Medical device errors crop up in the news a few times every year. A medical device may concern a knee or hip replacement, insulin pump, vaginal meshes, ventilators or anything else that was designed for a medical purpose. A defect in any of these devices can cause complications that can be catastrophic or even fatal, or lead to chronic suffering, repeated surgeries and diminished quality of life to its victims.

The following are 5 recent medical device errors that consumers should be cognizant of and, if injured, contact an experienced medical device injury lawyer. All of these were designated Class 1 recalls by the FDA, meaning that a defect in the device has a reasonable probability of causing severe injury or death.

  1. Greatbatch Medical Orthopedic Surgery Tool

In January 2014, Greatbatch, Inc. voluntarily recalled all its Standard Offset Cup Impactors after revealing that it had not met sterilization standards. Although no adverse events had been reported, it was more a matter of time before reports of infections would begin to filter in. The FDA was advised that its products manufactured from 2004 to 2013 were being recalled. Customers who had this product have been advised to immediately follow the new sterilization procedures. The device is a reusable instrument employed during acetabular replacement surgery to implant an acetabular cup. The procedure is used during total hip arthroplasty. The acetabulum is a socket in the hip bone that receives the head of the thighbone.

  1. Custom Procedural Trays/Kits by Hospira

One lot of Hospira’s 1% lidocaine hydrochloride injection that is part of its Custom Procedural Trays/Kits was recalled following the discovery of oxidized stainless steel in a container of the drug. Lidocaine is a drug used to numb tissue and is given by surgeons during heart surgery to prevent irregular heartbeats. The FDA is advised of any medical or drug recall. In this case, it designated this as a Class 1 recall because an injected oxidized stainless steel particulate could place a patient at considerable risk during an MRI where a strong magnetic field is present and cause lung and other tissue to tear.

Although Hospira has reported that it has spent millions upgrading its facility following a warning letter it received in 2010 following a previous incident regarding failed leak tests at its North Carolina facility, the FDA is continuing to monitor the facility.  Reports are that the FDA was not fully satisfied with the facility’s monitoring practices.

  1. Phillips Respironics Ventilators

Phillips Respironics, Inc. issued a voluntary recall of its Trilogy Ventilators Models 100, 200 and 202 manufactured between December 31, 2013 and January 30, 2014 because of a potentially defective ferrite component on the power management board of the device. These devices are used at homes or institutions and hospitals. The defect could result in mechanical breaths not being delivered. The FDA designated the recall as a Class 1 though no adverse events had been reported.

  1. GE Healthcare Infant Resuscitators with Assembly Error

In another Class 1 recall, GE Healthcare announced that its infant resuscitators manufactured over the past 5 years were being recalled because of an assembly error that had reversed the oxygen and air wall inlet fittings on the back panels. The error could interfere with oxygen delivery during oxygen regulation given to newborns and lead to low blood oxygen or high blood oxygen, either of which are potentially fatal.

  1. Teleflex Tracheal Tube That Kinks

In early 2015, Teleflex, Inc. recalled its ISIS HVT tracheal tube because of its potential to kink during use and deprive patients of oxygen or adequate ventilation when the tube is inserted into the trachea. Injuries could include hypoxia and/or anoxia. In these event, the body or vital organs are completely deprived of oxygen.

Reasons for the High Number of Recalls

There are a number of reasons why medical devices fail. Plain human error is one where workers mistakenly forget to install a part, use the wrong one or reverse the method of where certain parts are to be placed. Some of the factors leading to recalls are as follows:

  • Lack of expertise

Many startups jump into a market after recognizing a need and simply do not have the resources or the technical and management skills needed. Some of the mishaps could be prevented by outsourcing some of the technical development if not the project management functions. A firm knowledge of the materials required for medical devices is essential and which seems to be a factor in some of these recalls.

  • Lack of Human Factors Research

A broad range of disciplines is necessary to ensure that a device is produced and used correctly or for its intended purpose. Successful companies utilize data and input from biomechanics, psychology, industrial design, graphic design, operations research and others.

  • Systems Failure

Getting a sophisticated medical device to market that meets all expectations means that every step from its design, assembly, marketing, instructions and eventual use are followed. If you have a checklist in place, it must be followed. Errors occur because a practitioner did not read the instructions or they were too obscure. Other mistakes are in in its assembly, storage, inputting incorrect settings, or failing to communicate vital data.

Consult the Tetzel Law Firm

Paul Tetzel and John Malone of Tetzel Law are Boston legal practitioners with the knowledge and resources needed to successfully bring claims of defective medical devices that have led to catastrophic injuries or death. Contact Tetzel Law if you or a loved one was seriously injured or died because of a malfunctioning medical device.