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Received April 23, 2020, accepted February 16, 2021, date of publication February 22, 2021

Lean and Computerized Management System for Non-
Hospital-Owned Medical Equipment in Hospital

By Y. Y. Wu, K. Zheng, B. P. LI, C. X. Zheng  

Department of Purchasing/Logistical/Clinical Engineering, the Children's Hospital Zhejiang University School of Medicine/ National Clinical 
Research center for child health, Hangzhou 310052, China

ABSTRACT

Many challenges exist in the management of non-hospital-owned medical equipment. This paper proposes implementing a 
novel kind of lean and computerized management method, including the management policy, procedures, agreement signing, 
equipment installation, acceptance and maintenance, and exit procedure. The result shows that the Lean and computerized 
management system can improve oversight and assure the safe integration of non-hospital-owned equipment to reduce liability 
exposure and increase compliance with regulations.
Keywords – Non-Hospital-Owned Medical Equipment, Lean Management, computerized management system, Trial Protocol, 
Medical Safety, assets control.

Copyright © 2021. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY): Creative Commons - Attribu-
tion 4.0 International - CC BY 4.0. The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) 
are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is 
permitted which does not comply with these terms.

INTRODUCTION

With the rapid development of the modern hospital, 
increasing demand for the medical equipment and tech-
nology experienced both in clinical and research environ-
ments. Due to the diversity of novel medical equipment, 
some are supplied for free by the vendors. Vendors have 
a variety of reasons for bringing in their equipment. They 
may bring in as a service loaner or as a new model to 
demonstrate to clinicians. As this equipment may be left 
for weeks for a clinical trial and evaluation only, the new 
products' technical parameters and performance can be 
evaluated and compared in hospitals1. We define this kind 
of equipment as trial equipment in this article. The trial 
equipment we refer to here is not medical equipment 

in clinical trials for pre-market approval but equipment 
already approved for the market. All the indirect hospital 
purchased equipment are treated as non-hospital owned 
equipment, including trial equipment, research collabora-
tion equipment, household appliances, among other things.

The state of non-hospital-owned equipment is difficult 
to judge at times, and some of them may not meet the 
safety requirements, which can lead to safety problems2. 
Valid concerns about non-hospital owned medical equip-
ment include safety and effectiveness, compliance with 
applicable accreditation standards and legal requirements, 
proper integration, and technical support. Therefore, they 
should be under the oversight of clinical engineering, and 

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23 J Global Clinical Engineering Vol.4 Issue 1: 2021

Y. Wu, K. Zheng, B. LI, C. Zheng: Lean and Computerized Management System for Non-Hospital-Owned Medical Equipment 
in Hospital

all medical equipment should receive any needed atten-
tion regardless of their ownership. In our hospital, all 
non-hospital-owned equipment is supervised by a Lean 
and computerized management system. This article takes 
the trial equipment we defined before as an example and 
describes the relevant management program.

MATERIALS

Lean management is designed to enhance productivity 
by improving work efficiency3. During the whole proce-
dure, the manager's duty is specified and explicit, and the 
management process is standardized and systematized. 
On the one hand, the Lean management's core idea is ap-
plied in non-hospital-owned medical equipment, and a 
strict management policy and procedure ensure its safety. 
On the other hand, information technology is applied to 
develop a customized tool for implementing the overall 
non-hospital owned medical equipment management4. 
Our hospital's medical equipment management system 
includes the management functions of hospital-wide 
medical equipment such as testing, reporting for repair, 
and maintenance, among which the management of non-
hospital owned medical equipment is an important module.

A.  Design a Rigorous Management Policy and 
Procedure 

Before its first clinical use, all non-hospital-owned 
medical equipment providers need to sign an agreement 
or protocol with the hospital represented by the clinical 
engineering department. Any unauthorized or disap-
proval use of non-hospital-owned medical equipment is 
strictly forbidden. Hence, the recommended procedure 
is shown in Figure 1.

Step 1: Trial application. The corresponding depart-
ment is asked to complete the medical device clinical 
trials' application form, with a description of application 
reasons, device name, brand and model, quantity, regula-
tion registration certificate number, vendor name. 

Step 2: Legal compliance examination and verifica-
tion. All the necessary documents are reviewed by the 
department of clinical engineering, including the medical 
device registration certificate issued by the China Food 
and Drug Administration (CFDA), production enterprise 

license, business certificate business license, factory au-
thorization letter, operation manuals. The copies of these 
documents are saved for future reference.

Step 3: Approving or comments by the related func-
tional departments such as the medical administration 
department and finance department.

Step 4: Submission to hospital medical equipment 
management committee for consideration. 

Step 5: Signing a protocol of authorized usage for the 
non-hospital owned medical equipment. 

Step 6: Labeling the device and informed users.

B. Sign Medical Equipment Trial Protocol

The trial protocol is signed by the hospital (Party A) 
and the vendors such as the sales company or manufac-
turer (Party B), in which the duties and obligations for 
both sides and the agreed usage duration (usually no 

FIGURE 1. The access protocol for non-hospital owned medi-
cal equipment. 



Y. Wu, K. Zheng, B. LI, C. Zheng: Lean and Computerized Management System for Non-Hospital-Owned Medical Equipment 
in Hospital

J Global Clinical Engineering Vol.4 Issue 1: 2021  24

more than 3 months) are specified. According to the trial 
protocol, Party B's equipment should be conforming to 
all the regulations made by CFDA. Also, Party B should 
provide valid certificates, installation procedures, and user 
training. When the trial period ends up, the equipment 
should return to Party B in time. Party A should take good 
care of the devices during the trial period. If the device 
breaks due to the user's carelessness or abuse, the hos-
pital (Party A) will be responsible for the compensation. 

C. Standardization of Installation and Acceptance 
Process

When the medical equipment trial protocol is imple-
mented, the supplier shall be responsible for the trial 
equipment installation, and the engineers of the depart-
ment of clinical engineering at the hospital will make an 
acceptance check to ensure the safety of the equipment.

After the completion of the acceptance process, the 
supplier needs to conduct training for potential users. 
Some of the non-hospital-owned equipment is surgical 
instruments in the operating room. Such instruments 
may be used already many times in different hospitals. 
Therefore, it might cause potential surgical infection if 
sterilization protocol is not carried out strictly or ad-
equately5. For example, in orthopedic implant surgery, 
if the bacteria contaminate the implant, it will be quite 
challenging to tackle this problem since a layer of protec-
tive film is generated in the implant surface, which makes 
the antibiotics useless and brings about great pain for 
the patients6. Hence, additional precautions should be 
taken, and relevant measures should be taken according 
to hospital infection control policy if the trial device is 
the surgical instrument7,8. The corresponding training, 
assembly, and disassembly demonstration should be 
provided for the central sterile supply department staff to 
ensure that all the operations conform to the disinfection 
and sterilization requirements9,10 and make sure that the 
instruments are used in a safe situation11.

D. The Application of Non-Hospital Owned Medical 
Equipment Management Module

After completion of the acceptance and training pro-
cedures, the trial equipment is commissioned. Simulta-
neously, all the useful information will be loaded into 

the computerized management system by the clinical 
engineering department staff, including basic info, clinical 
department, maintenance record, and the trial's validity 
period. Besides, a QR code label containing affiliation, 
equipment name, brand and model, serial number, and 
the clinical department is labeled on each piece of trial 
equipment (Figure 2).

In this paper, a lean and computerized management 
system is proposed and implemented in the hospital, in 
which non-hospital owned equipment is subject to over-
sight and control in a standardized framework, especially 
in terms of the following several aspects.
1. Based on the strict management policy and procedure, 

some unnecessary and less prominent medical devices 
are filtered in the approval process. The quantity of 
external medical equipment is better controlled and 
quality is better guaranteed. There are no more than 
10 cases of trial medical equipment in our hospital 
every year in recent years.

2. QR code label. More detailed information is obtained 
following the scanning of the QR code. It contains device 
type, serial number, registration certificate informa-
tion. Besides, repair and maintenance records can be 
documented in the computerized management system. 

FIGURE 2. The QR code label. 



25 J Global Clinical Engineering Vol.4 Issue 1: 2021

Y. Wu, K. Zheng, B. LI, C. Zheng: Lean and Computerized Management System for Non-Hospital-Owned Medical Equipment 
in Hospital

The registration certificate period for non-hospital-
owned equipment will be monitored by the clinical 
engineering department's computerized management 
system. If the clinical department applies for extending 
the trial time, its validity period must be reviewed and 
confirmed. Hence, the working efficiency is enhanced 
since the validity of the registration certificate and trial 
period validity can be checked by scanning the QR code. 

3. Planned maintenance. The computerized manage-
ment system alerts the need for any maintenance due 
three days in advance, at which time the department 
of clinical engineering will contact the vendors for a 
timely inspection and maintenance. The maintenance 
task and its record can be easily accessed and carried 
out by scanning the QR code. All the corresponding 
information can be reviewed by logging in the system. 

4. End of the trial. The computerized management system 
reminds the trial ending time three days in advance. 
The clinical engineering department is responsible for 
reminding and contacting the vendors to remove the 
trial equipment from the hospital. Also, it is recorded 
in the information system.

CONCLUSIONS

The lean management system we described takes 
key management elements of non-hospital owned medi-
cal equipment into consideration. Combined with the 
government requirements of rules and regulations with 
hospital real-practice scenarios, the department of clini-
cal engineering has designed and implemented an effec-
tive lean management system for non-hospital-owned 
medical equipment. Furthermore, the whole management 
process is carried out with the support of an information 
system, in which all the corresponding information and 
certificates, and quality control activities are recorded 
and is reviewed together conveniently. By doing so, the 
management efficiency and performance improves. The 
risks and potential damages from non-hospital-owned 
medical equipment are effectively mitigated; medical 
safety for hospitals and patients is enhanced; compliance 
with regulations increases.

ACKNOWLEDGMENT

This work was supported by National Key Research 
and Development Project (2017YFC0114107). We want 
to extend our sincere gratitude to Dr. Yadin David for his 
revising this paper. We are also deeply indebted to our 
other clinical engineering staff that supported our work.

CONFLICT OF INTEREST

The authors declare that they have no conflict of interest.

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