed, very good concord-
ance was observed in particular for the Conclusion
critical surfaces, hence the definition of Since the bioburden on the medical de-
in-house threshold values can be dis- vices being reprocessed is higher in the
pensed with in favour of general ones. cleaning and disinfection zone (C+D

302 Zentralsterilization | Volume 29 | 5/2021

 Appendix: Recommendation for testing the environmental conditions in
a RUMED
Zones: TEST LOCATION
Packing zone
Sterilization zone
Surfaces:
Critical surfaces
Worktops in the packing zone (packing ta-ble, heat sealer station)
Hand-touch surfaces/sites in both zones (e.g. mouse, touch screen, magni-
fying lamp, pistol handle, …)
Storage surfaces in both zones
Non-critical surfaces
Surfaces not coming into contact with re-processed MDs (e.g. MD consign-
ment store, MD release site, thermal protection glove, etc.)
Test material: MATERIAL + SCOPE
Rodac plates
TSA agar or TSA with neutralizer
25 cm², round, rigid, with lid
Scope:
All packing tables/heat sealer stations with at least 3 contact plate samples from:
Worktops and
Hand-touch surfaces
At least, 5 contact plate samples from non-critical surfaces in the packing zone
At least, 5 contact plate samples from critical + non-critical surfaces in the ster-
ilization zone
Frequency intervals:
Frequency intervals must be specified within the respective establishment.
Quarterly tests are recommended; less frequent test intervals can be used if the
results are normal
Conduct: CONDUCT
Sampling is done in workflow
Clearly label the underside of plates with water-proof pen
Record date, time, room + sampling site in the accompanying document/
protocol
With disinfected hands, remove the lid of the Rodac plate without touching the
nutrient medium
Applying gentle pressure, press the nutrient me-dium to the test surface for
around 5 – 10 seconds
Replace the lid without contaminating the nutrient medium
Evaluation: EVALUATION
Total CFU per Rodac plate
Differentiation at species level, including quantitative specification per Rodac
plate of Gram-negative rods, S. aureus, enterococci, streptococci
Differentiation of spore-forming from vegetative microorganisms
Differentiation of other microorganisms as needed for further evaluation (e.g.
coagulase-negative staphylococci, micrococci, moulds, Candida spp.)
Limit values: LIMIT VALUES
Critical surfaces:
≤ 20 CFU/Rodac plate
Non-critical surfaces:
≤ 25 CFU/Rodac plate
The following applies for both surfaces: no evidence of
S. aureus
Humidophilic microorganisms
Pathogenic microorganisms
Limit value overshooting:
Repeat test at unsatisfactory site
In addition, test four similar sites
If the threshold value is exceeded again in the repeat test, documented analysis
of the causes must be conducted and remedial action taken.

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 RECOMMENDATIONS | Environmental conditions and their control in RUMEDs

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1.
Anforderungen an die Hygiene bei der Oberflächenkeimgehaltes auf Einrich- care BMC Research Notes 2014, 7:121
Aufbereitung von Medizinprodukten, tungs- und Bedarfsgegenständen im Le- 14. Wai Khuan Ng How clean is clean: a
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