for Daisy Arabella

IND 494

Dewen Liu

Joseph Velasquez

1.20.2018

Inadequate Sterilization for an Orthopedic Surgery Tool

The FDA is warning that a Greatbatch Medical Orthopedic surgical tool could cause serious injury or death because it came with inadequate sterilization recommendations.

Greatbatch initiated a voluntary field corrective action in late January for all Standard Offset Cup Impactors. An internal review at the company caught that the steam sterilization recommendation in the tools' instructions for use did not meet requirements for sterility assurance.

Standard Offset Cup Impactor from Greatbatch

Greatbatch has developed new sterilization recommendations that meet acceptable sterility assurance levels (AAMI ST79 standard) and provided them to affected customers.

The Standard Offset Cup Impactors are reusable tools used during acetabular replacement surgery to implant an acetabular cup.

The FDA has designated the recall as Class I.

Philips Respironics Ventilators with Defective Component

Roughly 600 Philips Respironics Trilogy Ventilators could cause serious injury or death because of a power management board issue that could cause the ventilators to not actually deliver mechanical breaths, the FDA recently reported.

In announcing a voluntary recall on February 11, Philips' Respironics Inc. business said there had been no reports of death or serious injury related to the problem.

The issue involves Trilogy Ventilator Models 100, 200, and 202, with affected units manufactured between December 31, 2013, and January 30, 2014. Serial numbers are available on the FDA's website.

The Philips Respironics Trilogy Ventilator is meant to provide support in a both a home and an institution/hospital, as well as portable applications such as wheelchairs and gurneys.

Philips Respironics says it became aware of a problem during production testing, discovering that the Trilogy ventilators contain a potentially defective ferrite component on the power management board of the device.

The company says customers should remove affected devices from service and to return them to Philips for replacement. All distributors, providers, and customers with potentially affected Trilogy devices will have their units replaced.

The FDA has designated the recall as Class I】