FDA Bans Use of Powdered Gloves

Noncompliance Cited at Joint Commission Standard

The US Food and Drug Administration (FDA) recently published a final rule banning the use of powdered gloves.* As stated in the citation summary, “The Food and Drug Administration (FDA or Agency) has determined that Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling. Consequently, FDA is banning these devices. This rule is effective on January 18, 2017.”

Further clarification in the final rule indicates that “the ban applies to all powdered surgeon’s gloves and powdered patient examination gloves without reference to the type of material from which they are made. Additionally, the identification of non-powdered surgeon’s gloves and non-powdered patient examination gloves is also being revised to remove reference to material.”

As a result of this FDA ban, The Joint Commission now evaluates organizations to assure that required implementation of non-powdered glove use occurs as part of the routine survey evaluation. Effective January 18, 2017, for all accreditation programs, instances of noncompliance are being cited at Leadership (LD) Standard LD 04.01.01, Element of Performance (EP) 2: The [organization] provides care, treatment, and services in accordance with licensure requirements, laws, and rules and regulations.”

The final rule also provides guidance on the proper disposal of remaining stock of powdered gloves, recommending that “unused supplies at hospitals, outpatient centers, clinics, medical and dental offices, other service delivery points (nursing homes, etc.), and in the possession of end users, will need to be disposed of according to established procedures of the local community’s waste management system.” While it is important for organizations to address and manage the disposal process, The Joint Commission will not evaluate the organization’s disposal process of any remaining stock because this is outside the scope of the Joint Commission survey.

Questions may be submitted via the form at: https://web.jointcommission.org/sigsubmission/sigquestionform.aspx

* US Food and Drug Administration (FDA). Banned Devices; Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove. Accessed Feb 9, 2016. federalregister.gov


Preventing violent and criminal events in a healthcare setting

Anyone in a health care facility can become a victim of violence. Since January 2010, The Joint Commission has received 185 reports of violent criminal events from its accredited organizations. Of these, 102 were patient-on-patient violence (61 rapes, 22 homicides and 18 physical assaults). Six of the physical assaults were patient-on-staff violence. Half of the 185 reports were committed by and/or on behavioral health/psychiatric patients, or in a behavioral health setting.

The majority of homicides and physical assaults involved beating, punching or kicking, or strangulation or asphyxiation. Of the injuries sustained, the most common were head injury, head trauma, or eye injury. Of the 28 reports of physical assault, six resulted in the death of the victim and six resulted in permanent loss of function.

Safety Actions to Consider:

While risk factors for violence vary depending on the facility and the patient population, the following general prevention strategies may be considered, especially if your organization’s patient population includes behavioral health or psychiatric patients.

Identify risks and plan to reduce those risks:

  • ♦  Form a multidisciplinary committee (such as the environment of care or safety committee) that includes direct-care staff and union representatives (if available) to identify risk factors in specific work scenarios and to develop risk reduction strategies.
  • ♦  Conduct a risk assessment of the organization, including geographic location and service area, as violent offenders may travel to your site seeking services.
  • ♦  Conduct an assessment of risks associated with the patient population. Periodically reassess for those risks and any new risks.
  • ◊ In non-acute care settings, determine admission and exclusionary criteria for patients who have a history of violence and who pose a risk to existing patients and staff.
  • ♦  Survey employees to determine how safe they feel while working, and how prepared they are for handling violent situations.
  • ♦  Maintain an ongoing dialogue with local law enforcement regarding risk factors in the community (for example, gangs), and the local crime rate. Although the facility may be located in a low crime area, patients and their families may be from other areas.
  • ♦  Implement a comprehensive violence prevention program and periodically evaluate the program.
  • ♦  Implement a plan to address identified risks and update the plan as new information is presented. For example:
  • Hospitals may consider having the security lead on each shift meet with the charge nurse on each open unit to dialogue regarding emerging issues, or may instruct EMTs to take rival gang victims to separate hospitals (if clinically appropriate).
  • Behavioral health care programs may consider having a daily shift meeting to alert the team about risk factors related to newly admitted patients or new risk factors in the existing patient population.
  • Community and home-based programs may consider changing the locations for providing service when there are risks present in the area in which a patient’s home is located.

Environmental design

  • ♦  Develop emergency signaling, alarms, and monitoring systems.
  • ♦  Install security cameras and panic buttons.
  • ♦  Improve lighting in hallways, rooms, clinical offices and parking areas.
  • ♦  Provide security escorts to the parking lots at night.
  • ♦  Design the triage area and other public areas to minimize the risk of assault.
  • ♦Some strategies may include: 
    Provide staff restrooms and emergency exits.
    Install enclosed nurses’ stations.
    Install deep service counters in, or enclose, reception areas.
    Arrange furniture so that staff can easily access the closest exit.
    Minimize the presence of objects that could be used as weapons.
    Make waiting areas comfortable and accommodating.
  • ♦  Restrict the movement of the public by using card-controlled

Administrative Controls

  • ♦  Design staffing patterns to prevent personnel from working alone and to minimize patient waiting time.
  • ♦  Develop a system for alerting security personnel and other staff when violence is threatened.
  • ♦  Flag charts of patients who have exhibited prior violent behavior.
  • ♦  Establish a “zero tolerance” expectation for threatening and violent behavior and communicate how this behavior will be addressed up to and including discharge or transfer from care.
  • ♦  Consider establishing a police check-in station or substation.


  • ♦  Work with local law enforcement to provide employees with crime prevention training.
  • ♦  Train staff to recognize and manage assaults, resolve conflicts, and maintain hazard awareness. Training should address how to manage crises with potentially volatile patients and visitors, especially those under the influence of drugs or alcohol, or those who have a history of violence or certain psychotic diagnoses.
  • ♦  Provide staff with tips on how to be alert and cautious when interacting with patients and visitors.
  • ♦  Familiarize staff with policies, procedures and materials on violence prevention.

Safety Culture

  • ♦  Provide a culture where employees are comfortable reporting events to management, security and law enforcement.

Plan for post-event activities

  • ♦  Provide an environment that promotes open communication.
  • ♦  Develop written procedures for reporting and responding to violence.
  • ♦  Offer and encourage counseling whenever a worker is threatened or assaulted.


Source: The Joint Commission’s Workplace Violence Prevention Resources Portal

Legal disclaimer: This material is meant as an information piece only; it is not a standard or a Sentinel Event Alert. The intent of Quick Safety is to raise awareness and to be helpful to Joint Commission-accredited organizations. The information in this publication is derived from actual events that occur in health care.

©The Joint Commission, Division of Health Care Improvement

History of Joint Commission Pain Standards, Lessons to Address Opioid Epidemic Detailed in JAMA ‘Viewpoint’

The Journal of the American Medical Association (JAMA) has published a Viewpoint editorial “The History of the Joint Commission’s Pain Standards: Lessons for Today’s Efforts to Address the Prescription Opioid Epidemic” by David W. Baker, MD, MPH, executive vice president, Division of Healthcare Quality Evaluation, The Joint Commission.   The Feb. 23 editorial summarizes lessons to be learned since 2000, when The Joint Commission introduced standards for organizations to improve care for patients with pain, amid national efforts to address underassessment and under-treatment of such patients.

“Our sincere hope is this analysis of lessons learned over the last 16 years will help our country’s efforts to address the prescription opioid crisis,” Baker says. “Our goal at The Joint Commission is to try to prevent the pendulum of medical practice from swinging back too far toward the poor pain control of the past. It’s imperative we find a way to balance effective pain management for patients with the need to safely and judiciously prescribe opioids and protect the health of the general population.”

The Joint Commission continues to address pain management for patients. In 2016, based on extensive assessment of public health, health care organization and patients’ needs, The Joint Commission, with expert input from a Technical Advisory Panel of national pain experts, began drafting revisions to its pain management standards for accredited hospitals. The proposed standards were posted at The Joint Commission website for public comment Jan. 9 through Feb. 20, and will be finalized based on analysis of the information gathered during the comment period.

More information on pain management including the draft pain management standards is available on The Joint Commission’s website.


Source: https://www.jointcommission.org/pain_standards_jama_viewpoint/