Problems With Products, Devices May Cause ‘Never Events’

Products or devices used in a health care facility may cause problems when
they are contaminated, when they malfunction, or when their use results in an
intravascular air embolism.

The National Quality Forum’s list of 28 ‘never events’ is classified into six
different main categories. One of these categories involves products or
devices used in health care, which is a fairly short list. The first item on
the list is death or serious disability associated with use of contaminated
drugs, devices, or biologics provided by the health care facility.

The health care facility needs to know where their products and devices are
coming from and whether they have been certified by the Food and Drug
Administration. If certain products or devices are being reused, then the
processes for reusing them must be reliable, and culturing must be performed
at every possible point to check for contamination.

The next item in the products or devices category is that of death or
disability associated with use or malfunction of a device used in patient
care. The most frequent kinds of events in this situation deal with use of
infusion pumps. Investigation usually shows that the pump performed exactly as
programmed, but a staff member or a clinician had not read it appropriately,
had programmed in cc/hour instead of mg/kg, had chosen a wrong medication
concentration, or had substituted a medication.

Most infusion pumps come with a library of things in their formularies, which
helps with ease of use. In addition, you can type in almost any drug, in which
case significant double-check protocols must be in place to ensure that the
correct drug and concentration have been entered.

Another fairly common device malfunction is seen with use of intraoperative
staplers. During investigation of these events, there is always a question of
whether the stapler misfired or whether user error occurred. These situations
are not always easily fixed. True stapler-related problems occur when blood
vessels or soft organs (such as liver or kidneys) have been injured.

The third item in the ‘never events’ products or devices category is that of
death or disability associated with intravascular air embolism that occurs
while being cared for in a health care facility.

These very rare events typically involve central line placement or removal.

There are simple things that can be done while inserting or removing a line to
minimize the risk of embolism. Most staff members are very conscious of these
practices, but on occasion, you find a situation where an embolism occurred
when a patient took a breath at an inopportune time, or the staff was unaware
of what was going on with patients while they were draped.

Reference:
Kathleen Hale, RN, BSN, MHSA, and Richard P. Kidwell, JD Never Events:
Problems With Products or Devices Used in Health Care