Infusion pumps. Orthopedic implants. Defibrillators. CT scanners. Syringes.
Devices are an invaluable part of our health care system. They save lives, relieve suffering, and enable us to provide care for patients every day.
But what happens when they don’t work the way they’re supposed to? What happens when a device malfunctions and causes harm to a patient? Or could cause harm if it happened again?
As of December 16, 2019, new federal regulations associated with Vanessa’s Law make it mandatory for hospitals to report all medical device incidents (MDIs) to Health Canada within thirty days of incident documentation within the hospital.
In British Columbia, this process is facilitated by BCPSLS.
To ensure hospitals are well positioned to comply with the new requirements, BCPSLS partnered with Health Canada, the Ministry of Health, and BC’s health authorities to take a hard look at how MDIs are reported and investigated in BC.
The result? It’s now simpler than ever to report MDIs in BCPSLS. And the investigation process has been refreshed, as well.
But, let’s back up a bit to clarify what medical device incident reporting is really about.
What is a medical device incident?
Health Canada defines an MDI as an incident related to the failure of a medical device, deterioration in its effectiveness, or inadequacy in its labeling or directions that led to the death or serious deterioration in health of a patient, user, or other person, or could do so were it to recur.
There’s a lot packed into that definition, so let’s take it apart, piece by piece:
A failure is anything wrong with the device that is the suspected fault of the manufacturer, not the user. Failures can be related to shipping, or due to deficiency in design, labelling, instructions, or packaging.
This includes invasive, non-invasive, active, and biomedical devices; electronic and non-electronic equipment; implants, products, supplies, disposables; and general items used in all aspects of patient care, such as beds and lifts. So, pretty much any kind of health care device, equipment, instrument, or product you can think of!
Death or serious deterioration in health
Serious medical device problems are mandatory for reporting to Health Canada. This means incidents that result in a life-threatening disease, disorder or abnormal physical state, permanent impairment of a body function, or permanent damage to a body structure. It’s also mandatory to report incidents where unexpected medical or surgical intervention was needed to prevent a serious impact from occurring.
Could do so were it to recur
Medical device problems with the potential to cause serious harm are also mandatory for reporting to Health Canada. It’s relatively straight-forward to assess patient harm once an incident has taken place; however, it’s also important to report incidents when no harm/minor harm resulted, if there is a potential for serious harm if the incident happened again to someone else.
Criteria for mandatory reporting
To help clear things up, we reached out to Colleen Turpin, a dialysis nurse and the Medical Device Problem Report Information Specialist for Health Canada’s Marketed Health Products Safety and Effectiveness Information Bureau in Ottawa, which is the department that will be receiving your MDI reports.
“What we’re really looking for are defects in the product or its packaging, instructions, or labelling that led, or could lead, to serious patient harm,” says Colleen.
When determining whether or not it’s mandatory to report an event, Colleen suggests asking yourself these four questions:
- Does the incident involve a medical device?
- Do you suspect failure of that device, deterioration in its effectiveness, or any inadequacy in its labelling, packaging, or directions for use?
- Has the incident resulted in the death or serious deterioration in health of a patient, user, or other person, or could it do so were it to recur?
- Did the incident take place in hospital or was the patient treated in hospital?
If you suspect that the answer to all four questions is YES, it is mandatory to report the incident. Submit your report in BCPSLS and the Central Office team will ensure it’s reviewed and forwarded to Health Canada by the 30-day deadline.
If an incident doesn’t meet the criteria for mandatory reporting, you can still report it in BCPSLS if it presents an opportunity for learning, tracking, or trending within your department or program.
It can be tricky to determine whether or not an event meets the criteria for mandatory reporting. If you’re unsure, report! There are no adverse consequences to reporting an incident in BCPSLS that doesn’t meet Health Canada’s criteria for mandatory reporting.
Here are a few examples, assuming events were documented in hospital:
For a comprehensive outline of reporting criteria, refer to Health Canada’s Guidance Document.
Reporting in BCPSLS
It’s easier than ever to report MDIs in BCPSLS!
There’s a new Medical Device Incident (MDI) Report Form with its own icon on the BCPSLS landing page. The form can be used to report incidents, near misses, and hazards where you suspect that device malfunction or failure has caused or could cause harm to a patient.
In addition to the new form, all other report forms in BCPSLS now have updated fields to better capture how medical devices and equipment are involved in other types of safety incidents.
Equipment lists have also been updated, so it’s easier to identify the type of device involved.
Improved notifications are being set up in each health authority in order to ensure the most appropriate people are aware and can follow up, depending on the type of device involved. For example, individuals in Biomedical Engineering are automatically notified of MDIs reported in BCPSLS involving biomedical equipment.
Colleen’s number one tip for reporting? Provide enough information for Health Canada to be able to uniquely identify the device. This includes the company and model (device size or type) information in addition to the brand name. Identifying numbers (e.g. catalogue, serial, lot number) from the device label are also helpful!
Visit our Vanessa’s Law page on bcpslscentral.ca for more information and downloadable resources about adverse drug reaction and medical device incident reporting. You’ll also find a blog story introducing Vanessa’s Law and a guest blog from Lower Mainland Biomedical Engineering about the high incidence of over-infusions that took place in BC over the past two years.
Enjoyed the story? Follow BCPSLS Central and never miss a blog post!