Ken’s Take on the World


Preparing the Central Sterile Processing Department for Ebola

Ebola electron photograph Photo MD Health

The Ebola virus is something that has been on the mind of virtually every American these days.  In addition to becoming a formal public health concern within the past month and a half, it has managed to become a political issue.  The fact this has become a political issue is disappointing and a topic for a different post.  This post is to inform readers of preparations that must be made to protect healthcare providers from the very real possibility of providing medical care to a patient who presents with symptoms that are consistent with the Ebola virus.

Hospitals in the United States have already provided care for at least seven individuals who have become infected with Ebola virus.  This includes two missionary medical aid workers who contracted the virus while working with Africa, a man from Liberia who arrived in the Dallas Texas area, two nurses who cared for the Texas patient, and a cameraman for a media outlet that was covering the epidemic in west Africa.  The infections involving the two nurses who provided care for Thomas Duncan, the Texas patient, are troubling and put on display flaws with the Centers for Disease Control and Prevention (CDC) response to the currently unfolding public health situation.  While I have great respect and admiration for the CDC, and especially the work of Dr. Anthony Fauci who I personally admire a great deal, I am disappointed with their response to the current situation unfolding in the US with regards to Ebola.  Dr. Fauci has been the single beacon of confidence in the current conversation on this major public health concern.

It is important to note that not a single healthcare worker involved in the treatment of the two missionary workers contracted Ebola during their care of these patients.  It is also wise to note that no healthcare worker who provided care to Mr. Duncan during his initial visit to Dallas Presbyterian Hospital nor the Emergency Medical Technicians (EMT’s) who transported Mr. Duncan to the hospital a couple of days later have contracted the virus.  None of Mr. Duncan’s personal contacts on the area in which he was staying prior to his admission to the hospital were infected either.  These bits of news should provide some reassurance to an American public that seems to thrive on fear and conspiracy.

This brings us to the two nurses who, apparently, provided care to Mr. Duncan after he was admitted into the hospital.  By all accounts, these two nurses, as well as other nurses, technicians and physicians who cared for him until his demise in the hospital from multiple-organ failure, were wearing at least the level of personal protective equipment (PPE) that had been recommended by the CDC.  Guidance on donning (putting on) and doffing (removal) of PPE has been made available on the CDC website here: http://www.cdc.gov/sars/downloads/ppeposter1322.pdf  I have found this document to be flawed in regards to the acceptable level of PPE required for the safe and effective care of a patient in the most contagious stages of Ebola virus infection and, in particular, with the sequence for removal of PPE in any case.  However, until now, this is what healthcare workers have had for a resource.  In defense of the CDC, they have stated that the PPE guidelines provided are the minimum levels of protection for healthcare workers caring for a patient with confirmed or suspected Ebola virus infection.  This is not very reassuring.

Donning PPE

It is believed that the two nurses that have become infected with Ebola following the care of their patient may have inadvertently contaminated themselves during removal of their contaminated PPE.  This, in itself, is a tragedy.  It is likely that additional healthcare workers caring for Ebola patients using the same measures could become infected based on the selection of PPE and if they are removing their PPE using the steps outlined by the CDC.

Part of the rationale behind the CDC’s guidance is an awareness that very few American hospitals currently have the capacity to provide enhanced forms of PPE for significant numbers of their healthcare providers.  Full protective suits and gear are limited and stockpiled in small quantities for acute, transient, emergencies and quantities necessary to provide extended care for a patient requiring such gear is not on hand in most facilities.  I have learned this at my own facility as I began researching to prepare a policy for, specifically, Central Sterile Processing Department (CSPD) staff members who will be on the front lines of cleaning, decontaminating, disinfecting and sterilizing items used in the care of a patient with Ebola.

To date, no patient hospitalized for treatment of Ebola in the United States has required surgical intervention in the course of their treatment or recovery.  This is great news, because there is currently no guidance from the CDC on how to handle surgical intervention on such a patient.  The American College of Surgeons has issued guidance on surgical intervention for a patient with Ebola virus infection here: https://www.facs.org/ebola/surgical-protocol  This is a good resource for Operating Room (OR) team members including surgeons, nurses, anesthesia providers and surgical technologists.  It does not, however, address the concerns related to the reprocessing of items used in surgical procedures for these patients.  In my contacts with other CSPD managers, including at US hospitals that have treated patients with Ebola, there are no policies in place and the comments are that they are, essentially, relying on current CDC guidance if necessary.

Below is the first draft of a policy specifically addressing the needs of CSPD staff members who will bear the responsibility of cleaning, decontaminating, disinfecting, and sterilizing items used in the care of a patient with Ebola virus infection.  I am also attaching two of the appendices that address donning and doffing of PPE.  Perhaps someone at the CDC might incorporate these into a poster format!

While the vast majority of US hospitals are currently unprepared to handle an onslaught of Ebola cases, I have extreme confidence that most hospitals can safely and effectively care for a patient infected with the Ebola virus if they are given the proper resources and training.  It is critical to tamp down the hysteria and fear surrounding Ebola and base our actions on a scientific understanding and using evidence-based measures for providing care that is safe and effective for both our patients and our healthcare workers.

The Policy:

Handling and Processing of Items Exposed, or Potentially Exposed, to Ebola or Other Hemorrhagic Fever Patients

Purpose:

To provide guidance and direction for Central Sterile Processing personnel on the handling of instruments and durable medical equipment (DME) exposed, or potentially exposed, to the blood or other body fluids of a confirmed, or suspected, patient with Ebola, other hemorrhagic fever viruses.

Rationale:

XXXXXXXXXXX serves as the primary quarantine facility for travelers arriving through Detroit Metropolitan Airport.  The possibility exists for a disembarking passenger to present to airport officials with symptoms that may be consistent with suspected infection with Ebola, or other hemorrhagic fever, viruses.

To ensure that all proper infection control practices are implemented in order to protect staff members, patients, visitors and others who may be exposed to surgical instrumentation or durable medical equipment (DME) that has been used on a patient with confirmed, or suspected, infection with Ebola, or other hemorrhagic fever, viruses.

Policy:

All Central Sterile Processing personnel must follow specific guidelines when handling surgical instrumentation and durable medical equipment (DME) that has been exposed, or potentially exposed, to the blood, or other bodily fluids, of a patient with confirmed, or suspected, infection with Ebola, or other hemorrhagic fever, viruses.

Procedure:

It is the responsibility of the attending physician to notify the Infection Control (IC) Director, or her/his designee, anytime a patient presents with symptoms consistent with exposure to, or infection with, Ebola, or other hemorrhagic fever, viruses.

The Infection Control (IC) Director, or her/his designee will notify, in addition to other appropriate Managers, the Manager of the Central Sterile Processing Department (CSPD), that a patient with confirmed, or suspected, Ebola, or other hemorrhagic fever, viruses has been admitted to the facility.

The Manager of the Central Sterile Processing Department (CSPD), or her/his designee, will work with other appropriate Managers to ensure that items necessary for the cleaning, decontamination, disinfection and/or sterilization of items used in the care of patients with confirmed, or suspected, Ebola, or other hemorrhagic fever, viruses are readily available for staff members within CSPD.  (See Appendix A)

The Manager of the Central Sterile Processing Department (CSPD) will ensure that appropriate education and training has been conducted for all staff members responsible for the cleaning, decontamination, processing, disinfection and/or sterilization of surgical instrumentation, or durable medical equipment (DME), used on a patient with confirmed, or suspected, Ebola, or other hemorrhagic fever, viruses.

The Manager of the Central Sterile Processing Department (CSPD) will maintain documentation of the qualifications of CSPD staff members with regard to the cleaning, decontamination, processing, disinfection and/or sterilization of surgical instrumentation, or durable medical equipment (DME), used on a patient with confirmed, or suspected, infection with Ebola, or other hemorrhagic fever, viruses.  The Manager of CSPD, or her/his designee, will be responsible for conducting annual in-service education and training for addressing Ebola, or other hemorrhagic fever, viruses.

The Nurse Manager, or her/his designee, of a unit providing care for a patient with a confirmed, or suspected, diagnosis of infection with Ebola, or other hemorrhagic fever, viruses will immediately notify the Central Sterile Processing Department (CSPD) Manager, or her/his designee, when an item used in the care of the patient is to be transported for processing by the CSPD.

Items transported to the Central Sterile Processing Department (CSPD) must be contained within a sealed, impervious, barrier.  Small items should be transported within an enclosed, or covered cart and not carried by hand.  Durable medical equipment (DME) should be contained within a large plastic bag, or similar impervious containment device, and transported on a cart that is also covered, where possible. Isolation carts, crash carts and other wheeled carts or equipment that have been used in the care of a patient with confirmed, or suspected, infection with Ebola, or other hemorrhagic fever, viruses are to be covered with a large plastic bag, or similar impervious containment device, for transportation to the decontamination area.  Fluids are to be contained within sealed suction canisters.  Linen and trash must be contained within autoclaveable, leak resistant bags.  These bags must then be contained in impervious bags for transport to the CSPD.  Items that cannot be autoclaved must be segregated and discarded in red biohazard containers that are leak-proof and puncture-proof.

Items transported from a patient care area to the decontamination area must be constantly attended.  Items are not to be placed on an elevator or left in hallways awaiting transportation.  Contaminated items are not to be transported through the pneumatic tube system.  The person delivering the item(s) to the decontamination area must immediately notify the Sterile Processing Technician on duty that an item has been delivered to the decontamination area.  The Sterile Processing Technician on duty must immediately notify the Central Sterile Processing Department (CSPD) Supervisor on duty or on call.  The CSPD Supervisor will designate qualified individuals to perform the cleaning and decontamination of items associated with the care of a patient with confirmed, or suspected, infection with Ebola, or other hemorrhagic fever, viruses.  The CSPD Supervisor will directly supervise the cleaning and decontamination of such items.

The Central Sterile Processing Department (CSPD) Supervisor will ensure the decontamination area is prepared and appropriately stocked for the decontamination process.  (See Appendix B)

Central Sterile Processing Department (CSPD) staff members assigned to the cleaning and decontamination of items used in the care of a patient with confirmed, or suspected, infection with Ebola, or other hemorrhagic fever, viruses are to wear specific personal protective equipment (PPE). (See Appendix D)  CSPD staff members are to work in pairs as assigned by the CSPD Supervisor.  One staff member is designated as the “Primary” Technician and the other is designated as the “Secondary” Technician.  Both staff members shall wear the specific personal protective equipment (PPE) required for this process.  All other staff members are to be removed from the decontamination area for the duration of the cleaning and decontamination process of items associated with the care of a patient with confirmed, or suspected, infection with Ebola, or other hemorrhagic fever, viruses.

The cleaning and decontamination process for surgical instrumentation used in the care of a patient with confirmed, or suspected, infection with Ebola, or other hemorrhagic fever, viruses is consistent with established cleaning and decontamination processes recommended by the Association for the Advancement of Medical Instrumentation (AAMI), the Association of Professionals in Infection Control (APIC) and the Association of Perioperative Registered Nurses (AORN) regarding the cleaning and decontamination of any surgical instrumentation.  In all cases, manufacturer instructions for use (IFU’s) must be followed consistently.  NOTE:  Surgical instrumentation that cannot be processed using immersion, automated cleaning processes, ultrasonic cleaning, or high-temperature sterilization methods should not generally be used in the care of a patient with confirmed, or suspected, infection with Ebola, or other hemorrhagic fever, viruses.

The Primary Technician will be responsible for performing all tasks associated with the cleaning, decontamination and disinfection of surgical instrumentation and durable medical equipment (DME) associated with a patient with confirmed, or suspected, Ebola, or other hemorrhagic fever, viruses.  The Secondary Technician will be responsible for ensuring no other personnel enter the decontamination area during this process, as well as directly observing the Primary Technician to identify any compromise in the personal protective equipment (PPE) and ensuring that the process for removal of PPE by the Primary Technician is performed properly.

Durable medical equipment (DME) used in the care of a patient with confirmed, or suspected, infection with Ebola, or other hemorrhagic fever, viruses is to be cleaned using an appropriate, hospital-grade, disinfectant that is capable of inactivating non-enveloped viruses.  Adherence to wet times is to be strictly enforced.  Wheeled equipment, including IV poles, crash carts, isolation carts, stretchers, wheelchairs, etc are to have all surfaces, including wheels, wiped down with approved, hospital-grade disinfectants that are capable of inactivating non-enveloped viruses.

Donning Specialized PPE:

Appendix D—Donning of personal protective equipment (PPE) for the cleaning, decontamination, disinfection and sterilization of items involved in the care of a patient with confirmed, or suspected, infection with Ebola, or other hemorrhagic fever, viruses

 

The employees who are assigned as “Primary” or “Secondary” Technician will be identically attired for the duration of the cleaning and decontamination process.

  1. The employees will don disposable scrub tops and pants.
  1. The employees will remove all jewelry including earrings, bracelets, necklaces, finger

            rings, and wristwatches.

  1. The employees will apply standard shoe covers over shoes.
  1. The employees will wear a hair cover and a surgical mask (if they will be wearing a

completely enclosed hood) or N95 high-filtration disposable respirator mask.

  1. The employees will don a pair of surgical-grade gloves ensuring adequate fit.
  1. The employees will don a Tyvek® biohazard suit hood. Ensure flaps of hood are

fully extended down the front and the back.  NOTE:  This is for a suit with a

separate hood/face-shield.  Attire must comply with ASTM: F1671.

  1. The employees will don a Tyvek® biohazard suit with attached booties. If the suit

does not have attached booties (one-piece), the employees will need to don water-

proof, disposable, knee-high booties.  The employees will ensure that the hood

flaps are completely contained within the suit.  Attire must comply with ASTM: F1671.

  1. The employees will use Duct tape to completely seal the sleeve to the inner gloves

making sure to leave a one (1) inch flap of tape for removal after the cleaning and

decontamination process.  Duct tape will also be used to seal knee-high booties if

these are worn leaving a one (1) inch flap of tape for removal.

  1. The employees will use Duct tape to completely seal the collar of the suit and the

body of the suit making sure to leave a one (1) inch flap of tape for removal after

the cleaning and decontamination process.  NOTE:  This is for a suit with a separate

hood/face-shield.

  1. The employees will use Duct tape to completely seal the zippers of the Tyvek® suit

making sure to leave a one (1) inch flap of tape for removal after the cleaning and

decontamination process.

  1. If the Tyvek® suit does not have an enclosed hood with face-shield, the employees

will don fully-enclosed goggles that secure with an elastic band AND a full face-shield.

  1. The employees will don a second pair of gloves that must be at least surgical-grade or

thicker-ply.

  1. The employees will use Duct tape to completely seal the outer glove and sleeve

making sure to leave a one (1) inch flap for removal after the cleaning and

decontamination process.

  1. The Central Sterile Processing Department (CSPD) Supervisor will verify that all

steps of the PPE donning process have been followed before permitting the

Technicians to enter the decontamination area.  This includes ensuring all areas

have been taped/sealed properly.

Removal of PPE:

Appendix E—Doffing (Removal of) personal protective equipment (PPE) used in the cleaning, decontamination, disinfection and/or sterilization of items involved in the care of a patient with confirmed, or suspected, infection with Ebola, or other hemorrhagic fever, viruses

The employees who are assigned as “Primary” or “Secondary” Technician will be identically attired for the duration of the cleaning and decontamination process.  Personal protective equipment (PPE) is to be removed in a specific order in order to reduce the risk of inadvertent contamination of self during the removal of this gear.  The Central Sterile Processing Department (CSPD) Supervisor will directly observe the removal of PPE to ensure there are no breaks in technique.

  1. Verify the decontamination area has been properly cleaned and all items exposed,

or potentially exposed, to any contamination resulting from the cleaning and

decontamination process have been correctly disposed of.

  1. Position waste hamper with empty, autoclaveable, waste bag near tarpaulin that

has been positioned on the floor near the entry vestibule.

  1. Step onto tarpaulin to be sprayed off with approved, hospital-grade, disinfectant

ensuring that all surfaces of the PPE has been wetted.

  1. After the established wet-time criteria has been met, PPE may be removed in the

following order:

  1. Face-shield (if worn) is removed by grasping strap at back of head and pulling

up and over the head.  NOTE:  Applies if a separate hood/face-shield was not

worn.  Discard in waste hamper.

  1. Goggles (if worn) are removed by grasping strap at back of head and pulling

up and over the head.  NOTE:  Applies if a separate hood/face-shield was not

worn.  Discard in waste hamper.

  1. Remove each strip of Duct tape by pulling on tab left during donning of PPE.

Exercise care to not tear Tyvek® suit material.  Roll tape between hands into

a ball and discard into waste hamper.

  1. Remove booties (if used) and discard in waste hamper.
  2. Unzip Tyvek® suit exercising care to not let gloves touch scrubs.
  3. Remove outer gloves and discard in waste hamper.
  4. Remove Duct tape from inner glove/sleeve by pulling on tab left during

donning of PPE.

  1. One-piece suit—Grasp back of hood and pull back and downwards rolling

suit down back and arms ensuring outside of suit does not come into

contact with skin or scrubs.  Carefully step out of suit and off tarpaulin onto

clean floor.  Carefully roll suit up, ensuring suit does not come into contact with

skin or scrubs, and discard into waste hamper.

  1. Two-piece suit—Grasp suit at shoulders and pull back and downwards rolling

suit down back and arms ensuring outside of suit does not come into contact

with skin or scrubs.  Remove hood by grasping material of hood and pulling up

and over the head, ensuring outside of hood does not come into contact with

skin or scrubs, and discard in waste hamper.  Carefully step out of suit and off

tarpaulin onto clean floor.  Carefully roll suit up, ensuring suit does not come

into contact with skin or scrubs, and discard in waste hamper.

  1. Remove first inner glove by grasping palm of second glove and pulling downward

and off hand and discard in waste hamper.

  1. Remove second inner glove by sliding finger under cuff and rolling glove down

and off fingers and discard in waste hamper.

  1. The Primary and Secondary Technician will each don a pair of gloves then an impervious

gown and a pair of outer gloves to roll up and discard the tarpaulin, secure the waste

hamper and place hamper on autoclave cart.  The waste hamper is to be

decontaminated as other pieces of equipment.  These items will then be removed as

described above and discarded in a regular waste hamper along with shoe covers,

hair covers, masks, and disposable scrub tops and pants.  Clean scrub tops and pants will

be immediately available in the vestibule to change into.

  1. Remove mask by untying strings, or by grasping band, and pulling up and over

head and away from face.

  1. Remove hair cover by grasping top and pulling up and over head.
  2. Remove shoe covers by grasping shoe cover at heel and pulling down and

toward toes.

  1. Remove first glove by grasping palm of second glove and pulling downward

and off hand.

  1. Remove second glove by sliding finger under cuff and rolling glove down and

off fingers.

  1. The Primary and Secondary Technician will be escorted to an area where they are to

perform hand-washing and be permitted the opportunity to shower.

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1 Comment so far
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