Equipment that Requires Bio-Medical Inspection:
The equipment that requires bio-medical inspections at medical care facilities are medical devices that are in contact with the patients and/or residents of the home. These medical devices either require a calibration check or an electrically powered item that requires an electrical safety test and plugs into a wall outlet. All patient care equipment, whether owned, leased, or rented must be tested for compliance with safety and performance standards before being used for the first time or brought into the facility by a patient.
Equipment Calibration Checks:
For equipment that takes patient measurements such as a patient scale, or an item that has to preform to a specified criteria such as an oxygen concentrator, a measurement needs to be taken in order to define weather the item in question is preforming at the standard it should be. Medicanix uses calibrated devices to check such items and documents the device’s status. If the device in question is not preforming to the acceptable standard our customer is notified and the equipment is taken out of service unless an on-site adjustment can be made to rectify the equipment’s performance. At our customers discretion such items that are not preforming acceptably can be taken by Medicanix to their shop for further repair.
Equipment performance checks are taken during bio-medical inspections. A performance check is a quick and simple check that is taken it ensure the equipment inspected is functioning the way it is supposed to be. If an item is not functioning the way it should the Medicanix team member is to notate it and inform our customer.
Electrical Safety Checks:
Medicanix preforms Electrical Safety Inspections according to the requirements outlined by the NFPA99 code for patient areas.
Standards for Health Care Facilities (NFPA 99),(1) NFPA defines a patient care area as “any portion of a health care facility wherein patients are intended to be examined or treated.” For equipment intended to be used within these areas—which include patient examining and treatment rooms, resident rooms, as well as any similar areas in which the patient is likely to come into contact with electrical devices—NFPA specifies that chassis leakage currents should not exceed 300 microamperes. However there can be some exceptions under certain conditions; for example, leakage currents up to 500 microamperes are permitted if the leakage current does not represent a hazard to the patient and if the grounding connection remains intact, in this case a proper ground test is preformed to insure it is sufficient.
Within the patient care area, NFPA further requires that any equipment intended for placement near the patient to meet additional requirements. NFPA refers to the area near the patient as the patient care vicinity, which it defines as “a space, within a location intended for the examination and treatment of patients, extending 6 ft (1.8 m) beyond the normal location of the bed, chair, . . . or other device that supports the patient . . . [and] vertically to 7 ft 6 in (2.3 m) above the floor.” For equipment to be used in this space, NFPA requires that the resistance between conductive chassis surfaces and a reference grounding point not exceed 0.50 W.
In contrast, locations such as business offices, nurses’ stations, clinical labs, corridors, waiting rooms, and similar areas are classified as non-patient care areas, and NFPA’s electrical safety requirements do not apply.
Equipment designed with isolated grounding and only have 2 prong plugs and do not require an electrical safety check Medicanix performs a visual safety analyst to ensure there are no safety hazards, such as: missing covers, exposed or frayed wires and a performance check is done.
A control number is to be given to each item that is inspected. Depending on the size of the inspection, this control number is sometime labeled and attached to the equipment. This control number is also listed on the inspection report. The report contains the item’s credentials from the equipment’s name plate such as the equipment’s Make, Model, and Serial Number if available.
Medicanix can only preform and inspect and document items that are present at the time of an inspection. If items are missing, lost or not present at the time of the inspection such items will have to be removed from the list. In the event that an item on the previous list cannot be found by a Medicanix inspector they will then notify our customer to let them know of such items and unless they are found at the time of the inspection they will be removed from the inspection report.
The Inspection report is a list of all items inspected listing the item’s Control Number, item description (Make, Model, Serial Number – when available), the status in which the item was found, the items electrical leakage reading any notes regarding the item and the Medicanix tech initials that preformed the inspection. The report also contains the facilities name, address, date of the inspection and the date the next inspection is due.
The inspection reports reflect only the items which are reported at the day and time of the inspection. As new items are purchased by the facility through the year, such items are reported as they are inspected and then added to the master inspection report on the date of the following master inspection.
Inspection reports are stored in both in hard copy and electronically. A hard copy is mailed to the customer along with the invoice. At the customer’s request a report in a PDF format can also be provided via email. In the event an article of equipment is removed from use or disposed of, Medicanix is notified and such items are removed from the list on the following inspection.
When unscheduled service calls are required, Medicanix dispatches a service technician to provide troubleshooting and, if possible, on site repair or bio-medical inspections. If the equipment cannot be repaired on-site or is in need of replacement parts, the equipment is then picked up and brought back to Medicanix workshop for further investigation.
When manufacturers repair is required, Medicanix coordinates the repair, and shipping/freight, which is charged back to the customer.
In the event of an emergency equipment breakdown a call is to be placed into Medicanix main office and responded to within 4 hours during a normal business day. A technician can then be dispatched to the facility within 16 hours of the call to do bio-medical inspections and resolve the issue as quickly as possible.
Medicanix technicians are required to document the time and date of service of the bio-medical inspections. The equipment’s make model and serial number, the nature of the problem and all services, parts and materiel which were supplied on a service order 4 copies of these service orders are generated: One copy gets left with the customers’ staff, the 2nd copy gets filed into customer file at Medicanix’s office, the third copy gets filed in a numerical file and the 4th copy gets returned to the customer along with the invoice for the services rendered.