Vol 10, No 7

OR Manager

17

  For instance, written action plans for improving medical equipment safety and efficacy are strong indicators of compliance. Ask questions to see if your hospital has a functioning equipment management program (see box on page 16).
  Beginning this year, surveyors will place more emphasis on staff orientation and training. They may ask staff members what kind of training they have had on specific kinds of equipment. The training should be well documented and often must be specific not just to the type of device but to the model.

   Pointers for standard compliance.
Other pointers for OR managers:
   · Be sure the OR's equipment inventory is complete and accurate. If you are responsible for anesthesia equipment, be sure that inventory is complete also.
   The decision to include equipment in the program is based on a risk assessment.
   "There must be written criteria for evaluating medical devices for the PL.3 program," Barkalow points out.
   Factors include: equipment function, physical risks of clinical application, maintenance requirements, and history of equipment incidents.

Employee training
needs to be
model-specific.

   If the equipment meets criteria for risk, it must be included regardless of ownership. This pertains to physician-owned equipment, leased equipment, rentals, and loaners. Delegate field checks of the equipment inventory to the appropriate people to make sure it is right--down to the last digit of the model and serial numbers.
   ·  The inventory can be kept in a computerized database so it is easily sorted and retrieved.
   There are special programs for PL.3 compliance, but a simple database can be created using a personal computer and commercial software. Be sure there is a protocol for entering data correctly and uniformly. (See box for suggested information.)
   "If you classify equipment using,

Information required in equipment inventory

    The OR's equipment inventory should include at least this information:

  • control number (a unique
    identifying number)

  • common device name
    (electrosurgical unit, not Bovie)

  • official device name and code
    (suggested reference is ECRI's
    Health Devices Source Book)

  • Manufacturer (not distributor;
    also available from the Source
    Book    )

  • code number indicating the
    device's importance (eg, "A" for
    life-supporting device such as a
    defibrillator, "B" for important

 devices such as endoscopy equipment, and "C" for important but relatively simple or reliable equipment such as surgical lights)
  • vendor or distributor, if appropriate
  • model number
  • serial number
  • date of acquisition
  • inspection intervals, eg, six months
  • date of last inspection
  • field to record number of incidents within a specified time period.
for instance, the ECRI Source Book for device terminology, it will be easier to make interhospital comparisons of device performance.  Comparisons can also be made to recorded incidents in public databases," Barkalow said.
   Ideally, the inventory can be correlated with an OR employee database to keep track of who has been trained on what equipment and when. One approach is to develop such a database with the nursing education department to maintain the training information.
   Employee training needs to be model-specific. Say your hospital buys a new model of electrosurgical unit of the same brand you already own. Can you document that employees received training on that specific model, including the new features?
  • The equipment management program identifies and addresses user problems, not just maintenance issues and device malfunctions.

   "When you talk about 'failure' of medical devices, half or more may be related to user education, not the hardware," Barkalow said.
   With the Joint Commission's new emphasis on performance improvement, hospitals are expected to monitor user problems, take action to correct the problems, and evaluate the results.
   "It's important to document these incidents so patterns can be reviewed over time."
   A computerized database enables

the hospital to spot trends. For example, you could call up a list of "A" priority equipment such as ventilators, anesthesia machines, and surgical lasers, sorted in descending order by the number of incidents in the past six months.  Examine the incidents in detail and look for patterns of failure that can be addressed by, say, specific user education, a change in preventive maintenance, or, perhaps, device replacement.  This analysis should be done with the clinical engineer or qualified biomedical equipment technician.
   In another six months, call up the same list. If the quality improvement effort is successful, the same devices should no longer be at the top of the problem list.
  • Make sure every diagnostic or therapeutic device is included in the equipment program.

   Some kinds of equipment tend to be over looked.  An example is pneumatic equipment such as surgical drills powered by compressed gas.
   "In my experience, devices like this are missed because they are not electrically powered. Also, since they need to be sterilized, it is difficult to perform an inventory and assign an equipment control number," Barkalow commented.
   "I often find there aren't control files to record maintenance and calibration. Records are scattered or missing."
Another gray area--devices the

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