The Current Challenges in the North American Reprocessing Field and Proposed Solution!

1
The Current Challenges in the North American
Reprocessing Field and Proposed Solution!

• By Colleen Landers
• Registered Nurse
• Consultant

2
Objectives

• Define the major issues facing reprocessing
  departments.
• Provide options to solve these issues.
• Refer to the standards that reprocessing
  departments require to solve these issues.

3
Challenges

• Cleaning and sterilization instructions.
• Turn around demands.
• Sterilization extended cycles.
• Staff orientation, education and competency
  testing.
• Weight of Sets.
• Loaner Sets.
• Flash Sterilization

4
Medical Procedures

• First Do no Harm
• New Millennium Age of the Internet and
  Litigation!!(The Public are informed and
  demanding more
• of HealthCare).

5
Cleaning and Sterilization of Medical Devices

• Medical Devices have become increasingly complex
  as more sophisticated and less invasive surgical
  procedures are developed.
• The manufacturers validated reprocessing
  instructions for these devices have not kept pace
  with the requirements listed in the Canadian and
  American standards.

6
Cleaning and Sterilization of Medical Devices

• Along with this issue, the increased demand to do
  more surgical procedures, requires faster turn
  around of instruments to meet the surgical
  demand.
• Concern regarding the safety of patients
  receiving healthcare in North America has
  required the standards to be reviewed and
  requirements increased.

7
Cleaning of Medical Devices Who is responsible
for What??

• Manufacturers validate that instrument can be
  reliably cleaned and sterilized/disinfected and
  is therefore re-usable.
• Users verify that cleaning sterilization
  equipment is working properly and that
  in-hospital cleaning sterilization methods are
  consistently performed and verified.

8
Medical Device Specific Instructions for
Reprocessing

• What you dont
• Know?

9
Manufacturer recommended cleaning that is not
validated!

• Ivory Snow!
• No detergent! (only sterile distilled water)
• Use regular hospital cleaning protocol!

10
Crud Issue
Patient-used (no side-panel) un cleaned
Patient-used repeatedly side-panel removed
11
Show Me the MONEY!!

• STERILE Crud???- Acetabular reamers- Electronic
  drill Hand pieces
• No infection risk ? ? What is the issue?
• Cost/Benefit What is realistic???

12
Sterile Crud ???

• Foreign organic material- Endotoxin (LPS) from
  dead bacteria- blood and other organic debris
  from previous patient or from cleaning process
  (e.g. enzymatic detergent residuals, water
  organisms etc).
• Adverse antigenic reaction to foreign organic
  material (e.g. implants LPS).
• Foreign body Nidus for endogenous infection.

Xing et al. Accumulation of LPS by polyethylene
particles decreases bone attachment to implants.
J Orthopedic Res 200624959-966
13
Cleaning and Sterilization of Medical Devices

• Health Care Facilities need to make sound
  decisions when purchasing a reusable medical
  device.
• Documents that guide you are
• ISO 17664 Information to be provided by the
  manufacturer for reprocessing of a resterilizable
  medical devices. (CSA Z17664)
• AAMI ST81 Sterilization of medical devices
  Information to be provided by the manufacturer
  for the processing of resterilizable medical
  devices.

14
Comply with ISO 17664 AAMI ST81Validated
Cleaning Methods
Coiled reamer
shafts
Alternative solid shaft
Crud from between coils
15
Information provided by manufacturers

• Adequate and appropriate cleaning and
  sterilization.
• Instruments with cannulation (lumens or holes)
  these instructions need to be device specific
  include ultrasonic. If the device retracts or
  requires disassembly include pictures.
• Instruments with crevices (i.e. nuts, bolts,
  broaches, cutting blocks) device specific.
• Instruments that are hinged (i.e. pliers,
  cutters, forceps) instructions to include
• Cleaning brush size and type
• Ultrasonic
• Lubrication if required type of lubricant that
  is recommended.

16
Information provided by manufacturers

• Flexible reamers Instructions need to be device
  specific including pictures.
• Manufacturers to give maximum number of
  reprocessing times for implants (i.e. screws,
  plates) how to identify when replacement is
  required.
• Manufacturers to review design. Cleaning tools
  should be provided by manufacturers.
• Ensure that when manufacturers update, revise
  and/or change sterilization instructions for
  medical devices the new procedures are
  communicated to the current users in a systematic
  documented fashion.

17
WHY?

• Health Care facilities require a policy and
  procedure requiring all information on
  reprocessing from the manufacturer of the device
  prior to reprocessing cleaning, decontamination,
  wrapping and sterilization.
• Required prior to purchase, lease, trial or
  evaluation or purchase.
• Why?
• To protect the facility from error and
  protect patients from risk.

18
POLICY PROCEDURE FOR ORDERING REUSABLE MEDICAL
DEVICES

• Requires the following
• Purchase approved by the Reprocessing Manager and
  Infection Prevention and Control prior to
  evaluation, consignment, loaned/leased or
  purchases.
• Written manufacturers instructions for cleaning,
  wrapping and sterilization reviewed and
  attainable by Central Processing department
  before purchase.
• In-service for cleaning and sterilization shall
  be provided to all staff, prior to the medical
  device being placed in circulation for use on a
  patient.

19
POLICY PROCEDURE FOR ORDERING REUSABLE MEDICAL
DEVICES

• The decisions to make changes to cleaning
  products, purchases of new equipment for surgical
  procedures, etc., shall be performed by a
  Product Evaluation Team endorsed by the OEM.
• All medical devices that will be loaned/leased,
  used on consignment, evaluated or purchased will
  be reviewed and a decision made by the Product
  Evaluation Team.

20
Why?

• To determine if the medical device can be cleaned
  and sterilized in the facility before evaluation,
  consignment, loaned/leased or purchased in the
  healthcare facility.
• To ensure that the reprocessing will meet the
  requirement for organism kill.
• To prevent risk to patients and staff.

21
Solution

• If healthcare facilities require staff to
  reprocess medical devices then clearly written
  instructions with pictures are required.
• In service of all medical devices given to the
  reprocessing staff on the cleaning, wrapping and
  sterilization prior to the implementation of the
  device in the health care facility.
• Sound decisions, when purchasing the medical
  device, to ensure it can reprocessed in the
  facility to meet the best practices required in
  the standards.

22
Solution

• If increased numbers of surgical procedures are
  required then increase in instrumentation to meet
  these demands is required.
• Short cuts in reprocessing are a risk to
  patients! They are are not a means to meet the
  demand.
• All patients have the right to the same level of
  care and the same level of reprocessed
  instrument.
• ST79 covers these requirements as does CSA Z314.3
  and Z314.8.

23
EXTENDED CYCLES
24
Sterilization Cycles

• Typical steam sterilization method used in health
  care are
• the dynamic air removal cycles.
• Typical cycles are
• 3 Minutes at 135 degrees C (275F)
• 4 Minutes at 132 degrees C (270 F)
• Cycle is dependent upon specific sterilizer
  manufacturer.
• Hospital sterilizers are only validated for these
  hospital
• cycles.
• Gravity cycles rarely used today in healthcare
  facilities.

25
Extended Cycles

• Up to 10 different extended cycle times exist and
  the number grow daily!
• These cycles are greater than the standard
• hospital cycles.
• Extended cycles are now being recommended by
• various device manufacturers.
• e.g. Range of 5 to 40 minutes

26
Sterilizer Manufacturer Validated Cycles
This table represents the variation in
sterilizer manufacturers recommendations for
exposure at different temperatures. For a
specific sterilizer, consult only that
manufacturers recommendations. Dry times have
not been indicated as this varies substantially
depending upon the sterilizer manufacturer,
season and/or other site specific issues. Note
Extracted from AAMI DS2/ST79/2005-02-07
27
Problems

• Large sterilizers are designed to
• accommodate loads of multiple devices
• with similar requirements for sterilization.
• Having only a small number of sets in a large
  sterilizer chamber increases the challenge to
  sterilization and the likelihood that air will
  not be completely removed from the set being
  reprocessed. This may compromise sterilization.
• It is inefficient to run a load with a single
  device that requires a different sterilization
  cycle.
• Sterilizing items in multiple loads does not
  allow
• departments to meet the daily
  sterilization demands.

28
Problems

• Changing the settings on sterilizer
• equipment, for each load, can lead to
• human error resulting in the wrong cycle
• being selected.
• This can lead to devices being weakened,
  destroyed or incorrectly sterilized in subsequent
  loads.

29
Problem

• Packaging for containment of devices or sets
• has not been validated for use in extended
• cycles e.g. reusable and single use wraps,
• pouches, rigid containers and their filters.
• May not maintain sterility .
• May not allow sterilization of all device
  surfaces due to tightness of fitting, excessive
  metal mass or layering of devices.

30
Recommended Solution

• Standardize to a minimum number of cycles e.g.
• one extended cycle, the length of time to be
• determined, in addition to the 3 or 4 minute
  cycle
• routinely used.
• to allow BI and CI manufacturers to develop
  products specific to these cycles.
• to decrease likelihood of human error.
• to increase productivity.
• to decrease likelihood of sterilization failure.

31
Recommended Solutions

• When a device manufacturer develops extended
  cycle recommendations, the type of appropriate
  packaging to be used for the extended cycle
  (reusable or single use wrappers, rigid
  containers or pouches) should be included in the
  validation process.
• Packaging manufacturers should validate their
  products for extended cycle times.

32
AAMI TIR 31- Process Challenge Devices/test packs
used for healthcare facilities.

• The standard extended cycles has been addressed
  in this AAMI TIR.
• They include
• Pre Vacuum cycles 270 274 degrees at
• 10 or 20 minutes.
• Gravity 250 degrees 40 or 60 minutes.
• Recommend Solid Load PCD and Hollow
• Load PCD for each recommended cycle.

33
Proposed Chart for Extended Cycles

Standard Extended Steam Sterilization Cycle Times and Temperature Standard Extended Steam Sterilization Cycle Times and Temperature Standard Extended Steam Sterilization Cycle Times and Temperature Standard Extended Steam Sterilization Cycle Times and Temperature
Cycle Type Temperature Time (minutes)
Dynamic-air removal 132C - 135C (270F - 275F) 10
Dynamic-air removal 132C - 135C (270F - 275F) 20
Gravity-displacement 121C (250F) 40
Gravity-displacement 121C (250F) 60
34
Recommended Solution

• This will allow PCD manufacturers to develop PCDS
  for these cycles.
• Adopted by the ST 8 - Hospital Steam Sterilizers
  so sterilizers validated for these cycles.
• Adopted as hospital cycles in ST79 Comprehensive
  Guide to steam sterilization and sterility
  assurance in health care facilities.
• Wrapping manufacturers can then test their wrap
  at these cycles.
• CSA in Canada has agreed to also adopt these
  cycles recommended.

35
Conclusion Extended Cycles

• Device manufacturers must work together, with
  other manufacturers, to ensure that the
  recommended extended cycle meets capabilities of
  the sterilizer, the packaging, and process
  monitors to be used.
• Health Canada and the FDA, when reviewing pre
  market applications for devices will require the
  medical device manufacturer to provide
  appropriate Validation
• Packaging will be validated for these cycles.
• Process monitoring device will be available for
  these cycles.
• Healthcare sterilizers will be validated for all
  of the hospital cycles recognized as healthcare
  steam sterilization cycles.

36
Staff Orientation, Training and Competency
Testing.
37
Reprocessing Staff

• Since the 1990s with the advent of Minimal
  Invasive Surgery, instruments became complex and
  more difficult to clean.
• Simple instruments like kockers and criles made
  of stainless steel are no longer the norm.
• These changes brought larger challenges for
  cleaning, requiring knowledgeable staff that are
  current and trained.
• Staff now require greater education and critical
  thinking abilities in order to do the cleaning
  and reprocessing safely.
• Reprocessing departments require a Quality System
  
• which requires monitoring and documentation.

38
Quality Control

• Standards require
• Continuous supervision of personnel performance.
• Competency testing.
• Supervision of work practices.
• Ongoing verification of adherence to
• policies and procedures.
• Verification of reprocessing practices.

39
Quality Systems

• Deviations from normal operating procedures are
  identified, investigated and evaluated.
• Corrective action required.
• Audits
• Internal audits by knowledgeable staff to verify
  effectiveness of system. Audit reviews documented
  and corrective action taken.
• Periodic external reviews to measure progress are
  recommended.
• Contractors or other organizations that perform
• functions that could effect quality systems
  then they
• must demonstrate they will have adequate
  control and
• supervisions so as not to effect quality
  system.

40
This Requires Educated Staff with Critical
Thinking Skills!

• Challenge is to find these people and then to
  maintain them in the field.
• Orientation after they obtain a formal course
  requires months of supervision before they can
  function alone.
• Due to the complexity of the instruments and vast
  numbers of sets to master, this does not occur
  overnight.
• Ongoing education, competency testing of staff
  yearly, in service on all new medical devices is
  costly and time consuming.
• Staffing compliments must address release time
  for this to occur and is rarely considered when
  financial allocations are given to reprocessing
  areas.

41
Proposed Solutions

• Require formal education as hiring practice.
• Ensure the staff have job satisfaction.
• Provide ongoing education opportunities for
  staff.
• Have internal audits be opportunities for
  improvement.
• Staff that know why they are required to do
  something do a better job.
• Ensure you have detailed procedure cards for all
  cleaning and reprocessing practices for all
  medical devices that are current and have
  pictures to facilitate processes.
• Provide opportunities for open houses in the
  department so users understand the complex tasks
  the reprocessing staff deal with on a daily
  basis.

42
Proposed Solutions!

• Offer opportunities for user staff to spend time
  in reprocessing.
• Offer opportunities for reprocessing staff to
  view surgical procedures so they understand the
  use of medical devices.
• Celebrate success!
• Teach staff to understand that an error is a
  learning opportunity as long as corrective action
  results.
• Do customer service surveys and involve staff in
  the results and solutions.
• Liaison staff between the operating room and
  reprocessing is a requirement, in order to solve
  issues rather then let them become issues that
  break relationships.

43
Proposed Solutions!

• Reprocessing budgets must include release time
  for training and ongoing education.
• Auditing must be scheduled documented!
• Recommendations must be documented, and
  addressed to improve process and action taken!

44
Why knowledge is Important?
45
Weight of Sets!
Imagine working in a Reprocessing Department or
Operating Room where there is a maximum weight
limit on instrument trays! Imagine that this
maximum weight limit policy is routinely
enforced! Picture your staff no longer
complaining about having to repeatedly lift heavy
trays! Imagine if you did not have to deal with
wet pack problems or other sterilization
concerns due to heavy trays! This vision can
come true by just saying NO to instrument
trays that are too heavy!
46
WEIGHT OF SETS
47
Heavy Sets!

• No matter what the reason for an instrument set
  being on the heavy side, it can be a problem when
  it comes to the sterilization process.
• Overweight sets and sets that do not have the
  metal mass evenly distributed can create concerns
  with adequate steam contact with all surfaces.
• In addition, a problem with drying may result in
  the potential for wet packs.
• The Association of Preoperative Registered Nurses
  (A O R N s) 2006 recommended practice for
  Packaging Systems states rigid container systems
  should be used according to manufacturers
  instructions. The approved sterilization method
  and cycle exposure times for each rigid container
  system should be provided in the manufacturers
  data and instructions.
• Your sterilization standards state weight of a
  wrapped instruments set should be no more then 16
  pounds!
• The sterilizers are validated for this weight.

48
Heavy Sets

• Why? The more mass metal the more steam forms
  water thus drying issues wet packs.
• The new CSA Z314.3 states the total weight with
  container cannot be over 10 kg/22 pounds.
• Sterilization cannot occur unless the steriliant
  can reach all surfaces of the instrument. With
  multi layer sets users must verify that the
  steriliant will sterilize all medical devices in
  all areas.
• Testing with BIs has been done and failure has
  occurred. (User Alert- Problems with process
  monitors for extended cycles)

49
Instrument sets excessive weight mass

• If failure of any BIs report to medical device
  manufacturer
• Break down set to smaller tray sets and re-test

50
Ergonomic Concerns with Heavy Sets

• In the hospital setting we see many injuries of
  staff due to repeated lifting of heavy instrument
  containers.
• The health and safety of healthcare workers
  should be protected through reasonable weight
  restrictions, especially when these trays must be
  lifted an average of 12 to 15 times each time the
  set is used and reprocessed.
• Instrument sets used for a surgical procedure are
  lifted on and off case carts, on and off surgical
  areas, in and out of instrument washers, onto and
  off of processing tables, lifted to be wrapped or
  containerized, into and out of the sterilizer, on
  and off storage shelves, etc.
• This repetitive lifting can be an ergonomic
  nightmare, particularly when the set weight
  exceeds 10kg/22 pounds or if there are several
  heavy sets.
• Studies have shown that repetitive lifting
  greater then 9kg will cause injury to staff such
  as shoulder, arm, back, neck.
• The statistics are showing that these heavy sets
  are making patients of our reprocessing and
  operating room staff.

51
Solution Say No!

• Write policy statement, no instrument set,
  including its package is to exceed 20 pounds.
  Once we had the policy in place we could enforce
  it.
• SPD purchased a scale for the instrument room,
  and the weighed all of the sets that we owned
  that seemed heavy.
• We found about 25 sets that exceeded the 20-pound
  weight limit. The majority of hefty sets were
  orthopedic, and we also found some urology,
  neurology, cardiovascular and retractor sets that
  exceeded our weight limit.
• We put together a list and then asked the OR
  service leader for each area to help us eliminate
  some items in each set or to separate the sets.

52
Solution Say No!

• We then added a deadline of three weeks to
  complete this project, knowing that if we set a
  deadline it was more likely to be completed in a
  timely manner.
• In some instances we were able to remove
  infrequently or unused instruments that were
  added to the set in case they were needed. We put
  these additional items in peel packs or small
  wrappers.
• In other cases, such as cardiovascular (CV) sets,
  we separated the string instruments and the
  retractor and put them in separate smaller pans.

53
Solution!

• The number of pans is irrelevant to the outcome
  of the procedure, as long as the correct items
  are readily available. Moreover, in addition to
  being readily available, the sterility assurance
  of each device had been verified, which is
  essential for safe patient care.
• SPD gets asked to add an instrument to a set, we
  ask if we can remove anything first.
• Once the changes had been made, and the
  sterilization process was verified, the surgeons
  preference lists were updated to reflect the
  changes and the need to pick both parts of a set,
  since some were now in more than one package
  (i.e., trays are labeled A and B). In addition,
  we made sure the pick list made note of just
  in case items to be picked that were taken out
  of sets and wrapped or peel packed separately.
• We realize that even though surgeons may say they
  want everything in one pan, all they really want
  is to make sure they have what they need, when
  they need it. It doesnt matter if it is in one
  or more pans.

54
Weighing Sets and Limiting Weight

Instrument set being weighed
Fukushima Day Retractor set with one level
wrapped separately
.
55
Solution!

• Work with the manufacturers as users to educate
  them that the weight is important and to aim for
  10kg/22 pound weight.
• Users when making purchases start standing up for
  the weight requirement to achieve sterility,
  protect workers as our sterilizers are validated
  with 16 pounds of mass metal.
• Health care committees when making purchasing
  decisions this must be taken into account.
• If we dont say NO to overweight sets, you will
  all be an occupational injury before you reach
  retirement age.
• Remember we are humans not robots!
• Our body will react to abuse by breaking down!
• Why should we make reprocessing and operating
  staff suffer injury when we can divide sets into
  reasonable weights?

56
Loaner Specialty Equipment Sets
57
Loaner Specialty Equipment Sets

• Inventory issues!
• Receipt on site 48 hours prior to scheduled
  surgical procedure.
• - Cleaning- Sterilization
• Quality Control for sets!

58
Loaner Sets

• Healthcare facilities use loaned and shared
  medical devices for a number of procedures for
  potential cost savings from not purchasing
  expensive devices in their inventory.
• Loaned and shared devices allow facilities to
  save on maintenance costs and keep up with
  changing technology.
• The biggest concern comes from those instrument
  sets that we do not own.
• Loaner sets come and go without written
  instructions, pictures, in service, etc. all not
  meeting ISO 17664, AAMI ST81, and CSA Z314.22
  Management of Loaned, Shared, Leased Medical
  Devices.
• If you write your policy for your facility
  meeting these standards you will eliminate the
  problems.

59
Problems!

• Sets coming with no list of items.
• No pictures.
• No cleaning or sterilization instructions.
• No in service.
• Heavy sets.
• Sets received in complete or soiled from previous
  user.
• Come with no time to check and reprocess the sets
  properly.
• Sets received and not sure what is supposed to be
  in the set.
• All of these issues place the patient at risk of
  injury and infection!
• If manufacturers want your business then they
  will follow your policy.
• When doing the evaluation of which vendor you
  will deal with use the standards to set policy to
  get all your concerns addressed.

60
Write Policy as a Solution!

• Policy must address
• Identify responsibilities as sender, receiver,
  qualifications and training of personnel, risk
  management, quality management and insurance.
• Have a policy to cover emergencies related to
  loaned and shared devices including the necessary
  signatures to designate that situation as an
  emergency.
• Not accept Medical Devices unless they are
  licensed by Health Canada and FDA, and conform to
  codes and standards.
• Have procedures in place for sending,
  transporting and receiving of loaned and shared
  devices.
• Have in place mutually accepted written
  documentation, outlining the responsibilities of
  individuals during the transactions between
  senders and receivers.

61
Write Policy as a Solution!

• In written form (e.g. in binders, manuals or
  monographs) and/or electronic format.
• In a central location so they are readily
  accessible and shall be updated as required.
• Documented and reviewed on a regular basis by the
  facilitys Infection Prevention and Control or
  Risk Management personnel, or their designates.
• Policies required for
• Quality system!
• Documentation!

62
Transportation

• Check environmental and handling conditions
  
  
  
  
• required and transport accordingly.
• Routinely clean and maintain the trucks.
• Prevent physical damage, tampering and loss.
• Maintain records of devices transported.
• Deliver the device to the next organization or
  
• facility at the contractually agreed time.

63
Solution to Loaner Set Weights

• How can you enforce the weight limit on those
  sets that we
• borrowed or that the company brought in for us to
  use as
• long as we purchased their implants?
• The answer is in policy. The weight limit
  statement into your loaner policy then shared
  with the MDM representatives that had surgical
  instrument sets in our facility.
• Ask the MDMs to work with you to get their set
  weights down to 20 pounds. Some were very helpful
  and made suggestions on how we could divide the
  sets, while others took a little convincing and
  negotiating to get them to see that if they
  wanted us to sterilize their sets, they had to
  follow our policy.
• Purchase additional instrument container or two
  to house the items removed from the
  vendor-owned sets.
• (MDM medical device manufacturer)

64
Solution to Loaner Set Weights

• Validated for sterilization by the MDM, and even
  lighter by placing them in two containers, we
  could use its sterilization process
  recommendation.
• Follow manufacturers instructions and conduct
  your own sterilization verification testing per
  AAMIs recommendation on product testing.
• When it comes to MDMs sterilization validation
  testing, never take the representatives verbal
  word for it. Always ask for that information in
  writing directly from the MDM.

65
FLASH STERILIZATION
66
What is flash sterilization?
Z314.13-01(CSA) Emergency Sterilization
Which now will be replaced by CSA Z314.3
Why? Flash sterilization - a special steam
sterilization process designed and used for the
emergency sterilization of surgical goods when
proper sterilization cannot be done.
67
Flash Sterilization
Flash sterilization, if used by facility policy,
shall be used only for emergency sterilization
(for example when a dropped instrument requires
immediate sterilization). Flash sterilization
shall not be used to compensate for inventory
shortages or scheduling problems. Flash
sterilizers will be biologically monitored
minimally daily and all items traceable to the
patient.
68
Current practice!
Flashing total sets and implants is
routine. Quick rinse in a sub-sterile room or
scrub-sink area -Uniform or scrub suit sink is
now contaminated Excess flashing due to lack of
inventory and scheduling practices. Flash
Sterilizers with no preventative maintenance No
verification of sterility of items being
sterilized.
69
Where do we need to be?

• Instrument sets should not be flash sterilized.
  Flash sterilizers are only validated for 1-2
  instruments.
• The following conditions shall be met if you are
  flashing
• a) there is an urgent unplanned need
• b) there are documented procedures for this
  practice
• the physical layout and documented procedures
  assure direct delivery of the sterilized item to
  the point of immediate use.
• d) The flash sterilizers has routine preventative
  maintenance that is documented.
• e) Staff trained in reprocessing practices and
  yearly competency testing.

70
Where we need to be contd
d. Proper decontamination of instruments
Performed in a separate room/environment
by people who are properly attired with PPE
(personal protective equipment). CSA Z314.8
e. Load documentation monitoring system is
in place. f. All flashed items tracked to
the patient .
71
Measures to Avoid Flash Sterilization

• Measure to avoid flash sterilization
• maintenance of adequate inventories of medical
  devices
• coordinating device reprocessing with surgical
  schedules so that properly processed devices are
  available when needed
• adherence to policies and procedures for loaned
  and shared instrumentation (see Z314.22) so that
  devices arrive in time for proper reprocessing
  and
• education of medical staff and materials managers
  in the risks associated with flash sterilization
• Computerized booking systems that cannot be
  converted to override inventory.

72
Why not Flash Sterilize?

• Sterilization process itself can be similar to
  sterilization process performed in reprocessing
  department but the lack of pre- and post-
  sterilization precautions introduces additional
  risks to the use of flashed devices.
• The facility has a responsibility to ensure that
  every patient receives the same level of care
  therefore should endeavour to avoid the
  additional risks to patient safety associated
  with flash sterilization.
• Remember that flash sterilizers are only
  validated for 1-2 instruments, and should only be
  used for life and death situations or loss of
  limb not routine for scheduling and lack of
  instrumentation.
• CSA Standard Z314.3 Flash sterilization shall
  not be used on
• complete sets or trays of instruments.

73
What can be done to change?

• Develop policies based on CSA standards that both
• SPD and OR staff could follow and live with!
• How do we do that?
• Research the CSA documents which are best
  practices in reprocessing
• Invite an expert to speak to the Peri-operative
  Policy and Procedure Committee about the CSA
  Standards.
• ORNAC Standards are based on CSA.

74
CSA Standards and ORNAC

• Are they mandatory?

• Why are they written if hospitals cant follow?
  Why write a policy based on CSA Standard that
  cant be upheld due to resources available?

• Do we bend the Standard to fit resources of the
  hospital?

• Lots of great questions!

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What can be done to change practices?

• Develop policies AND..
• Standardize practices throughout Canada for OR
  SPD
• Identify staff competencies
• Develop an education plan
• Decrease flash sterilization
• Share our resources 
• Be a leader!
• Provide every patient with the same level of
  care

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Policies and Procedures

• The requirements for policies, procedures,
  documentation and quality
• system are required.
• If a flash sterilized medical device is used in a
  procedure, an incident
• report shall be created that includes the
  following information
• patients name
• physicians name
• date and time the of procedure using the flash
  sterilized device
• procedure it was used for
• reason that flash sterilization was needed
• results of physical monitoring and biological /
  chemical indicator monitoring of the sterilizer
  and load.
• Periodic review incident reports to help identify
  ways to reduce the need for flash sterilization.

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Policies

• Flash sterilization process is composed of
  several phases that
• are critical to achieving and maintaining
  sterility.
• These phases include
• transport of contaminated devices to
  decontamination area
• disassembly and decontamination
• preparation
• loading the sterilizer
• sterilization procedures
• monitoring and recording of cycle parameters
• unloading and aseptic transfer of items to the
  sterile field.

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Personnel Requirements

• 1. All aspects of emergency steam sterilization
  require
• supervised staff that are knowledgeable,
  trained
• personnel wearing appropriate attire,
  including personal
• protective equipment.
• 2. Personnel must have demonstrated expertise in
  medical
• device reprocessing and in the use and
  application of the
• steam sterilization process.
• 3. Control of bio burden and containment of
  contaminants are essential to the sterilization
  process.

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Personnel Requirements

• 4. The health care facility administration to
  ensure that operators of all steam sterilizers
  used for flash sterilization in the facility are
  trained.
• 5. Education documented with ongoing competency
  in the operation of steam sterilizers.
• 6. Staff are aware of the hazards associated with
  steam sterilizers.
• 7. Monitoring and maintenance of sterilizers
  required.

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Flash Sterilization Personnel

• Flash sterilization personnel must be responsible
  for verifying exposure time and temperature, and
  for aseptically transferring the sterilized items
  to the point of use.
• Personnel engaged in the processing of items for
  flash sterilization require an initial
  orientation and on-the-job training, including
  instruction in the following
• a) sterilizer operation and monitoring
  (sterility assurance)
• b) the parameters of steam sterilization
• c) basic microbiological principles
• d) the health care facility's infection
  control and prevention
• policies and procedures
• e) decontamination of medical devices

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Flash Sterilization Personnel

• f) monitoring of sterilization
• g) preparation of the incident report
• h) action to be taken if there is a failure
  during reprocessing
• i) unloading and transfer to the sterile
  field.
• The facility shall assign specific responsibility
  to a staff
• member or position for the maintenance of quality
  system
• documentation relating to flash sterilization,
  including
• documentation of staff training, and the
  collection, review
• and retention of flash sterilization incident
  reports.

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Work Area for Flash Sterilization

• The steam sterilizer used for flash sterilization
  shall be
• located in a restricted-access area
  immediately adjacent to the area where the
  sterilized items will be used in patient care.
• The sterilizer shall not be located in the
  operating room theatre, and shall not be near any
  potential source of contamination, such as sinks,
  hoppers, linen, or trash disposal areas.
• Sterile storage shall not be located immediately
  adjacent to
• the sterilizer used for flash sterilization.
• Flash sterilization must be carried out in a
  clean environment.
• Devices processed by this method must be
  transferred and handled as little as possible as
  may not be protected by packaging before or
  immediately after the sterilization process.

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Work Area

• At least one flash sterilizer in the OR suite
  shall be on the emergency power system.
• The facility shall have written validation from
  the sterilizer manufacturer that it is suitable
  for flash sterilization and specifying the size
  of loads for which it has been validated.
• All instruments shall be cleaned and
  decontaminated prior to sterilization by trained
  staff wearing appropriate PPE. Refer to Z314.8.
  Saline shall not be used. Before they are
  cleaned, general operating instruments shall be
  separated from delicate instruments or devices
  requiring special handling.

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Work Area Decontame

• Soiled items shall be contained during the
  transport from the point of use to the
  decontamination area.
• They shall be cleaned immediately.
• Gloves and appropriate PPE shall be worn when
  handling soiled items.
• Containment may be accomplished by any means that
  adequately prevents inadvertent personnel contact
  with or exposure to the soiled items during the
  transfer.
• Reusable transportation containers shall be
  cleaned and decontaminated after each use.

85
Sterilization

• High-temperature saturated steam must come into
  direct contact with all surfaces of all items.
• Air removal, steam contact, and drainage of
  condensate are enhanced by proper positioning and
  by the use of perforated or mesh bottom trays.
  Items to be sterilized may be placed in
• (a) protective organizing cases
• (b) open trays
• (c) rigid sterilization container systems
• (d) single wrapped trays
• Closed container system is preferred, to minimize
  the chance
• of contamination occurring between sterilizer and
  patient.

86
STERILIZATION

• The health care facility shall follow the
  device manufacturers instructions, including
  those for
• time and temperature
• load size (including any necessary adjustments to
  time or temperature with relation to load size)
• maximum loads (by weight or by number of
  instruments)
• load configuration
• Each flash sterilization cycle shall be verified
  by the health care facility through actual
  testing of loads configured as specified in the
  manufacturers instructions.

87
Sterilization

• If flashing will occur for life, limb or organ
  emergency disaster then
• after cleaning, items shall be placed in a
  perforated or mesh bottom
• instrument tray and arranged in the following
  manner
• (a) instruments and devices with concave surfaces
  shall be positioned with the open side down
• (b) all hinged instruments shall be opened,
  without engaging the ratchet, and shall be
  placed on racks or stringers as needed
• (c) items with easily removable parts shall be
  disassembled
• (e) for complex instruments (e.g., air-powered
  instruments), the instructions of the device
  manufacturer shall be followed
• (f) lumens of tubing, suction devices, and
  needles shall be moistened with pyrogen-free
  water immediately prior to steam sterilization.

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Do Health Care facilities meet these requirements?

• Auditing of healthcare facilities across the
  nation will show that most
• do not meet these requirements.
• Most
• Wash instruments in scrub sinks or small sink in
  between OR theatres.
• Decontame areas not under negative pressure
  Z314.8
• Maintenance on these sterilizers not done,
  sterilizers not cleaned, records not kept. Some
  so old should be replaced.
• Staff not trained to reprocess and do not have
  competency testing or required education.
• It goes on and
  on!

89
Notice from Ministry Ontario of Health re Flash
Sterilization
90
Do you meet all these requirements?

• IF NOT YOUR FACILITY NEEDS
• TO TAKE ON A PROJECT TO
• IMPROVE PROCESS!

91
Implement to improve patient care!
92
Set up a Quality Improvement Project

• Joint Quality Assurance/Accreditation Project
• Sterile Processing Department and Surgical
  Suites
• Called The Flash Project.
• Must have buy in from all parties!
• Why do it? Best Practices are provided in the CSA
  standards and every facility should be aiming
  for these practices.
• Accreditation will now be examining flashing
  practices as a part of their review.

93
Reprocessing Challenges!

• I have touched on a few challenges but there are
  many more.
• Reprocessing is complex, always changing, and a
  very demanding profession!
• It requires ongoing education, and knowledge that
  is current.
• Staff with critical thinking skills,
  knowledgeable is required.
• Reprocessing staff must be the patient advocates!

94
Change can be accomplished!

• Working together for the betterment of the
  patient we can all meet best practices in
  reprocessing as
• Remember!
• You could be that patient having a surgical
  procedure and
• would you want a totally processed instrument or
  a flashed
• one?
• I know what I would want and so do you!

95
Remember!We
never know when we will require treatment in the
facility we work at! Always advocate for all
patients!When any reprocessing staff or their
family require care, we want to know that the
instruments are the best quality and meet
standards!
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What Can We do?

• Raise the bar in reprocessing!
• Ensure all patients are not put at risk during
  their hospital stay!
• PARTNERSHIP
• OPTIMAL PATIENT CARE
• REQUIRES WORKING
• TOGETHER!

97
References

• AAMI ST 79 Comprehensive guide to steam
  sterilization and sterility assurance in a health
  care facilities
• AAMI TIR 31 Process Challenge devices/test packs
  for use in health care facilities
• CSA Z314.3 Effective Sterilization in Health Care
  Facilities by the Steam Process
• CSA Z314.8 Decontamination of Reusable Medical
  Devices
• CSA Z314.22 Management of Loaned, Shared and
  Leased Medical Devices
• Just Say No by Rose Seavey RN, MBA, CNOR, ACSP
• Best Practices for Cleaning, Disinfection and
  Sterilization in Health Care Facilities

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Lets all provide every patient with the care
that we all would like to receive!
Questions!