Hospital Policies
| HOSPITAL POLICY NUMBER | SUBJECT |
| 0055 | Use of Non-UVA Medical Center Equipment |
| 0076 | Medical Devices Evaluation and Monitoring System |
| 0139 | Equipment that Transmits Radio Frequency |
| 0165 | Safe Medical Devices Act Reporting |
| 0188 | Laser Policy |
MEDICAL POLICY NO. 0055
SUBJECT: Use of Non-UVA Health System Equipment
EFFECTIVE DATE: October 1, 2000 (R)
POLICY:
The use and/or application of personally owned or rented equipment within the Medical Center facilities is restricted. In order to reasonably protect patients, staff, and visitors from hazards related to the use of certain devices, the Health System conforms to applicable state and federal codes and control the use of these devices. The Health System acknowledges no liability for loss or damage related to the utilization of personal equipment.
Medical Equipment
1. If the medical equipment is part of the patient’s pre-existing medical care and the patient wishes to continue the same care, the patient may do so only when:
a. written approval is obtained from his/her physician, and;
b. the Health System’s Patient Medication/Device Release Form is signed and included in the patient’s chart, and;
c. the equipment has passed a safety check by Clinical Engineering.
2. Durable medical equipment (DME) rented or purchased for patient use, and/or for patient/family teaching prior to discharge is permitted when the patient’s treatment plan includes extended in-hospital teaching for proper use of the equipment, and either:
a. the health care staff is competent to use the equipment after training that is documented in the employee’s competency or skills check list, or;
b. DME companies or outside agencies providing direct patient/family training for equipment unfamiliar to the healthcare staff will be available at all times for patient/family assistance.
Non-Medical Equipment
1. Radio-frequency producing equipment (examples: cell phones, CD players, personal computers) is restricted as specified in Health System Policy No. 0139.
2. Equipment with the potential for personal injury, fire or electromagnetic interference is strictly prohibited. Examples include but are not limited to:
portable electric heaters, televisions, hair dryers, toasters, toaster ovens, curling irons and electric rollers, video games (a/c powered), hot plates or other cooking devices, VCR’s and DVD players
The Medical Center Safety and Security Subcommittee or its designee has the authority to remove any device that is unsafe or is being used in an unsafe manner.
The Medical Center reserves the right to inspect and/or impound any/all devices suspected of causing adverse operational characteristics or patient outcomes.
Staff of the Department of Clinical Engineering (924-2391), and the Safety Manager (924-2304), and members of the Safety and Security Subcommittee are available for assistance, if questions arise.
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MEDICAL CENTER POLICY NO. 0076
SUBJECT: Medical Devices Evaluation and Monitoring System (Formerly:Medical Center Equipment Utilization)
EFFECTIVE DATE: March 31,1996 (R)
POLICY: 0076
The University of Virginia Medical Center is committed to providing an environment which fosters quality health care for our patients. In order to assure both patient safety and adherence to regulatory guidelines, no medical device (supplies, accessories or equipment), whether purchased, contracted. donated, loaned or for trial, may be used in the Medical Center for inpatient or outpatient care purposes without first being evaluated to ensure that:
- An acceptance and safety inspection has been conducted prior to being used for patient care;
- Compatibility with other medical devices in use at the Medical Center has been assessed;
- Annual preventive maintenance, where appropriate, has been scheduled; and
- There is documentation that the appropriate training and education has been provided to potential users to achieve competence.
Additionally, a listing of all types of medical devices used in the process of caring for patients shall be maintained and, when appropriate, individual items will be recorded and tracked. Clinical Encrineering and Property Accounting shall be notified prior to disposal of patient equipment.
MEDICAL CENTER POLICY NO. 0139
SUBJECT: Equipment that Transmits Radio Frequency
EFFECTIVE DATE: September 30,1996 (Rvd)
POLICY: 139
Patient care, diagnostic, life. support and laboratory equipment that was used in the hospital some years ago was not often affected by interference. The new generations of more sensitive and microprocessor controlled equipment may be adversely affected by radio frequency transmissions that may cause incorrect operation. The microprocessors and other digital logic components can be affected by this type of interference and it is recommended that radio frequency transmitters be no closer than one meter to this equipment if the transmitted field strength is two volts per meter or higher.
To preclude potential problems that could be caused by these devices, field strength measurements must be made on each device relative to patient care, diagnostic, life support and laboratory equipment.
- Equipment specifically prohibited to patients and staff are:
- CB radios
- amateur "ham" radio transmitters
- wireless andcellular telephones
- walkie-talkies.
Excluded equipment are those devices needed by fire, security and police on an intermittent basis.
PROCEDURE:
All equipment must be checked by Clinical Engineering prior to use in the Medical Center. Field strength measurements will be made and equipment locations confu-med. Both will be documented. These devices will be set up on a preventive maintenance program and scheduled for a re-testing annually.
Field Strength Measurements will be made on each device prior to its use in the Medical Center. Field strength must not exceed 2 (two) volts per meter at one meter distance from patient care, diagnostic, life support, or laboratory equipment.
These devices must be placed in a location that will minimize effects to patient care, life support diagnostic and/or laboratory equipment. They must not be used in patient rooms, operating rooms, emergency rooms, at nursing stations next to nurse call intercom stations, or next to physiological central station monitoring equipment, in laboratories, diagnostic areas, or in rooms that are adjacent to any of these. Tle measurements and limits stated above will be used in determining the location of these devices. The Director of Clinical Engineering will be available to help define questionable areas.
SUBJECT:Safe Medical Devices Act Reporting
EFFECTIVE DATE:March 7, 1995
POLICY:0165
The Safe Medical Devices Act of 1990 (Public Law 101-629) mandates that incidents where a medical device has or may have caused or contributed to a patient's death, serious illness or injury be reported to the FDA and manjfacturers. This law also requires healthcare facilities to track information on certain implantable and life-support devices and to report this information to medical device manufacturers. The University of Virginia Medical Center has established the following procedures to ensure compliance with the requirements of the Safe Medical Devices Act of 1990.
PROCEDURE:
Device Incident Reporting
- is life threating,
- results in permanent impairment of a patient's body structure or function, or
- needs any medical or surgical intervention to prevent permanent damage to a patient.
2. The Food and Drug Administration (FDA) defines a medical device as any instrument, apparatus, or other article that is used to prevent, diagnose, mitigate, or treat a disease or to affect the structure or function of the body, with the exception of drugs. This means that the FDA classifies common hospital products such as catheters, thermometers, patient restraints and syringes as medical devices. 3. When reporting incidents to the Office of Risk Management, the name of the device, manufacturer, model number, serial or lot number and clinical engineering tag number should be included under #14 (briefly describe variance) on the QCC report. 4. Impounding and Examining Equipment: If a device is involved in a serious incident, the device should be impounded in consultation with the Office of Risk Management, without changing any control settings so that an analysis can be performed. It should not simply be sent to clinical engineering. Disposable devices and accessories, including packaging with lot number, are no exception and must be saved for later analysis. 5. The Office of Risk Management, in consultation with the Health Care Evaluation Committee, will determine which incidents are reportable under the Safe Medical Devices Act and will coordinate all safe medical device reports to manufacturers and to the FDA. Coordination of all reporting by the Office of Risk Management does not limit the perogatives of individual clinicians to report concerns regarding the safety of medical devices, but establishes an institutional flow path for this important information. Device Tracking and Reporting
A list of all devices subject to tracking will be maintained in the Office of Risk Management and by the Medical Device Coordinator. The Medical Device Coordinator will notify the appropriate department when a device has been added to or deleted from the FDA list of medical devices required to be tracked. - At the time a device that is required to be tracked is received at the University of Virginia Medical Center, the information specific to the device is captured and reported to the manufacturer by the department receiving the device.
- At the time a device that is required to be tracked is used, the information specific to the patient, implanting physician, and follow-up physician is captured and reported to the manufacturer by the department using the device.
- At the time a device that is required to be tracked is explanted or otherwise disposed of, the available device tracking information should be captured and reported to the manufacturer, if known, by the department explanting or otherwise disposing of the device.
- Each department/area that uses a device that is on the FDA's list of devices required to be tracked is responsible for maintaining a database of medical device tracking information for their department.
- At the time a recall or request is made for a device that is required to be tracked, the Medical Device Coordinator will notify the appropriate departments, per Policy #19 (Product Alerts, Product Recalls and Hazard Warnings). If a recall notification is sent directly to a department from a manufacturer or vendor, the Medical Device Coordinator should be notified immediately.
SUBJECT: Laser Policy
EFFECTIVE DATE:March 4, 1997
POLICY:
Each location in the Health Sciences Center where non-ionizing radiation in the form of lasers is utilized will review such usage and establish the appropriate safety and health procedures. Such procedures will address usage, condition and health exposures of those involved.
PROCEDURE:
- Training of employees and students in the proper use and safe handling of these devices (clinical privileges for use of lasers are granted by Clinical Chairs to physicians through the credentialling process);
- Registration of all lasers with the University Laser Safety Officer, including: location (building and room number) of equipment, manufacturer, model and serial numbers, wave length, power and a telephone number of a contact person;
- Labelling of all laser equipment with wave length and power;
- Hazard warning signs in areas where lasers are in use and a risk of injury is present;
- The immediate report of any injuries or accidents involving these devices to Occupational Health (employees) or Medical Center Risk Management (patients or visitors). All other incidents shall be reported to the University Laser Safety Officer (2-4911).
ANSI (American National Standards Institute) Standards Z 1 36.1 (1993) and ANSI Z. 136.3 (1996) shall be adopted as the standard guidelines for laser safety.
It shall be the responsibility of the University Laser Safety Officer to monitor the compliance of the procedures established for the use of these devices. Non-compliance shall be reported to the Health Sciences Center Safety and Security Committee or to the appropriate subcommittee of the Safety and Security Committee.