A Call for Safer Utilization of Radio Frequency Identification in the e-Health Era

Abstract

The main purpose of this study was to investigate the perceptions of the electromagnetic interference (EMI) caused by radio frequency identification (RFID) with medical devices among hospitals as well as to call the attention of medical institutions to the development of RFID applications. A survey sponsored by the Department of Health of Taiwan was conducted and the target subjects were every hospital in Taiwan (486 in total). The survey topics included testing of RFID interference with medical devices and perceptions of safety issues of RFID. The main targets of the survey were the Chief Information Officers (CIOs) or the main person responsible for RFID systems in each hospital. Of the original 486 questionnaires mailed, 273 were returned. A return rate of 56.17% was obtained. The survey results revealed that only six hospitals had carried out tests on interference by RFID with medical devices, and the results of these tests indicated that RFID does not interfere with medical devices. A majority of hospitals understood that RFID may interfere with medical devices but did not think that this would seriously harm patients. The application of RFID in the healthcare industry is certainly promising; however, EMI issues must be appropriately handled. This study asserts that most hospitals do not understand or pay insufficient attention to the issue of RFID interference with patient safety or medical devices. In addition, most hospitals believe that the problem of RFID should be resolved by RFID vendors. Therefore, this study argues that medical institutions should develop more understanding of RFID issues and that more attention should be given to the potential problems of RFID interference when developing RFID applications.

Introduction

As wireless communications technologies such as cell phones, wireless networks, radio frequency identification (RFID), near field communication, and far field communication have progressed, numerous wireless applications have been proposed in various industries. The information-intensive healthcare industry is no exception and has proposed applications such as Mobile-Health, Ubiquitous-Health, Pervasive Healthcare, and Telemedicine.^1

–7 The purpose is to utilize anytime and anywhere computing to facilitate easier retrieval of the comprehensive data required by medical personnel for healthcare. These applications can also facilitate real-time communication between medical personnel, increase the timeliness of medical care, and improve the efficiency of healthcare processes, thus enhancing the quality of healthcare services.¹ Among these wireless communication technologies, RFID is widely applied to inventory control in supply chain management and even to customer relations management in the retail industry because of its capacity for automatic identification, gathering of information, and tracking of specific products.⁸ RFID is viewed as a new technology with high development potential.

The application of RFID in the healthcare industry can be roughly divided into three general categories: (1) automatic identification: for example, identification of patients,^5,9
–11 (2) medical devices tracking,^12,13 and (3) gathering of information, such as automatic gathering of specific information about patient movements.^14,15 Additionally, there are many applications of RFID to telemedicine.^4,16
–18 Further opportunities to utilize RFID in the healthcare industry lie in the areas of patient care process management, medical waste management, and patient medication management. Such applications could reduce medical errors^8,19 and enhance the quality of healthcare services. The use of RFID in the healthcare industry is growing in multiple ways.¹³ Estimates are that in 2016, the value of RFID in the healthcare industry will reach USD 2.1 billion and that the healthcare industry will become the main industry for application of RFID.²⁰

Although RFID can improve patient care processes, reduce medical errors, and enhance the quality of healthcare, RFID has the potential to cause electromagnetic interference (EMI), in the same way as mobile phones, wireless networks, and other wireless communications technologies. With regard to application of wireless communication technologies in the healthcare industry, medical professionals have raised concerns about the possible interference with medical devices or harm to patients these technologies may cause.⁵ Using the EMI of mobile phones as an example, hospitals usually ask patients and their families to avoid using their mobile phones in hospitals, as these devices may cause life-sustaining devices such as respirators, pacemakers, or dialysis machines to crash or become inoperative. However, serious effects of EMI caused by mobile phones on medical devices have been rarely reported. On the other hand, strict control of the mobile phone usage of patients and visitors in Taiwanese hospitals is difficult. A majority of medical personnel also often carry at least one mobile phone to facilitate real-time communication with colleagues. In recent years, to develop telemedicine or e-health applications, many medical institutions have established widespread wireless networks. Thus, medical institutions have been in the shadow of wireless EMI for quite some time.

In 2008, a study published in the Journal of American Medical Association (JAMA) experimentally proved (in nonclinical conditions) that RFID systems cause partial interference with medical devices and are hazardous to patients.²¹ However, other studies have responded to the JAMA paper by indicating that RFID does not interfere with medical devices.²²

When the communication frequency range of medical devices matches that of wireless communication devices (such as mobile phones or RFID), errors may occur because of EMI, resulting in unexpected responses. The opinion in current literature is divided with regard to the possible EMI of RFID with medical devices, and the number of actual cases proving that EMI (not necessarily from RFID) in clinical practice is truly hazardous to the life and safety of patients is insufficient. The U.S. Food and Drug Administration presently does not take the position that it is necessary to prohibit the use of equipment that emits electromagnetic energy in healthcare environments.²³

In the efforts of the healthcare industry to improve its service quality, the use of RFID has presented itself as a feasible scheme. Because of the potential influence of RFID on medical devices and the health and safety of patients, this study surveyed hospitals in Taiwan with regard to testing of the potential interference of RFID with medical devices and perceptions of the safety of RFID use. Lastly, this study provides practical recommendations on use of RFID in medical institutions, to serve as reference for such institutions in future induction of RFID.

Materials and Methods

This study surveyed 486 Taiwanese hospitals including medical centers (roughly with >900 beds), regional hospitals (roughly with 400–600 beds), and district hospitals (roughly under 200 beds) to understand the perceptions of RFID interference and preventive measures against such interference among hospitals in Taiwan. The main targets of the survey were the CIO or the main person responsible for RFID-related systems in each hospital.

The initial draft of the questionnaire was mainly developed from RFID-related literature. Three experts with wide experience in the healthcare industry (a physician, a nurse, and a CIO) and two scholars with healthcare information management expertise were invited to form an expert panel. Two expert panel meetings were held to discuss and refine the questionnaire. The purpose was to ensure that the questionnaire content matched the practical situation of healthcare and to make semantic revisions to enhance the content validity of the questionnaire.

This study also gathered basic information on the survey targets and asked the Department of Health, Executive Yuan, to provide supporting documents, to improve the respondent rate. The questionnaire content consisted of three main sections: (1) basic information on the respondent and his/her affiliated hospital; (2) results of tests on the potential interference of RFID with medical devices; and (3) perceptions of the potential interference of RFID with medical devices. The survey period consisted of 2 months and ended on January 3, 2010. A total of 273 valid questionnaires were returned, achieving a valid response rate of 56.17%.

Results

Analysis of Basic Information on Respondents and Their Affiliated Hospitals

The questionnaire respondents were mainly CIOs or deputy CIOs (139/273) of information system (IS) department. A number of regional hospitals or district hospitals did not have IS departments. Therefore, the questionnaires were filled out by employees in the hospital departments responsible for IS (such as the medical records department or medical affairs office). On average, respondents had been employed in the healthcare industry for more than 9 years, indicating that the respondents should possess sufficient knowledge to respond to this questionnaire. The ages of the respondents ranged from 31 to 45; male respondents (145/273) were in the majority, accounting for 66.79%. With regard to different types of hospitals, 16 of 23 medical centers responded (response rate of 69.57%), 65 of 79 regional hospitals responded (response rate of 82.28%), and 192 of 384 district hospitals responded (response rate of 50.00%). The overall response rate was 56.17%. The individual response rates for hospitals at various levels and the overall response rate all exceeded 50%, indicating that the results of this survey should be representative of the viewpoints of hospitals in Taiwan regarding RFID interference. The characteristics of the samples are shown in Table 1.

Table 1.

Sample Characteristics

	FREQUENCY	PERCENTAGE
Age
<25	1	0.4
25–30	40	14.7
31–35	52	19.0
36–40	47	17.2
41–45	44	16.1
46–50	19	7.0
>51	17	6.2
N/A	53	19.4
Gender
Male	145	53.1
Female	43	15.8
N/A	85	31.1
Position
CIO	139	50.9
Others	84	30.8
N/A	50	18.3

N/A, not available.

Results of Tests on the Interference of RFID with Medical Devices

This study first surveyed whether the responding hospitals had tested the potential interference of RFID with medical devices. The survey results demonstrated that very few of the surveyed hospitals (only six) had tested for RFID interference with medical devices including control systems of operating table, electric scalpels, respirators, defibrillators, and endoscopy systems. The results of these tests indicated that RFID does not interfere with the regular operation of medical devices. (Note: this survey was not able to ascertain the methodology used in these tests; therefore, these data should be cited with caution.)

Perceptions of the Potential Interference of RFID with Medical Devices

This survey utilized nine questions to measure the perceptions of hospitals regarding the potential interference of RFID with medical devices. A 5-point Likert scale was used, and respondents assigned a score of 1 to 5 to each question (1=strongly disagree; 5=strongly agree). The mean and standard deviation for each question were calculated according to different types of hospital. Statistics were limited to valid questionnaires; blank questionnaires were not entered in statistical calculations. The analysis results are depicted in Table 2.

Table 2.

Mean and Standard Deviation of Questionnaire Items

QUESTIONNAIRE ITEMS	MEDICAL CENTERS: MEAN (SD)	REGIONAL HOSPITALS: MEAN (SD)	DISTRICT HOSPITALS: MEAN (SD)	ALL: MEAN (SD)
Q1. I think RFID does not seriously affect medical equipments.	3.15 (0.69)	3.11 (0.92)	3.03 (0.85)	3.06 (0.86)
Q2. I think RFID does not seriously affect patients.	3.23 (0.73)	3.28 (0.90)	3.03 (0.92)	3.12 (0.91)
Q3. 3. I think the interference of RFID with medical equipments does not threaten the safety of patients.	3.00 (0.58)	3.07 (0.98)	2.93 (0.82)	2.97 (0.85)
Q4. To ensure the safety of patients, RFID equipments should not be used in hospitals. (reverse question)	2.46 (0.66)	2.38 (0.68)	2.65 (0.63)	2.55 (0.65)
Q5. I think that the use of RFID equipments must meet relevant medical standards and specifications.	3.92 (1.12)	3.89 (1.08)	3.76 (1.17)	3.81 (1.14)
Q6. I think that the electromagnetic wave standards of medical equipments in hospitals need to be measured to determine which are at high risk.	3.77 (1.01)	3.75 (1.07)	3.59 (1.15)	3.65 (1.12)
Q7. To ensure the safety of patients, I think that specific control measures for RFID use should be implemented based on the electromagnetic wave standards of medical equipments in hospitals.	3.69 (0.95)	3.44 (1.06)	3.30 (1.04)	3.37 (1.04)
Q8. I think that the development of RFID in hospitals should adhere to the radio frequency factor guidelines for medical equipment, established by the U.S. FDA.	3.69 (0.85)	3.63 (1.05)	3.49 (1.02)	3.54 (1.02)
Q9. Overall, using RFID in hospitals is safe.	3.46 (0.88)	3.23 (0.98)	3.23 (0.91)	3.24 (0.93)

FDA, Food and Drug Administration; RFID, radio frequency identification; SD, standard deviation.

The main purpose of the first four questions was to understand the attitude of each hospital with regard to the issue of whether RFID affects the operation of medical devices and patient safety and whether RFID should be used in hospitals. The survey results revealed that both medical centers and regional hospitals adopted a more neutral attitude. In other words, they were not sure about whether RFID will affect medical devices or safety of patients, whereas district hospitals held more negative views. In addition, most hospitals held neutral view about testing of RFID interference and the survey results showed that only six hospitals had performed RFID interference tests, the results of which were all negative.

As the summative statistics show in Figure 1, error bars surrounding the mean responses represent the standard deviation of their respective mean values. Overall, the average rating of respondents (including medical centers, regional hospitals, and district hospitals) was almost between 3 and 4. In other words, hospitals neither agreed nor disagreed. This could mean that hospitals do not fully understand or even ignore the risk of RFID interference. Therefore, it is likely that the majority of hospitals rely on RFID vendors for ensuring safety and absence of interference. This phenomenon could be due to the fact that RFID is a relatively new technology for hospitals that are still exploring how to utilize it effectively rather than considering potential issues posed by RFID interference.

Fig. 1.

Comparison of questionnaire responses.

Discussion

Previous research proving that RFID interferes with the operation of medical devices was mainly conducted in laboratory conditions. However, the difference between the conditional variables of the test environment and those of a healthcare environment was not investigated in-depth. Further, few cases of severe harm to patients caused by RFID EMI exist in the medical domain. The survey results in this study indicated that hospitals still have reservations about the potential interference of RFID with medical devices and its effect on patient safety but tend to support the viewpoint that RFID does not cause severe harm to patients. The perception level of RFID interference by district hospitals was slightly lower. This may be because the information technology infrastructures and IS capability of district hospitals is lower compared with medical centers and regional hospitals, resulting in a lower level of understanding with regard to RFID.

Nevertheless, to be prudent, because healthcare issues involve human lives, a majority of hospitals at various levels agreed that use of RFID equipments should be accompanied by comprehensive planning and training as well as adhere to established usage standards and specifications. With regard to tests on the interference of RFID with medical devices, survey results revealed that out of 273 hospitals, only 6 had performed such tests. The results of these tests indicated that RFID does not interfere with these medical devices. However, a majority of hospitals had not conducted such tests. A possible reason may be that literature lacks cases of RFID causing serious threat to the lives of patients.

According to the results of this survey, this study asserts that RFID offers definite value to the healthcare industry. However, the potential problems RFID may pose, according to the results of this study, are ignored by the healthcare industry in general. Therefore, the correct attitude in use of RFID is to seek to both properly respond to the issue of potential interference and effectively bring the benefits of RFID into play.

Conclusions

Whether electromagnetic waves of wireless communication devices are hazardous to the human body has been an ongoing debate. Similar to the process that led to the now common installation of wireless networks in hospitals and the free use of mobile phones, the benefits of using RFID are being affirmed. Use of RFID should not be discontinued on the basis of concerns about interference that cannot be objectively confirmed. Under conditions where the pros far outweigh the cons, the healthcare industry must still pay attention to the potential problems that may be caused by RFID and propose appropriate strategies to handle them. Thus, we believe that the potential hazards of RFID could be effectively eliminated, and the effectiveness of RFID in patient identification and other areas be brought into full play. Additionally, the authorities, hospitals, and suppliers of RFID-related equipments should cooperate to promote the development of RFID application that is even more mature, safe, and appropriate for use in the healthcare industry. We believe that this is the most feasible approach of promoting use of RFID in healthcare industry.

Footnotes

Acknowledgments

Sincere thanks and recognition are given to the Department of Health of Taiwan for funding this study (98L7295).

Disclosure Statement

No competing financial interests exist.

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