ISO 14971:2019–Risk Management To Medical Devices

Surgeon in health care facility picking up medical devices that adhere to risk management requirements in ISO 14971:2019.

Flint knives, saws, and drills were used for surgery, amputation, and trepanation during the Upper Paleolithic and Mesolithic times in 6000 BCE. These were the world’s oldest medical devices. These days, manufacturers of medical devices need to adhere to risk management controls like those provided in ISO 14971:2019 –Medical Devices – Application Of Risk Management To Medical Devices before a medical device is placed on the market for its intended use.

What Is ISO 14971:2019?

ISO 14971:2019 specifies terminology, principles, and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The concept of risk has two key components, the probability of occurrence of harm and the consequences (i.e., severity) of that harm. The risk management process described in ISO 14971:2019 intends to assist manufacturers of medical devices to do the following:

  1. Identify the hazards associated with the medical device
  2. Estimate and evaluate the associated risks
  3. Control these risks
  4. Monitor the effectiveness of the controls

The process specifically includes four elements—risk analysis, risk evaluation, risk control, and production and post-production activities. It applicable to all phases of the life cycle of a medical device and applies to risks associated with a medical device, such as those related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability. The risk-management process in this standard can also be applied to products that are not necessarily medical devices.

The standard does not apply to decisions on the use of a medical device in the context of any particular clinical procedure or business risk management. Guidance on the application of this document can be found in ISO/TR 24971.

Risk Management in Relation to Medical Devices

The use of a medical device involves an inherent degree of risk, even after the risks have been reduced to an acceptable level. In other words, in the context of a clinical procedure some residual risks remain. The concepts of risk management are particularly important because of the variety of stakeholders involved—including medical practitioners, the organizations providing health care, governments, industry, patients, and members of the public.

As one of the stakeholders, the manufacturer reduces risks and makes judgments relating to the safety of a medical device, such as the acceptability of residual risks. The manufacturer takes into account the risk management process specified in ISO 14971:2019 to determine the suitability of a medical device to be placed on the market for its intended use. The decision to use a medical device in the context of a particular clinical procedure requires the residual risks to be balanced against the anticipated benefits of the procedure.

Old medical equipment used in health care facilities before safety risk management manufacturing requirements for medical devices.

Interesting Medical Devices Used in History

The road to modern medicine experienced interesting—sometimes gruesome—tools along its way. Here are some of them:

1. Artificial leeches

In the 1800s, live leeches were unavailable (or perhaps too gross). The artificial leech, a metal cylinder with blades, performed the same function: its rotating blades quickly cut into the patient’s skin, while the cylinder tube suctioned the blood out.

2. Osteotome

Amputations before the use of the osteotome in the 1800s were extremely dangerous and painful because the harsh impact of a hammer and chisel or the jolts of a saw would often splinter bones and the tissue around them. Hence, surgeons used the osteotome to speed up the procedure while reducing the risk of complications. This medical device was cranked manually, utilizing a chain and sharp cutting teeth to cut through bone and virtually everything else.

3. Hernia tool

Recognizing that the human body could often patch things up better than they could, doctors in the 1850s had a tool specifically for hernias. Once doctors repaired the tear in the muscle or tissue, they would insert the hernia tool into the area. This medical device would be in place for about a week while scar tissue formed on it to help seal a repaired hernia.

4. Arrow Remover

When a patient in the 1500s sported a protruding arrow, medical professionals did not just yank it out. Instead, they held the shaft of arrow in the center barrel of a scissor-like arrow remover. But unlike scissors, the sharp edges of the blades faced away from the center. The blades cut the patient’s skin. so that the arrow’s head could be removed without much further injury.

5. Dental key

During the late 1700’s when someone needed to get a tooth pulled, a dental key was the primary solution. The key’s claw would be placed over the tooth and the bolster (the part attached to the rod and handle) would be placed along the tooth’s root. Then, the dentist would twist and turn like a key until the tooth, root and all, was (quite painfully) pulled out. According to a 2005 industry review, the dental key caused more accidents and injuries than all other tooth extraction instruments before 1900 combined.

Thankfully, hundreds of years of medical and technological advancements as well as standardizations have made these clinical procedures much safer. For instance, ANSI/AAMI SW96:2023 provides requirements on methods to perform security risk management for a medical device in the context of the safety risk management process required by ISO 14971:2019. Learn more in ANSI/AAMI SW96:2023—Medical Device Security.

ISO 14971:2019 –Medical Devices – Application Of Risk Management To Medical Devices is available on the ANSI Webstore.

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