[Federal Register Volume 89, Number 156 (Tuesday, August 13, 2024)]
[Notices]
[Pages 65911-65912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17935]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Environmental, Clinical 
and Economic Outcomes of Hospital Resources To Prevent Hospital-
Acquired Infections

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for supplemental evidence and data submission.

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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public. Scientific 
information is being solicited to inform our review on Environmental, 
Clinical and Economic Outcomes of Hospital Resources to Prevent 
Hospital-Acquired Infections, which is currently being conducted by the 
AHRQ's Evidence-based Practice Centers (EPC) Program. Access to 
published and unpublished pertinent scientific information will improve 
the quality of this review.

DATES: Submission Deadline on or before September 12, 2024.

ADDRESSES: 
    Email submissions: [email protected].
    Print submissions:
    Mailing Address: Center for Evidence and Practice Improvement, 
Agency for Healthcare Research and Quality, ATTN: EPC SEADs 
Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.
    Shipping Address (FedEx, UPS, etc.): Center for Evidence and 
Practice Improvement, Agency for Healthcare Research and Quality, ATTN: 
EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, 
MD 20857.

FOR FURTHER INFORMATION CONTACT:  Kelly Carper, Telephone: 301-427-1656 
or Email: [email protected].

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Centers (EPC) 
Program to complete a review of the evidence for Environmental, 
Clinical and Economic Outcomes of Hospital Resources to Prevent 
Hospital-Acquired Infections. AHRQ is conducting this review pursuant 
to section 902 of the Public Health Service Act, 42 U.S.C. 299a.
    The EPC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. In 
order to do so, we are supplementing the usual manual and electronic 
database searches of the literature by requesting information from the 
public (e.g., details of studies conducted). We are looking for studies 
that report on Environmental, Clinical and Economic Outcomes of 
Hospital Resources to Prevent Hospital-Acquired Infections. The entire 
research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/prevent-hai/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Environmental, Clinical and Economic Outcomes 
of Hospital Resources to Prevent Hospital-Acquired Infections helpful:
    [ssquf] A list of completed studies that your organization has 
sponsored for this topic. In the list, please indicate whether results 
are available on ClinicalTrials.gov along with the ClinicalTrials.gov 
trial number.
    [ssquf] For completed studies that do not have results on 
ClinicalTrials.gov, a summary, including the following elements, if 
relevant: study number, study period, design, methodology, indication 
and diagnosis, proper use instructions, inclusion and exclusion 
criteria, primary and secondary outcomes, baseline characteristics, 
number of patients screened/eligible/enrolled/lost to follow-up/
withdrawn/analyzed, effectiveness/efficacy, and safety results.
    [ssquf] A list of ongoing studies that your organization has 
sponsored for this topic. In the list, please provide the 
ClinicalTrials.gov trial number or, if the trial is not registered, the 
protocol for the study including, if relevant, a study number, the 
study period, design, methodology, indication and diagnosis, proper use 
instructions, inclusion and exclusion criteria, and primary and 
secondary outcomes.
    [ssquf] Description of whether the above studies constitute ALL 
Phase II and above clinical trials sponsored by your organization for 
this topic and an index outlining the relevant information in each 
submitted file.
    Your contribution is very beneficial to the Program. Materials 
submitted must be publicly available or able to be made public. 
Materials that are considered confidential; marketing materials; study 
types not included in the review; or information on topics not included 
in the review cannot be used by the EPC Program. This is a voluntary 
request for information, and all costs for complying with this request 
must be borne by the submitter.
    The draft of this review will be posted on AHRQ's EPC Program 
website and available for public comment for a period of 4 weeks. If 
you would like to be notified when the draft is posted, please sign up 
for the email list at: https://effectivehealthcare.ahrq.gov/email-updates.
    The review will answer the following questions. This information is 
provided as background. AHRQ is not requesting that the public provide 
answers to these questions.

Guiding Questions (GQ)

    GQ 1. What healthcare research examines the health, economic, and 
environmental outcomes of reprocessed reusable devices and items or 
reprocessed single-use devices and items compared with non-reprocessed 
single-use devices and items in hospital settings?
    GQ 2. What are key evidence gaps and opportunities for future 
research?

[[Page 65912]]



 PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and
                Setting) Inclusion and Exclusion Criteria
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         Category             Inclusion criteria     Exclusion criteria
------------------------------------------------------------------------
Population................  Primary: Individuals   Individuals receiving
                             receiving acute        ambulatory care.
                             medical care.
                            Secondary: Healthcare
                             workers using or
                             caring for devices
                             used in patient care.
Interventions.............  Primary interest:      Devices/items with
                             Devices/items that     minimal or no
                             are intended to        pathogen
                             prevent infection or   transmission risk.
                             are used for general  Devices/items
                             bedside care,          primarily used in an
                             including but not      ambulatory or non-
                             limited to PPE,        acute-care setting.
                             drapes, linens,       Devices/items that
                             laryngoscopes, blood   have been
                             pressure cuffs,        reprocessed under
                             pulse oximeters.       emergency use
                            Secondary interest:     authorization only.
                             Other devices/items   Implantable devices
                             used during hospital   other than
                             care, including but    catheters.
                             not limited to:
                             surgical devices,
                             other scopes.
                            Regulatory status:
                             All devices/items
                             must be either.
                                FDA
                                approved as
                                reusable, and
                                reprocessed per
                                specifications.
                            OR
                               
                                Designated as
                                single-use, FDA
                                authorized for
                                reprocessing, and
                                reprocessed per
                                specifications.
Comparators...............  Devices/items that     Single-use devices/
                             are approved as        items for which no
                             single-use and are     reusable or
                             discarded after one    authorized
                             use.                   reprocessed
                                                    alternatives are
                                                    available in the US.
Outcomes..................  Health outcomes        Quality of
                             (Patient-level or      reprocessing.
                             aggregated patient    Usability by
                             data).                 healthcare workers
                            Outcomes include but    or patients.
                             are not limited to:   Device/item
                             HAI, SSI, or           preferences of
                             pathogen               healthcare workers
                             transmission           or patients.
                             (including MDRO;      Device/item
                             Sepsis; ICU stay       availability.
                             related to HAI;       Bacterial
                             Length of stay;        colonization of
                             Mortality; Adverse     device/item.
                             effects; Healthcare
                             worker infection or
                             injury.
                            Economic outcomes
                             (Hospital/health
                             system perspective).
                            Outcomes include but
                             are not limited to:
                             Procurement cost;
                             Cost per procedure/
                             use; Costs for:
                             reprocessing,
                             transportation,
                             storage,
                             functionality
                             testing,
                             maintenance, repair,
                             disposal,
                             replacement; Supply
                             chain implications.
                            Environmental
                             outcomes
                            a. Environmental
                             impact
                            (Global, national, or
                             regional
                             perspective).
                            Outcomes include but
                             are not limited to:
                             Greenhouse gas
                             emissions; Air
                             pollution; Water
                             use; Water
                             contamination;
                             Energy use; Chemical
                             use and toxicity;
                             Recycling volume;
                             Landfill use;
                             Carcinogenic
                             exposure; Climate
                             change; Raw material
                             extraction and
                             processing.
                            b. Environmental
                             health
                            (Population health
                             perspective).
                            Outcomes include but
                             are not limited to:
                             Respiratory illness;
                             Cardiovascular
                             disease; Cancer
                             risk; Infectious
                             disease outbreaks.
Timing....................  Any..................  NA.
Setting...................  Acute care hospitals   Non-hospital
                             in countries rated     settings.
                             ``very high'' on the  Other countries.
                             2021 Human
                             Development Index
                             (as defined by the
                             United Nations
                             Development
                             Programme) *.
Publication type..........  English language.....  Non-English-language,
                            For primary interest    abstracts, case
                             interventions          reports, non-
                             (devices/items used    comparative studies,
                             to prevent             narrative reviews,
                             infections or for      commentaries,
                             general bedside        guidelines.
                             care): SRs,
                             randomized
                             controlled trials,
                             nonrandomized
                             controlled studies.
                            For secondary
                             interest
                             interventions (other
                             devices/items used
                             for hospital care):
                             SRs.
------------------------------------------------------------------------
FDA: Food and Drug Administration; HAI: Healthcare-associated infection;
  ICU: Intensive care unit; MDRO: Multi-drug resistant organism; NA: Not
  applicable; PPE: Personal protective equipment; SR: Systematic review;
  SSI: Surgical site infection; US: United States.
* Human development index. United Nations Development Programme.
  Accessed April 16, 2024. https://hdr.undp.org/data-center/human-development-index#/indicies/HDI.


Mamatha Pancholi,
Deputy Director.
[FR Doc. 2024-17935 Filed 8-12-24; 8:45 am]
BILLING CODE 4160-90-P