Reporting adverse events related to medical devices: A single center experience from a tertiary academic hospital.

Intensive care units (ICU) rely on multiple technical resources with extensive use of different medical devices, such as ventilators, vital sign monitors, infusion, and injection pumps. This study explored how ICU nurses approach adverse events related to medical devices in a single tertiary center and identify their level of awareness of the national reporting system for adverse events related to medical devices beside their source for risk information updates. Totally, 297 nurses working in the ICU at King Saud University Medical City completed a survey on medical devices and adverse events reporting and 198 reported experiencing an adverse event related to equipment failure. However, 195 nurses were unaware of an official national reporting system for reporting such events. It is important to develop a framework of safe operation of medical devices based on international standards. This reporting system should include the national patients' safety authorities, and should be anonymous, confidential, and non-punitive.

Introduction

Intensive care units (ICUs) are complex multidisciplinary work environments. Efficient workflow in such areas depends on all team members’ knowledge and skills, including the medical and nursing staff, clinical pharmacists, respiratory therapists, dieticians, porters, and technicians, whose integrated efforts result in optimal patient care. This feature of the multidisciplinary team increases patient safety and improves the quality of care in the intensive care unit (ICU).

As intensive care delivery relies heavily on technical resources, the development and use of different devices—including ventilators, vital sign monitors, infusion, and injection pumps, as well as consumables—is fundamental to the integration and functioning of the ICUs. In addition, the safe operation of these devices necessitates the availability of different procedures such as safe use, maintenance, disinfection, reporting of adverse events, and communicating recurrent misuse among users and with manufacturers.[1,2] Locally, there is limited literature on adverse events related to medical devices. In 2007, the Saudi Food and Drug Authority (SFDA) launched a national project for establishing a Medical Devices National Registry (MDNR) to create a database for all medical devices, manufacturers, agents, suppliers, and end-users.[3]

However, the development of the MDNR system remains in its infancy [4] as the national law of “Medical Devices Interim Regulation” was Issued by the SFDA Board of Directors on 27 December 2008, and amended on 27 December 2017. [3] In countries with regulated medical device markets, manufacturers of medical devices, users, and their organizations benefit from reporting adverse events by updating them with latent hazards and hazardous situations of these devices, while they are being used in real life, which allows them to apply the required corrective actions, since risk management is obligatory in these countries for all parties involved in the lifecycle of medical devices. This is an iterative process for the manufacturers, even after placing the device in the market. [5-7]

Therefore, this study aims to assess and explore the level of awareness of ICU nurses in reporting adverse events related to medical devices and how frequently they report adverse events.

Methods

This is a single center cross-sectional questionnaire-based survey that was conducted in February 2018 and targeted nurses working in the ICUs of King Saud University Medical City (KSUMC) in Riyadh, Saudi Arabia. The required representative sample comprised 218 nurses out of the 502 nurses working in the critical care units (a 95% confidence and a margin of error equal to 5%).

The survey (S1 Form.) was distributed to all the critical care units in the hospital including surgical ICU, Medical ICU, Coronary Care Unit (CCU), High dependency Unit (HDU), Pediatric ICU (PICU) and Neonatal ICU (NICU). The nurses were invited to fill the survey.

The questionnaire was drafted by the authors based on a review of the literature regarding the adverse events related to medical devices. A combination of evidence appraisal together with expert opinion were used in order to draft a suitable questionnaire for this study. MEDLINE® and PubMed searches were performed using the search terms “medical”, “device”, “reporting”, “safety”, “usability” and “adverse events OR critical care’”. The reference lists of identified papers were screened to identify other relevant papers. After that, four publications were utilized to draft the questionnaire. [8-11] Then a multidisciplinary team focus group meeting was conducted to produce the final version (Appendix I). Experts from biomedical engineering department, Nursing department and pediatric critical care unit reviewed the questionnaire. It was then piloted in our department, and tested to ensure and determine its clarity, before sending it to the targeted group.

Ethics statement

Participants provided their written informed consent to participate in this study on the first page of the questionnaire (Appendix I). This study was done as quality improvement project at our hospital and received ethical approval by the Institutional Review Board (IRB) of King Saud University. Participants were informed that participation was voluntary and were assured of the confidentiality of their responses and the survey was an anonymous questionnaire. Consent from the participants was obtained.

The questionnaire

A self-administered questionnaire was designed to explore how the nurses approach different technical issues related to medical devices. The medical devices indicated in the questionnaire were the devices related to the critical care settings, such as mechanical ventilators, defibrillator, cardiopulmonary monitors, and infusion pumps. The questions were grouped into the following three categories:

- The first part of the questionnaire contained questions regarding the participants’ demographic data such as: age, gender, credentials, discipline, and length of experience.

- Next, the participants were requested to indicate whether they had ever experienced an adverse event related to the use of a medical device and whether they are aware about any national reporting system for such events. Appropriate response was defined as “examining the device as per the manufacturer’s guidelines (User Manual) as received during the user training on a particular device“.

- Finally, they were requested to indicate the sequence of steps to manage issues related to any of the devices in the ICU.

Statistical analysis

Nurses were asked to select the steps they followed when they encountered an adverse event related to the medical devices in the ICU (from the first to the sixth step, starting with the item of priority). The frequencies and percentages of nurses who selected each action were computed and the relative importance index (RII) was used to compute an overall relative order, which we ranked ascendingly to understand the nurses’ sequence of action (lower Relative Importance index denotes higher orderly importance). The RII was computed using the method devised by Aziz et al. [12] by summing the individual item responses and dividing them by the product of N × the maximum possible scores.

Results

Demographic data

A total of 297 nurses out of 502 nurses working in the critical care units of King Saud University Medical City responded to the survey which makes a response rate of 59%, this rate exceeded the required calculated needed sample size of 218 respondents. The percentage of women was high in the sample (93.3%). Most of the nurses had 6–10 years working experience (26.3%), followed by those with either 3–5 years’ or more than 10 years’ experience (24.9% in each case), and those who had 1–2 years’ experience (23.9%). The majority of nurses were clinical bedside nurses (99%) and only three head nurses responded to the survey. Their working clinical units are shown in Table 1.

Table 1

Respondents' demographic and professional characteristics N = 297.

	Frequency	Percentage
Sex
Female	277	93.3
Male	20	6.7
Experience in years
1–2 years	71	23.9
3–5 years	74	24.9
6–10 years	78	26.3
> 10 years	74	24.9
Clinical Role
Nurse	294	99
Head Nurse	3	1
Discipline/working unit
Medical ICU	32	10.8
Surgical ICU	48	16.2
HDU	25	8.4
CCU	30	10.1
PICU	87	29.3
NICU	41	13.8

ICU: Intensive Care Unit, HDU: High Dependency Unit, CCU: Coronary Care Unit, PICU: Pediatric Intensive Care Unit, NICU: Neonatal Intensive Care Unit.

Experiencing adverse events

One hundred ninety eight nurses (66.7%) reported that they had experienced an adverse event related to equipment failure (sudden errors, malfunctions, or shutdown) while using the device. However, 195 nurses (65.7%) were not aware of an official national reporting system for reporting adverse events related to equipment failure. Among the nurses who were aware of the national reporting system, only 44 (14.8%) had reported at least one equipment-related adverse event. Of the 198 who had experienced an equipment-related adverse event, only 44 had reported the incidence, implying that approximately 77.8% of encountered events may go unreported. Additionally, only 31 nurses (10.4%) received feedback from their hospital superiors regarding the reported adverse events. (Table 2) No correlation was found between the length of respondents’ experience or age with their knowledge about the existence of that national database (S1 Table.).

Table 2

Items in the questionnaire and the frequency and percentage of responses N = 297.

	Frequency	Percentage
In the past year, have you encountered a sudden malfunction EVENT with these devices*
Yes	198	66.7
No	99	33.3
Are you aware of any official national reporting system regarding these ADVERSE EQUIPIMENT events?
Yes	102	34.3
No	195	65.7
Have you ever reported an adverse occurrence failure of any equipment,
Yes	44	14.8
No	253	85.2

*Malfunction was defined as a sudden user error, device malfunction, or sudden shut down of the machine.

Approach to malfunction

As shown in Table 3, the first action selected by most nurses (89.2%) when they experienced an equipment-related adverse event, in terms of relative importance weight, was to examine the device per the guidelines (RII = 20.8%). The next steps selected by the nurses were contacting the superior user/supervisor (RII = 42.1%), turning off the device to restart it (RII = 53.3%), calling the biomedical engineers (RII = 60.2%), and calling the vendor of the device (RII = 79.2%)

Table 3

Nurses’ actions ranked in the order of a case of sudden equipment failure/adverse event. N = 297.

	1st step	2nd step	3rd step	4th step	5th step	6th step	RII (%)	Order
Respond to it appropriately by examination	265 (89.2%)	18 (6.1%)	4 (1.3%)	4 (1.3%)	6 (2%)	4 (1.3)	20.8	1
Contact the superior user or the supervisor	7 (2.4%)	161 (54.2%)	98 (33%)	27 (9.1%)	4 (1.3%)	0	42.1	2
Call the biomed technician	0	10 (3.4%)	120 (40.4%)	48.8%)	19 (6.4%)	3 (1.6%)	60.2	4
Call the company	0	6 (2%)	2 (0.7%)	78 (26.3%)	184 (62%)	27 (9.1%)	79.2	5
Turn it off	23 (7.7%)	94 (31.6%)	65 (21.9%)	39 (13.1%)	69 (23.2%)	7 (2.7%)	53.3	3
Other actions	2 (0.7%)	8 (2.7%)	12 (4%)	4 (1.3%)	15 (5.1%)	256 (86.2%)	94.3	6

* Lower Relative Importance index denotes higher order of importance.

Reporting adverse events

Regarding the reporting of medical equipment failures and adverse events, the Saudi Ministry of Health was selected by 51.1% of the nurses as their first option to report these events, followed by the in-hospital quality improvement and biomedical engineering departments through the hospital built in Electronic Occurrence Variance Report (E-OVR) system (30.8%), the manufacturer via their representative (13.2%), the Saudi Council for Health Specialties (11.0%), the Central Board for Accreditation of Healthcare Institutions (CBAHI) (9.9%), the Saudi Council of Cooperative Health Insurance (3.3%), and the Saudi Food and Drug Authority (2.2%). See Fig 1.

Fig 1

Nurses reported destinations of reporting equipment related adverse event alerts/incidence.

Communicating risk information updates

The nurses considered the manufacturer as their primary source of information on adverse equipment events (80.5%), followed by their colleagues (35.7%), medical literature (33.7%), and the Saudi Ministry of Health (14.5%). Other less frequently sought sources of information included the hospital quality department adverse occurrence system and biomedical engineering departments’ email alerts and memoranda (12.8%), public advertisements (4.5%), and the SFDA (2.0%) (6 respondents out of 279 respondents). See Fig 2.

Fig 2

Nurses Sources of update Information on equipment adverse occurrence alerts.

Discussion

Reporting of adverse events affecting medical devices is an important factor that contributes massively to their safe operation. The Saudi CBAHI standard only requires this for medical devices in the occurrence of adverse events, while there is neither a clear definition of the meaning of an adverse event nor a clear procedure for reporting these adverse events to a competent national authority. In Saudi Arabia, this consists of a web-based electronic incident reporting system provided by the Medical Devices Sector of the SFDA. [13,14] This could lead to ambiguity since the SFDA defines adverse events related to medical devices as follows:

“: means any malfunction or deterioration in the characteristics and/or performances of a medical device, including any inadequacy in its labeling or the instructions for use that may lead to compromise the health or safety of patients, users or third parties.”

What is reportable and not reportable is specified through the following definition:

“: means any adverse event or any technical or medical reason leading to a Field Safety Corrective Action, which, directly or indirectly, might lead to or may have led (a) to the death of a patient, a user or another person or (b) to a serious deterioration in their state of health”. [15]

Although over 66% of respondents indicated that they had experienced technical or usage errors related to medical devices, the majority of them (78%) have never reported these adverse events. This low rate could be attributed to the lack of knowledge about the existence of specific legislation for adverse events related to medical devices. [8]

Another possible reason is the fact that healthcare workers might avoid legal and liability consequences that could be traced back to them, because these adverse events might be related to errors in usage and there is no solid protective legislation. [8] This problem has been resolved in different countries with various kinds of legislation by considering anonymous reporting and legal protection for the reporter. Anonymous reporting as a feature has been offered either by the MedSun Approach used by the United States Food and Drug Administration (USFDA) or the Danish Health Care System approach. [16,17] Legislation that does not penalize the reporter should be created similar to that of the Danish Act on Patient Safety. [16,18] The MedSun approach is a voluntary medical device adverse event electronic reporting system that guarantees the anonymity of the reporter’s personal information by USFDA and maintains contact with the reporter. Each user report will be forwarded in detail to an intermediary appointed by the USFDA MedSun at the user facility, who will review the message report and stay in contact with the reporter to complete the report, to make the report usable from a technical and clinical point of view, to improve the medical device. Another practice to overcome the limitation of anonymous reporting is that of the Danish Health Care System, as they approved and enforced the Act on Patient Safety. This law has been drafted to enhance patient safety and communication of risk information from adverse events by enforcing sanction free reporting. As result of this law, the reporter of adverse events is not subjected to any disciplinary action by his employer or other supervisor or any legal process as a consequence of his/her report. This act was enforced in 2004 and reports showed an increase exceeding 80% within the first two years. [16-18]

In the current context of the national reporting system, it is worth mentioning that errors in usage could result from poor usability research and design by the manufacturer, which could result in recall of the product because usability and human factor issues are considered sources of hazards that need to be eliminated or controlled based on the International Electrotechnical Commission (IEC) requirements. [1, 15, 19–21]

The results show that almost all respondents did not consider the SFDA as a source for medical device risk information. Majority of them relied heavily on the manufacturer feedback. This might be due to a lack of proper communication between the SFDA and the hospital as it has been reported previously in the literature. [8] Another possible cause could be that, although the CBAHI requires healthcare providers to implement a recall management system for medical equipment, they did not mention the SFDA as a source for such information. While for the medication recall management system, the CBAHI incorporated the SFDA in their requirements. [13]

Another striking finding was the low level of awareness of the national reporting system for medical device adverse events among the ICU nurses, as only 2% of respondents reported the correct existing national reporting system, despite that over 66% of the respondents indicated that they have experienced technical or use errors by using medical devices. This might explain why the number of adverse events reported to the SFDA is extremely low compared to the international community. Per a report from the SFDA, the number of adverse event reports received by the SFDA slightly increased from 2 in 2008 to 26 in 2011, then increased to 410 reports in 2012, while in 2013 the number of reports dropped to 68, with a slight increase to 87 in 2016, until it reached 114 in 2017 (SFDA 2013, 2016, 2017). The total number of adverse events reported, per these statistics from 2008 to 2013 and from 2016 to 2017, could not exceed 726 reports. In 2007, the USFDA received over 150000 reports. [22] The Medicine and Healthcare Product Regulatory Agency (MHRA) in the UK received about 10000 incidents reports in 2010. [23] This significant low reporting rate of adverse events to the SFDA must be considered as serious, as these events could have a non-negligible negative impact on patient or user safety.

Study limitations

We considered the usage error as one of the possible technical problem that might be faced by the healthcare worker as this might result from poor usability research and design by the manufacturer. The usability and human factor issues are considered sources of hazards that need to be eliminated or controlled based on the International Electrotechnical Commission (IEC) requirements. [1]

While this study highlights significant medical device reporting system from one hospital, this needs further exploration in the other healthcare facilities. The self-reporting nature of this survey may be subjective to recall bias that needs further direct observations in prospective, ICU-based clinical trials.

Conclusion and recommendations

This study has raised the need to develop a framework for the safe operation of medical devices, based on international standards, that has the following characteristics:

- The Health care workers need to be familiar with the existence of a national reporting system of adverse events to the SFDA. Legislation that does not penalize the reporter should be created.

- The role of the Medical Devices SFDA-Officer for healthcare providers should be activated (Saudi Food & Drug Authority 2018).

- The internal E-OVR in the hospitals should be directed to the Saudi Center for Patient Safety and the center will direct the report to the SFDA.

- Recalls for medical devices should be directed from the SFDA through the Saudi Center for Patient Safety and disseminated to hospitals.

- A database should be created where risk information is categorized and made accessible with multiple interfaces for:

Medical device users (Voluntary)–the aim of this database is to facilitate networking and sharing experiences among users

Medical device manufacturers or designers (mandatory)

Healthcare organizations (such as for risk management departments) (mandatory).

This is the S1 Form of the questionnaire of the survey.

(PDF)

Click here for additional data file.

This is the S1 Table where it shows the correlation of the respondents’ characteristics and their awareness of the national reporting system for adverse events.

(XLSX)

Click here for additional data file.

7 Aug 2019

PONE-D-19-19700

Reporting adverse events related to medical devices: A single center experience from a tertiary academic hospital

PLOS ONE

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Reviewer #1: Reviewer’s comments

A reporting system was described in this manuscript. However, there are some issues that need to be addressed.

Major comments

1. There is little description about the national reporting system, the name of the law, the time of legislation, the details in the required reporting, etc.

2. Demographic characteristics: the nationality/citizenship was not reported. Howe many of them were native? Do they have difficulties in understanding the regulations?

3. Can the authors be more specific about the “devices”? What are the devices that are more frequently used in the settings?

4. How was “Respond to it appropriately by examination” in the questionnaire defined?

5. The reporting interface (?) or methods were not described. In the Results, it seemed complicated. Was the reporting part of nursing education?

6. In the Discussion, the explanations about the key terms should be moved to the Introduction or the Methods.

Minor comments

1. In the first sentence, Line 67, what does “(a 95% confidence interval and 5% marginal error)” mean?

2. In the Discussion, was there any data about the reporting rates in previous studies?

Reviewer #2: Dear authors,

I got to review your manuscript "Reporting adverse events related to medical devices: A single center experience from a tertiary academic hospital". In my opinion, your manuscript is already in a quite good state dealing with a topic highly worthwhile to further assess. However, there are some aspects, that should be covered/questions that were raised during the reading:

1.) In your introduction, line 53, you state that the development of the MDNR system remains in its infancy. However, you do not further elaborate. Please write one or two sentences as to why this system is not that well developed yet.

2.) In line 71 you state, that the questionnaire was drafted by the authors based on a review of the literature - can you further elaborate as to how this review was assessed? Do you refer to specific papers?

3.) Please keep the same order in Methods (1, 2, 3) and in results/discussion (1, 3, 2). I recommend to first present the results of the step sequence and THEN the personal experience (as it is in methods section).

4.) Have there been any nurse pupils, assistance care givers been questioned, as well?

5.) Please delete "approximately" in line 118, as it makes no sense.

6.) I recommend to give the percentage of those who had reported an AE compared to those who were aware of the system, as you state in the sentence (line 121f.). Then you can also lose the next sentence.

7.) In table 2, why does it say n=103 at the third question? Does that not have to be 102? And further, if n=102, how come the frequency is higher? I would only indicate the nurses, that have ticked yes in the second question (therefore n=102; yes: 44, No: 58).

8.) In your sequence of steps, I do miss the relevance of the patient - how comes, that there is no step "securing the patient's survival" or similar?

9.) In table 3 the n at "call the biomed technician" is missing.

10.) On page 12 in your discussion, you state, that the nurses had also reported usage errors - however, prior to that there is no mentioning of usage errors, just technical errors. So I recommend to delete it here AND

11.) Introduce a limitations section, in which you could also discuss, that some of these technical errors could be due to wrong usage and so on. In general, a limitations section would be helpful.

12.) In the middle of page 14, where do the 2% come from? I thought it would have been n=102, therefore around 34%? If the rest could not name the right system, then please introduce these 2% and this fact in results section already.

13.) Have you found any correlation between length of experience/age with the knowledge of the existence of that database? Please add this to your manuscript.

14.) Have you found any literature concerning the same topic with other medical professions? E.g. doctors - I would be interested in how many of those know about the existence of said systems. Please discuss.

Thank you.

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Reviewer #2: No

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28 Aug 2019

Dear Dr. Kamolz

We would like to thank you and the reviewers for the comments and suggestions pertaining to the manuscript #PONE-D-19-19700: “Reporting adverse events related to medical devices: A single center experience from a tertiary academic hospital” in PLOS ONE

We have now addressed all points, as detailed below.

Reviewer #1: Reviewer’s comments

A reporting system was described in this manuscript. However, there are some issues that need to be addressed.

Major comments

1. There is little description about the national reporting system, the name of the law, the time of legislation, the details in the required reporting, etc.

Thank you for your comment. The name of the national law is the “Medical Devices Interim Regulation“. This law was issued by the Saudi Food and Drug Authority (SFDA) Board of Directors decree number (1-8-1429) and dated 27 December 2008, and amended by SFDA Board of Directors decree number (4-16-1439) dated 27 December 2017

(https://www.sfda.gov.sa/ar/medicaldevices/regulations/Documents/MD-InterimRegulation-en.pdf)

The details in the required reporting can be found in the folowing link

(https://ncmdr.sfda.gov.sa/Default.aspx)

Changes done in the text.

2. Demographic characteristics: the nationality/citizenship was not reported. Howe many of them were native? Do they have difficulties in understanding the regulations?

Thank you for raising this point. We did not enquire about the nationality to avoid creating bias among the healthcare workers. All of them speak English fluently as first or second language. The questionnaire was constructed in English knowing that the official language of the healthcare system in Saudi Arabia is the English language and all the legislative regulations related to the healthcare are issued in both English and Arabic.

3. Can the authors be more specific about the “devices”? What are the devices that are more frequently used in the settings?

Thank you for this comment. The medical devices indicated in the questionnaire were the devices related to the critical care settings; such as mechanical ventilators, defibrillator, cardiopulmonary monitors, infusion pumps,.. etc.

Changes done in the text.

4. How was “Respond to it appropriately by examination” in the questionnaire defined?

Thank you for your comment. Appropriate response was defined as “examining the device as per the manufacturer‘s guidelines (User Manual) as received during the user training on a particular device“.

Changes done in the text.

5. The reporting interface (?) or methods were not described. In the Results, it seemed complicated. Was the reporting part of nursing education?

Thank you for your point. Indeed, the reporting interface is an electronic website (https://ncmdr.sfda.gov.sa/Default.aspx) designed for healthcare workers to report the adverse events. Unfortunately, it is not included in the nursing education and this study aimed to support the need to integrate this reporting system the healthcare education.

6. In the Discussion, the explanations about the key terms should be moved to the Introduction or the Methods.

Thank for your comment. In the beginning of the discussion, we wanted to elaborate more on the adverse events related to medical devices as this would help the reader to better understand the evolution of this system over the last several years.

Minor comments

1. In the first sentence, Line 67, what does “(a 95% confidence interval and 5% marginal error)” mean?

Sorry for the typo, it was corrected to:

“95% confidence and a margin of error equal to 5%”

The 95% level is the most commonly used. If the level of confidence is 95%, the "true" percentage for the entire population would be within the margin of error around a poll's reported percentage 95% of the time.

http://theknowledge.site/wp/m/Margin_of_error.htm

2. In the Discussion, was there any data about the reporting rates in previous studies?

Unfortunately, studies in this field are scarce and extremely limited. The existing source of the reporting rate of adverse events related to medical device over the last several years is the annual statistical report released by the Saudi Food and Drug Authority SFDA

Reviewer #2: Dear authors,

I got to review your manuscript "Reporting adverse events related to medical devices: A single center experience from a tertiary academic hospital". In my opinion, your manuscript is already in a quite good state dealing with a topic highly worthwhile to further assess. However, there are some aspects, that should be covered/questions that were raised during the reading:

1.) In your introduction, line 53, you state that the development of the MDNR system remains in its infancy.

However, you do not further elaborate. Please write one or two sentences as to why this system is not that well developed yet.

Thank you for your comment. This was elaborated now in the text, mentionioning that the national law “ Medical Devices Interim Regulation“ was Issued by the Saudi Food and Drug Authority Board of Directors decree number (1-8-1429) and dated 27 December 2008, and amended by Saudi Food and Drug Authority Board of Directors decree number (4-16-1439) dated 27 December 2017

(https://www.sfda.gov.sa/ar/medicaldevices/regulations/Documents/MD-InterimRegulation-en.pdf)

2.) In line 71 you state, that the questionnaire was drafted by the authors based on a review of the literature - can you further elaborate as to how this review was assessed? Do you refer to specific papers?

A combination of evidence appraisal together with expert opinion were used in order to draft a suitable questionnaire for this study.

MEDLINE® and PubMed searches were performed using the search terms “medical”, “device”, “reporting”, “safety” “ Usability” and “‘adverse events OR critical care’”. The reference lists of identified papers were screened to identify other relevant papers.

*Teow N and Siegel SJ. FDA Regulation of Medical Devices and Medical Device Reporting. Pharmaceut Reg Affairs. 2013;2:110.

* Geissler N, Byrnes T, Lauer W, Radermacher K, Kotzsch S, Korb W, Hölscher UM. Patient safety related to the use of medical devices: a review and investigation of the current status in the medical device industry. Biomed Tech (Berl). 2013;58(1):67-78.

* Mattox E. Medical devices and patient safety. Crit Care Nurse. 2012;32(4):60-8.

* Rich S. How human factors lead to medical device adverse events. Nursing. 2008 Jun;38(6):62-3.

3.) Please keep the same order in Methods (1, 2, 3) and in results/discussion (1, 3, 2). I recommend to first present the results of the step sequence and THEN the personal experience (as it is in methods section).

Thank for your comment. In the beginning of the discussion, we wanted to elaborate more on the adverse events related to medical devices as this would help the reader to better understand the evolution of this system over the last several years.

4.) Have there been any nurse pupils, assistance care givers been questioned, as well?

No, in our study we included only the practicing nurses.

5.) Please delete "approximately" in line 118, as it makes no sense.

Thanks for highlighting this, it was deleted in the revised manuscript.

6.) I recommend to give the percentage of those who had reported an AE compared to those who were aware of the system, as you state in the sentence (line 121f.). Then you can also lose the next sentence.

The aim of the study is to explore the awareness of the correct national reporting system, that’s why the question about if they ever reported an adverse event or not was limited only to the 102 nurses who reported that they were aware of the national reporting system as we assumed that those nurses who were not aware about the reporting system were never exposed to an event that lead to report this event. So only 44 nurses (14.8%) among the 102 nurses who were aware of the reporting system had reported at least one equipment-related adverse event over the last year.

7.) In table 2, why does it say n=103 at the third question? Does that not have to be 102? And further, if n=102, how come the frequency is higher? I would only indicate the nurses, that have ticked yes in the second question (therefore n=102; yes: 44, No: 58).

Thank you. Indeed, this is a typing error. Correction carried out

8.) In your sequence of steps, I do miss the relevance of the patient - how comes, that there is no step "securing the patient's survival" or similar?

Thank you for this important point. The patient safety is always included in the Appropriate response to a device malfunction as per the manufacturer guidelines (User Manual). Changes done in the text.

9.) In table 3 the n at "call the biomed technician" is missing.

The typo was corrected.

10.) On page 12 in your discussion, you state, that the nurses had also reported usage errors - however, prior to that there is no mentioning of usage errors, just technical errors. So I recommend to delete it here AND

11.) Introduce a limitations section, in which you could also discuss, that some of these technical errors could be due to wrong usage and so on. In general, a limitations section would be helpful.

Thank you. We considered the usage error as one of the possible technical error that might be faced by the healthcare worker and this was indicated in the questionnaire. Correction carried out in the text.

We considered the usage error among the technical problems as poor usability research and design by the manufacturer, which could result in recall of the product because usability and human factor issues are considered sources of hazards that need to be eliminated or controlled based on the International Electrotechnical Commission (IEC) requirements

12.) In the middle of page 14, where do the 2% come from? I thought it would have been n=102, therefore around 34%? If the rest could not name the right system, then please introduce these 2% and this fact in results section already.

6 respondents out of 279 respondents considered the Saudi FDA the source of risk information such as recalls.

13.) Have you found any correlation between length of experience/age with the knowledge of the existence of that database? Please add this to your manuscript.

No correlation has been found. This information has been added to the text

14.) Have you found any literature concerning the same topic with other medical professions? E.g. doctors - I would be interested in how many of those know about the existence of said systems. Please discuss.

Unfortunately, studies in this field are scarce and extremely limited.

We included the nurses in the critical areas as they are the frontliners who are dealing first with these technical issues

Submitted filename: Reviewer comments 24-8-2019.docx

Click here for additional data file.

20 Sep 2019

PONE-D-19-19700R1

Reporting adverse events related to medical devices: A single center experience from a tertiary academic hospital

PLOS ONE

Dear Dr Alsohime,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

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Academic Editor

PLOS ONE

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

Reviewer #2: (No Response)

**********

2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: (No Response)

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: I Don't Know

Reviewer #2: (No Response)

**********

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Reviewer #1: Yes

Reviewer #2: (No Response)

**********

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PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: (No Response)

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Thank you for the revision.

Major comments

- I am not familiar with the type of statistics used in the manuscript. The fixed effects of the types of ICUs may need to be controlled or specified by the ICUs, because the types of medical devices most frequently used and the levels of training might vary accordingly.

- Discussion: there are several recommendations. However, they are not all based on the findings. For example, “The reporting system of adverse events to the SFDA should be anonymous, confidential, and non-punitive” was unrelated to the findings and inferred based on the comparisons with other jurisdictions. The non-punitive principle was mentioned in the first and second points. The term, “activated”, was not clear.

Minor comments

- Results: please use the tense consistently. Both present and past tenses were used.

- Abstract: “international standard”? Do you mean the Danish system?

- Table 1 and 2: please add total.

- Fig 1 & 2: the units? Abbreviations?

Reviewer #2: Dear authors,

thank you for your revision. In my opinion, there is still some space for improvement. I would like to ask you to consider the following:

1.) While I can imagine, that the development of the MDNR system remains in its infancy because it has just been amended, it still remains elusive to me, if you mean that. If so, please indicate (see previous comment 1.)

2.) Even if you want to elaborate more on the adverse events in the discussion, the logical flow is compromised if you switch the orders. If you want to discuss the personal experience before the approach, please switch the order in the methods section then. (see previous comment 3)

3.)In table 2, the third question still makes no sense to me. How can the frequency of no be 253, if the whole n is just 102? Again a typo? Should it be 58? (See previous comment 7).

4.) Even if you explained the 2% (6 out of 279) now, you should really introduce that number in the results already. I do not want to think about the numbers again, when I am in discussion already. Every "new" result just leads to confusion. (see previous comment 12).

5.) You should really introduce a clearly delineated limitations section. (see previous comment 11)

Thank you.

**********

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Reviewer #1: No

Reviewer #2: No

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23 Sep 2019

Dear Dr. Kamolz

We would like to thank you and the reviewers for the comments and suggestions pertaining to the manuscript #PONE-D-19-19700: “Reporting adverse events related to medical devices: A single center experience from a tertiary academic hospital” in PLOS ONE

We have now addressed all points, as detailed below.

Reviewer #1: Thank you for the revision.

Major comments

1- I am not familiar with the type of statistics used in the manuscript. The fixed effects of the types of ICUs may need to be controlled or specified by the ICUs, because the types of medical devices most frequently used and the levels of training might vary accordingly.

Thanks dear reviewer for the above comment. Regarding the first part, we suggest to refer to the below studies which can explain the type of the statics that we applied for our study.

For the second part in term of fixed effects of the types of the ICUs, we conducted a descriptive, qualitative and quantitative analysis for universal parameters and concepts applicable for the different types of the ICUs. Investigated in this study.

Aziz, N., Zain, Z., Mafuzi, R. M. Z. R., Mustapa, A. M., Najib, N. H. M., & Lah, N. F. N. (2016). Relative importance index (RII) in ranking of procrastination factors among university students.

Holt, G. D. (2014). Asking questions, analysing answers: relative importance revisited. Construction Innovation, 14(1), 2–16.

2- Discussion: there are several recommendations. However, they are not all based on the findings. For example, “The reporting system of adverse events to the SFDA should be anonymous, confidential, and non-punitive” was unrelated to the findings and inferred based on the comparisons with other jurisdictions. The non-punitive principle was mentioned in the first and second points. The term, “activated”, was not clear.

Thank you for your observation, adjustments carried out as it appears in the below text and these changes were done in the manuscript.

Many thanks

Conclusion and Recommendations

This study has raised the need to develop a framework for the safe operation of medical devices, based on international standards, that has the following characteristics:

- The Health care workers need to be familiar with the existence of a national reporting system of adverse events to the SFDA. Legislation that does not penalize the reporter should be created.

- The role of the Medical Devices SFDA-Officer for healthcare providers should be activated (Saudi Food & Drug Authority 2018).

- The internal E-OVR in the hospitals should be directed to the SFDA.

- Recalls for medical devices should be directed from the SFDA through the Saudi Center for Patient Safety and disseminated to hospitals.

- A database should be created where risk information is categorized and made accessible with multiple interfaces for:

• Medical device users (Voluntary) – the aim of this database is to facilitate networking and sharing experiences among users

• Medical device manufacturers or designers (mandatory)

• Healthcare organizations (such as for risk management departments) (mandatory).

Minor comments

1- Results: please use the tense consistently. Both present and past tenses were used.

Thank you for your remark, changes done accordingly in the text.

2- Abstract: “international standard”? Do you mean the Danish system?

Mainly we refer to the standards implemented in the western countries such as the United States Food and Drug Administration (USFDA) or the Danish Health Care System approach.16-17

3- Table 1 and 2: please add total.

Indeed, we added the total

4- Fig 1 & 2: the units? Abbreviations?

Thank you for your kind observation. Changes carried out.

Reviewer #2:

thank you for your revision. In my opinion, there is still some space for improvement. I would like to ask you to consider the following:

1.) While I can imagine, that the development of the MDNR system remains in its infancy because it has just been amended, it still remains elusive to me, if you mean that. If so, please indicate (see previous comment 1.)

Thank you for your notion. Exactly, as the national law of “ Medical Devices Interim Regulation” was Issued by the SFDA Board of Directors on 27 December 2008, and amended on 27 December 2017 (change in the text carried out)

And this was elaborated from Ref (No 4) too that states in their abstract: “However, the progress of medical device registry systems and post-market medical device surveillance systems remains in its infancy in Saudi Arabia and within the region. In 2007, a royal decree assigned the responsibility for regulating medical devices to the Saudi Food and Drug Authority (SFDA). Soon afterwards, the SFDA established the Medical Devices National Registry (MDNR) to house medical device information relating to manufacturers, agents, suppliers and end-users.

2.) Even if you want to elaborate more on the adverse events in the discussion, the logical flow is compromised if you switch the orders. If you want to discuss the personal experience before the approach, please switch the order in the methods section then. (see previous comment 3)

Thank you for this remark. We totally agree with you and we switched the order in the method section.

3.)In table 2, the third question still makes no sense to me. How can the frequency of no be 253, if the whole n is just 102? Again a typo? Should it be 58? (See previous comment 7).

Our sincere apology, that was a typing error.

The question “Have you ever reported an adverse occurrence failure of any equipment?” Was directed to all the nurses, 44 of them indicated ‘yes’, and 253 answered ‘No’

4.) Even if you explained the 2% (6 out of 279) now, you should really introduce that number in the results already. I do not want to think about the numbers again, when I am in discussion already. Every "new" result just leads to confusion. (see previous comment 12).

Indeed, This was moved to the Results section, thank you for the advice.

5.) You should really introduce a clearly delineated limitations section. (see previous comment 11)

This is an excellent advice. It was added to the text

Study limitations:

We considered the usage error as one of the possible technical problem that might be faced by the healthcare worker as this might result from poor usability research and design by the manufacturer. The usability and human factor issues are considered sources of hazards that need to be eliminated or controlled based on the International Electrotechnical Commission (IEC) requirements. 1

While this study highlights significant medical device reporting system from one hospital, this needs further exploration in the other healthcare facilities. The self-reporting nature of this survey may be subjective to recall bias that needs further direct observations in prospective, ICU-based clinical trials.

Submitted filename: Reviewer reply 2 Version 1 21Sep2019.docx

Click here for additional data file.

9 Oct 2019

Reporting adverse events related to medical devices: A single center experience from a tertiary academic hospital

PONE-D-19-19700R2

Dear Dr. Alsohime,

We are pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it complies with all outstanding technical requirements.

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With kind regards,

Lars-Peter Kamolz, M.D., Ph.D., M.Sc.

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

Reviewer #2: All comments have been addressed

**********

2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: (No Response)

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: (No Response)

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: (No Response)

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: (No Response)

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Thank you for the revision.

Please revise the following items:

Typos to remove:

1. Line 112: remove 4.

Reviewer #2: (No Response)

**********

7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #2: No

16 Oct 2019

PONE-D-19-19700R2

Reporting adverse events related to medical devices: A single center experience from a tertiary academic hospital

Dear Dr. Alsohime:

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