A medical device is any instrument or component used to treat, diagnose, or prevent a human disease or abnormal physical condition. In this context, medical devices used on animals are not included. All medical devices pose some level of risk based on their use in diagnosis or treatment, or due to malfunction. In Canada, medical devices are grouped into four classes based on the expected level of risk to a person's health and safety with Class I offering the lowest risk.
Medical devices range from adhesive bandages, toothbrushes and contact lenses to complex devices, such as x-ray units, insulin pumps and pacemakers. They also include in vitro diagnostic devices, such as cancer screening tests, blood glucose monitors, and pregnancy test kits. (Health Canada, 2020).
A medical device problem is related to:
- inadequate labelling or instructions for use
- a failure of the device or a deterioration in its effectiveness
- an actual or potential deficiency that may affect product performance or safety
- a serious deterioration in the patient's health (possibly related to a medical device)
- death, or has the potential to lead to death if the device is used again (Health Canada, 2020)
Canada's monitoring of therapeutic products plays an important role in public health and patient safety. Hospitals help make health products safer by reporting serious medical device incidents in order to:
- promote the safe use of health products by Canadians
- may be the first sign of previously unrecognized rare or serious ADRs or MDIs
- help Canada take action against products that may pose a risk to health and safety
Medical device incidents refer to medical device failures that take place in a hospital. As of December 16, 2019, hospitals are required to report medical device incidents. Canadian hospitals are required to report all serious medical device incidents (MDIs), according to the Medical Devices Regulations (SOR/98-282) for medical device incidents. By law, a medical device is defined as:
Active device: a medical device that depends on a source of energy for its operation, other than energy generated by the human body or gravity. A medical device that transmits or withdraws energy or a substance to or from a patient without substantially altering the energy or the substance is not an active device.
Active diagnostic device: an active device that, whether used alone or in combination with another medical device, is intended to supply information for the purpose of detecting, monitoring, or treating a physiological condition, state of health, illness, or congenital deformity.
Active therapeutic device: an active device that, whether used alone or in combination with another medical device, is intended to support, modify, replace, or restore a biological function or structure for the purpose of treating or mitigating an illness or injury, or a symptom of an illness or injury (Medical Devices Regulations).
Health Canada's system designed to track incidents where devices may have harmed patients is so hobbled by under-reporting, the toll on Canadians is unknown. Never-before-released federal data shows at least 1,400 Canadians have died since 2008 in incidents involving devices that were designed to help them. During those 10 years, another 14,000 Canadians were injured (McLean & Cribb, 2018).
In August 2020 and for the first time, the Canadian Institute for Health Information (CIHI) released an analysis focused on the 12-high volume, high-cost implantable medical device (IMD) procedures provided in hospitals across the country each year. The top12 IMD procedures include (in order of frequency):
- Cataract lens insertion;
- Knee replacement;
- Hip replacement;
- Coronary stent;
- Ear tube;
- Spinal fusion and fixation hardware;
- Transvaginal mesh implant and Tension Free Vaginal Tape (TVT) procedure;
- Breast implant prosthesis;
- Shoulder replacement;
- Defibrillator (CIHI, 2020a).
The incidence of in-hospital device failures reported for the HHIR ranged from 3,802 in fiscal 2014-2015 to 4,109 in fiscal 2019-2020 (CIHI, 2020b).
The Medicines & Healthcare products Regulatory Agency (MHRA) recommends that an integral part of system management for medical devices, is that healthcare organizations should appoint a director or board member with overall responsibility for medical device management. In addition, Medical Device Safety Officers (MDSO) and a Medical Devices Management Group should be appointed to review and report adverse incidents to the MHRA and other official agencies.
Reporting of Medical Device Incidents
Reporting of an adverse incident or near miss which has the potential to cause, unexpected
or unwanted effects involving the safety of patients, users or other persons is critical and should include any known problems associated with product design, documentation, and common use related issues should also be reported for follow-up. Reporting is essential to ensure that lessons are learnt, and adverse events are not repeated. National reporting is essential to ensure that trends are spotted, and appropriate action is taken across the country to help ensure the safe and effective use of medical devices, for example through safety messages. Unless all adverse events are reported, emerging problems cannot be identified, continuing the risk of repeat events and patient harm (MRHA, 2021).
The results of a systematic review of 30 studies suggested four main barriers to error reporting as follows: fear of punishment or censure, uncertainty regarding what should be reported, uncertainty as to how incident reports will be used, and lack of time. Potential strategies to improve incident reporting include accessible electronic error reporting systems, training about what to report and how, and feedback on actions taken based on error reported (Polisena et al., 2015a).
The results of another study by the same author, in two large Canadian tertiary hospitals, revealed that the knowledge and experience of hospital staff, as well as the patient's clinical characteristics and device performance were important factors in incident recognition. Incident severity, awareness, and ease of use of reporting systems and processes, as well as organizational culture, and personal attitudes and perceptions of responses contributed to the frequency of reporting device incidents. The discontinued use of a medical device or equipment was the most common resolution to prevent the reoccurrence of a similar error. Suggested strategies for improvement involved education and training, institutional and professional cultures, and improved reporting systems and processes (Polisena et al., 2015b).
Medical device problems may surface years after they have been used or implanted in thousands of patients. Health Canada is responsible for the surveillance and reporting of device advisories, warnings, or recalls and posts this information in the Advisories, Warnings and Recall Database and Drug and Medical Device Recall Listing available on their website (Polisena et al., 2014). The Protecting Canadians from Unsafe Drugs Act, also known as Vanessa's Law, is intended to increase drug and medical device safety in Canada by strengthening Health Canada's ability to collect information and to take quick and appropriate action when a serious health risk is identified. As of December 16, 2019, it became mandatory for hospitals to report serious adverse drug reactions (serious ADRs) and medical device incidents (MDIs) to Health Canada (Health Canada et al., n.d.).
An audit conducted by the UK National Patient Safety Agency reported that device-related incidents are caused by device failure (43.8 per cent), inappropriate use (29.3 per cent), lack of training (12.3 per cent), and poor maintenance (1.5 per cent) (Polisena et al., 2014).
Reduce the incidence of mechanical complications or failures of devices including: breakdown, displacement, leakage, malposition, obstruction, perforation or protrusion of devices, catheters, grafts, implants, or prostheses associated with a medical or surgical procedure.
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