Assessment Of Utilization Pattern of Medical Devices and Associated Adverse Events in A Tertiary Care Teaching Hospital

The World Health Organization has defined medical device as any “instrument, apparatus, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of diagnosis, prevention, monitoring, treatment or alleviation of disease.1-4 The global medical device (MD) market grew from $260 billion in 2006 to $380 billion in 2016. India, among the top 20 MD markets, contributed $3 billion but lacks a robust system for reporting and tracking medical device adverse events (MDAEs), relying instead on data from developed countries. To strengthen regulatory oversight, a structured vigilance system is essential. Materiovigilance addresses this gap by systematically monitoring, reporting, and managing adverse events linked to medical devices. Its goal is to enhance patient safety by minimizing the recurrence of such events during the post-marketing phase. 5, The demand for medical devices is rising due to the global increase in metabolic disorders like stroke, obesity, diabetes, and cancer. While these devices greatly aid patient care, they also pose risks such as electrical burns or metal contamination from malfunctioning implants. Adverse events (AEs) can lead to serious health issues, with an estimated 450,000 emergency visits annually in the U.S. linked to device-related AEs. These vary by device type, including insulin pumps, ventilators, and implants. Despite their benefits, devices have been recalled due to defects causing harm. Therefore, rigorous risk-benefit assessment and a strong monitoring system are crucial, yet such systems exist in only a few countries. The U.S. FDA alone receives around 1,000 reports yearly of device malfunctions or injuries, highlighting the need for consistent AE reporting to ensure device safety and performance. 7,8,9 The exact number of adverse medical device events (AMDEs) in hospitals is unknown. A UK study in 1999 reported over 6,600 device-related incidents, including 87 deaths and 345 serious injuries, among 8.5 million hospital admissions. While some studies explored device-related issues, few assessed patient outcomes or examined AMDEs within hospitals. One study found AMDEs often stem from organizational flaws and user errors, but no research has yet identified the incidence of potentially preventable AMDEs in a representative hospital population.10-12 The limitation of MD rule-2017 is that all medical devices are not amenable to this law. Presently MD rule-2017 is limited to medical devices that are periodically notified by the Government of India. Usually, registration is not required for the import and marketing of non-notified medical devices in India. As of 1st January 2020, only 37 medical devices are notified and many medical devices are not included in the notified list. The frequently used non-notified medical devices include oxygen masks, infusion pumps, ventilators, incubators, etc. Previous studies in other countries have shown adverse events including SAE with above devices. The magnitude of adverse events caused by these non- notified medical devices is also limited in India.11,13 The present study aims to evaluate the utilization pattern of medical devices in a tertiary care teaching hospital. It seeks to categorize these devices based on the risk-based classification system defined by the Global Harmonization Task Force (GHTF) and the Central Drugs Standard Control Organization (CDSCO). Additionally, the study intends to assess and estimate the occurrence of adverse events associated with the use of medical devices within the hospital setting.

METHODS:

Study Design & Sample size:

A Prospective observational study was conducted at  Navodaya Medical College & Research Centre, Raichur. Sample size was calculated based on the previous study prevalence and it was 100. Inpatients using medical device in the Surgery, Orthopaedics, General Medicine, or OBG departments was included in the study. Additionally, patients who had experienced adverse events associated with medical devices  also be included in the study. The study excluded inpatients in the Paediatrics and Emergency departments, as well as all patients attending the OPD. A Structured data entry form was designed with socio-demographic characteristics of respondent like patient name, age, gender, weight and height, socioeconomic status and marital status. A special provision was included to record the information of patients regarding the use of Medical Devices. Our data entry form has focused more on the utilization of medical devices and the risk class of the medical devices and the cost of the medical devices. Study followed the Materiovigilance form provided by the Govt. Of India for documenting the adverse events. The severity of adverse event was also assessed. The study was approved by IEC by using ethical clearance.

Collection of data

The Project team includes five Pharm D students. Study wards were visited daily by the project team as per schedule. A total of 100 cases were collected from Orthopaedics, Surgery and followed by General Medicine and OBG department. Project team approached patients and explained about the study purpose. After admission and clinical examinations, data was collected from patients with the device he/she used. Demographics and clinical parameters of the patients included age, complaints, vital signs, electrocardiographic (ECG) findings, physical examinations findings, serum electrolyte level, ESR level, discharge information from patient profile, any adverse events due to medical devices also monitored.

Statical analysis

Collected data was entered in the SPSS Version 20 and was analysed using descriptive statics such as percentage, mean, standard deviation etc.

Flowchart.1: Methodology Adopted For the Study

RESULTS:

The study entitled “Assessment of Utilization Pattern of Medical Devices and Associated Adverse Events in a Tertiary Care Teaching Hospital ’’ was carried out in 100 patients admitted in Navodaya Medical College Hospital and Research Centre, Raichur.  Out of  100 patients 57% patients were male and 43% patients were female with the male female ratio 1.33:1. Age was taken into consideration by dividing it into 8 groups with class interval of 10 between 0-80 years of age Mean age of the patients who were prescribed with medical devices 44.1 years. It was found that devices were prescribed more in age group of 31-40 years (23 %) followed by 16 patients in 41-50 years and 51-60 years of age groups. least percentage were observed in paediatrics and adolescent age groups that is 2 and 7 percent respectively.

Figure. 1 :  Ward Wise Distribution (n=100)

Out of 100 patients who were prescribed with the medical device 40 % were from Orthopaedic followed by 30% in Surgery and 16 and 10% of patients from General medicine and OBG departments. (Figure.1)

Table No 1: CDSCO Risk Categorization of Device (n=100)

We have analysed device used in the hospital as per risk categorization by CDSCO and found that most used medical devices belongs to class-B ( Low to Moderate risk ) with the percentage of 45.83 followed by class-C ( Moderate to High risk ) and class -A ( Low risk ) with the percentage of 33.33 and 12.5 respectively . least used medical devices belongs to class-D ( High risk ) with the percentage of 8.33. This result was depicted in the Table 1

Out of 24 devices 75% of device was used for the therapeutic purpose and 25% of diagnostic purpose(Figure. 2). We categorize devices according to invasiveness and found that 52.94% of device involved in Invasive procedure like IV-Cannula, Orthopaedic Implants, Sutures, Haematological Testing kit, Hypodermic syringe, Vacuum Suction etc. and 47.06% device used in Non-Invasive procedure like X-Ray, Infusion set, Alcohol swab, Catheter, Cotton Bandage etc.

Figure. 2: Distribution According to Purpose of Use (n=24)

As shown in figure 3 Frequent use of medical devices was also noted and it was observed that Alcohol Swab was frequently used (15.49%) which is a common procedure for every parenteral administration followed by IV Cannula 15.33%, BP Monitoring devices 14.85% Nebulizer was used only 4 times (0.63%).

Figure. 3:  Frequency of Device Used (n=626)

We also observed adverse events any occur due to medical device prospectively. We identified 17 events occur due to medical devices in which 4 are serious AEs like Thrombophlebitis, Clot, Urinary tract infection etc. and 13 are Non serious AEs like leakage of IV set, redness, itching, Wrong Reading etc data was depicted in table 2 

Table 2: Details of Suspected MDAEs Occurred During Study Period (n=17)