As previously reported in Hospital Infection Control & Prevention, the FDA has banned1 the use of all powdered gloves in healthcare due to latex allergies and other issues.
Following suit, The Joint Commission (TJC) announced on March 7, 2017, that it will issue citations for use of the gloves during accreditation surveys.
“As a result of this FDA ban, TJC now evaluates organizations to assure that required implementation of non-powdered glove use occurs as part of the routine survey evaluation,” the commission stated. “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 FDA also called for “proper disposal” of any remaining stock of powered gloves, but TJC will not evaluate compliance with that provision.
The FDA banned all powdered surgical and examination gloves regardless of the material with which they are made.
Although powdered synthetic gloves do not present the risk of latex allergic reactions, these gloves “are associated with an extensive list of potentially serious adverse events, including severe airway inflammation, wound inflammation, and post-surgical adhesions, which are bands of fibrous scar tissue that form between internal organs and tissues. These side effects have been attributed to the use of glove powder with all types of gloves,” the FDA noted in the proposed rule,2 which was finalized and became effective Jan. 18, 2017.
REFERENCES
- FDA. Banned Devices; Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove. Fed Reg 2016;81:91722-91731.
- FDA. Banned Devices; Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove. March 22, 2016: Fed Reg 2016;81: 15173-15188.
Table 1
Before surgery
- Wash scalp hair, remove dirt or debris, and cover open wounds with a clean dressing.
- Clip, but do not shave, hair.
- Use chlorhexidine or an iodine-based skin preparation.
- Drape the surgical site with adhesive drapes and transparent adhesive film to prevent implantable hardware from coming in contact with exposed skin.
- Maintain sterile field with careful aseptic techniques.
- Administer prophylactic antibiotics to achieve adequate tissue concentrations before incision.
During surgery
- Minimize blood loss and tissue trauma; avoid hypothermia unless it is deliberately induced.
- Remove devitalized and grossly contaminated tissue and small bone fragments.
- Use a double layer of gloves when handling implantable devices.
- Irrigate the operative field with warmed sterile physiologic solution.
- Perform careful hemostasis to avoid postoperative wound hematomas.
- Position the cerebrospinal fluid drainage devices carefully to maintain a continuous flow of cerebrospinal fluid; ensure the exit site is fashioned so there is no leakage around the cerebrospinal fluid drain; ensure that the catheter is tunneled from the insertion site and secured to the skin so that it cannot be dislodged and that it is connected securely to a sterile drainage system.
- Close the skin carefully, with wound edges secured to prevent leakage of cerebrospinal fluid but with good skin perfusion; avoid passing hardware directly beneath the incision.
After surgery
- Use percutaneous drains to collect postoperative hemorrhage; ensure that the drains are tunneled so that they will not leak and secured so that they cannot be dislodged.
- Apply a barrier dressing where necessary, particularly to prevent the patient from inadvertently opening the wound.
- Avoid putting pressure on the wound in the postoperative period; take measures to prevent pressure sores in other areas.2
As previously reported in Hospital Infection Control & Prevention, the FDA has banned1 the use of all powdered gloves in healthcare due to latex allergies and other issues.
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