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1
ACCEPTANCE INSPECTIONS OF MEDICAL DEVICES IN HEALTH CARE FACILITIES
-
THE QUALITY CONTROL
APPROACH
  Amit Gefen, Nurit Gefen, Nadav
Sheffer 
*
 
*Medical Devices Dept., Pharmaceutical Administration, Ministry of Health, Sheba Medical Center, Bldg 130, Tel Hashomer 52621, Tel-Aviv, Israel, Tel: +972-3-5303291/2/3, Fax: +972-3-5344552, e-mail: sheffer@eng.tau.ac.il.
Abstract
 The acceptance procedure of medical devices for usage in health care facilities is of a significant effect on patients treatment quality, personnel safety and maintenance cost. An acceptance inspection is needed when new or repaired medical devices are received by the institute. It may discover equipment failure or dysfunction, and thus prevent false diagnosis, an inefficient or dangerous treatment, risking the patient or staff. Nevertheless, a general and comprehensive inspection procedure of medical devices has not yet been described, and there are no publications regarding the quality control of the process. We therefore suggest a quality controlled inspection process, which can be easily applied in hospitals and sick funds. The process refers to portable and non-mobile, new and repaired medical equipment. The means and instruments needed for the process application are detailed.
Introduction
 The procedure in which medical devices and instrumentation are accepted for usage in health care facilities, such as hospitals, sick funds or military medical corps clinics, has a major effect on patients treatment quality, personnel safety and maintenance cost. Manufacturing of medical devices in Israel and their import to Israel are performed under the supervision of the Israeli ministry of
health
 
2,6,7,8
. The medical devices are then received by the health care facility which is responsible for their maintenance and proper function. By applying an acceptance procedure, which is based on quality assurance methodology, it is possible for the medical institute to significantly decrease the number of equipment faults and thus reduce its maintenance cost. This work describes a quality controlled process aimed to test medical devices at the time of their acceptance for usage in health care facilities. Since medical devices are used to sustain and support human life or to improve their quality, the inspection procedure is based on a stringent policy; medical devices which are to be used in health care facilities should be of the highest quality. This quality should be determined by using a sufficient safety factor 
1,3,4,5
.
Inspection
Methods
 The inspection procedure is based on the following assumptions: 1. The institute should have a medical devices inspection unit. It is the duty of this unit to verify that the accepted medical devices conform the purchase specifications. 2. The inspection unit personnel includes well trained clinical engineers and technicians with specific skills in the field of medical instrumentation and technology (such as ventilators, radiographic imaging devices or dental equipment). 3. The inspection unit should posses testing equipment. General testing equipment may include ECG simulators, blood-pressure simulators,
etc’.
 Specific testing equipment may be required for special medical devices and instrumentation in the institute. The testing equipment should be periodically calibrated by an authoritative body. The work of the inspection unit will generally be performed in a FIFO (First In First Out) order of priorities. A maximal waiting duration for medical devices before inspection should be defined, for each type of equipment in the institute. Although the FIFO method is generally applied, the urgency in which medical devices are needed in a certain body of the institute (such as a department in a hospital) is considered, and should be explained on the device request form in order to accelerate the inspection procedure. The flow of medical devices which are received by the institute is shown in Fig. 1. The devices are transferred from the manufacturer/agent or service laboratory to the inst
itute’
s received- equipment storehouse. The inspection unit transfers the devices which should be tested, to a specific zone that is defined as a
medical devices before inspection storage area
. This separation is requested by ISO 9002 standard. Devices are then to be moved to the inspection zone. The inspection results will determine the device status, which may be
functional
,
non-complete
,
for re-repair 
 or 
 
2
defective
. Next, the device is clearly labeled using a sticker of a respective color and transferred to its storage zone, which should be clearly marked and signed using the same color as the sticker. The functional devices should be physically separated from all other devices and stored in a storehouse which is specifically defined to contain functioning medical devices for supply. Medical devices accepted for usage in health care facilities may be one of the following two types: (a) New medical devices (received from the manufacturer or agent). (b) Repaired medical devices (received from the service laboratory). Used medical devices, accepted as a contribution etc. are included in the second category.
Testing new medical devices
- The inspection procedure of new devices is shown in Fig. 2. As the devices are received from the manufacturer or agent, completion of the package should be verified and delivery form including contents list be accepted. Portable
“s
tand-
alone”
 medical devices should then be transferred to the
medical devices before inspection storage area
. If the received instrumentation requires installation before it can be inspected, it should first be assembled and then tested. From the
medical devices before inspection storage ar 
ea”
 the devices are transferred to the inspection zone, where their conformity to the purchase specifications is checked. The test should be performed according to an inspection standard (that was prepared in advance, together with the purchase specifications). In some cases, the inspection may be performed together with the end-user or a professional advisor. The inspection should be documented using a ready-to-use computerized checklist which details the different inspection categories (such as contents list, functional and safety tests, etc.). The checklist construction should be based on relevant standards and regulations, databases and documentation of past experience
9
. The checklist and databases should be updated if a new type of device fault has occurred. At the end of the inspection, the device should be clearly labeled using an endurable color sticker which indicates its status and details the date of inspection and inspector 
s name. For example, a functioning device will be labeled with a green sticker, a non- complete device (e.g. some of the accessories required for operation are missing or technical manuals were not provided) will be marked with a blue sticker, and a defective device will be identified with a red sticker. In addition, an endurable label detailing the manufacturer/agent name and address and the liability duration will be placed or stamped in a constant location (according to the device type). If the device has an expiration date (such as in the case of sterilized equipment) it should also be marked. Medical devices which are defined as life sustain and support equipment (i.e. ventilators, defibrillators etc.), are each tested, regardless of the purchased items quantity. Non life-supporting devices (such as band-aids, syringes etc.) may be tested by using a statistical sampling, derived from statistical tables according to the maximal quality factor. Generally, the performed tests are non-destructive, unless it is impossible to test to device without damaging it (such as in the case of sterile Band-Aids which requires package opening). If a specific subsoil is needed in order to operate the device (such as X-ray imaging room which requires lead walls or a dental-clinic which requires special air and water connections) the inspection unit should verify that the subsoil construction was done properly and according to the purchase specification, before the device is installed. It should be noticed that the process of a new medical devices has an important aspect of maintenance: Since the inspection unit is the first technical authority in the health care facility to deal with the new device, it should bring into attention of the end-users and maintenance unit important information related to specific maintenance actions. For example, periodic maintenance care for filter replacing should be done in some ventilators.
Testing repaired medical devices
- The inspection procedure of repaired medical devices is described in Fig. 3. As the devices are received from the service laboratory to the health care facility storehouse, completion of the package should be verified. A full and comprehensive report should be accepted describing the cause of fault, detailing repair procedures, replaced parts and results of tests made in the device, including safety tests if required (e.g. electrical safety test according to IEC-601 standard using a safety analyzer). From the
medical devices before inspection storage area
 the devices are transferred to the inspection zone, where they should be tested using a specific testing equipment (such as simulators, measurement instrumentation, etc.). Again, accessories should first be installed and only then tested as an integral part of the system. The inspection should be documented using a checklist as discussed previously. Status stickers detailing inspection date and inspector 
s name should be used to identify the devic
e’
s condition. For example, green sticker for a functional device, yellow sticker for re-repair and red sticker for a defective device.

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