Hospital Harm: Device Failure

Overview

Healthcare Excellence Canada has developed this Hospital Harm Improvement Resource – a compilation of resources to support patient safety and improvement efforts.

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;

• Pacemaker;

• IUD;

• 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.).

Risk Factors

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).

Device Failure: Importance to Patients and Families

Medical device incidents are problems with any type of medical product or equipment that led to or could have led to a serious health concern. A medical device incident can occur shortly after beginning treatment or much later. Harm from a medical device can be mistaken for a symptom of a disease (PFPSC et al., n.d.).

Everyone who witnesses or experiences a problem with a medical device is strongly encouraged to report it. A patient or their care provider can also work with their healthcare provider to submit a report . 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).

Examples of Medical Device Incidents are:

An infusion pump stopped working and did not give an alarm. The patient needed a longer stay in hospital.

A defibrillator used to treat a cardiac arrest did not work properly. The patient was not revived.

A prosthetic knee replacement failed due to damaged material.

A breast implant was suspected of causing a rare cancer.

Awareness and conversation with health care providers are key components in identifying a serious adverse drug reaction or medical device incident (PFPSC et al., n.d.).

Patient Story

Two weeks after his brush with death, Nicholas Bravi stepped out of his shower with the steri-strips washed away and the angry red scar on his chest fully visible for the first time (CPSI, 2014).

Success Stories

One important success factor that will enhance the safety of medical devices is to gain trust from the frontline healthcare providers and ensure that their incident reports will be reviewed to resolve the errors and prevent future similar errors. These individuals, therefore, should be kept abreast of any relevant developments and receive timely feedback (Polisena, 2014).

HSO – Leading Practices

Reporting of Adverse Events in Reprocessing of Medical Devices

Hôpital Charles LeMoyne, Quebec. 2011

https://healthstandards.org/leading-practice/reporting-of-adverse-events-in-reprocessing-of-medical-devices/

This a system for identifying risks in reprocessing medical devices and analysing the underlying causes. It is used to develop a profile of the risks inherent in the process for reprocessing reusable medical devices. Using this practice, information on reprocessing is also disseminated throughout the organization, primarily to the risk manager and management. Each adverse event is identified either by the clinicians who notice errors in their trays during use or by computer searches in the organization's tracking software. These events are recorded in a database, Access, and the underlying causes are analysed to develop and implement measures to prevent recurrence (HSO, 2011).

The Development of an Interdisciplinary Smart Pump Working Group reporting to Safe Medication Practices for the Management of Parenteral Administration using Smart Pump Technology

Royal Victoria Regional Health Centre, 2019

https://healthstandards.org/leading-practice/development-interdisciplinary-smart-pump-working-group-reporting-safe-medication-practices-management-parenteral-administration-using-smart-pump-technology/

The Smart Pump Working Group is an inter-professional group (clinical educators, front-line pharmacists, Professional Practice Manager, Pharmacy Manager, Biomedical Engineering representative, Network Administrator from Information Technology Services) that reports to Safe Medication Practices Committee. Its primary mandates are to review current practices of smart pump devices within the organization and to develop recommendations to the Safe Medication Practices Committee by utilizing the data from smart pumps to improve safety and develop an on-going process for smart pump updates and continued data analysis. It is also mandated to review, on an on-going basis, any required additions/changes to ensure consistent, scheduled drug library (DL) updates occur, aligning with medication safety standards and recommendations from organizations such as ISMP Canada.

The Working Group meets monthly, and the work accomplished has led to a drug library compliance rate of greater than 98 per cent for over one year and the almost elimination of medication errors related to I.V. administration of medications due to over-riding parameters.

We feel that this is innovative and transformative because, in a meeting with ICUMedical, when we were reviewing next steps in report development for presentation to our hospital executives, ICUMedical (the manufacturers for the Plum 360 Smart Pumps) had indicated that there were not aware of any other institution in Canada that had an efficient and effective Working Group, and who are using the actual data for on-going quality improvements. They were the ones who had indicated that we should be putting this initiative forward as a Leading Practice (HSO, 2019).