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Radiology Daily
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Facilities Need Protocols, Personnel for Product Recalls

March 26, 2008
Written by: , Filed in: Practice Management
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Health care facilities must have a process in place allowing for prompt and
appropriate responses to product recall notices and for thorough documentation
of each facility’s response to the recall.

From time to time, health care facilities must deal with the issue of product
recalls. When responding to these recalls, the facility must ensure that they
do not rely solely on the representative from the device or drug manufacturer
to make sure that all recalled items have been retrieved. Instead, the
facility must verify that all recalled products are managed appropriately by
relying on their own processes and personnel.

The “Dear Doctor” recall letters are very important. We must pay attention to
these letters when they announce recalls or issues with drugs or devices. Our
health care facilities must also have a process in place allowing for prompt
and appropriate responses to these recall notices and for thorough
documentation of each facility’s response to the recall.

Most hospitals and clinics have a process in place and a dedicated staff
member or two to handle product recalls. You probably want to consider having
a staff member who is responsible for knowing what kind of equipment is in the
office, what kind of products are being used, what kind of medications you
have, and so forth. You need to keep an inventory of anything that is stocked
in the facility or used on patients so that when a recall notice arrives,
there are no surprises.

In the past 10 years or so, a couple of recalls have impacted hundreds and
sometimes thousands of patients. In the early 2000s, a recall on bronchoscopes
impacted hundreds of patients across the United States. In the late 1990s, an
even larger recall involved ETHICON sutures. Because sutures are so ubiquitous
to any health care situation, attempting to identify lot numbers of what was
in stock and what had been used was a daunting task.

Therefore, make sure you know what products are coming into the facility and
how each is being used. This allows more efficient tracking of products or
devices should a recall occur. There are specific regulations for products
that are implanted in patients, regardless of whether done on an inpatient or
outpatient basis.

Hospitals and associated clinics have an obligation to track these implanted
devices, and they typically have protocols in place to do just that, making
recalls of implanted devices a little easier to handle.

Reference:
Kathleen Hale, RN, BSN, MHSA, and Richard P. Kidwell, JD Recommendations
for Response to and Protocols for Managing Product Recalls.

Health care facilities must have a process in place allowing for prompt and appropriate responses to product recall notices and for thorough documentation of each facility's response to the recall. From time to time, health care facilities must deal with the issue of product recalls. When responding to these recalls, the facility must ensure that they do not rely solely on the representative from the device or drug manufacturer to make sure that all recalled items have been retrieved. Instead, the facility must verify that all recalled products are managed appropriately by relying on their own processes and personnel. The "Dear Doctor" recall letters are very important. We must pay attention to these letters when they announce recalls or issues with drugs or devices. Our health care facilities must also have a process in place allowing for prompt and appropriate responses to these recall notices and for thorough documentation of each facility's response to the recall. Most hospitals and clinics have a process in place and a dedicated staff member or two to handle product recalls. You probably want to consider having a staff member who is responsible for knowing what kind of equipment is in the office, what kind of products are being used, what kind of medications you have, and so forth. You need to keep an inventory of anything that is stocked in the facility or used on patients so that when a recall notice arrives, there are no surprises. In the past 10 years or so, a couple of recalls have impacted hundreds and sometimes thousands of patients. In the early 2000s, a recall on bronchoscopes impacted hundreds of patients across the United States. In the late 1990s, an even larger recall involved ETHICON sutures. Because sutures are so ubiquitous to any health care situation, attempting to identify lot numbers of what was in stock and what had been used was a daunting task. Therefore, make sure you know what products are coming into the facility and how each is being used. This allows more efficient tracking of products or devices should a recall occur. There are specific regulations for products that are implanted in patients, regardless of whether done on an inpatient or outpatient basis. Hospitals and associated clinics have an obligation to track these implanted devices, and they typically have protocols in place to do just that, making recalls of implanted devices a little easier to handle. Reference: Kathleen Hale, RN, BSN, MHSA, and Richard P. Kidwell, JD Recommendations for Response to and Protocols for Managing Product Recalls. [text_ad]
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