Safely Managing Medical Equipment in Occupational Health Settings

Maureen Summers

Patients coming to the occupational health clinic for services have expectations
regarding their care. They expect to receive appropriate services by qualified staff
members using equipment that is safe and functioning correctly. In order to deliver on
that expectation, clinic management must have in place procedures to monitor the
competency of the staff and the safety and accuracy of the equipment used in testing.
The Joint Commission on Accreditation of Healthcare Organizations (JCAHO),
Occupational Safety and Health Administration (OSHA), Environmental Protection
Agency, and Federal Department of Transportation have requirements regarding the
maintenance and calibration of medical equipment used in the delivery of care in the
occupational health clinic.
Each clinic should have policies in place that address these requirements and that are
updated annually and whenever regulations change. The responsibility for the daily
equipment monitoring should be delegated clearly. Often the responsibility falls to the
individual who is also responsible for the daily calibration checks. If clinical engineering
is available, as in a hospital department, that department may perform the annual safety
reviews. In the case of audiometers, it is recommended that an agency with equipment
that meets ANSI standards be utilized for the annual review. Review of established
policies and associated training on procedures should be included in the orientation of
new employees who will be performing testing services, as well as of management
personnel.
JCAHO Requirements
The standards that address medical equipment are found in the Management of the
Environment of Care function. The goal of these standards is to provide a safe,
functional, and effective environment for patients, staff members, and other individuals
in the Ambulatory Care setting. Specifically, Standard EC1.8 states a "management plan
addresses medical equipment." This standard requires a plan that includes:
Acquisition of equipment
Evaluation and inventory of equipment
Assessing and minimizing clinical and physical risks of equipment
Monitoring and acting on equipment hazard notice recalls
Monitoring and reporting incidents in which equipment is connected to a sentinel event

 Reporting and investigating equipment management problems, failures, and user

errors
Medical equipment orientation and education
Emergency procedures
Annual evaluation of the medical equipment management plan.
In addition, Standard EC2.13 states "Medical equipment is maintained, tested, and
inspected." The intent of this standard is that the organization will maintain
documentation of its inventory as well as the performance and safety testing of all
equipment in the management plan prior to initial use and at least annually thereafter.
This includes "new" equipment that may be acquired from another area of the system or
hospital storage. A longer interval between safety checks may be justified, based on
previous experience and authorization by the safety officer. Additionally, preventive
maintenance and inspection should be scheduled based on manufacturers
recommendations, industry standards, or current organization policy.
OSHA Regulations
Spirometry: The maintenance and calibration of spirometry equipment are outlined in
the Recommended Standardized Procedures for Pulmonary Function Testing, Federal
Register, Vol. 43, Friday, June 23, 1978 (Ia, Ij, IIb, IVb,) pp. 58-59. The required
procedures include:
The spirometer must be properly calibrated daily
Calibrate for volume and time or flow and time
Calibrate before each shift with both spirometer and syringe at the same temperature
Calibrate whenever the spirometer is transported
Calibrate after every thirty tests or sooner (2-3 hours) under field conditions.
Audiology: The requirements for testing audiometers are stated in the OSHA Noise
Standard, but are based on the American National Standards Institute (ANSI) standard
(S3.6, 1969 or the revised ASA 81, 1989), which regulates the Audiometric Test
Requirements. They include:
Audiometric tests shall be conducted with audiometers (including microprocessors)
that meet the specifications of, and are maintained and used in accordance with, the
ANSI standard.

 Daily functional calibration of the audiometer using a bio-acoustic simulator and record
of daily log. This is often referred to as a biological check. Deviation of 10dB or more in
the audiometers desired output trigger the next stage of calibration.
Acoustic calibration, performed by audiometer service companies, must be performed
at least annually and include calibration results for intensity and linearity. The calibration
results must be within the tolerances permitted by American Standard Specification for
Audiometers, S3.5, 1969.
Exhaustive calibration should be performed at least every two years.
Federal DOT Regulations
These regulations address the use of Evidentiary Breath Alcohol Testing (EBT)
equipment. Congress mandated testing for alcohol as well as controlled substances in
1991 in the Omnibus Transportation Employee Testing Act.
Clinics may use only evidential-grade EBT devices that are approved by the National
Highway Transportation Safety Administration (NHTSA), are capable of testing blank air
samples, and discriminate between alcohol and acetone (produced by diabetics when
their condition is out of control).
The EBTs must have a quality assurance plan (QAP) developed by the manufacturer. If
you have EBTs from different manufacturers, there must be a separate plan for each.
The plan shall:
Designate the method or methods to be used to perform external calibration checks of
the device, using only calibration devices on the NHTSA "Conforming Products List of
Calibrating Units for Breath Alcohol Tests".
Specify the minimum intervals for performing external calibration checks of the device
including frequency of use, environmental conditions, and contexts of operation.
Specify the tolerances on an external calibration check within which the EBT is
deemed properly calibrated.
Specify inspection, maintenance, and calibration.
Require a device be removed from service if any external calibration check results in a
reading outside the tolerance level set in the QAP.
Maintain a record of the external calibration checks of all EBTs.
Environmental Protection Agency & Department of Health and Human Services

The Environmental Protection Agency issues standards to limit human exposure to

radiation and measures environmental levels of radiation.
The Center for Devices and Radiological Health (part of the Health and Human Services
Food and Drug Administration) set the standards for x-ray machines. For the purposes
of this article, we recommend that you follow your states guidelines for licensure and
regulation.
Equipment Maintenance & Safety Policy
Each clinic should have a policy that addresses the safety and maintenance of all
equipment, but particularly the medical equipment used in patient care. In addition to
the above regulations, the clinic manager must consider the manufacturers
recommendations when writing procedures and educating staff on the use of
equipment. Your policy should include:
Inventory management
Acquisition of new equipment
Inspection of new equipment prior to putting into service
Orientation of employees prior to using equipment
Visual inspection of equipment prior to use
Preventive maintenance of equipment
Calibration procedures
Procedure to follow in case of injury
Action in case of recall
Required signage
Responsible party for management of the equipment.
Each clinic must determine who will be responsible and how required quality control
checks will be maintained. Some clinic managers choose to delegate the responsibility
to the technician and keep the documentation in the room where the procedures are
performed. Logs can be transferred every three months to a central location.

Maintenance Scheduling
Once your policy is in place, you can implement a plan to schedule all annual quality
control monitoring. The annual inventory can be scheduled on the clinic managers
schedule and reviewed for additions and deletions. The annual reviews can be
scheduled with a time for completion set. This can then provide the basis for on-going
annual reviews. Scheduling these maintenance tasks seasonally, when the clinic
volume is lower, should allow you sufficient time to complete them thoroughly.
Adequately maintained equipment can prevent delays in delivery of clinic services due
to malfunctioning equipment. Equipment that operates safely and accurately improves
the completion of the tasks performed in your clinic and meets your patients
expectations of quality care.