EVALUATION OF CHALLENGES AND COST-BENEFIT ANALYSIS OF

REPROCESSING SINGLE USE DENTAL DEVICES (SUDs) IN GENERAL

DENTAL PRACTICE.

Author: Dr. Shoeb Ahmed Ilyas BDS, MPH, EMSRHS, M.Phil (HHSM), MHRM, MS (PSY), MS

(BIOTECH), PGDMLE, F.H.T.A.

Health Care Quality Management Consultant

Ruby Med Plus, Telangana State, India.

E-mail: support@rubymedplus.com / shoebilyas@gmail.com

“The right patient, the right drug, the right dose, the right route, the right

time.”

“Problems cannot be solved by thinking within the framework in which the

problems were created.”

- Albert Einstein

INTRODUCTION

Today’s Dental Devices are often complex, which makes cleaning and re-sterilization

process more difficult and lead to a potentially high risk for cross infections and device

failure. In India, most instruments, in general dental practice, were designated as re-

usable. Re-sterilization of instruments used on one patient for reuse on another has been

common practice.

Single-use device, often called SUD, is a medical / dental device used only on one patient

for a single procedure. SUDs are classified as critical, semi-critical and non-critical

according to the set of criteria known as spaulding definitions. The use of disposable

instruments does not come without a significant cost to health care system as well as

environmental concerns. (5). Reprocessing of used instruments is becoming more and

more prevalent with overall goal of saving money and decreasing environmental

pollution. (4).

REVIEW OF LITERATUIRE

Burke and others found 93% of Dental practioners reused matrix bands on multiple

patients in their practices. (6).

Bagg and others found 88% of Dental practioners reused Endodontic files. (2)

Smith and others concluded that, cleaning methods used were insufficient to remove

the organic material on Endodontic files & suggested cost benefit analysis in

determining whether these files would be suitable for designation as SUDs. (7)

Nicholas J.V. Hogg and Archibald D. Morrison concluded that, classification of

Rotary instruments as SUDs can be considered if sterilization cannot be guaranteed

and Reuse of rotary instruments can be cost-effective measure in the practice of oral

and maxillofacial surgery if the safety of patients can be assured. (8)

CHALLENGES IN REUSE OF SUDs

INFORMED CONSENT

Law and Ethics requires Dentist to obtain informed consent by informing nature of

proposed treatment, benefits and material risk of dental procedure that would influence

the patient decision whether or not to proceed. The Dentist-based standard for disclosure

of information is based on a professional negligence theory and is cast in terms of the

dentist’s duty owed to the patient as measured by the standard of care in communicating

information about a proposed dental treatment. Under patient-based informed consent

standard, patients have the right to choose between a single use device (SUD) and reused

device.

LEGAL CHALLENGES

Dentist / dental hospital exposure to liability for reuse of dental SUDs would likely rest

on Theories of Malpractice, Vicarious Liability or Failure to obtain informed consent. A

Malpractice Suit might allege that, by permitting reuse of SUD Dental Hospital violated

reasonable standards of dental practice as the device stating/ labeling “SINGLE USE

ONLY”. Dental Hospitals, risk liability threats may also range from ethical issues to

employee safety and protocol development.

HEALTH AND SAFETY CHALLENGES

The contact of Endodontic files with peripheral branches of the trigeminal nerve may

present a risk of transmission of Creutzfeldt-Jakob Disease (CJD), although there is no

evidence of transmission of CJD in dentistry. (2,6). Department of Health Risk

Assessment for VCJD and Dentistry categorizes dentistry as “Low Risk” for potential

transmission of VCJD, possibility of infectivity in dental pulp tissue cannot be ruled out

as Endodontic files, coming in direct contact with pulp are especially difficult to clean.

Studies pointed at bacterial and viral contamination of dental instrumentation and safety

of sterilizing and re-using these instruments. (1)

Many dental practices lack infection control policies, surveillance system for reporting

dental errors and adverse events to detect infections and injuries from use of reprocessed

dental devices in general.

OTHER ISSUES

Lack of clear information from many manufacturers on safe decontamination, method of

sterilization of device, restrictions on number of reuses, validation of equipment used for

sterilization process. Many dental practices have no written policies for decontamination

and quality assurance, Training deficiencies in persons involved in reprocessing of dental

instruments, traceability of dental instruments, waste management and environmental

concerns.

REGULATORY ISSUES

Since 1996, safety and ethical considerations for reuse of single use devices were raised.

In India there are no guidelines either by FDA or DCI on reprocessing and reuse of SUDs

in clinical Dentistry and most Dental practices follow their own policies in this regard.

The US FDA re-examined its policy on the issue of reuse of Medical devices labeled for

single use and issued a guidance document on August 14, 2000, with primary goal of

protecting the health of public by assuring that the practice of reprocessing and reusing

SUDs is safe and effective and based on good science. Based on above recommendations,

a good reuse program should include following steps (3)

Perform cost analysis,

Develop policies and procedures

Implement quality system requirements, and

Maintain an employee training and Safety program.

Only two categories of SUDs require consideration for reprocessing:

Open and unused

Open and used.

Two different processes are required accordingly:

Reprocessing Repacking and Re-sterilizing are required for all items open and

unused.

Cleaning, packaging and sterilization are required for all items that are open and

used.

QUALITY ASSURANCE

Monitoring of control points and quality indicators, regular sampling and inspection of

devices and periodic review of factors that affect safety or function of reprocessed

devices.

The protocol includes subjective measurements like

VISUAL INSPECTION

After cleaning and before sterilizing Endodontic files and burs should be examined

visually for debris by means of Dissecting light microscope. The heat of sterilization

may act to fix residual material onto the surface of the file resulting in a vicious cycle,

if files are reused.

1. Use of Kastle-meyer test for detection of blood on surfaces of files and burs in

dilutions between 1:50,000 and 1: 100,000. Positive result is shown by development

of vivid pink color in 20 sec or less.

2. Crosschecking of sterilized devices with TODD-HEWITT BROTH Used for growth

of oral bacteria. Acceptable sterility assurance level (SAL) of at least 10-6 is required,

which means the probability of a microorganism surviving a sterilization process

cannot be greater than one in million.

3. MECHANICAL TESTS

Mechanical tests like tensile strength, torsional rigidity, flexibility and fatigue are

useful in determining function and integrity of the device and very important quality

assurance tool for Endodontic files. Breaking of Endodontic files in root canals will

lead to extra time of dentist for retrieval and psychological distress to patient and if

left un-informed to patient may lead to negligence and litigations.

4. TRACKING

All reprocessed items should be labeled correctly with description of manufacturer

name, catalog number, lot number by using tracking device and log book for

documentation purposes.

REFERENCES

1. Lewis DL, Arens M, Appleton SS, Nakashima K, Ryuj, Boe R k and others. Cross

contamination potential with dental equipment. Lancet 1992; 340 (8830): 12252-

4.

2. Bagg J, Sweeney CP, Roy KM, Sharp T, Smith A. Cross infection control

measures and treatment of patients at risk of Creutzfeldt Jakob disease in UK

general dental practice. Br. Dent J 2001; 191(2): 87-90.

Part II

“GROWTH OF ORAL HEALTH CARE EXPENDITURE IS A NORMATIVE ISSUE

REFLECTING THE VALUE JUDGEMNTS EXPRESSED BY ANY GIVEN

COUNTRY”

COST ANALYSIS

The first step in cost analysis is to determine the life cycle cost of a single item that has

been reused. This cost includes the item’s initial purchase cost, including administrative

cost plus reuse costs.

The Second step is to determine the real cost per use of the item by dividing the number

of reuses plus the initial use into the life cycle cost.

The cost per use for reused items can be compared with the cost of disposable devices

used one time. The difference between two costs is the savings achieved assuming that

every patient pays the same price. To annualize the total savings, the annual number of

uses of the device multiplies the savings achieved.

REUSE PROGRAMME COST CATEGORIES

1. DIRECT LABOUR

Wages and benefits to employees involved.

2. EDUCATION

Training Programmes and competency testing.

3. INDIRECT COSTS

Capital equipment costs.

Overhead.

Maintenance costs.

4. PURCHASE OF SUPPLIES FOR REPROCESSING

Costs of validation and quality assurance.

Liability insurance.

Administrative costs for preparing policies and protocols.

GUIDELINES FOR ASSESSING THE COST OF REUSE PROGRAMME FOR

DENTAL HOSPITAL BY A HPOTHETICAL ILLUSTRATION

Direct Labor Costs

Salary and benefits of one scientific assistant and one technician and one department

Helper involved in reprocessing of SUD per working day is calculated to be RS. 650/day.

Direct Material Cost

The materials used are:-

Disinfectants worth RS. 100/-Per day.

Medical grade paper for packing worth RS. 100/-per day.

One Ethylene Oxide cartridge/cycle worth RS. 250/-per day.

Biological indicator worth RS. 40/-per day.

Total costs = RS. 490/-per day

COST OF CAPITAL EQUIPMENT

EO sterilizer runs for six hours a day, which is equal to one cycle per day.

The Equipment cost and Depreciation,

The annual maintenance charges and

Electricity charges per day.

Total cost = 300/-per day.

OTHER COSTS

Administrative costs for preparing policies and protocols.

Laboratory teats and quality assurance programme

Training costs for technicians.

The cost of reprocessing event per day is calculated

Per day cost of one reprocessing cycle =

Direct labor+ Direct material+ cost of EO sterilizer running 6 hours

= (650+490+300) = 1440.

Approximated to RS. 1600/-per day

TOTAL COST OF REUSE PROGRAM PER YEAR

= 1600 Χ 300 working days

= 480000 + other costs referred above approximating 20,000

= RS. 500,000/- per reuse programme per year as a conservative approach.

EXAMPLE OF REUSE COST OF ROTATING BONE BUR/ ENDODONTIC FILE

(UNIT COST = 120/-)

Number of procedures performed with this SUD annually

= (50/week ×4×12)

This is equivalent to 2400 SUDs per year if each device is used only once.

The annual expenditure for this SUD without reuse programme

= (120 × 2400) = 288000. ………………………(1)

Calculations with Reuse programme

The number of SUDs of this type required initially for 2400 procedure per year if each

device is reused 2 more times (1+ 2 reuses) = p

P= 2400 ÷ 3 = 800

THE COST OF REPROCESSING THESE SUDs IS CALCULATED AS

FOLLOWS

Approximately 100 bone bur/ Endodontic files would be required to undergo the EO

sterilization in one cycle and the cost incurred in one such cycle is already calculated as

RS. 1600/- per reprocessing process.

The cost of reprocessing each SUD once = (1600 ÷ 100) = RS 16/-.

The per use cost of the reprocessed item is then calculated as follows

PER USE COST =

{Unit cost + (16 × Number of reuses per device)} ÷ total number of uses of the device ---

------------------------------------(2)

Peruse cost of reused device = {120+ (16 × 2)} ÷ 3 = RS. 50.66/-

The Annual device expenditure with a reuse programme is calculated

P {unit cost + (reprocessing cost per device × Number of reuses per device)}

= 800 {120 + (16 × 2)}

= 121600

The Annual Device Expenditure with a reuse programme is equal to RS.121600/-.

……………………. (3)

Comparing (1) and (3), the Annual savings to the Dental Hospital is RS.166400 .

Cost- Benefits

Reuse program is economical only if device is low priced item, frequently used or device

is costly and used in high volumes. Most of benefits associated with reuse program are

achieved in first reuse cycle, with successive reprocessing yields progressively lower

incremental savings and greater risk of adverse events.

The cost-Benefit analysis as done above shows Net gross profits, if dental hospitals

reprocess dental devices on large scale, hence it is not feasible for individual practices to

gain advantage from reprocessing of devices, which are difficult to clean. Most dental

practices do not have required reprocessing instruments due to Economic Disparity, size

of practice, lack of training in reprocessing, deficiency of trained technicians and quality

assurance hence it is feasible for them to send their devices to third party agents for

reprocessing by outsourcing.

Future strategy

Local IDA branches can establish standard CSSD facilities by employing certified or

trained technicians and individual dental practices can send their devices for reprocessing

at these facilities at low rates, based on the concept of Economies of scale and ensure

patient safety, low risk of cross infections and improve quality of dental procedures.

The competition created by SUD reprocessing at local centralized facilities by IDA local

branches will reduce the price of original device and better negotiation of prices by dental

hospitals.

SUD reprocessing must represent a balance between its regulatory obligations and proper

decision to reprocess, so that it may not pose significant risk to oral public health.

Recommendations

Proper listing of dental devices as SUDs.

Stressing dental manufacturers to give clear instructions on decontamination and

sterilization standards.

Guidance on commissioning, testing and maintenance of cleaning and sterilizing

equipments.

Written policies and procedures related to reprocessing procedure for each type of

dental device along with documentation of quality assurance, testing and

validation requirements to ensure both sterility and function of device.

Appropriate training to the staff involved in cleaning, reassembly and sterilization

with all reusable devices, according to manufacturer instructions. The instructions

can be retrieved and consulted by users.

Urgent need to formulate guidelines by regulatory bodies on these issues.

REFERENCES

Development of a program model to evaluate the potential for reuse of single use

medical devices: Results of a pilot study. Biomed Instrum Technol. 2002 Nov-Dec:

36(6): 389-404.

Dunn D. Reprocessing of single-use devices-the Ethical Dilemma.AORN J.2002; 75(5):

989-99.

Dunn D. Reprocessing of single-use devices-The equipment connection. AORN J 2002;

75(6); 143-58.

Lowe AH, Burke FJ, McHugh S, Bagg J.A survey of use of matrix bands and their

decontamination in general dental practice. Br Dent J 2002; 192(1); 40-2.

Smith A, Dickson M, Aitken J, Bagg J. Contaminated dental instruments. J Hosp Infect

2002; 51(3): 233-5.

Nicholas J.V.Hogg, Archibald D. Morrison. Resterilization of instruments used in a

Hospital-based Oral and Maxillofacial surgery clinic. J Can Dent Assoc 2005; 71 (3):

179-82.