March 17, 2009

 

Mary Ann Monaghan, RN, CPHQ

Executive Director-Quality

St. Vincent Hospital and Healthcare Center

2001 W 86th Street

Indianapolis, IN 46260

 

Re: Report on Mitomycin C Exposure Monitoring During the HIPEC Procedure at St. Vincent Hospital of Indianapolis

 

This is the second report on exposure monitoring of Mitomycin C (also called Mitomycin) during the HIPEC Procedure activities at St Vincent Indianapolis Hospital in Indianapolis, Indiana on February 17, 2009.  There has been a long-standing concern amongst hospital employees and in the HIPEC community at large that they may be exposed to Mitomycin during the course of the surgery, either by way of airborne exposure, or through dermal exposure.  This study is an attempt to assess exposure through these potential routes of entry, and to address these concerns.

 

This study was conducted by Stuart D Bagley, MS, CIH, CSP of IAQ Services under contract with the St Vincent Indianapolis Hospital and with the expertise of Oncology Clinical Nurse Specialist, Sue Storey, MSN, RN, AOCNS.

 

Summary

Employees at the St. Vincent Hospital in Indianapolis , Indiana were monitored for exposure to Mitomycin on February 17, 2009 during the HIPEC procedure.  HIPEC is the acronym for “Heated Intraperitoneal Chemotherapy”, a procedure used to treat advanced abdominal cancers. 

 

Mitomycin, used during the HIPEC, is a sterile drug presented in an enclosed vial as a powder cake by its manufacturer[1].  There were a total of ten environmental samples taken and analyzed by the laboratory[2], four air samples and six surface samples.  Four additional surface samples were taken but not analyzed at this time.

 

The following employees have the potential for exposure to Mitomycin at this facility:  Pharmacy Technician, Perfusionist, Anesthesiologist, Surgeon, Operating Room Nurses and the Decontamination Technician.   Air and surface samples were collected in areas or on the person of several different employees representing a number of job functions related to HIPEC.  They were taken at various times on February, 17 of 2009 during the preparation; during surgery and during post-surgery.  Those jobs are as follows:

 

·         Surgeon

·         Perfusionist

·         Anesthesiologist

·         Operating Room Nurses

·         Decontamination Technician

 

The Recommended Exposure Limits (REL) for Mitomycin C by the pharmaceutical manufacturer of the drug is 0.05 micrograms per cubic meter (micrograms per cubic meter) for Mitomycin C.  There were no airborne exposures detected and no direct skin contact found with Mitomycin in any of the samples gathered.  The Biogel™ gloves appear to offer sufficient protection of the skin and the risk of exposure to hospital workers is minimal when good housekeeping practices are used.

 

Observations

Mitomycin is supplied by its manufacturer (Bedford) in a small vial as a solid mixture with a non-active ingredient, according to its MSDS.  The pharmacy mixes the dried powder at room temperature in a laboratory hood into an aqueous dextrose solution.   The liquid solution used in this HIPEC was prepared on February 17, 2009 by the Hospital Pharmacy with the following percentages of active ingredients based on the formulation provided by the lead surgeon. 

 

The end concentration of Mitomycin in the HIPEC solution was approximately 7.94 mg per liter according to the hospital pharmacist[3].  According to the hospital pharmacy, 16 mg of Mitomycin was diluted in 2000 ml of 1.5% Dextrose solution.  

 

Mitomycin C:  16.00 mg /2000 ml x 100 = ~ 0.794%

 

It was of course further diluted by the presence of body fluids from the intraperitoneal cavity of the patient in an unknown quantity.  This study served to assess the potential for exposure to employees during the preparation, use, cleanup and disposal of this pharmaceutical agent. 

 

The surgeons present during the procedure wore two layers of Biogel® gloves[4] on each hand.  Biogel gloves are designed specifically for surgery and are resistant to pinhole leakage of fluids.  Other surgical personnel present during the procedure wore similar gloves, also double-gloved.  All surgery room personnel wore surgical masks, as seen in the photographs below.

 

The following photographs were taken to document observations during the course of the HIPEC procedure on February 17, 2009.

 

Overview of the Operating Room Personnel

Surgeon with Hand Immersed in HIPEC Solution

Decontamination Technician at Sonic Bath

Decontamination Area

 

Mitomycin Sampling Results

Results for all samples are shown in detail in the attachment: "Laboratory Analysis Report…” and in the tables shown below.

 

Results indicate that none of the employees monitored had detectable level of exposure to Mitomycin via air or dermal routes and none exceeded the recommended airborne exposure guidelines for Mitomycin. 


 

Surface Monitoring Results

Environmental sampling consisted of four air samples and six surface samples. 

 

Six surface samples were taken for Mitomycin from numerous surfaces during the course of the HIPEC Procedure covering the preparation, use during surgery and post-surgical procedures. 

The six surfaces sampled in the Operating Room were as follows: Surgeon - Dr Arregui’s Outer Glove, on the surface of his inner glove, on the surface of his bare hand; the Surgical Nurse – Shelly, on the surface of her inner glove, on the surface of her bare hand and finally the Decontamination Technician – Tina, on the surface of her outer glove.  Mitomycin C, sampled on six surfaces, was not found on any of the surfaces tested. 

 

Mitomycin Air Monitoring Results

Employees of the St. Vincent Hospital in Indianapolis, Indiana were monitored for Mitomycin exposure on February 17, 2009.  Four air samples were taken in the breathing zone of key personnel during the HIPEC Procedure. 

 

See tables below.

 

Mitomycin Air Samples on February 17, 2009

Sample ID

Job Function

Location

Analysis

Sample Location

Results micrograms per cubic meter

Interpretation

S101

Mark Schiess, Perfusionist

Operating Room

Mitomycin in Air

Operating Room

<0.22 per m3

Below Limit of Detection or Not Present

S102

Dr. Arregui, Chief Surgeon

Operating Room

Mitomycin in Air

Operating Room

<0.32 per m3

Below Limit of Detection or Not Present

S103

Nina, Scrub Nurse

Operating Room

Mitomycin in Air

Operating Room

<0.24 per m3

Below Limit of Detection or Not Present

S104

Tina, Decontamination Tech

Decontamination

Mitomycin in Air

Operating Room

<0.21 per m3

Below Limit of Detection or Not Present

                                                                  


                       

Mitomycin Wipe Samples on February 17, 2009

Sample ID

Job Function

Location

Analysis

Sample Location

Results micrograms per 100 square centimeter

Interpretation

4806

Surgeon - Dr Arregui

Operating Room

Mitomycin on Surface

Outer Glove

< 0.50

Below Limit of Detection or Not Present

4714

Surgeon - Dr Arregui

Operating Room

Mitomycin on Surface

Inner Glove

< 0.50

Below Limit of Detection or Not Present

4813

Surgeon - Dr Arregui

Operating Room

Mitomycin on Surface

Bare Hand

< 0.50

Below Limit of Detection or Not Present

4709

Surgical Nurse - Shelly

Operating Room

Mitomycin on Surface

Inner Glove

< 0.50

Below Limit of Detection or Not Present

4803

Surgical Nurse - Shelly

Operating Room

Mitomycin on Surface

Bare Hand

< 0.50

Below Limit of Detection or Not Present

4739

Surgical Tech - Tina

Decontamination

Mitomycin on Surface

Outer Glove

< 0.50

Below Limit of Detection or Not Present

Surfaces sampled are 100 sq. cm each

               

The following laboratory controls samples were analyzed by the ALS Datachem Laboratory as a means of assuring integrity of laboratory methodology.

 

Laboratory Control Samples

Sample Type

Purpose

Analysis

Result

Interpretation

QC Sample from Sigma Aldrich

Control Sample

Mitomycin per Sample

mean of 13.55 ug per sample

Mitomycin was detected within 10% of the expected result

Media Blank

Blank MCE Filter

Mitomycin per Sample

not detected

False positive not detected


 

A similar study was done in February of 2007.  As with the most recent study, no surface contamination was detected.  Results are presented here.

 

Table III-Mitomycin C Surface Sample Results on February 27, 2007

Sample ID

Job Function

Sample Location

Sample Surface Area Tested cm2

Analysis

Results micrograms per 100 square centimeter

Interpretation

W102

Surgeon Dr B--

Outer glove Dr. B

100 cm2

Mitomycin C on Surface

not detected

Below Limit of Detection or Not Present

W196

Surgeon Dr B--

Bare hand Dr. B

100 cm2

Mitomycin C on Surface

not detected

Below Limit of Detection or Not Present

W176

Perfusionist Mark Schiess

Outer gloves Mark S

100 cm2

Mitomycin C on Surface

not detected

Below Limit of Detection or Not Present

W182

Perfusionist Mark Schiess

Bare hand Mark S

100 cm2

Mitomycin C on Surface

not detected

Below Limit of Detection or Not Present

W103

na

Floor near table

14641 cm2

Mitomycin C on Surface

not detected

Below Limit of Detection or Not Present

 

Discussion of Results

Results are based on the data gathered from two separate HIPEC procedures approximately two years apart.  Air monitoring results indicate that none of the employees monitored during the procedure on February 17, 2009 had detectable levels of Mitomycin in the four air samples or on the six surfaces tested, including the gloves and bare skin (palm) of surgical personnel.  As well, none of the surfaces tested in February 2007, including the palm, had detectable quantities of Mitomycin.   The recommended exposure limit (REL), 0.05 micrograms per cubic meter of Mitomycin was not exceeded.

 

Results indicate that no detectable quantities of surface or airborne of Mitomycin were found in the operating room during this procedure.  Mitomycin in its purest form is a solid powder cake.  As a solid material at room temperature, it has an infinitesimally low vapor pressure, so in essence it will not evaporate.  In its aqueous dextrose solution (dissolved solid) as used in HIPEC, it has not been known to aerosolize during its normal and routine application.  Thus it is very unlikely to be inhaled in any form.  The need for any local exhaust ventilation (such as portable smoke evacuators) is superfluous and unnecessary and may take up valuable floor space.

 

 

The laboratory used a method of analysis known as liquid chromatography-mass spectrometry (LCMS).[5] This method has a limit of detection (LOD) for Mitomycin that ranged from 2.20 micrograms per cubic meter to 0.22 micrograms per cubic meter based on sampling times ranging from 24 minutes to 4 hours and 4 minutes.  Any quantity below the limit of detection would be reported as “not detected” though in theory it may be present.  At this time there are no readily available analytical methods known to this researcher with a lower level of detection.

 

On surfaces in close proximity to the operating table, Mitomycin was not detected.  Additionally, no “breakthrough” of Mitomycin was seen during the use of the Biogel™ gloves.  They appear to offer adequate protection of the skin surface.

 

About IAQ Services

IAQ Services is a full service consulting firm in the areas of environmental health and safety testing and remediation.  The Indiana firm was incorporated in 1998.  Stuart Bagley is a senior consultant from IAQ Services   He is a Certified Industrial Hygienist (CIH) and a Certified Safety Professional (CSP).  He has a Master of Science degree in Occupational and Environmental Health from Wayne State University and a Bachelor of Science degree in Biology from the University of Michigan.  Mr. Bagley’s field experience includes serving as a Compliance Safety and Health Officer for US Dept. of Labor-Occupational Safety and Health Admin (OSHA), working in corporate safety management, and as a senior consultant for IAQ Services, a total of 24 years. 

 

Thank you for your assistance during this vital work at St. Vincent Hospital of Indianapolis.

 

Sincerely,

 

Stuart D Bagley

 

Stuart D. Bagley, MS, CIH, CSP

Attachments:  lab report, invoice

 

 



 

[1] BEN VENUE LABORATORIES, INC., 300 NORTHFIELD ROAD, BEDFORD, OH 44146

[2] ALS Datachem Laboratory, Salt Lake City, UT

[3] Leslie Mach, Pharm.D., St.Vincent Hospital

[4] Biogel gloves are made from a laminate of high-tech latex to which is bonded a thin inner coating of acrylate terpolymer.  Standard Biogel gloves are recommended for all general surgery and other specialties that do not require specific glove characteristics, according to their manufacturer.

[5] Liquid chromatography-mass spectrometry (LC-MS, or alternatively HPLC-MS) is an analytical chemistry technique that combines the physical separation capabilities of liquid chromatography (or HPLC) with the mass analysis capabilities of mass spectrometry. LC-MS is a powerful technique used for many applications which has very high sensitivity and specificity. Generally its application is oriented towards the specific detection and potential identification of chemicals in the presence of other chemicals (in a complex mixture).