Download Sales Representative Regulatory Compliance Training

INCISIVE Surgical
FQ 180009 Rev. D
--INTERNAL USE ONLY--
Sales Representative Regulatory Compliance Training Record
Incisive Surgical Sales Representative Certification of
Regulatory Responsibilities
Incisive Surgical maintains a rigorous Quality System to comply with medical device regulations throughout the world as promulgated by the Food and Drug Administration (FDA) in the United
States and International Regulatory Agencies (ISO 13485). The discipline of documenting and controlling our business processes is a Quality System requirement that defines how we conduct
business with our customers and to ensure that we provide SAFE & EFFECTIVE products to the market. Your responsibility as an Incisive Surgical Sales Representative is to review and
understand the following ELEVEN Key Regulatory Responsibilities. You are required to certify in writing that you have reviewed and understand your regulatory responsibilities by signing this
form and returning the signed form to Incisive Surgical as a record of your training. If you have additional questions or need additional information pertaining to any element of this training call
Incisive Surgical Customer Service at 877-246-7672 (x032).
1
UNDERSTANDING AND COMMITMENT TO THE INCISIVE SURGICAL QUALITY POLICY - Incisive Surgical's corporate pursuit of quality is a proactive, perpetual process that
begins in design and manufacturing, flows through every single department in our company culminating in sales, customer support, and clinical training. This pursuit of quality is not
limited to product quality, but truly encompasses all that we do as a company. Our ultimate customers, our clinicians and patients, are relying on us to provide high-quality medical
devices that are reliable, safe, and effective. We can only be assured of success if every Incisive Surgical team member makes a serious commitment to maintain the highest quality
standards each and every day.
2
UNDERSTANDING THE INDICATIONS & CONTRAINDICATIONS IN THE INSTRUCTIONS FOR USE (IFU) – Our risk management and design control systems require specific
content is published in the IFU, as regulated by the FDA and International Regulatory Agencies. You are required to review and understand all the information in the IFU.
The indications for the INSORB Stapler are:
Synthetic absorbable INSORB staples are intended for the subcuticular closure of skin where an absorbable tissue fastener is desired for temporary tissue approximation. The
contraindications for the INSORB Stapler are:
Do NOT use the staple on scar tissue if an effective tissue capture cannot be achieved.
Do NOT place a staple where the needle path is obstructed or a collision with any object any occur.
Do NOT use the staple on tissue which is too thin to permit an effective tissue capture.
Do NOT use the staple on tissue which is too thick to permit an effective tissue capture.
Do NOT use when radiopacity is necessary or desired since INSORB staples are radiotransparent.
Do NOT use where prolonged tissue approximation beyond that needed for normal skin tissue closure is necessary or desired.
3
STORAGE AND EXPIRATION OF CLINICAL PRODUCT – The bioabsorbable polymer used in the staple is affected by time and temperature. Inventory must be stored at 16-25°C
(61-77°F). The integrity of the product will be compromised if it is exposed to elevated temperatures, e.g., if it is stored in the trunk of a car. A temperature indicating “circle” is
applied to the front of the primary carton. Stock should be kept in this primary carton and staplers should NOT be used if the “circle” has turned RED. Each unit is also labeled with a
lot number and an expiration date. Do NOT use expired product. You are responsible for monitoring the product in your possession.
4
LOT TRACEABILITY TO CUSTOMERS - Traceability to identify and locate Incisive products throughout the product’s lifetime is important for handling complaints and for
conducting product recalls. Most product traceability is handled automatically through the normal shipping process, but Sales Representatives are responsible for reporting the lot
numbers, quantity, and the location of the end user when they use or sell their Trunk Stock product.
5
RETENTION OF LEGIBLE, COMPLETE, & CORRECT QUALITY RECORDS – All Quality Records, such as Trunk Stock Tracking forms, Returned Materials Authorizations, and
Sales Orders, must be filled out legibly and completely, and must be available for retrieval far past the expiration date of the product. Incomplete or missing information (e.g., lot
number or date) can jeopardize the effectiveness of corrective actions. Never discard or destroy an original quality record. If a correction to an existing record is necessary, a pen
must be used to cross out the error with a single line, make the correction, initial and date.
6
COMPLAINTS – Obtaining and forwarding to Incisive Surgical all customer feedback, both positive and negative, by either a Clinical Evaluation Form or a Complaint is a key
responsibility of all sales personnel. A Complaint is defined as any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability,
reliability, safety, effectiveness, or performance of a device after it is released for distribution. In the case of more serious complaints, such as those requiring medical intervention
under general anesthesia, the timeliness of receiving the complaint information from the field is very important because the regulations require that we report serious incidents within
strict prescribed timelines. Call an Incisive Surgical employee at Customer Service 877-246-7672 (x032) for assistance in initiating a complaint and procuring the necessary
information, as shown on page 2 of this form. Complaints can be received by an INCISIVE Surgical Employee by phone, email, letter, fax or personal communication.
7
CLINICAL FEEDBACK AND POST MARKET SURVEILLANCE - The Clinical Evaluation Form is used to elicit feedback from physicians. This report may be authored by any
employee or sales representative with customer contact. Clinical feedback from our customers is essential for ensuring high quality products, as well as driving product
improvements. Sometimes the feedback is a complaint (see above). The feedback examples on page 2 of this form may be used as an aid in determining how to report new
information. Remember: All market feedback is valuable to the company.
8
FIELD SAFETY CORRECTIVE ACTIONS (RECALLS) - In the event of a product recall from the field, Sales Representatives will be responsible for assistance in the removal of the
affected product from the customer. A product withdrawal plan will be developed by Incisive Surgical that identifies the affected product and the actions needed to be taken by the
sales representatives.
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RETURNS -.Sales Representatives may be authorized to handle goods to be returned from a customer from time to time. If a customer has a complaint alleging the product is
deficient as it relates to quality, identity, durability, reliability, effectiveness, or performance, then an Incisive Surgical engineer may authorize the retrieval of devices for further
investigation. This could include unused stock of the same lot or used devices which must be handled as being contaminated with bloodborne pathogens (customer service will
send a package specifically designed for shipping Biohazards which includes returned paid postage). If the customer wants to initiate a return for other reasons, Customer Service
can authorize a Returned Materials Authorization (RMA). The RMA number must be included on the shipping label for any inventory sent back to Incisive Surgical. Both of the
above authorizations for returning product from a customer’s shelf must come from Incisive Surgical using defined procedures in our Quality System. The Sales Representative is
NOT authorized to remove product by any other method. When product is being retrieved for investigative purposes, the Complaint Handling Team at Incisive Surgical will have
several additional questions as they gather factual evidence from that customer’s experience and any potential trends for the suspect device. The result of the investigation can be
shared with the customer if they request more information. Until that complaint investigation is complete, Sales Representatives should not offer opinions or speculation based on
the limited information at the start of the complaint investigation.
10
SALES ORDERS – The Sales Transaction Process is an important component of the overall quality system. Sales orders initiated by Sales personnel require training which must be
documented. Upon a customer’s initial order, Customer Service or the sales rep will fill out a Customer Account Form (FM020022 for domestic customers). Once the form is
complete, Customer Service will enter information into Incisive’s business system to create the new account.
11
ADVERTISING, CLINICAL CLAIMS AND OFF-LABEL USE - The advertising and labeling prepared and approved by Incisive Surgical is reviewed to be in regulatory compliance
with the product’s intended use and clinical data. Sales Representatives must not create any promotional materials, must not make any changes to Incisive literature and labeling,
and must not make any claims or promote use beyond those approved by Incisive Surgical.
Signature:
PRINT Name:
Date:
INCISIVE Surgical
Sales Representative Regulatory Compliance Training Record
FQ 180009 Rev. D
--INTERNAL USE ONLY--
Select Examples of Clinical Feedback:
Clinical Feedback
May be a
Complaint
Probably Not a Complaint but may be
included on a feedback form or other
communication
Identity
Example: Proper labeling, serial
or lot numbers
Quality
Example: Condition of product
out of the box
Durability
Example: Product broke
during use
Reliability
Safety
Example: Captures tissue
each time the stapler is fired
Example: Injury, Medical Intervention,
Package Sterility…
Effectiveness
Performance
Example: Results of
incision closure
Example: Technique
Requires Completion
of Complaint Record
e.g. “The stapler only has a two year
dating.”
e.g. “The lot number is smudged,
but legible”
e.g. “The expiration date is illegible”
e.g. “It’s hard to read the staple
count.”
e.g. “The red desiccant holder
seemed hard to pull off.”
e.g. “The stapler did not contain any
staples”
e.g. “The stapler arm broke off when
the stapler was dropped”
e.g. “The handle made a crunch
noise when I closed the
stapler around my forceps.”
e.g. “The penetrators are bent.”
e.g. “I had to pull the lever open, but
then it worked.”
e.g. “The stapler only captured on
one side at first.”
e.g. “The staple failed to capture tissue.”
NA
NA
e.g. Wound Dehiscence, Infection, Injury,
Permanent Impairment, or Death
e.g. “The incision is everted”
e.g. “The wound was excessively
wet ”
e.g. “The patient is concerned about some
staples that surfaced at 10 weeks.”
e.g. “I don’t like to lift before I close
the lever”
e.g. “The staples were placed too
deep.”
e.g. “I am going to stop using the stapler
because it perforated the skin…
staples on the outside.”
Example of the Complaint Initiation data we would like to have…
Name(s) (prefer Surgeon’s name)
Institution (Company, Hospital…) City, State, Country, Zip Code
Phone:
Model Number, Lot Number and Quantity:
Section A:
INITIAL COMPLAINT DETAILS
Death or serious deterioration in health?
Death
Serious deterioration in health
No Death or Serious Deterioration in Health
Comments from the Complainant on the Event(s): If Death, Injury, or Medical Intervention have possibly occurred, notify Management Rep immediately
Timing of Event (If during receiving or prior to use, skip B and C):
Receiving
Classification of Event:
Quality of Closure:
Poor Approximation
Surfaced Staples
Palpable Staples
Wound Disruption
Wound Infection
Wound Inflammation
Patient Pain
Seroma / Hematoma
Excessive Bleeding
Other Closure Complaint:
Prior to use (Out of Box)
Reliability of Stapler:
Stopped Firing Staples
Lever is “Sticky/Stuck”
Stapler Component “Broke”
Stapler Makes “Noise“
Other Stapler Problem:
During Use in Sterile Field
Shipping & Identification:
Damaged Outer Package
Damaged Pouch / Inner Package
Label/IFU Unclear or Illegible
Temp Indicating Circle Turned Red
Other Shipping / ID Complaint:
Section B:
PROCEDURE
(sex, age, weight, other medical conditions…):
N/A
Technique:
External Captures
Other Technique Related Complaint:
Other Type of Complaint (Explain):
Surgical Procedure: Date of initial surgery:
Comments on Procedure and Patient
Post Op (Closure/Healing)
Data NOT Provided
Likelihood of Contraindicated Use:
Scar Tissue
Obstructed Needle Path
Tissue too Thick
Tissue too Thin
Required Prolonged Approximation to heal
Needed Radiopacity
Adjunctive skin closure methods used: (if data provided, check all that apply):
None
Deep Dermal Suture
Steri-strips
Running Suture over top
Metal Skin Staples
Skin Adhesive
“Abnormal Use” (No adjunctive skin closure & used in case with excessive tension (obesity, closing an excision, excessive swelling)
Likely
Not Likely
Unknown
Did the issue require medical intervention?
No Medical Intervention
Yes
Data NOT provided
Unknown